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Prebiehajúce klinické skúšania na Slovensku

Filter onkologických klinických skúšaní na Slovensku


  • Otvorené klinické skúšanie fázy IIIb na zhodnotenie účinnosti adaptovaného postupu pre liečbu nežiaducich udalostí súvisiacich s pyrexiou počas adjuvantnej liečby dabrafenibom v kombinácii s trametinibom u pacientov s melanómom štádia III s BRAF V600 pozitívnou mutáciou po úplnej resekcii nádoru.
    Liečivo: Dabrafenib /DRB436/,Trametinib /TMT212/
    Diagnóza: Melanóm
    Kód skúšania: 2018-000168-27, CDRB436F2410
    Sponzor: Novartis Pharma AG

    Otvorené pre nábor: 2018-09-11
    Uzatvorené pre nábor: 2020-01-01
    Uzatvorené: 2021-08-30

    Pracoviská klinického skúšania:
    1. Názov: Onkologický ústav sv. Alžbety, s.r.o., Chemoterapeutická ambulancia I., Heydukova 10, 812 50 Bratislava
      Mesto: Bratislava
      Zodpovedný skúšajúci: MUDr. Milada Mikulová
    2. Názov: Východoslovenský onkologický ústav, a.s., Oddelenie klinickej onkológie, Rastislavova 43, 041 91 Košice
      Mesto: Košice
      Zodpovedný skúšajúci: MUDr. Mária Višňovská
  • Randomizované otvorené skúšanie fázy III kombinácií REGN2810 (protilátky proti PD-1), ipilimumabu (protilátky proti CTLA-4) a chemoterapie s platinovým dubletom v prvolíniovej liečbe pacientov s pokročilým alebo metastatickým nemalobunkovým karcinómom pľúc s nádormi exprimujúcimi PD-L1 < 50 %.
    Liečivo: cemiplimab /REGN2810/
    Diagnóza: Karcinóm pľúc
    Kód skúšania: 2017-001311-36, R2810-ONC-16113
    Sponzor: Regeneron Pharmaceuticals, Inc.

    Otvorené pre nábor: 2018-06-18
    Uzatvorené pre nábor: 2020-01-01
    Uzatvorené:

    Pracoviská klinického skúšania:
    1. Názov: Nemocnica s poliklinikou Štefana Kukuru Michalovce, a.s., Oddelenie onkológie a radioterapie, Špitálska 2, 071 01 Michalovce
      Mesto: Michalovce
      Zodpovedný skúšajúci: MUDr. Gabriela Hermanová, MPH
  • Randomizované, otvorené, multicentrické skúšanie fázy II./III. hodnotiace účinnosť a bezpečnosť rogaratinibu (BAY 1163877) v porovnaní s chemoterapiou u pacientov s FGFR-pozitívnym, lokálne pokročilým alebo metastatickým uroteliálnym karcinómom, ktorí boli predtým liečení chemoterapiou na báze platiny.
    Liečivo: BAY 1163877, rogaratinib
    Diagnóza: Urotelový karcinóm
    Kód skúšania: 2016-004340-11, 17403
    Sponzor: Bayer AG

    Otvorené pre nábor: 2018-03-16
    Uzatvorené pre nábor:
    Uzatvorené: 2020-01-16

    Pracoviská klinického skúšania:
    1. Názov: Národný onkologický ústav, Klenová 1, 833 10 Bratislava
      Mesto:
      Zodpovedný skúšajúci: MUDr., Bc. Patrik Palacka PhD., MPH, MBA, LL.M.
    2. Názov: POKO Poprad s.r.o., Mnoheľova 2, 058 01 Poprad
      Mesto: Poprad
      Zodpovedný skúšajúci: MUDr. Mária Rečková PhD.
    3. Názov: UROEXAM, spol. s.r.o., Urologická ambulancia, Špitálska 13, 949 01 Nitra
      Mesto: Nitra
      Zodpovedný skúšajúci: MUDr. Marek Brezovský PhD.
  • Multicentrické, randomizované, pre hodnotiteľa zaslepené, kontrolované skúšanie, v ktorom sa porovnáva výskyt závažných nežiaducich kardiovaskulárnych udalostí (MACE) u pacientov s karcinómom prostaty a kardiovaskulárnym ochorením užívajúcich degarelix (antagonista receptora pre GnRH) alebo leuprolid (agonista receptora pre GnRH).
    Liečivo: Degarelix
    Diagnóza: Karcinóm prostaty
    Kód skúšania: 2017-002495-20, 000108
    Sponzor: Ferring Pharmaceuticals A/S

    Otvorené pre nábor: 2018-02-15
    Uzatvorené pre nábor: 2020-01-01
    Uzatvorené: 2021-03-29

    Pracoviská klinického skúšania:
    1. Názov: CUIMED s.r.o., Urologická ambulancia, Strečianska 13, 851 05 Bratislava
      Mesto: Bratislava
      Zodpovedný skúšajúci: doc. MUDr. Frederico Manuel Goncalves, PhD.
    2. Názov: Fakultná nemocnica Nitra, Urologická ambulancia, Špitálska 6, 950 01 Nitra
      Mesto: Nitra
      Zodpovedný skúšajúci: MUDr. Michal Korček
    3. Názov: Fakultná nemocnica s poliklinikou Žilina, Urologické oddelenie, V. Spanyola 43, 012 07 Žilina
      Mesto: Žilina
      Zodpovedný skúšajúci: MUDr. Juraj Mikuláš, CSc
    4. Názov: MILAB, s.r.o., UROCENTRUM, Hollého 14/D, 080 01 Prešov
      Mesto: Prešov
      Zodpovedný skúšajúci: doc. MUDr. Ivan Minčík, PhD.
    5. Názov: MIRAMED s.r.o., Urologická ambulancia, P. Dobšinského 4380, 979 01 Rimavská Sobota
      Mesto: Rimavská Sobota
      Zodpovedný skúšajúci: MUDr. Obaidullah Mir
    6. Názov: Nemocnica Košice-Šaca a.s. 1. súkromná nemocnica, Urologická ambulancia, Lúčna 57, 040 15 Košice-Šaca
      Mesto: Košice-Šaca
      Zodpovedný skúšajúci: MUDr. Igor Milichovský
    7. Názov: Univerzitná nemocnica Martin, Urologická klinika, Kollárova 2, 036 59 Martin
      Mesto: Martin
      Zodpovedný skúšajúci: prof. MUDr. Ján Kliment, PhD.
    8. Názov: UROAMB s.r.o., Urologická ambulancia, Jilemnického 22, 031 01 Liptovský Mikuláš
      Mesto: Liptovský Mikuláš
      Zodpovedný skúšajúci: MUDr. Viktor Kováčik
    9. Názov: Urobet s.r.o., Urologická ambulancia, Duklianských hrdinov 34, 091 01 Malacky
      Mesto: Malacky
      Zodpovedný skúšajúci: MUDr. Peter Lendyel
    10. Názov: Urocentrum Bratislava s.r.o., Urologická ambulancia, Vajnorská 40, 832 63 Bratislava
      Mesto: Bratislava
      Zodpovedný skúšajúci: MUDr. Jozef Dubravický, MPH
    11. Názov: UROCENTRUM LEVICE s.r.o., Ambulancia urológie, onkológia v urológii, SNP č. 19, 934 01 Levice
      Mesto: Levice
      Zodpovedný skúšajúci: MUDr. Ladislav Macko
    12. Názov: UROCENTRUM ŠAĽA, s.r.o., Hlavná 6, 927 01 Šaľa
      Mesto: Šaľa
      Zodpovedný skúšajúci: MUDr. Richard Polák
    13. Názov: UROEXAM, spol. s.r.o., Urologická ambulancia, Špitálska 13, 949 01 Nitra
      Mesto: Nitra
      Zodpovedný skúšajúci: MUDr. Jozef Marko
    14. Názov: Východoslovenský onkologický ústav, a.s., Oddelenie radiačnej onkológie, Rastislavova 43, 041 91 Košice
      Mesto: Košice
      Zodpovedný skúšajúci: Doc. MUDr. Pavol Dubinský, PhD. MHA
    15. Názov: Železničná nemocnica s poliklinikou Košice, Urologická ambulancia, Masarykova 9, 040 01 Košice
      Mesto: Košice
      Zodpovedný skúšajúci: MUDr. Ivan Vargovčák
  • Otvorené, multicentrické, randomizované klinické skúšanie fázy III na zistenie účinnosti a bezpečnosti atezolizumabu v porovnaní s chemoterapiou u pacientov s doteraz neliečeným pokročilým alebo recidivujúcim (v štádiu IIIB, neprístupným pre multimodálnu liečbu) alebo metastatickým (v štádiu IV) nemalobunkovým karcinómom pľúc, pre ktorých sa liečba na báze platiny považuje za nevhodnú.
    Liečivo: atezolizumab, gemcitabin
    Diagnóza: Karcinóm pľúc
    Kód skúšania: 2015-004105-16, MO29872
    Sponzor: F. Hoffmann-La Roche Ltd

    Otvorené pre nábor: 2017-10-05
    Uzatvorené pre nábor: 2020-01-01
    Uzatvorené:

    Pracoviská klinického skúšania:
    1. Názov: Fakultná nemocnica Trnava, Onkologická klinika, ul. A. Žarnova 11, 917 75 Trnava
      Mesto: Trnava
      Zodpovedný skúšajúci: MUDr. Marián Streško, PhD.
    2. Názov: Špecializovaná nemocnica sv. Svorada Zobor, n,o., Oddelenie klinickej onkológie, Kláštorská 134, 949 88 Nitra
      Mesto: Nitra
      Zodpovedný skúšajúci: doc. MUDr. Peter Beržinec, PhD.
  • Randomizované klinické skúšanie fázy IIb, posudzujúce účinnosť a bezpečnosť kombinácie ublituximabu + TGR-1202 s alebo bez Bendamustinu a TGR-1202 samotného u pacientov v minulosti liečených pre Non-Hodgkinov lymfóm.
    Liečivo: ublituximab, TGR-1202 /Umbralisib/
    Diagnóza: Non-Hodgkinov lymfóm
    Kód skúšania: 2016-004718-90, UTX-TGR-205
    Sponzor: TG Therapeutics

    Otvorené pre nábor: 2017-11-09
    Uzatvorené pre nábor: 2019-04-11
    Uzatvorené: 2022-07-21

    Pracoviská klinického skúšania:
    1. Názov: POKO Poprad s.r.o., Mnoheľova 2, 058 01 Poprad
      Mesto: Poprad
      Zodpovedný skúšajúci: MUDr. Mária Rečková
  • Skúšanie fázy II skúmajúce bezpečnosť a účinnosť atezolizumabu podávaného v kombinácii s obinutuzumabom alebo rituximabom, terapiou cielenou proti antigénu CD20 u pacientov s recidivujúcim alebo refraktérnym lymfómom z plášťových buniek, lymfómom z marginálnej zóny a Waldenstromovou makroglobulinémiou.
    Liečivo: atezolizumab, obinutuzumab, rituximab
    Diagnóza: Non-Hodgkinov lymfóm
    Kód skúšania: 2016-003579-22, MO39107, TEGAR
    Sponzor: F. Hoffmann-La Roche Ltd

    Otvorené pre nábor: 2017-10-05
    Uzatvorené pre nábor: 2020-01-01
    Uzatvorené: 2021-04-26

    Pracoviská klinického skúšania:
  • Randomizované, dvojito zaslepené, kontrolované, multicentrické klinické skúšanie fázy III intravenózne podávaného inhibítoru PI3K copanlisibu v kombinácii so štandardnou imunochemoterapiou verzus štandardná imunochemoterapia u pacientov s recidivujúcim indolentným non-Hodgkinovým lymfómom (iNHL) - CHRONOS-4.
    Liečivo: copanlisib
    Diagnóza: Non-Hodgkinov lymfóm
    Kód skúšania: 2015-001088-38, BAY80-6946/17833
    Sponzor: Bayer AG

    Otvorené pre nábor: 2017-07-11
    Uzatvorené pre nábor: 2020-03-24
    Uzatvorené: 2022-04-02

    Pracoviská klinického skúšania:
    1. Názov: Národný onkologický ústav, Klinika onkohematológie LFUK a NOÚ, Oddelenie onkohematológie II., Klenová 1, 833 10 Bratislava
      Mesto: Bratislava
      Zodpovedný skúšajúci: MUDr. Andrej Vranovský
    2. Názov: Východoslovenský onkologický ústav, a.s., Oddelenie radiačnej onkológie, Rastislavova 43, 041 91 Košice
      Mesto: Košice
      Zodpovedný skúšajúci: MUDr. Martin Petrilák
  • Klinické skúšanie fázy Ib/IIa zamerané na bezpečnosť a farmakokinetiku produktu G1T28 u pacientov v minulosti liečených na malobunkový karcinóm pľúc (SCLC) v rozsiahlom štádiu, ktorým je podávaná chemoterapia topotekanom.
    Liečivo: G1T28 Di-HCI
    Diagnóza: Karcinóm pľúc
    Kód skúšania: 2016-004611-13, G1T28-03
    Sponzor: G1 Therapeutics

    Otvorené pre nábor: 2017-03-16
    Uzatvorené pre nábor: 2019-01-02
    Uzatvorené: 2019-05-31

    Pracoviská klinického skúšania:
    1. Názov: POKO Poprad s.r.o., Mnoheľova 2, 058 01 Poprad
      Mesto: Poprad
      Zodpovedný skúšajúci: MUDr. Juraj Beniak
    2. Názov: Východoslovenský onkologický ústav, a.s., Oddelenie klinickej onkológie, Rastislavova 43, 041 91 Košice
      Mesto: Košice
      Zodpovedný skúšajúci: doc. MUDr. Igor Andrašina, CSc
  • Fáza IIIb nezaslepeného klinického skúšania so včasnou dostupnosťou liekovej kombinácie trifluridín/tipiracil (S 95005/TAS-102) u pacientov s metastatickým kolorektálnym karcinómom po predchádzajúcej liečbe.
    Liečivo: trifluridine/tipiracil hydrochloride
    Diagnóza: Kolorektálny karcinóm
    Kód skúšania: 2016-002311-18, CL3-95005-004
    Sponzor: Laboratorios Servier S. L.

    Otvorené pre nábor: 2017-02-16
    Uzatvorené pre nábor: 2019-01-01
    Uzatvorené: 2019-11-18

    Pracoviská klinického skúšania:
    1. Názov: Onkologické centrum Univerzitná nemocnica Martin, Kollárova 2, 036 01 Martin
      Mesto: Martin
      Zodpovedný skúšajúci: MUDr. Zuzana Špaňová
    2. Názov: Onkologický ústav sv. Alžbety, s.r.o., Interná klinika VŚZ a SP a OÚSA, Heydukova 10, 812 50 Bratislava
      Mesto: Bratislava
      Zodpovedný skúšajúci: MUDr. Vanda Ušáková, PhD.
    3. Názov: Východoslovenský onkologický ústav, a.s., Oddelenie klinickej onkológie, Rastislavova 43, 041 91 Košice
      Mesto: Košice
      Zodpovedný skúšajúci: doc. MUDr. Igor Andrašina, PhD.
  • Randomizované, dvojito zaslepené, placebom kontrolované klinické skúšanie fázy III, hodnotiace účinnosť a bezpečnosť skúšaného produktu copanlisibu v kombinácii s rituximabom u pacientov s relabujúcim indolentným B-bunkovým non-Hodgkinovým lymfómom (iNHL) - CHRONOS-3.
    Liečivo: copanlisib
    Diagnóza: Non-Hodgkinov lymfóm
    Kód skúšania: 2013-003893-29, BAY80-6946/17067
    Sponzor: Bayer AG

    Otvorené pre nábor: 2016-08-22
    Uzatvorené pre nábor: 2019-12-17
    Uzatvorené:

    Pracoviská klinického skúšania:
    1. Názov: POKO Poprad s.r.o., Mnoheľova 2, 058 01 Poprad
      Mesto: Poprad
      Zodpovedný skúšajúci: MUDr. Juraj Beniak
  • Klinické skúšanie fázy II účinnosti gemcitabínu, karboplatiny a veliparibu (ABT-888) u refraktérnych germinatívnych nádorov.
    Liečivo: gemcitabine, carboplatin, veliparib
    Diagnóza: Germinatívny nádor semeníkov
    Kód skúšania: 2016-000171-24, GCTSK004
    Sponzor: Národný onkologický ústav

    Otvorené pre nábor: 2016-07-12
    Uzatvorené pre nábor: 2020-06-18
    Uzatvorené:

    Pracoviská klinického skúšania:
    1. Názov: Národný onkologický ústav, Klenová 1, 833 10 Bratislava
      Mesto:
      Zodpovedný skúšajúci: prof. MUDr. Michal Mego, DrSc.
  • Randomizované, dvojito zaslepené, placebom kontrolované, multicentrické klinické skúšanie fázy III, hodnotiace analgetickú účinnosť a bezpečnosť subkutánne podávaného skúšaného produktu tanezumab (PF-04383119) u účastníkov s nádorovou bolesťou prevažne v dôsledku kostných metastáz, užívajúcich základnú liečbu opiátmi.
    Liečivo: tanezumab
    Diagnóza: Nádorové ochorenia
    Kód skúšania: 2013-002223-42, A4091061
    Sponzor: Pfizer Inc.

    Otvorené pre nábor: 2015-12-11
    Uzatvorené pre nábor: 2020-07-23
    Uzatvorené: 2021-05-07

    Pracoviská klinického skúšania:
    1. Názov: DEMOMED s.r.o., Slovenská 11/a, 94034 Nové Zámky
      Mesto: Nové Zámky
      Zodpovedný skúšajúci: MUDr. Pavol Demo
    2. Názov: MUDr. Viliam Cibik, PhD., s.r.o., Slovak Research Center Team Member, Pruské 293, 018 52 Pruské
      Mesto: Pruské
      Zodpovedný skúšajúci: MUDr. Viliam Cíbik, PhD.
    3. Názov: Národný onkologický ústav, Klenová 1, 833 10 Bratislava
      Mesto:
      Zodpovedný skúšajúci: MUDr. Ľubomíra Nemčíková
  • Randomizované klinické skúšanie fázy III na vyhodnotenie účinnosti a bezpečnosti kombinácie enzalutamidu a leuprolidu, monoterapie enzalutamidom a kombinácie placeba a leuprolidu u mužov s vysokorizikovým nemetastatickým karcinómom prostaty progredujúcim po definitívnej liečbe.
    Liečivo: enzalutamide
    Diagnóza: Karcinóm prostaty
    Kód skúšania: 2014-001634-28, MDV3100-13
    Sponzor: Medivation, Inc., a wholly owned subsidiary of Pfizer Inc.

    Otvorené pre nábor: 2015-10-22
    Uzatvorené pre nábor: 2020-01-01
    Uzatvorené:

    Pracoviská klinického skúšania:
    1. Názov: CUIMED s.r.o., Urologická ambulancia, Strečianska 13, 851 05 Bratislava
      Mesto: Bratislava
      Zodpovedný skúšajúci: doc. MUDr. Frederico Manuel Goncalves, PhD.
    2. Názov: Fakultná nemocnica s poliklinikou Žilina, Urologické oddelenie, V. Spanyola 43, 012 07 Žilina
      Mesto: Žilina
      Zodpovedný skúšajúci: MUDr. Juraj Mikuláš, PhD.
    3. Názov: MILAB, s.r.o., UROCENTRUM, Hollého 14/D, 080 01 Prešov
      Mesto: Prešov
      Zodpovedný skúšajúci: doc. MUDr. Ivan Minčík, PhD.
    4. Názov: MIRAMED s.r.o., Urologická ambulancia, P. Dobšinského 4380, 979 01 Rimavská Sobota
      Mesto: Rimavská Sobota
      Zodpovedný skúšajúci: MUDr. Obaidullah Mir
    5. Názov: Nemocnica na okraji mesta, n.o., Onkologická ambulancia, Ul. Nová nemocnica 511, 958 01 Partizánske
      Mesto:
      Zodpovedný skúšajúci: MUDr. Alexandra Szabová
    6. Názov: Nemocnica Poprad a.s., Urologické oddelenie, Banícka 803/28, 058 45 Poprad
      Mesto: Poprad
      Zodpovedný skúšajúci: MUDr. Erik Chorvát
    7. Názov: Nemocnica s poliklinikou Štefana Kukuru Michalovce, a.s., Oddelenie onkológie a radioterapie, Špitálska 2, 071 01 Michalovce
      Mesto: Michalovce
      Zodpovedný skúšajúci: MUDr. Gabriela Hermanová
    8. Názov: Slovak Research Center- team member, PRIVÁTNA UROLOGICKÁ AMBULANCIA s.r.o., Piaristická 8/257, 911 01 Trenčín
      Mesto: Trenčín
      Zodpovedný skúšajúci: MUDr. Roman Sokol
    9. Názov: Univerzitná nemocnica Martin, Urologická klinika, Kollárova 2, 036 59 Martin
      Mesto: Martin
      Zodpovedný skúšajúci: prof. MUDr. Ján Kliment, PhD.
    10. Názov: UROCENTRUM LEVICE s.r.o., Ambulancia urológie, onkológia v urológii, SNP č. 19, 934 01 Levice
      Mesto: Levice
      Zodpovedný skúšajúci: MUDr. Ladislav Macko
    11. Názov: UROCENTRUM ŠAĽA, s.r.o., Hlavná 6, 927 01 Šaľa
      Mesto: Šaľa
      Zodpovedný skúšajúci: MUDr. Richard Polák
    12. Názov: UROEXAM, spol. s.r.o., Urologická ambulancia, Špitálska 13, 949 01 Nitra
      Mesto: Nitra
      Zodpovedný skúšajúci: MUDr. Jozef Marko
    13. Názov: Východoslovenský onkologický ústav, a.s., Oddelenie radiačnej onkológie, Rastislavova 43, 041 91 Košice
      Mesto: Košice
      Zodpovedný skúšajúci: doc. MUDr. Pavol Dubinský, PhD.
    14. Názov: Železničná nemocnica s poliklinikou Košice, Urologická ambulancia, Masarykova 9, 040 01 Košice
      Mesto: Košice
      Zodpovedný skúšajúci: MUDr. Marek Vargovčák
  • Liečebná stratégia 1-líniovej chemoterapie u pacientov s disseminovanými neseminomovými germinatívnymi tumormi s nepriaznivým poklesom nádorových markerov: klinické skúšanie fázy II-TIP
    Liečivo: ifosfamide
    Diagnóza: Germinatívny nádor semeníkov
    Kód skúšania: 2014-001270-33, GCTSK003
    Sponzor: Národný onkologický ústav

    Otvorené pre nábor: 2015-07-28
    Uzatvorené pre nábor: 2020-05-12
    Uzatvorené: 2021-06-01

    Pracoviská klinického skúšania:
    1. Názov: Národný onkologický ústav, Klenová 1, 833 10 Bratislava
      Mesto:
      Zodpovedný skúšajúci: prof. MUDr. Jozef Mardiak, PhD.
  • Štúdia fázy II s avelumabom u relabovaných/refraktérných testikulárych germinatívnych nádorov testis.
    Liečivo: avelumab
    Diagnóza: Germinatívny nádor semeníkov
    Kód skúšania: 2016-004632-38
    Sponzor: Národný onkologický ústav

    Otvorené pre nábor: 2017-11-09
    Uzatvorené pre nábor: 2019-01-02
    Uzatvorené: 2019-05-09

    Pracoviská klinického skúšania:
    1. Názov: Národný onkologický ústav, Klenová 1, 833 10 Bratislava
      Mesto:
      Zodpovedný skúšajúci: prof. MUDr. Michal Mego, DrSC.
  • Prevencia irinotekanom indukovanej hnačky použitím probiotík.
    Liečivo: PROBIO-FIX INUM®
    Diagnóza: Kolorektálny karcinóm
    Kód skúšania: biomedicínsky výskum, kód ProbioSk-5
    Sponzor: Národný onkologický ústav sponsor S&D Pharma SK s.r.o.
    Link:

    Otvorené pre nábor: 2016-06-30
    Uzatvorené pre nábor:
    Uzatvorené:

    Pracoviská klinického skúšania:
    1. Názov: Fakultná nemocnica Trnava, Onkologická klinika, ul. A. Žarnova 11, 917 75 Trnava
      Mesto: Trnava
      Zodpovedný skúšajúci: MUDr. Marián Streško, PhD.
    2. Názov: FNsP Trenčín, Onkologické oddelenie, Legionárska 28, 911 71 Trenčín
      Mesto: Trenčín
      Zodpovedný skúšajúci: MUDr. Branislav Bystrický
    3. Názov: Nemocnica s poliklinikou Štefana Kukuru Michalovce, a.s., Oddelenie onkológie a radioterapie, Špitálska 2, 071 01 Michalovce
      Mesto: Michalovce
      Zodpovedný skúšajúci: MUDr. Radovan Barilla, PhD.
    4. Názov: Nemocnica s poliklinikou Trebišov, a.s., Onkologická ambulancia, ul. SNP 1079/76, 075 01 Trebišov
      Mesto: Trebišov
      Zodpovedný skúšajúci: MUDr. Bibiana Brezinová
    5. Názov: NsP Sv. Jakuba, n.o., Bardejov, Onkologická ambulancia, ul. Sv. Jakuba 21, 085 01 Bardejov
      Mesto: Bardejov
      Zodpovedný skúšajúci: MUDr, Jozef Chovanec
    6. Názov: POKO Poprad s.r.o., Mnoheľova 2, 058 01 Poprad
      Mesto: Poprad
      Zodpovedný skúšajúci: MUDr. Mária Rečková, PhD.
    7. Názov: UNsP Milosrdní bratia, spol. s r.o., Oddelenie klinickej onkológie, Námestie SNP 10, 814 65 Bratislava
      Mesto: Bratislava
      Zodpovedný skúšajúci: MUDr. Vladimír Václav
    8. Názov: Východoslovenský onkologický ústav, a.s., Oddelenie klinickej onkológie, Rastislavova 43, 041 91 Košice
      Mesto: Košice
      Zodpovedný skúšajúci: doc. MUDr. Mária Wagnerová, CSc.
    9. Názov: Zdravspol, spol. s r.o., Onkologická ambulancia, Pevnostný rad 6, 945 01 Komárno
      Mesto: Komárno
      Zodpovedný skúšajúci: MUDr. Peter Konkolovský
  • Multicentrické, randomizované, dvojito zaslepené klinické skúšanie fázy III s atezolizumabom anti-PD- v kombinácii s paklitaxelom oproti placebu s paklitaxelom u pacientov s doteraz neliečeným, neoperovateľným, lokálne pokročilým, alebo metastatickým trojnásobne negatívnym karcinómom prsníka.
    Liečivo: atezolizumab
    Diagnóza: Karcinóm prsníka
    Kód skúšania: 2016-004024-29, MO39196
    Sponzor: F. Hoffman-La Roche Ltd.

    Otvorené pre nábor: 2017-04-24
    Uzatvorené pre nábor: 2019-07-11
    Uzatvorené: 2023-03-17

    Pracoviská klinického skúšania:
    1. Názov: FNsP Trenčín, Onkologické oddelenie, Legionárska 28, 911 71 Trenčín
      Mesto: Trenčín
      Zodpovedný skúšajúci: MUDr. Branislav Bystrický, PhD.
    2. Názov: Mammacentrum sv. Agáty Banská Bystrica, a.s., Tibora Andrašovana 46, 974 01 Banská Bystrica
      Mesto: Banská Bystrica
      Zodpovedný skúšajúci: MUDr. Etela Mišurová
    3. Názov: POKO Poprad s.r.o., Mnoheľova 2, 058 01 Poprad
      Mesto: Poprad
      Zodpovedný skúšajúci: MUDr. Marián Kakalejčík
  • Klinické skúšanie zamerané na vyhodnotenie účinnosti a bezpečnosti avelumabu podávaného v kombinácii s chemoterapiou s následnou udržiavacou liečbou avelumabom podávaným v kombinácii s talazoparibom u pacientok s predtým neliečeným karcinómom ovária v pokročilom štádiu.
    Liečivo: avelumab/talazoparib/bevacizumab/Carboplatina+ Paclitaxel
    Diagnóza: Karcinóm vaječníkov
    Kód skúšania: B9991030, 2017-004456-30
    Sponzor: Pfizer Luxembourgh SARL

    Otvorené pre nábor: 2018-09-13
    Uzatvorené pre nábor: 2019-03-20
    Uzatvorené: 2019-03-20

    Pracoviská klinického skúšania:
    1. Názov: Fakultná nemocnica s poliklinikou Žilina, Oddelenie klinickej a radiačnej onkológie, ul. Vojtecha Spanyola 43, Žilina
      Mesto: Žilina
      Zodpovedný skúšajúci: MUDr. Dagmar Sudeková
    2. Názov: Národný onkologický ústav, Klenová 1, 833 10 Bratislava
      Mesto:
      Zodpovedný skúšajúci: MUDr. Jozef Šufliarsky, PhD.
    3. Názov: Nemocnica na okraji mesta n.o., Ambulancia klinickej onkológie, Nová Nemocnica 511, 958 01 Partizánske
      Mesto: Partizánske
      Zodpovedný skúšajúci: MUDr. Alexandra Szabova
    4. Názov: Nemocnica s poliklinikou Štefana Kukuru Michalovce, a.s., Oddelenie onkológie a radioterapie, Špitálska 2, 071 01 Michalovce
      Mesto: Michalovce
      Zodpovedný skúšajúci: MUDr. Gabriela Hermanová
    5. Názov: NsP Sv. Jakuba, n.o., Bardejov, Onkologická ambulancia, ul. Sv. Jakuba 21, 085 01 Bardejov
      Mesto: Bardejov
      Zodpovedný skúšajúci: MUDr. Jozef Chovanec
    6. Názov: Onkologický ústav sv. Alžbety, s.r.o., Heydukova 10, 812 50 Bratislava
      Mesto:
      Zodpovedný skúšajúci: Doc. MUDr. Lýdia Heľpianska, CSc.
    7. Názov: POKO Poprad s.r.o., Mnoheľova 2, 058 01 Poprad
      Mesto: Poprad
      Zodpovedný skúšajúci: MUDr. Juraj Beniak
    8. Názov: Východoslovenský onkologický ústav, a.s., Rastislavova 43, 041 91 Košice
      Mesto:
      Zodpovedný skúšajúci: MUDr. Hana Garanová
  • Otvorené, multicentrické klinické skúšanie fázy IIIb na hodnotenie bezpečnosti a účinnosti midostaurínu (PKC412) u pacientov vo veku 18 rokov alebo starších s novodiagnostikovanou akútnou myeloidnou leukémiou (AML) s mutáciou FLT3, ktorí sú vhodní na "7+3" alebo "5+2" chemoterapiu.
    Liečivo: Midostaurin
    Diagnóza: Leukémia
    Kód skúšania: 2016-004440-12, CPKC412A2408
    Sponzor: Novartis Pharma AG

    Otvorené pre nábor: 2018-11-27
    Uzatvorené pre nábor: 2020-03-01
    Uzatvorené: 2020-04-14

    Pracoviská klinického skúšania:
    1. Názov: Fakultná nemocnica s poliklinikou F. D. Roosevelta, Hematologické oddelenie, Námestie L. Svobodu 1, 975 17 Banská Bystrica
      Mesto: Banská Bystrica
      Zodpovedný skúšajúci: MUDr. Monika Matejková
    2. Názov: Národný onkologický ústav, Klenová 1, 833 10 Bratislava
      Mesto:
      Zodpovedný skúšajúci: MUDr. Ľudmila Demitrovičová, PhD.
    3. Názov: Univerzitná nemocnica Bratislava, Nemocnica sv. Cyrila a Metoda, Klinika hematológie a trasfuziológie LF UK SZU a UNB, Antolská 11, 851 07, Bratislava
      Mesto: Bratislava
      Zodpovedný skúšajúci: MUDr. Firas Farkaš, PhD.
    4. Názov: Univerzitná nemocnica Martin, Klinika hematológie a transfuziológie, Kollárova 2, 036 59 Martin
      Mesto: Martin
      Zodpovedný skúšajúci: MUDr. Ivana Plameňová, PhD.
  • Odslepené, multicentrické, randomizované skúšanie 3. fázy na preskúmanie účinnosti a bezpečnosti BGB-A317 (protilátky proti PD1) v porovnaní s docetaxelom u pacientov s nemalobunkovým karcinómom pľúc s progresiou po predchádzajúcom liečebnom režime na báze platiny
    Liečivo: Tislelizumab (BGB-A317)
    Diagnóza: Karcinóm pľúc
    Kód skúšania: 2018-000245-39, BGB-A317-303
    Sponzor: BeiGene Ltd.

    Otvorené pre nábor: 2018-06-21
    Uzatvorené pre nábor:
    Uzatvorené:

    Pracoviská klinického skúšania:
  • Otvorené klinické skúšanie vzájomnej liekovej interakcie vo fáze 1 na stanovenie účinku produktu Rucaparib na farmakokinetiku Rosuvastatínu podávaného perorálne (rameno A) a perorálnej antikoncepcie (etinylestradiol a levonorgestrel) (rameno B) u pacientov s pokročilými solídnymi nádormi
    Liečivo: Rucaparib, Rosuvastatin, Levonorg./Eth.
    Diagnóza: Nádorové ochorenia
    Kód skúšania: 2018-000884-98, CO-338-095
    Sponzor:
    Link:

    Otvorené pre nábor: 2019-03-12
    Uzatvorené pre nábor: 2020-01-01
    Uzatvorené: 2021-06-09

    Pracoviská klinického skúšania:
    1. Názov: Summit Clinical Research, s.r.o., Bárdošova 2/A, Bratislava
      Mesto: Bratislava
      Zodpovedný skúšajúci: MUDr. Bc. Viera Skarbová
  • Dvojdielne, otvorené, randomizované, klinické skúšanie fázy II/III na porovnanie Dinutuximabu a Irinotecanu s Irinotecanom ako liečby druhej línie u účastníkov s relapsujúcim alebo refraktérnym malobunkovým karcinómom pľúc
    Liečivo: dinutuximab
    Diagnóza: Karcinóm pľúc
    Kód skúšania: 2017-000758-20, DIV-SCLC-301
    Sponzor: United Therapeutics Corporation

    Otvorené pre nábor: 2018-04-20
    Uzatvorené pre nábor: 2020-01-02
    Uzatvorené: 2020-02-26

    Pracoviská klinického skúšania:
    1. Názov: Fakultná nemocnica s poliklinikou Žilina, Oddelenie klinickej a radiačnej onkológie, ul. Vojtecha Spanyola 43, Žilina
      Mesto: Žilina
      Zodpovedný skúšajúci: MUDr. Dagmar Sudeková
  • Klinické skúšanie fázy II: Cisplatina + disulfiram u pacientov s relapsom germinatívneho tumoru.
    Liečivo: disulfiram + cisplatina
    Diagnóza: Germinatívny nádor semeníkov
    Kód skúšania: 2019-000558-68, GCTSK006
    Sponzor: Národný onkologický ústav

    Otvorené pre nábor: 2019-05-03
    Uzatvorené pre nábor:
    Uzatvorené: 2021-12-13

    Pracoviská klinického skúšania:
    1. Názov: Národný onkologický ústav, Klenová 1, 833 10 Bratislava
      Mesto:
      Zodpovedný skúšajúci: prof. MUDr. Michal Mego, DrSC.
  • Randomizované, dvojito zaslepené, placebom kontrolované klinické skúšanie fázy III na zhodnotenie účinnosti a bezpečnosti pembrolizumabu v kombinácii s chemoterapiou dubletom na báze platiny s alebo bez kanakinumabu v prvolíniovej liečbe pacientov s lokálne pokročilým alebo metastatickým neskvamóznym a skvamóznym nemalobunkovým karcinómom pľúc (CANOPY-1)
    Liečivo: canakinumab + pembrolizumab
    Diagnóza: Karcinóm pľúc
    Kód skúšania: 2018-001547-32, NCT03631199 CACZ885U2301, CANOPY-1
    Sponzor: Novartis Pharma AG

    Otvorené pre nábor: 2019-02-25
    Uzatvorené pre nábor: 2019-12-09
    Uzatvorené:

    Pracoviská klinického skúšania:
    1. Názov: Nemocnica na okraji mesta n.o., Ambulancia klinickej onkológie, Nová Nemocnica 511, 958 01 Partizánske
      Mesto: Partizánske
      Zodpovedný skúšajúci: MUDr. Alexandra Szabová
  • Randomizované, multicentrické, otvorené skúšanie vo fáze 3 na porovnanie účinnosti a bezpečnosti liečby acalabrutinibom (ACP-196) v kombinácii s venetoklaxom a s/bez obinutuzumabu v porovnaní s chemoimunoterapiou podľa voľby skúšajúceho lekára u pacientov s doteraz neliečenou chronickou lymfocytovou leukémiou (CLL) bez delécie 17p alebo mutácie TP53
    Liečivo: Acalabrutinib (ACP-196),Obinutuzumab, Venetoklax
    Diagnóza: Leukémia
    Kód skúšania: 2018-002443-28, ACE-CL-311/D8221C00001
    Sponzor: Acerta Pharma B.V.

    Otvorené pre nábor: 2019-06-07
    Uzatvorené pre nábor: 2021-05-01
    Uzatvorené:

    Pracoviská klinického skúšania:
    1. Názov: Národný onkologický ústav, Klinika onkohematológie LFUK a NOÚ, Oddelenie onkohematológie II., Klenová 1, 833 10 Bratislava
      Mesto: Bratislava
      Zodpovedný skúšajúci: MUDr. Eva Mikušková, PhD.
  • Randomizované, dvojito-zaslepené, placebom kontrolované, multicentrické klinické skúšanie vo fáze III na porovnanie liečby olaparibom + abiraterónom oproti placebu + abiraterónu v prvej línii u mužov s metastatickým kastračne rezistentným karcinómom prostaty.
    Liečivo: Olaparib + abiraterón
    Diagnóza: Karcinóm prostaty
    Kód skúšania: 2018-002011-10, D081SC00001
    Sponzor: AstraZeneca AB

    Otvorené pre nábor: 2018-11-20
    Uzatvorené pre nábor: 2020-01-01
    Uzatvorené:

    Pracoviská klinického skúšania:
    1. Názov: CUIMED s.r.o., Urologická ambulancia, Strečianska 13, 851 05 Bratislava
      Mesto: Bratislava
      Zodpovedný skúšajúci: Doc. MUDr. Federico Goncalves, PhD
    2. Názov: MILAB, s.r.o., UROCENTRUM, Hollého 14/D, 080 01 Prešov
      Mesto: Prešov
      Zodpovedný skúšajúci: MUDr. Ivan Minčík, PhD.
    3. Názov: Privátna Urologická Ambulancia s.r.o., Piaristická ul č. 8, 911 01 Trenčín
      Mesto: Trenčín
      Zodpovedný skúšajúci: MUDr. Roman Sokol MPH
    4. Názov: UROCENTRUM ŠAĽA, s.r.o., Hlavná 6, 927 01 Šaľa
      Mesto: Šaľa
      Zodpovedný skúšajúci: MUDr. Richard Polák
    5. Názov: UROEXAM, spol. s.r.o., Urologická ambulancia, Špitálska 13, 949 01 Nitra
      Mesto: Nitra
      Zodpovedný skúšajúci: MUDr. Marek Brezovský, PhD.
  • Medzinárodné, multicentrické, randomizované dvojito zaslepené placebom kontrolované klinické skúšanie na posúdenie účinnosti a bezpečnosti lieku BCD-100 v kombinácii s pemetrexed+Cisplatina/Karboplatina oproti Placebu v kombinácii s Pemetrexed+Cisplatina/Karboplatina ako prvej línie liečby u pacientov s pokročilým štádiom neskvamóznej nemalobunkovej rakoviny pľúc (NSCLC).
    Liečivo: BCD-100 (PROLGOLIMAB, anti-PD-1 monoklonálna protilátka)
    Diagnóza: Karcinóm pľúc
    Kód skúšania: BCD-100-3/ DOMAJOR, 2018-004791-36
    Sponzor: JSC BIOCAD SANACLIS

    Otvorené pre nábor: 2019-09-09
    Uzatvorené pre nábor: 2021-11-16
    Uzatvorené:

    Pracoviská klinického skúšania:
    1. Názov: Fakultná nemocnica s poliklinikou Žilina, Oddelenie klinickej a radiačnej onkológie, ul. Vojtecha Spanyola 43, Žilina
      Mesto: Žilina
      Zodpovedný skúšajúci: MUDr. Dagmar Sudeková
    2. Názov: Nemocnica na okraji mesta n.o., Ambulancia klinickej onkológie, Nová Nemocnica 511, 958 01 Partizánske
      Mesto: Partizánske
      Zodpovedný skúšajúci: MUDr. Alexandra Szabová
    3. Názov: NsP Sv. Jakuba, n.o., Bardejov, Onkologická ambulancia, ul. Sv. Jakuba 21, 085 01 Bardejov
      Mesto: Bardejov
      Zodpovedný skúšajúci: MUDr. Jozef Chovanec
    4. Názov: NsP Štefana Kukuru Michalovce, a.s., Ambulancia klinickej onkológie, Špitálska 2, 071 01 Michalovce
      Mesto: Michalovce
      Zodpovedný skúšajúci: MUDr. Gabriela Hermanová, MPH
  • Medzinárodný liečebný protokol pre deti a adolescentov s akútnou lymfoblastovou leukémiou
    Liečivo: Blinatumomab, Bortezomib
    Diagnóza: Leukémia
    Kód skúšania: 2016-001935-12, AIEOP-BFM_ALL_2017
    Sponzor: Universitätsklinikum Schleswig-Holstein, Campus Kiel
    Kritéria:

    Inclusion Criteria:

    newly diagnosed acute lymphoblastic leukemia or
    newly diagnosed mixed phenotype acute leukemia (MPAL) meeting one of the following criteria:
    biphenotypic with a dominant T or B lineage assignment
    bilineal either with a dominant lymphoblastic population or if another reasonable rationale exists to treat the patient with an ALL-based therapy regimen
    newly diagnosed acute undifferentiated leukemia
    age < 18 years (up to 17 years and 365 days) at the day of diagnosis
    patient enrolled in a participating center
    written informed consent to trial participation and transfer and processing of data A subsequent removal from the study is only allowed if the inclusion criteria turn out not to be fulfilled or in the case of pregnancy of the patient.
    Exclusion Criteria:

    Ph+ (BCR-ABL1 or t(9;22)-positive) ALL
    bilineal leukemia with a lymphoblastic and a separate non-lymphoblastic (≥ 10% of total cells) blast subset
    pre-treatment with cytostatic drugs
    glucocorticoid pre-treatment with ≥ 1 mg/kg/d for more than two weeks during the last month before diagnosis
    treatment started according to another protocol
    underlying disease that does not allow treatment according to the protocol (e.g. severe congenital heart disease, Charcot-Marie Syndrome, Ataxia-teleangiectasia…)
    ALL diagnosed as second malignancy and preceding chemotherapy and/or radiotherapy
    evidence of pregnancy or lactation period
    Sexually active adolescents not willing to use highly effective contraceptive method (pearl index <1) until 12 months after end of anti-leukemic therapy
    participation in another clinical trial except for add-on trials within the scope of supportive care approved by the sponsor
    live vaccine immunization within 2 weeks before start of protocol treatment


    Otvorené pre nábor: 2019-02-14
    Uzatvorené pre nábor:
    Uzatvorené:

    Pracoviská klinického skúšania:
    1. Názov: Detská fakultná nemocnica Košice, Oddelenie detskej onkológie a hematológie, Trieda SNP 1, Košice
      Mesto: Košice
      Zodpovedný skúšajúci: MUDr Natália Galóová
    2. Názov: Detská fakultná nemocnica s poliklinikou Banská Bystrica, Klinika pediatrickej onkológie a hematológie SZU, Námestie L. Svobodu 4, Banská Bystrica
      Mesto: Banská Bystrica
      Zodpovedný skúšajúci: MUDr. Eva Bubanská, PhD.
    3. Názov: Národný ústav detských chorôb, Klinika detskej hematológie a onkológie LF UK a NÚDCH, Limbová 1, Bratislava
      Mesto: Bratislava
      Zodpovedný skúšajúci: prof. MUDr. Kolenová Alexandra, PhD.
  • Prospektívna multicentrická štúdia fázy II deeskalácie primárnej chemorádioterapie skvamocelulárnych karcinómov orofaryngu (OPC) asociovaných s ľudským papiloma vírusom (HPV)
    Liečivo: Cisplatina
    Diagnóza: Nádory hlavy a krku
    Kód skúšania: 2019-003058-10, NADEJ201901, NáDej
    Sponzor: VÝCHODOSLOVENSKÝ ONKOLOGICKÝ ÚSTAV, a.s.
    Kritéria:

    Principal inclusion criteria
    • Oropharyngeal squamous cell carcinoma
    • Positivity of p16 by imunohistochemistry
    • Clinical stage T1-T2, N1-N2c or T3, N2-N2c, UICC 8th edition without distant metastases
    • The lifetime cumulative history of smoking cannot exceed 20 packages / years
    • WHO status 0-1
    • Age ≥ 18 years
    • Both genders
    • Hemoglobin ≥ 10 g/l
    • Platelets ≥1 00x 10x9/l
    • Neutrophils ≥ 1,5 x 10x9/l
    • Adequate renal functions enable one-week therapy of cisplatina
    • Bilirubin, AST or ALT 3x upper limit of norm
    • Negative pregnancy test
    • Signed informed consent
    • Slovak language
    • Diagnóza skvamocelulárneho karcinómu (SCC) orofaryngu
    • Pozitivita odobratého tkaniva p16 imunohistochemickým vyšetrením
    • Klinické štádium T1-T2, N1-N2c alebo T3, N2-N2c, UICC 8. vydanie bez vzdialených metastáz
    • Celková celoživotná história fajčenia nesmie prekročiť 20 balení / rokov
    • WHO výkonnostný stav 0-1
    • Vek ≥ 18 rokov
    • Obe pohlavia
    • Hemoglobín ≥ 10 g/l
    • Trombocyty ≥1 00x 10x9/l
    • Neutrofily ≥ 1,5 x 10x9/l
    • Adekvátne renálne funkcie umožňujúce podanie týždennej cisplatiny
    • Bilirubín, AST alebo ALT ˂ 3x vyšší limit normy
    • Negatívny test tehotenstva u fertilných žien
    • Podpísaný informovaný súhlas

    Principal exclusion criteria
    • Tumor in the oral cavity or in nasopharynx or in the hypopharynx or larynx if the p16 is also positive
    • Tumor of unknown origin (p16 positivity too)
    • Simultaneous tumors
    • Patients with invasive malignancy (except non-melanoma skin cancer) and a history of tumor diagnosis less than 3 years
    • Previous radiotherapy in the head and neck area to overlap the irradiated volume
    • Unstable angina or congestive heart failure requiring hospitalization for the last 6 months
    • Transmural myocardial infarction last 6 months
    • Active infection requiring i.v. antibiotics at the time of registration
    • Chronic obstructive bronchoplumonal disease with exacerbation or other respiratory disease requiring hospitalization or postponement of study treatment within 30 days of enrollment
    • Hepatic insufficiency with clinical jaundice and impaired coagulation
    • Active AIDS disease, but the protocol does not require HIV testing
    • Pregnancy
    • Previous allergic reaction to cisplatin
    • Nádor nachádzajúci sa v ústnej dutine alebo v nosohltane alebo v hypofaryngu alebo laryngu ak je aj p16 pozitívny
    • Karcinóm neznámeho pôvodu na krku (aj ak je p16 pozitívny)
    • Simultánne nádory
    • Pacienti s invazívnou malignitou (okrem nemelanómového karcinómu kože) a anamnézou diagnózy nádoru kratšou ako 3 roky
    • Predchádzajúca rádioterapia v oblasti hlavy a krku, ktorá by znamenala prekrývanie ožarovaného objemu
    • Nestabilná angína alebo kongestívne zlyhanie srdca vyžadujúce si hospitalizáciu posledných 6 mesiacov
    • Transmurálny infarkt myokardu posledných 6 mesiacov
    • Aktívna infekcia vyžadujúca si i.v. antibiotiká v čase registrácie
    • Chronická obštrukčná bronchoplumonálna choroba s exacerbáciou alebo iné respiračné ochorenie vyžadujúce si hospitalizáciu alebo odloženie štúdiovej liečby v rámci 30 dní pri registrácii
    • Hepatálna insufiencia s klinickou žltačkou a porušenou koaguláciou
    • Aktívne ochorenie AIDS, avšak protokol si HIV testovanie nevyžaduje
    • Tehotenstvo
    • Predchádzajúca alergická reakcia na cisplatinu


    Otvorené pre nábor: 2019-11-21
    Uzatvorené pre nábor: 2023-12-04
    Uzatvorené:

    Pracoviská klinického skúšania:
    1. Názov: Ústredná vojenská nemocnica SNP Ružomberok - Fakultná nemocnica, Klinika radiačnej a klinickej onkológie, Považská 2, Ružomberok
      Mesto: Ružomberok
      Zodpovedný skúšajúci: MUDr. Michaela Švajdová
    2. Názov: Východoslovenský onkologický ústav, a.s., Oddelenie radiačnej onkológie, Rastislavova 43, 041 91 Košice
      Mesto: Košice
      Zodpovedný skúšajúci: doc. MUDr. Pavol Dubinský, PhD., MHA
      Referovať pacienta do klinického skúšania
    3. Názov: Národný onkologický ústav, Oddelenie radiačnej onkológie, Klenová 1, Bratislava
      Mesto: Bratislava
      Zodpovedný skúšajúci: MUDr. PhD. Margita Pobijáková
  • Klinické skúšanie fázy II: Vinorelbín+ Cisplatina + disulfiram a meď u pacientov CTC_EMT pozitívnym metastatickým karcinómom prsníka
    Liečivo: Disulfiramum,Cisplatina, Vinorelbine
    Diagnóza: Karcinóm prsníka
    Kód skúšania: 2019-001957-16, BREAST-SK-001
    Sponzor: Národný onkologický ústav

    Otvorené pre nábor: 2019-10-31
    Uzatvorené pre nábor:
    Uzatvorené: 2021-12-13

    Pracoviská klinického skúšania:
    1. Názov: Národný onkologický ústav, II. Onkologická klinika LFUK a NOÚ, Klinika klinickej onkológie SZU a NOÚ, Klenová 1, 833 10 Bratislava
      Mesto: Bratislava
      Zodpovedný skúšajúci: Prof. MUDr. Michal Mego, DrSc.
  • Cielená liečba pokročilého Hodgkinovho lymfómu prispôsobená podľa veľmi skorej odpovede podľa FDG-PET: skúšanie fázy II s jedným ramenom
    Liečivo: Brentuximab, Vedotin,Doxorubicin,Vinblast
    Diagnóza: Hodgkinov lymfóm
    Kód skúšania: 2017-000498-35, EORTC-1537-LYMG, COBRA
    Sponzor: European Organisation for Research and Treatment of Cancer (EORTC)
    Kritéria:

    Inclusion Criteria:

    Previously untreated, histologically proven classical Hodgkin lymphoma;
    Staged by PET with diagnostic-quality CT (i.v. contrast).
    Clinical stages according to Lugano 2014 and based on FDG/PET CT:
    Stage IIB with large mediastinal mass > 1/3 max transverse diameter thorax and/or extranodal lesion(s)
    Stage III - IV
    Consent to participation in translational research:
    Archival tumor tissue available (15 blank formalin fixed paraffin embedded tissue samples mounted on APES slides or a tissue block).
    Women of child bearing potential (WOCBP) must have a negative serum pregnancy test within 72 hours prior to the first dose of study treatment.
    Patients of childbearing / reproductive potential should use adequate birth control measures, as defined by the investigator, during the study treatment period and for at least 6 months after the last dose of treatment. A highly effective method of birth control is defined as a method which results in a low failure rate (i.e. less than 1 percent per year) when used consistently and correctly.
    Female subjects who are breast feeding should discontinue nursing prior to the first dose of study treatment and until 6 months after the last study treatment.
    Absence of any medical, psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial
    Before patient registration, written informed consent must be given according to ICH/GCP, and national/local regulations.

    Exclusion Criteria:
    Known cerebral or meningeal disease (HL or any other etiology), including signs or symptoms of Progressive Multifocal Leukoencenphalopathy
    Symptomatic neurologic disease compromising normal activities of daily living or requiring medications
    Sensory or motor peripheral neuropathy greater than or equal to grade 2 according to CTCAE version 4.0
    Any of the following cardiovascular conditions or values:
    within 6 months before registration:
    A left-ventricular ejection fraction <50 percent (at registration)
    New York Heart Association (NYHA) Class III or IV heart failure.
    Evidence of current uncontrolled cardiovascular conditions, including cardiac arrhythmias, congestive heart failure (CHF), angina, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities
    symptomatic coronary heart disease (stable angina pectoris is allowed)
    severe uncontrolled hypertension within 2 years before registration
    Myocardial infarction
    Patients with poorly controlled diabetes mellitus (HbA1c > 7.5 percent or a fasting blood sugar > 200 mg/dL).
    Any active systemic viral, bacterial, or fungal infection requiring systemic antibiotics within 2 weeks prior to registration.
    Known HIV infection, chronic active hepatitis C, HBV positivity (HBsAg + patients; HBsAg -/HBcAb+/HBV DNA+ patients).
    Note: HBsAg-/HBV DNA - patients are eligible; patients who are seropositive due to vaccination are eligible
    Concomitant or previous malignancies within the past 5 years with the exception of adequately treated carcinoma in situ of the cervix , nonmelanoma skin cancer.
    Previous treatment with anti CD30 antibodies
    Known hypersensitivity to any excipient contained in Brentuximab Vedotin formulation and other study drugs. Refer to Summary Product Characteristics for list of excipients.
    Concurrent anti-cancer treatment or use of any investigational agent(s)


    Otvorené pre nábor: 2019-08-23
    Uzatvorené pre nábor: 2023-11-21
    Uzatvorené:

    Pracoviská klinického skúšania:
    1. Názov: Národný onkologický ústav, Klinika onkohematológie LFUK a NOÚ, Oddelenie onkohematológie II., Klenová 1, 833 10 Bratislava
      Mesto: Bratislava
      Zodpovedný skúšajúci: MUDr Andrej Vranovský
  • Otvorené, randomizované klinické skúšanie fázy III porovnávajúce trifluridín/tipiracil (S 95005) v kombinácii s bevacizumabom oproti kapecitabínu v kombinácii s bevacizumabom v prvej línii liečby u pacientov s metastatickým kolorektálnym karcinómom, pre ktorých nie je vhodná intenzívna terapia (klinické skúšanie SOLSTICE)
    Liečivo: Trifluridine/Tipiracil Hydrochloride, Bevacizumab, Kapecitabín
    Diagnóza: Kolorektálny karcinóm
    Kód skúšania: 2017-004059-22, CL3-95005-006, SOLSTICE
    Sponzor: I.R.I.S. (Institut de Recherches Internationales Servier)

    Otvorené pre nábor: 2019-04-29
    Uzatvorené pre nábor: 2020-08-01
    Uzatvorené: 2022-12-05

    Pracoviská klinického skúšania:
    1. Názov: NsP Štefana Kukuru Michalovce, a.s., Ambulancia klinickej onkológie, Špitálska 2, 071 01 Michalovce
      Mesto: Michalovce
      Zodpovedný skúšajúci: MUDr. Gabriela Hermanová, MPH.
    2. Názov: Ústredná vojenská nemocnica SNP Ružomberok - Fakultná nemocnica, Klinika radiačnej a klinickej onkológie, Považská 2, Ružomberok
      Mesto: Ružomberok
      Zodpovedný skúšajúci: MUDr. Roman Podoba, PhD.
    3. Názov: Východoslovenský onkologický ústav, a.s., Oddelenie klinickej onkológie, Rastislavova 43, 041 91 Košice
      Mesto: Košice
      Zodpovedný skúšajúci: doc. MUDr. Igor Andrašina, CSc.
    4. Názov: Všeobecná nemocnica s poliklinikou Levoča, a.s., Onkologická ambulancia, Probstnerova cesta 2/3082, Levoča
      Mesto: Levoča
      Zodpovedný skúšajúci: MUDr. Valér Kováč, PhD.
  • LBL 2018 - Medzinárodný kooperatívny liečebný protokol pre deti a adolescentov s lymfoblastovým lymfómom
    Liečivo: CYCLOPHOSPHAMIDE, DEXAMETHASONE + ďalšie
    Diagnóza: Non-Hodgkinov lymfóm
    Kód skúšania: 2017-001691-39, UKM17_0023, LBL 2018
    Sponzor: Universitätsklinikum Münster, NHL-BFM study center, Germany
    Kritéria:

    Inclusion criteria:

    newly diagnosed lymphoblastic lymphoma
    age <18 years
    patient enrolled in a participating center
    written informed consent of patient (>14 years of age or according to local law and regulation) and parents to trial participation and transfer and processing of data
    willingness of patients and the investigator/pathologist to provide adequate slides/blocks for reference (molecular) pathology and international pathology panel and/or fresh or fresh frozen samples for genetic risk group stratification if these samples are available after standard diagnostic procedures.

    Exclusion criteria:
    lymphoblastic lymphoma as secondary malignancy
    non-lymphoma related relevant medical, psychiatric or social conditions incompatible with trial treatment, including among others
    prior organ transplant
    severe immunodeficiency
    demyelinating Charcot-Marie Tooth syndrome
    serious acute or chronic infections, such as HIV, VZV and tuberculosis
    urinary tract infection, cystitis, urinary outflow obstruction, severe renal impairment (creatinine clearance less than 20 ml/min)
    severe hepatic impairment (bilirubin >3 times ULN, transaminases >10 times ULN)
    myocardial insufficiency, severe arrhythmias
    ulcers of the oral cavity and known active gastrointestinal ulcer disease
    known hypersensitivity to any IMP and to any excipient (listed in section 6.1 of the respective SmPC)
    steroid pre-treatment with ≥ 1 mg/kg/d for more than two weeks during the last month before diagnosis
    vaccination with live vaccines within 2 weeks before start of protocol treatment
    treatment started according to another protocol or pre-treatment with cytostatic drugs
    participation in another clinical trial that interferes with the protocol, except NHL-BFM Registry 2012 and trials with different endpoints, involving aspects of supportive treatment, which can run parallel to LBL 2018 without influencing the outcome of this trial (e.g. trials on antiemetics, antibiotics, strategies for psychosocial support)
    evidence of pregnancy or lactation period
    sexually active adolescents not willing to use highly effective contraceptive method (pearl index < 1) until 12 months after end of cytostatic therapy


    Otvorené pre nábor: 2020-01-08
    Uzatvorené pre nábor:
    Uzatvorené:

    Pracoviská klinického skúšania:
    1. Názov: Detská fakultná nemocnica Košice, Oddelenie detskej onkológie a hematológie, Trieda SNP 1, Košice
      Mesto: Košice
      Zodpovedný skúšajúci: MUDr. Natália Galóová
    2. Názov: Detská fakultná nemocnica s poliklinikou Banská Bystrica, Klinika pediatrickej onkológie a hematológie SZU, Námestie L. Svobodu 4, Banská Bystrica
      Mesto: Banská Bystrica
      Zodpovedný skúšajúci: MUDr. Eva Bubanská, PhD.
    3. Názov: Národný ústav detských chorôb, Klinika detskej hematológie a onkológie LF UK a NÚDCH, Limbová 1, Bratislava
      Mesto: Bratislava
      Zodpovedný skúšajúci: MUDr. Andrea Hrašková
  • Otvorené, multicentrické, rozširujúce klinické skúšanie u pacientov, ktorí sa predtým zúčastnili skúšania atezolizumabu sponzorovaného spoločnosťami Genentech a/alebo F. Hoffmann-La Roche Ltd (IMBRELLA B), (pozn: dlhodoba extenzia, pacientov po atezo studiach)
    Liečivo: Atezolizumab
    Diagnóza: Nádorové ochorenia
    Kód skúšania: 2018-003352-20, BO40729, IMBRELLA B
    Sponzor: F. Hoffmann-La Roche Ltd
    Kritéria:

    Inclusion Criteria:
    Eligible for continuing atezolizumab-based therapy at the time of roll-over from the parent study, as per the parent study protocol or
    Eligible for continuing the comparator agent(s) in a Genentech- or Roche-sponsored study as per the parent study protocol, with no access to commercially available comparator agent
    Time between the last dose of treatment received in parent study and first dose in extension study is no longer than the interruption period allowed in the parent study. First dose of study treatment in this extension study will be received within 7 days of the treatment interruption window allowed by the parent study
    Continue to benefit from atezolizumab-based study treatment or from the comparator at the time of roll-over from the parent study as assessed by the investigator
    Negative serum pregnancy test within 7 days prior to start of study treatment in women of childbearing potential
    For women of childbearing potential: agreement to remain abstinent or use contraceptive methods, and agreement to refrain from donating eggs
    For men: agreement to remain abstinent or use contraceptive measures, and agreement to refrain from donating sperm

    Exclusion Criteria:
    Meet any of the study treatment discontinuation criteria specified in the parent study at the time of enrollment in this extension study
    Study treatment or comparator agent is commercially marketed in the patient's country for the patient-specific disease and is accessible to the patient
    Treatment with any anti-cancer treatment during the time between last treatment in the parent study and the first dose of study treatment in this extension study
    Permanent discontinuation of atezolizumab for any reason during the parent study or during the time between last treatment in the parent study and the first dose of study treatment in this extension study (if applicable)
    Ongoing serious adverse event(s) that has not resolved to baseline level or Grade ≤1 from the parent study or during the time between the last treatment in the parent study and the first dose of study treatment in this extension study
    Any condition that, in the opinion of the investigator, would interfere with the interpretation of patient safety or place the patient at high risk for treatment-related complications
    Concurrent participation in any therapeutic clinical trial (other than the parent study)
    Pregnant or lactating, or intending to become pregnant during this extension study and for the period after the last dose of study treatment specified in the designated referenced safety information (RSI)


    Otvorené pre nábor: 2020-01-09
    Uzatvorené pre nábor:
    Uzatvorené:

    Pracoviská klinického skúšania:
    1. Názov: Národný onkologický ústav, II. Onkologická klinika LFUK a NOÚ, Klinika klinickej onkológie SZU a NOÚ, Klenová 1, 833 10 Bratislava
      Mesto: Bratislava
      Zodpovedný skúšajúci: MUDr. PhD. Jozef Šufliarsky
    2. Názov: Univerzitná nemocnica Bratislava, Nemocnica Ružinov, Oddelenie klinickej onkológie, Ružinovská 6
      Mesto: Bratislava
      Zodpovedný skúšajúci: MUDr. Peter Kasan
  • Zmena metabolickej nádorovej aktivity pozorovaná pri sekvenčnej FDG-PET a plazmatickej/tkanivovej miRNA ako biomarkery pre stratégiu predoperačnej liečby u lokálne pokročilého karcinómu žalúdka a gastroesofageálnej junkcie
    Liečivo: 5-fluorouracil,Oxaliplatina,Docetaxel,Ca
    Diagnóza: Karcinóm žalúdka a gastroesofageálnej junkcie
    Kód skúšania: 2017-001264-38, MOU-2017-01, GASTROPET
    Sponzor: Masarykův onkologický ústav,CZ
    Kritéria:

    Principal inclusion criteria
    1. Age of 18 years or more
    2. Not currently participating in another study
    3. Able and willing to sign informed consent and to comply with study procedures
    4. Biopsy-proven locally advanced resectable oesophago-gastric adenocarcinoma (Siewert I – III) with T3N0, T4N0, T2 – T4N+, stage Ib – IIIc I. Adenocarcinoma of distal part of the oesophagus II. Adenocarcinoma of the real cardia III. Adenocarcinoma of the subcardial stomach
    5. Staging procedures include endoscopy, endoscopic ultrasound and FDG-PET
    6. Eligible patients have to be fit for platinum-containing chemotherapy
    7. Tumours must be potentially R0 resectable tumours during consecutive operation.
    1. Vek 18 a viac rokov
    2. Pacient sa v súčasnej dobe nezúčastňuje inej štúdie
    3. Pacient je schopný a ochotný podpísať informovaný súhlas a plniť štúdijné postupy
    4. Biopticky potvrdený lokálne pokročilý operabilný adenokarcinóm oesophago-gastrického spojenia T3N0, T4N0, T2-T4N+, typ I - III podľa Siewerta: I. Adenokarcinóm distálnej časti pažeráka
    II. Adenokarcinóm kardie
    III. Adenokarcinóm subkardiálneho žalúdka
    5. Prevedený staging zahrňujúci endoskopiu, endoskopický ultrazvuk a PET/CT
    6. Pacient musí byť vhodný pre chemoterapiu obsahujúcu platinu
    7. Nádor musí byť potenciálne R0 operabilný pri nadväzujúcej operácii

    Principal exclusion criteria
    1. Participation in another clinical trial of a therapeutic drug during the past 14 days
    2. Addiction to alcohol or drugs
    3. Women of child-bearing potential who are not using a commonly accepted effective means of contraception; women of child-bearing potential will have negative blood pregnancy test before enrollment
    4. Pregnant women and nursing mothers are not allowed to enroll on this study
    5. Eastern Cooperative Oncology Group score >2
    6. Previous or secondary malignancy in past 5 years (Excluding skin cancer and early cervical carcinoma)
    7. Life expectancy of less than 3 months
    8. Uncontrolled bleeding from the tumour
    9. Uncontrolled diabetes
    10. Patients are also ineligible if they have undergone previous chemotherapy, radiotherapy, or endoscopic laser therapy for EGJ
    1. Účasť v liekovom klinickom skúšaní behom posledných 14 dní
    2. Závislosť na alkohole alebo drogách
    3. Ženy v plodnom veku, ktoré nepoužívajú efektívne antikoncepčné prostriedky (pred zaradením do štúdie musí byť u žien v plodnom veku doložený negatívny tehotenský test z krvi)
    4. Tehotné ženy a dojčiace matky
    5. Eastern Cooperative Oncology Group skóre > 2
    6. Predchádzajúce alebo sekundárne malígne ochorenie v posledných 5 rokoch (okrem kožného karcinómu a včasného karcinómu cervixu)
    7. Očakávané prežitie kratšie ako 3 mesiace
    8. Nekontrolované krvácanie z nádora
    9. Neliečený diabetes
    10. Pacienti nemôžu byť do štúdie zaradení, pokiaľ podstúpili predchádzajúcu chemoterapiu, rádioterapiu alebo endoskopickú laserovú terapiu EGJ


    Otvorené pre nábor: 2020-03-13
    Uzatvorené pre nábor:
    Uzatvorené: 2023-08-15

    Pracoviská klinického skúšania:
    1. Názov: Národný onkologický ústav, II. Onkologická klinika LFUK a NOÚ, Klinika klinickej onkológie SZU a NOÚ, Klenová 1, 833 10 Bratislava
      Mesto: Bratislava
      Zodpovedný skúšajúci: MUDr. PhD. Štefan Porsok
  • Randomizované, dvojito zaslepené, ekvivalenčné, multicentrické skúšanie III. fázy v paralelných skupinách na porovnanie účinnosti, bezpečnosti, farmakokinetiky a imunogenity HD204 oproti lieku Avastin u pacientov s metastatickým alebo recidivujúcim neskvamocelulárnym nemalobunkovým karcinómom pľúc
    Liečivo: Bevacizumab Biosimilar /HD204/
    Diagnóza: Karcinóm pľúc
    Kód skúšania: 2017-005175-78, SAMSON-II
    Sponzor: Prestige BioPharma Pte Ltd IQVIA
    Kritéria:

    Inclusion Criteria:

    Aged ≥ 18 years
    ECOG performance status of 0-1
    Histologically-confirmed metastatic or recurrent non-squamous non-small cell lung cancer
    At least one measurable lesion according to RECIST v1.1.
    Able to receive bevacizumab, carboplatin and paclitaxel based on adequate laboratory and clinical parameters
    Exclusion Criteria:

    Diagnosis of small cell carcinoma of the lung or squamous cell carcinoma
    Sensitizing EGFR mutations or ALK rearrangements
    Increased risk of bleeding determined by investigator based on radiographic / clinical findings
    History of systemic chemotherapy administered in the first-line setting for metastatic or recurrent disease of NSCLC.


    Otvorené pre nábor: 2019-07-23
    Uzatvorené pre nábor: 2022-07-30
    Uzatvorené:

    Pracoviská klinického skúšania:
    1. Názov: Nemocnica na okraji mesta n.o., Ambulancia klinickej onkológie, Nová Nemocnica 511, 958 01 Partizánske
      Mesto: Partizánske
      Zodpovedný skúšajúci: MUDr. Alexandra Szabová
      Referovať pacienta do klinického skúšania
  • Randomizované, otvorené, multicentrické globálne klinické skúšanie vo fáze III na porovnanie kombinovanej liečby durvalumabom + BCG (Bacillus Calmette-Guerin) oproti monoterapii BCG u vysokorizikových BCG-naivných pacientov s neinvazívnym karcinómom močového mechúra (POTOMAC).
    Liečivo: Durvalumab /MEDI4736/
    Diagnóza: Urotelový karcinóm
    Kód skúšania: 2017-002979-26, D419JC00001, POTOMAC
    Sponzor: AstraZeneca AB

    Otvorené pre nábor: 2019-07-25
    Uzatvorené pre nábor:
    Uzatvorené: 2020-12-14

    Pracoviská klinického skúšania:
    1. Názov: Medeon, s.r.o., Ambulancia klinickej onkológie, Kamenná 26/5102, 921 01 Banka
      Mesto: Banka
      Zodpovedný skúšajúci: MUDr. Monika Matejková
    2. Názov: MILAB, s.r.o., UROCENTRUM, Hollého 14/D, 080 01 Prešov
      Mesto: Prešov
      Zodpovedný skúšajúci: doc. MUDr. Ivan Minčík, PhD.
    3. Názov: Onkologický ústav sv. Alžbety, s.r.o., Heydukova 10, 812 50 Bratislava
      Mesto:
      Zodpovedný skúšajúci: MUDr. Boris Kollárik, PhD., FEBU.
    4. Názov: Univerzitná nemocnica Martin, Urologická klinika, Kollárova 2, 036 59 Martin
      Mesto: Martin
      Zodpovedný skúšajúci: Prof. MUDr. Ján Kliment, CSc.
    5. Názov: Nemocnica svätého Michala, a.s.,Satinského 1, 811 08 Bratislava
      Mesto: Bratislava
      Zodpovedný skúšajúci: doc. MUDr. Federico Manuel Figueiredo Goncalves, PhD.
  • EPIK-B3: Multicentrické randomizované dvojito zaslepené placebom kontrolované klinické skúšanie fázy III na zhodnotenie účinnosti a bezpečnosti alpelisibu (byl719) v kombinácii s nab-paklitaxelom u pacientov s pokročilým trojnásobne negatívnym karcinómom prsníka s mutáciou katalytickej podjednotky alfa fosfoinozitid 3 kinázy (pik3ca) alebo so stratou proteínu - homológu fosfatázy a tenzínu (pten) bez mutácie pik3ca
    Liečivo: ALPELISIB (BYL719)
    Diagnóza: Karcinóm prsníka
    Kód skúšania: 2019-002637-11, CBYL719H12301, EPIK-B3
    Sponzor: Novartis Pharma AG

    Otvorené pre nábor: 2020-04-24
    Uzatvorené pre nábor: 2022-11-11
    Uzatvorené:

    Pracoviská klinického skúšania:
    1. Názov: Národný onkologický ústav, II. Onkologická klinika LFUK a NOÚ, Klinika klinickej onkológie SZU a NOÚ, Klenová 1, 833 10 Bratislava
      Mesto: Bratislava
      Zodpovedný skúšajúci: Prof., MUDr., DrSc. Michal Mego
    2. Názov: Onkologický ústav sv. Alžbety, s.r.o., Interná klinika VŚZ a SP a OÚSA, Heydukova 10, 812 50 Bratislava
      Mesto: Bratislava
      Zodpovedný skúšajúci: MUDr, PhD. Bibiána Vertáková Krakovská
    3. Názov: Východoslovenský onkologický ústav, a.s., Oddelenie klinickej onkológie, Rastislavova 43, 041 91 Košice
      Mesto: Košice
      Zodpovedný skúšajúci: Doc. MUDr., PhD Igor Andrašina
  • Otvorené klinické skúšanie paralelných skupín s pevne stanovenou postupnosťou vo fáze 1 na zistenie účinku induktora cyp3a rifampínu a inhibítora cyp3a itrakonazolu na farmakokinetiku produktu pamiparib (bgb-290) u pacientov s rakovinou
    Liečivo: Pamiparib /BGB-290
    Diagnóza: Nádorové ochorenia
    Kód skúšania: 2019-000112-28 BGB-290-105
    Sponzor: BeiGene

    Otvorené pre nábor: 2019-05-23
    Uzatvorené pre nábor: 2020-01-01
    Uzatvorené: 2020-04-13

    Pracoviská klinického skúšania:
    1. Názov: Summit Clinical Research, s.r.o., Bárdošova 2/A, Bratislava
      Mesto: Bratislava
      Zodpovedný skúšajúci: MUDr. Viera Skarbová
  • Neinvazívna in-vivo predikcia odpovede na terapiu inhibítormi angiogenézy pomocou PET/CT s gálium (68Ga) NODAGA-RGD
    Liečivo: gallium (68Ga) NODAGA-RGD
    Diagnóza: Kolorektálny karcinóm
    Kód skúšania: 2018-001224-19, 1/0196/16
    Sponzor: Lekárska fakulta Univerzity Komenského v Bratislave
    Kritéria:

    Principal inclusion criteria
    In order to be eligible to participate in this study, all individual must meet all of the following criteria:
    1. Male or female over 18 years of age with histologicaly confirmed metastatic cancer of the colon or rectum fulfilling the following criteria :
    a) Scheduled for treatment including antiangiogenic agent
    b) At least one measurable lesions according to RECIST 1.1 criteria (>10mm in long axis for non-lymph node lesions and >15mm in short axis for lymph node lesions).
    c) Availability of following examination data in DICOM III format performed less than 31 days prior inclusion:
    - Diagnostic CT of thorax, abdomen and pelvis
    - Fludeoxyglucose (18F) PET/CT
    2. Capable of staying still in lying position for the duration of the PET/CT acquisition which can last up to 30 min in all, a "whole body" acquisition
    3. ECOG performance status ≤ 2 at inclusion
    4. Patient with a life expectancy ≥ 24 weeks from baseline
    5. For women of childbearing age, the possibility of pregnancy should be ruled out at inclusion
    6. Volunteer and able to follow the instructions necessary for the study
    7. Having signed an informed consent to participate in the study
    Na zaradenie do tejto štúdie musí každý jednotlivec spĺňať všetky nasledovné kritériá:
    1. Muž alebo žena staršia ako 18 rokov s histologicky potvrdeným pokročilým metastatickým karcinómom hrubého čreva alebo konečníka spĺňajúcim nasledovné kritériá:
    a) Plánovaná na liečba zahŕňajúca inhibítor angiogenézy
    b) Aspoň jedna merateľná lézia podľa kritérií RECIST 1.1 (> 10 mm v dlhej osi pre lézie mimo lymfatických uzlín a> 15 mm v krátkej osi pre uzlinové lézie).
    c) Dostupnosť nasledujúcich údajov o vyšetrení vo formáte DICOM III vykonaných menej ako 31 dní pred zaradením:
    - CT hrudníka, brucha a panvy
    - PET/CT s fludeoxyglukózou (18F)
    2. Pacient schopný zostať v ležiacej polohe počas snímania obrazov PET/CT, čo môže trvať do 30 minút pre celotelové snímanie
    3. Stav výkonnosti ECOG ≤ 2 pri zaradení do štúdie
    4. Pacient s očakávanou dĺžkou života ≥ 24 týždňov od zaradenia do štúdie
    5. U žien vo fertilnom veku sa má pri začlenení vylúčiť možnosť tehotenstva
    6. Pacient ochotný a schopný dodržať pokyny potrebné pre realizáciu štúdie
    7. Podpis informovaného súhlasu s účasťou na štúdii

    Principal exclusion criteria
    An individual who meets any of the following criteria will be excluded from participation in this study:
    - Pregnancy or lactation
    - Known allergy to components of the study product
    - Treatment scheduled does not include antiangiogenic agent
    - Life expectancy less than 6 months
    - ECOG Performance Status >2 or Karnofsky Performance Status <50%
    Jednotlivec spĺňajúci niektoré z nasledujúcich kritérií bude vylúčený z účasti na tejto štúdii:
    - Tehotenstvo alebo laktácia
    - Známa alergia na niektorú zo zložiek skúmaného produktu
    - Plánovaná liečba nezahŕňa liek s antiangiogénnym účinkom
    - Očakávaná dĺžka života je kratšia ako 6 mesiacov
    - Stav výkonnosti ECOG> 2 alebo stav výkonnosti Karnofsky <50%


    Otvorené pre nábor: 2019-02-11
    Uzatvorené pre nábor:
    Uzatvorené:

    Pracoviská klinického skúšania:
    1. Názov: Onkologický ústav sv. Alžbety, s.r.o., Klinika nukleárnej medicíny LF UK a OÚSA, Heydukova 10, 812 50 Bratislava
      Mesto: Bratislava
      Zodpovedný skúšajúci: doc. MUDr. Soňa Balogová, PhD.
  • Odslepené, randomizované, multicentrické skúšanie 2. fázy na vyhodnotenie účinnosti a bezpečnosti pemigatinibu spolu s pembrolizumabom v porovnaní so samotným pemigatinibom a so štandardnou starostlivosťou v prvej línii liečby metastatického alebo neresekovateľného uroteliálneho karcinómu u pacientov, pre ktorých nie je vhodná cisplatina a majú nádory s expresiou mutácie alebo preskupenia génu FGFR3 (skúšanie FIGHT-205)
    Liečivo: pemigatinib (INCB054828)
    Diagnóza: Urotelový karcinóm
    Kód skúšania: 2019-000721-50, INCB54828-205, FIGHT-205
    Sponzor: Incyte Corporation, US

    Otvorené pre nábor: 2020-05-27
    Uzatvorené pre nábor:
    Uzatvorené: 2020-10-06

    Pracoviská klinického skúšania:
    1. Názov: Fakultná nemocnica s poliklinikou Žilina, Urologické oddelenie, V. Spanyola 43, 012 07 Žilina
      Mesto: Žilina
      Zodpovedný skúšajúci: MUDr., CSc. Juraj Mikuláš
    2. Názov: FNsP Trenčín, Onkologické oddelenie, Legionárska 28, 911 71 Trenčín
      Mesto: Trenčín
      Zodpovedný skúšajúci: MUDr., PhD., MPH Branislav Bystrický
    3. Názov: MILAB, s.r.o., UROCENTRUM, Hollého 14/D, 080 01 Prešov
      Mesto: Prešov
      Zodpovedný skúšajúci: Doc., MUDr., PhD. Ivan Minčík
  • II. fáza klinického skúšania orálneho inhibítora tropomyozín-receptor-kinázy (TRK), larotrectinibu, u pacientov s karcinómom asociovaným s fúznymi génmi NTRK bez ohľadu na jeho lokalitu (tzv. „basket study“) P/0401/2019
    Liečivo: Larotrectinib (LOXO-101; BAY 2757556)
    Diagnóza: Nádorové ochorenia
    Kód skúšania: 2015-003582-28, LOXO-TRK-15002, NAVIGATE
    Sponzor: Bayer Consumer Care AG, Switzerland

    Otvorené pre nábor: 2020-06-02
    Uzatvorené pre nábor:
    Uzatvorené: 2023-06-16

    Pracoviská klinického skúšania:
    1. Názov: Národný onkologický ústav, II. Onkologická klinika LFUK a NOÚ, Klinika klinickej onkológie SZU a NOÚ, Klenová 1, 833 10 Bratislava
      Mesto: Bratislava
      Zodpovedný skúšajúci: prof.MUDr. DrSc. Michal Mego
  • Randomizované, kontrolované, odslepené klinické skúšanie fázy 3 na zhodnotenie kombinácie Melflufén a Daratumumab v porovnaní s Daratumumabom podávaným samostatne pacientom s relabujúcim alebo relabujúcim-refraktérnym mnohopočetným meylómom
    Liečivo: melphalan flufenamide hydrochloride (Melflufen), daratumumab
    Diagnóza: Mnohopočetný myelóm
    Kód skúšania: 2019-002161-36, OP-108, LIGHTHOUSE
    Sponzor: Oncopeptides AB, Sweden

    Otvorené pre nábor: 2020-09-11
    Uzatvorené pre nábor:
    Uzatvorené: 2021-11-03

    Pracoviská klinického skúšania:
    1. Názov: Národný onkologický ústav, Klinika onkohematológie LFUK a NOÚ, Klenová 1, 833 10 Bratislava
      Mesto:
      Zodpovedný skúšajúci: MUDr. Miriam Ladická
    2. Názov: Univerzitná nemocnica Bratislava, Nemocnica sv. Cyrila a Metoda, Klinika hematológie a trasfuziológie LF UK SZU a UNB, Antolská 11, 851 07, Bratislava
      Mesto: Bratislava
      Zodpovedný skúšajúci: MUDr., Ph.D. Ľubica Harvanová
    3. Názov: Univerzitná nemocnica L. Pasteura, Klinika hematológie a onkohematológie, Rastislavova 43, Pracovisko Trieda SNP 1, 041 66 Košice
      Mesto: Košice
      Zodpovedný skúšajúci: MUDr., Ph.D. Tomáš Guman
    4. Názov: Univerzitná nemocnica Martin, Klinika hematológie a transfuziológie, Kollárova 2, 036 59 Martin
      Mesto: Martin
      Zodpovedný skúšajúci: MUDr., Ph.D. Juraj Sokol
  • Otvorené jednoramenné klinické skúšanie na zaistenie pokračovania liečby darolutamidom u účastníkov, ktorí sa zapojili do predchádzajúcich klinických skúšaní vedených spoločnosťou Bayer.
    Liečivo: DAROLUTAMIDE (BAY 1841788)
    Diagnóza: Karcinóm prostaty
    Kód skúšania: 2019-003618-15, BAY1841788/20321, Darolutamide roll-over study
    Sponzor: Bayer Consumer Care AG
    Kritéria:

    Inclusion Criteria:
    Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
    Participants enrolled in any Bayer-sponsored darolutamide feeder study at the time of study closure or primary completion, who are currently receiving darolutamide and are experiencing clinical benefit from treatment.
    Participants who have not met any treatment discontinuation criteria in the feeder study protocol.
    Willingness to continue practicing acceptable methods of birth control during the study.

    Exclusion Criteria:
    Participant is unable to comply with the requirements of the study.
    Negative benefit/ risk ratio as determined by the investigator.
    Meet any criteria for treatment discontinuation of the feeder study the participant is coming from.


    Otvorené pre nábor: 2020-09-03
    Uzatvorené pre nábor:
    Uzatvorené:

    Pracoviská klinického skúšania:
    1. Názov: CUIMED s.r.o., Urologická ambulancia, Strečianska 13, 851 05 Bratislava
      Mesto: Bratislava
      Zodpovedný skúšajúci: Doc. MUDr. PhD. Frederico Goncalves
    2. Názov: Privátna Urologická Ambulancia s.r.o., Piaristická ul č. 8, 911 01 Trenčín
      Mesto: Trenčín
      Zodpovedný skúšajúci: MUDr. MPH. Roman Sokol
    3. Názov: J. BREZA MEDICAL s. r. o., Urologická ambulancia, Einsteinova 7, Bratislava
      Mesto: Bratislava
      Zodpovedný skúšajúci: Doc. MUDr. Msc. PhD. Ján Breza
  • Randomizované skúšanie fázy III neoadjuvantnej chemoterapie s následným chirurgickým zákrokom v porovnaní so samotným chirurgickým zákrokom u pacientov s vysoko rizikovým retroperitoneálnym sarkómom (STRASS 2)
    Liečivo: DOXORUBICIN HYDROCHLORIDE (Doxorubicin), Epirubicin Hydrochloride (Epirubicin), DACARBAZINE (Dacarbazin), IFOSFAMIDE (Ifosfamide)
    Diagnóza: Sarkómy
    Kód skúšania: 2019-003543-30, EORTC-1809-STBSG, STRASS 2
    Sponzor: European Organisation for Research and Treatment of Cancer, Belgium
    Kritéria:

    Inclusion Criteria:
    Histologically proven primary high risk leiomyosarcoma (LMS) or Liposarcoma (LPS) of retroperitoneal space or infra-peritoneal spaces of pelvis.
    LMS:
    Any grade LMS can be included
    Minimum size of LMS tumor should be 5 cm
    LPS:
    Diagnosis should be confirmed based on MDM2 (Mouse double minute 2 homolog) and CDK4 (Cyclin-dependent kinase 4) expression on IHC (immunohistochemistry), while proof of MDM2 amplification is highly recommended.
    All grade 3 DDLPS can be included.
    DDLPS with confirmed grade 2 on biopsy can be included when:
    The grade 2 DDLPS has an FNCLCC score=5 (Fédération Nationale des Centres de Lutte Contre Le Cancer), has no necrosis on the biopsy but clear necrosis on imaging.
    The tumors carry a high risk gene profile as determined by the Complexity INdex in SARComas (CINSARC-high)
    Representative formalin fixed, paraffin embedded tumor blocks or unstained tissue slides must be available at baseline for histological central review.
    Unifocal tumor
    Absence of extension through the sciatic notch or across the diaphragm
    Resectable tumor: resectability is based on pre-operative imaging (CT-abdomen, potentially also with MRI) and has to be defined by the local treating sarcoma team. A patients is not considered resectable when the expectation is that only an R2 resection is feasible.

    Criteria for non-resectability are:
    Involvement of the superior mesenteric artery, aorta, coeliac trunk and/or portal vein
    Involvement of bone
    Growth into the spinal canal
    Progression of retro-hepatic inferior vena cava leiomyosarcoma towards the right atrium
    Infiltration of multiple major organs like liver, pancreas and/or major vessels
    Tumor not previously treated (no previous surgery (excluding diagnostic biopsy), radiotherapy or systemic therapy)
    Patient must have radiologically measurable disease (RECIST 1.1), as confirmed by imaging within the 28 days prior to randomization. CT thorax abdomen pelvis with IV contrast is the preferred imaging modality. In case of any contra-indications (medical or regulatory), it is allowed to perform a non-contrast CT thorax + MRI abdomen & pelvis.
    ≥ 18 years old (no upper age limit)
    WHO (World Health Organization) performance status ≤ 2
    Adequate haematological and organ function:
    Haematological: haemoglobin > 9.0 g/dL or 5.6 mmol/L, absolute neutrophils > 1.5 x 109/L, platelets > 100 x 109/L Note: Platelet transfusions is allowed to achieve these baseline values
    Renal: estimated glomerular filtration rate (eGFR) > 50 ml/min/m2; No proteinuria CTCAE ≥ grade 2;
    Hepatic: Bilirubin ≤ 1.0 times upper limit of normal (1.0xULN) of institutional limits, ALT (alanine aminotransferase) and/or AST (aspartate transaminase) ≤1.5 x ULN. If isolated elevated bilirubin <2 x ULN and Gilberts syndrome suspected, suggest repeating bloods after food. If bilirubin improves to meet the criteria above this is acceptable. More severe persistent hepatic impairment of whatever cause would exclude the patient from treatment till resolved.
    Heart: Clinically normal cardiac function based on left ventricular ejection fraction (LVEF ≥ 50%) as assessed either by multi-gated acquisition scan (MUGA) or cardiac ultrasound and 12 lead ECG without clinically relevant abnormalities.
    American Society of Anesthesiologist (ASA) score < 3
    Women of child bearing potential (WOCBP) must have a negative serum pregnancy test within 7 days prior to the first dose of study treatment or surgery.
    Note: a woman is considered of childbearing potential (WOCBP), i.e. fertile, following menarche and until becoming post menopausal unless permanently sterile.
    Permanent sterilisation methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy.
    A postmenopausal state is defined as no menses for 12 months without an alternative medical cause. A high follicle stimulating hormone (FSH) level in the postmenopausal range may be used to confirm a post-menopausal state in women not using hormonal contraception or hormonal replacement therapy. However in the absence of 12 months of amenorrhea, a single FSH measurement is insufficient..
    Patients of childbearing / reproductive potential should use highly effective birth control measures, as defined by the investigator, during the study treatment period and for at least 6 months after the last dose of treatment or date of surgery. A highly effective method of birth control is defined as a method which results in a low failure rate (i.e. less than 1% per year) when used consistently and correctly. Such methods include:

    Combined (oestrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal)
    Progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable)
    Intrauterine device (IUD)
    Intrauterine hormone-releasing system (IUS)
    Bilateral tubal occlusion
    Vasectomized partner
    Sexual abstinence (the reliability of sexual abstinence needs to be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient)
    Female subjects who are breast feeding should discontinue nursing prior to the first day of study treatment and until 6 months after the last study treatment.
    Before patient registration/randomization, written informed consent must be given according to ICH/GCP, and national/local regulations.

    Exclusion Criteria:
    Sarcoma originated from bone structure, abdominal or gynecological viscera
    Metastatic disease
    Tumors with extension through the sciatic notch or across the diaphragm
    Hypersensitivity to doxorubicin, ifosfamide, dacarbazine or to any of their metabolites or to any of their excipients
    Persistent myelosuppression
    Myocardial infarction within the last 6 months
    Uncontrolled cardiac arrhythmia
    Previous treatment with maximum cumulative doses (450mg/m² Doxorubicin or equivalent 900mg/m² EpiADM) of doxorubicin, daunorubicin, epirubicin, idarubicin, and/or other anthracyclines and anthracenediones
    Active and uncontrolled infections
    Vaccination with live vaccines within 30 days prior to study entry
    Inflammation of the urinary bladder (interstitial cystitis) and/or obstructions of the urine flow.
    Other invasive malignancy within 5 years, with the exception of adequately treated non-melanoma skin cancer, localized cervical cancer, localized and presumably cured prostate cancer.
    Uncontrolled severe illness, infection,medical condition (including, uncontrolled diabetes or hypertension), other than the Primary LPS or LMS of the retroperitoneum.
    Female patients who are pregnant or breastfeeding or female and male patients of reproductive potential who are not willing to employ effective birth control method.
    Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before randomization in the trial
    Known contraindication to imaging tracer and to MRI


    Otvorené pre nábor: 2020-09-30
    Uzatvorené pre nábor:
    Uzatvorené:

    Pracoviská klinického skúšania:
    1. Názov: Národný onkologický ústav, II. Onkologická klinika LFUK a NOÚ, Klinika klinickej onkológie SZU a NOÚ, Klenová 1, 833 10 Bratislava
      Mesto: Bratislava
      Zodpovedný skúšajúci: MUDr. PhD Jozef Šufliarsky
  • Dvojito-zaslepené, randomizované klinické skúšanie vo fáze III na zhodnotenie účinnosti a bezpečnosti capivasertibu + paclitaxelu oproti placebu + paclitaxelu v prvej línii liečby u pacientov s histologicky potvrdeným lokálne pokročilým (neoperovateľným) alebo metastatickým triple-negatívnym karcinómom prsníka (TNBC) (CAPItello-290)
    Liečivo: capivasertib (AZD5363)
    Diagnóza: Karcinóm prsníka
    Kód skúšania: 2018-004687-64, D3614C00001, CAPItello-290
    Sponzor: AstraZeneca AB

    Otvorené pre nábor: 2020-10-06
    Uzatvorené pre nábor:
    Uzatvorené:

    Pracoviská klinického skúšania:
    1. Názov: Fakultná nemocnica s poliklinikou Žilina, Oddelenie klinickej a radiačnej onkológie, ul. Vojtecha Spanyola 43, Žilina
      Mesto: Žilina
      Zodpovedný skúšajúci: MUDr. MBA Dagmar Sudeková
    2. Názov: Onkologický ústav sv. Alžbety, s.r.o., Chemoterapeutická ambulancia I., Heydukova 10, 812 50 Bratislava
      Mesto: Bratislava
      Zodpovedný skúšajúci: MUDr. Milada Mikulová
  • OTVORENÉ KLINICKÉ SKÚŠANIE FÁZY 1 S PODANÍM VIACERÝCH DÁVOK NA ZISTENIE FARMAKOKINETIKY A BEZPEČNOSTI PERORÁLNE PODÁVANÉHO TAZEMETOSTATU U PACIENTOV SO STREDNE ŤAŽKÝM A ŤAŽKÝM POŠKODENÍM FUNKCIE PEČENE S POKROČILÝMI MALIGNITAMI
    Liečivo: TAZEMETOSTAT (EPZ-6438 )
    Diagnóza: Nádorové ochorenia
    Kód skúšania: 2019-003368-36, EZH-1201
    Sponzor: Epizyme, Inc.
    Kritéria:

    Inclusion Criteria:
    -Male or female ≥ 18 years age at the time of consent.
    -Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2.
    -Has the ability to understand informed consent and provided signed written informed consent.
    -Life expectancy of > 3 months.
    -Histologically and/or cytologically confirmed advanced metastatic or unresectable solid tumors has progressed after treatment for which there are no standard therapies available OR histologically and/or cytologically confirmed hematological malignancies that have relapsed, or refractory disease following at least 2 standard lines of systemic therapy for which there are no standard therapies available.
    -Must have evaluable or measurable disease.
    -Has all prior treatment (i.e., chemotherapy, immunotherapy, radiotherapy) related clinically significant toxicities resolve to ≤ Grade -1 per NCI CTCAE, Version 5.0 or are clinically stable and not clinically significant, at time of consent.
    -All subjects must have completed any prior chemotherapy, targeted therapy and major surgery, ≥ 28 days before study entry. For daily or weekly chemotherapy without the potential for delayed toxicity, a washout period of 14 days may be acceptable, and questions related to this can be discussed with the Medical Monitor.
    -Has adequate hematologic (bone marrow [BM] and coagulation factors), and renal function.
    -Able to swallow and retain orally-administered medication and without clinically significant gastrointestinal abnormalities that could alter absorption such as malabsorption syndrome or major resection of the stomach or bowels.
    -Subjects with abnormal hepatic function will be eligible and will be grouped according to established criteria. Subjects with active hemolysis will be excluded.
    -Manual differential with no significant morphologic abnormalities on complete blood count (CBC) testing.
    -Male subjects must have had a successful vasectomy OR must either practice complete abstinence or agree to use a latex or synthetic condom during sexual contact with a female of childbearing potential from the first dose of study drug, during study treatment (including during dose interruptions), and for 3 months after study drug discontinuation.
    -Females of childbearing potential must have a negative serum pregnancy test at screening and within 24 hours prior to the first dose of study drug. All females will be considered of childbearing potential unless they are naturally postmenopausal or have been sterilized.
    -Females of childbearing potential (FCBP) must either practice complete abstinence or agree to use a highly effective method of contraception beginning at least 28 days prior to the first dose of study drug, during study treatment (including during dose interruptions), and for 6 months after study drug discontinuation.
    -Has a QT interval corrected by Fridericia's formula (QTcF) ≤480 msec.
    -Subjects with diagnosed human immunodeficiency virus (HIV) are eligible to participate in the study if they meet established criteria.

    Exclusion Criteria:
    -Prior exposure to tazemetostat or other inhibitor(s) of EZH2.
    -Symptomatic or untreated leptomeningeal or brain metastases or spinal cord compression as documented by CT or MRI scan, analysis of cerebrospinal fluid or neurological exam. Subjects with primary glioblastoma multiforme are excluded.
    -Clinically significant bleeding diathesis or coagulopathy, including known platelet function disorders. Subjects on anticoagulation with low molecular weight heparin are allowed.
    -Known hypersensitivity to any of the components of tazemetostat.
    -Concurrent investigational agent or anticancer therapy. NOTE: Megestrol (Megace) if used as an appetite stimulant is allowed.
    -Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, clinically significant bleeding diathesis or coagulopathy, including known platelet function disorders, symptomatic congestive heart failure, unstable angina pectoris, clinically significant cardiac arrhythmias, or psychiatric illness/social situations that would limit compliance with study requirements.
    -Have a known active infection with hepatitis B virus (HBV, as measured by positive hepatitis B surface antigen, hepatitis C virus (HCV, as measured by positive hepatitis C antibody), OR human T-cell lymphotropic virus 1.
    -Subjects taking medications that are known potent CYP3A4 inducers/inhibitors (including St. John's Wort).
    Is unwilling to exclude grapefruit juice, Seville oranges and grapefruit from the diet and all foods that contain those fruits from 24 hours prior to the first dose of study drug until the last dose of study drug.
    -Any condition or medical problem in addition to the underlying malignancy and organ dysfunction that the Investigator feels would pose unacceptable risk.
    -Has thrombocytopenia, neutropenia, or anemia of grade ≥3 (per CTCAE 5.0 criteria) or any prior history of myeloid malignancies, including myelodysplastic syndrome (MDS).
    -Has abnormalities known to be associated with MDS and myeloproliferative neoplasms (MPN) observed in cytogenetic testing and DNA sequencing.
    -Has a prior history of T-LBL/T-ALL.
    -Ingestion of alcohol and smoking is not permitted any time during the study.
    -History of drug abuse (including alcohol) within the last 6 months prior to screening.
    -Severe hepatic encephalopathy (Grade >2) or degree of CNS impairment which the Investigator considers sufficiently serious to interfere with the informed consent, the conduct, the completion, or the results of this trial, or constitutes an unacceptable risk to the subject.
    -History of liver transplantation.
    -Advanced ascites or ascites that require drainage and albumin supplementation, as judged by the Investigator.
    -Acute damage of the liver with Grade 4 AST/ALT values at screening or admission.


    Otvorené pre nábor: 2020-09-10
    Uzatvorené pre nábor:
    Uzatvorené:

    Pracoviská klinického skúšania:
    1. Názov: Summit Clinical Research, s.r.o., Bárdošova 2/A, Bratislava
      Mesto: Bratislava
      Zodpovedný skúšajúci: MUDr. Viera Dammak
  • Dvojito-zaslepené, randomizované, placebom kontrolované klinické skúšanie vo fáze III na zhodnotenie účinnosti a bezpečnosti capivasertibu + abiraterónu oproti placebu + abiraterónu u pacientov s novo diagnostikovaným metastatickým hormonálne senzitívnym karcinómom prostaty (mHSPC) charakterizovaným stratou expresie PTEN (CAPitello-281)
    Liečivo: capivasertib (AZD5363)
    Diagnóza: Karcinóm prostaty
    Kód skúšania: 2020-000346-33, D361BC00001, CAPItello-281
    Sponzor: AstraZeneca AB
    Kritéria:

    Principal inclusion criteria
    - Asymptomatic or mildly symptomatic, histologically-confirmed de novo metastatic hormone-sensitive prostate adenocarcinoma without small-cell tumours
    - Provide a FFPE tissue block (preferred) or slides. Tissue from bone metastases is not acceptable
    - A valid PTEN IHC result indicating PTEN deficiency (centralized testing)
    - Metastatic disease documented prior to randomisation by clear evidence of ≥ 1 bone
    lesion and/or ≥ 1 soft tissue lesion accurately assessed at baseline and suitable for repeated assessment with CT and/or MRI. PSMA PET identification only will not be eligible
    - Candidate for abiraterone and steroid therapy
    - Ongoing ADT with GnRH analogue, or LHRH agonists or antagonist, or bilateral orchiectomy
    - Eastern Cooperative Oncology Group (ECOG)/WHO performance status 0 to 1 with no deterioration over the previous 2 weeks and minimum life expectancy of 12 weeks
    - Able and willing to swallow and retain oral medication
    - 7-day Brief Pain Inventory-Short Form (BPI-SF) and Brief Fatigue Inventory(BFI) questionnaires and the analgesic diary during screening completed
    - Agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating sperm

    Principal exclusion criteria
    -Radiotherapy with a wide field of radiation within 4 weeks(wks) before start of study treatment (capivasertib/placebo)
    -Major surgery (excl.placement of vascular access,transurethral resection of prostate,bilateral orchiectomy,internal stents) within 4 wks of start of study treatment
    -Brain metastases,or spinal cord compression (unless spinal cord compression is asymptomatic, treated and stable and not requiring steroids for at least 4 wks prior to start of study treatment)
    -Past medical history of interstitial lung disease,drug-induced interstitial lung disease,radiation pneumonitis which required steroid treatment,or any evidence of clinically active interstitial lung disease
    -Any of the following cardiac criteria:
    i.Mean resting corrected QT interval (QTc) >470 msec from 3 consecutive ECGs
    ii.Any clinically important abnormalities in rhythm, conduction or morphology of resting ECG
    iii.Any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as heart failure,hypokalaemia,potential for torsades de pointes,congenital long QT syndrome,family history of long QT syndrome or unexplained sudden death under 40 years of age,or any concomitant medication known to prolong the QT interval
    iv.Clinically significant heart disease as evidenced by myocardial infarction, or arterial thrombotic events in the past 6 months,severe or unstable angina,or NYHA or Class II to IV heart failure or cardiac ejection fraction measurement of <50%
    v.Experience of any of the following procedures or conditions in the preceding 6months: coronary artery bypass graft,angioplasty,vascular stent,myocardial infarction,angina pectoris,congestive heart failure NYHA Grade ≥2
    vi.Uncontrolled hypotension - systolic blood pressure <90 mmHg and/or diastolic blood pressure <50 mmHg
    vii.Cardiac ejection fraction outside institutional range of normal or <50% (whichever is higher) as measured by echocardiogram (or multiple-gated acquisition scan if an echocardiogram cannot be performed or is inconclusive)
    viii.Uncontrolled hypertension (SBP ≥160 mmHg or DBP ≥95 mmHg).
    -Clinically significant abnormalities of glucose metabolism as defined by any of the following:
    i.Patients with diabetes mellitus (MS) type 1 or MS type 2 requiring insulin treatment
    ii.HbA1c ≥8.0% (63.9 mmol/mol)
    -Inadequate bone marrow reserve or organ function
    -As judged by the investigator, any evidence of severe or uncontrolled systemic diseases, including active bleeding diatheses,or known active infection including hepatitis B and C,and HIV
    -Unevaluable for both bone and soft tissue progression as defined by meeting both of the following criteria:
    i.a "superscan" of bone scan,and
    ii.no soft tissue lesion that can be assessed by RECIST criteria
    -Refractory nausea and vomiting, malabsorption syndrome,chronic gastrointestinal diseases, inability to swallow the formulated product or previous significant bowel resection,or other condition that would preclude adequate absorption of capivasertib
    -Any other disease,metabolic dysfunction,physical examination finding,or clinical laboratory finding that,in the investigator’s opinion,gives reasonable suspicion of a disease or condition that contra-indicates the use of an investigational drug,may affect the interpretation of the results,render the patient at high risk from treatment complications or interferes with obtaining informed consent
    -Evidence of dementia,altered mental status,or any psychiatric condition that would prohibit understanding or rendering of informed consent
    -Previous allogeneic bone marrow transplant or solid organ transplant
    -Known additional malignancy that has had progression or has required active treatment in the last 3 years.Exceptions include basal cell carcinoma of the skin and squamous cell carcinoma of the skin that has undergone potentially curative therapy
    -Treatment with any of the following:
    i.Nitrosourea or mitomycin C within 6 wks of the start of study treatment
    ii.Any investigational agents or study drugs from a previous clinical study within 30 days or 5 half-lives (whichever is longer) of the start of study treatment
    iii.Any other chemotherapy,immunotherapy,immunosuppressant medication (other than corticosteroids) or anticancer agents within 3 wks of the first dose of study treatment.A longer washout may be required for drugs with a long half-life (eg,biologics)
    iv.Potent inhibitors or inducers of CYP3A4 within 2 weeks before the start of study treatment (3 weeks for St John’s wort), or sensitive substrates of CYP3A4,CYP2C9 and/or CYP2D6 with a narrow therapeutic window within 1 wk before the start of study treatment
    -Drugs known to prolong the QT interval within 5 half-lives of the first dose of study treatment
    -History of hypersensitivity to active or inactive excipients of capivasertib,abiraterone,or drugs with a similar chemical structure or class


    Otvorené pre nábor: 2020-10-09
    Uzatvorené pre nábor: 2023-12-06
    Uzatvorené:

    Pracoviská klinického skúšania:
    1. Názov: CUIMED s.r.o., Urologická ambulancia, Strečianska 13, 851 05 Bratislava
      Mesto: Bratislava
      Zodpovedný skúšajúci: Doc. MUDr. PhD. Frederico Goncalves
    2. Názov: MILAB, s.r.o., UROCENTRUM, Hollého 14/D, 080 01 Prešov
      Mesto: Prešov
      Zodpovedný skúšajúci: Doc. MUDr. PhD. Ivan Minčík
    3. Názov: Privátna Urologická Ambulancia s.r.o., Piaristická ul č. 8, 911 01 Trenčín
      Mesto: Trenčín
      Zodpovedný skúšajúci: MUDr. MPH Roman Sokol
    4. Názov: Univerzitná nemocnica Martin, Urologická klinika, Kollárova 2, 036 59 Martin
      Mesto: Martin
      Zodpovedný skúšajúci: Prof. MUDr. CSc. Ján Kliment
    5. Názov: UROCENTRUM ŠAĽA, s.r.o., Hlavná 6, 927 01 Šaľa
      Mesto: Šaľa
      Zodpovedný skúšajúci: MUDr. Richard Polák
    6. Názov: UROEXAM, spol. s.r.o., Urologická ambulancia, Špitálska 13, 949 01 Nitra
      Mesto: Nitra
      Zodpovedný skúšajúci: MUDr. PhD. Marek Brezovský
    7. Názov: URO clinic, s.r.o., Partizánska 2, 811 03, Bratislava
      Mesto: Bratislava
      Zodpovedný skúšajúci: MUDr. PhD. FEBU Boris Kollárik
  • Klinické skúšanie fázy 2 s PD-1 inhibítorom JTX-4014 použitým samostatne a v kombinácii s ICOS agonistom - vopratelimabom, v liečbe pacientov s metastatickým nemalobunkovým karcinómom pľúc selektovaných na základe biomarkerov, ktorí sú po jednej predchádzajúcej liečbe obsahujúcej platinu.
    Liečivo: JTX-4014 Vopratelimab
    Diagnóza: Karcinóm pľúc
    Kód skúšania: 2019-004953-96, JTX-4014-202
    Sponzor: Jounce Therapeutics, Inc., USA

    Otvorené pre nábor: 2020-10-28
    Uzatvorené pre nábor: 2022-03-12
    Uzatvorené: 2023-08-15

    Pracoviská klinického skúšania:
    1. Názov: Národný onkologický ústav, II. Onkologická klinika LFUK a NOÚ, Klinika klinickej onkológie SZU a NOÚ, Klenová 1, 833 10 Bratislava
      Mesto: Bratislava
      Zodpovedný skúšajúci: MUDr. Róbert Godál
    2. Názov: Východoslovenský onkologický ústav, a.s., Oddelenie klinickej onkológie, Rastislavova 43, 041 91 Košice
      Mesto: Košice
      Zodpovedný skúšajúci: MUDr. Zuzana Pribulová
  • Medzinárodné randomizované klinické skúšanie so skúšanými liekmi u hospitalizovaných pacientov s ochorením vyvolaným koronavírusom (COVID 19), ktorí sú na štandardnej liečbe.
    Liečivo: REMDESIVIR (Remdesivir), Hydroxychloroquine sulfate, LOPINAVIR, RITONAVIR, Interferon beta-1a
    Diagnóza: COVID 19
    Kód skúšania: 2020-001366-11, Solidarity, COVID
    Sponzor: Ministerstvo Zdravotníctva Slovenskej republiky

    Otvorené pre nábor: 2020-07-10
    Uzatvorené pre nábor:
    Uzatvorené:

    Pracoviská klinického skúšania:
    1. Názov: Národný onkologický ústav, Klenová 1, 833 10 Bratislava
      Mesto:
      Zodpovedný skúšajúci: Doc. MUDr. PhD Ľuboš Drgoňa
    2. Názov: Univerzitná nemocnica L. Pasteura, Klinika hematológie a onkohematológie, Rastislavova 43, Pracovisko Trieda SNP 1, 041 66 Košice
      Mesto: Košice
      Zodpovedný skúšajúci: MUDr. Ján Sýkora
  • Randomizované, otvorené klinické skúšanie fázy 3, ktoré porovnáva užívanie karfilzomibu raz týždenne verzus dvakrát týždenne, v kombinácii s lenalidomidom a dexametazónom, u pacientov s relabujúcim alebo refraktérnym mnohopočetným myelómom (A.R.R.O.W.2)
    Liečivo: carfilzomib
    Diagnóza: Mnohopočetný myelóm
    Kód skúšania: 2018-000665-36, 20180015, A.R.R.O.W.2
    Sponzor: Amgen Inc

    Otvorené pre nábor: 2020-09-18
    Uzatvorené pre nábor:
    Uzatvorené: 2023-02-01

    Pracoviská klinického skúšania:
    1. Názov: Univerzitná nemocnica Bratislava, Nemocnica sv. Cyrila a Metoda, Klinika hematológie a trasfuziológie LF UK SZU a UNB, Antolská 11, 851 07, Bratislava
      Mesto: Bratislava
      Zodpovedný skúšajúci: MUDr. PhD. Ľubica Harvanová
  • Randomizované, otvorené skúšanie vo fáze 3 na zhodnotenie liečby osimertinibom s/bez pridania chemoterapie na báze platiny a pemetrexedu v prvej línii liečby u pacientov s lokálne pokročilým alebo metastatickým nemalobunkovým karcinómom pľúc s mutáciou EGFR (FLAURA2)
    Liečivo: AZD9291, Cisplatin, Carboplatin, Pemetrexed
    Diagnóza: Karcinóm pľúc
    Kód skúšania: 2019-000650-61, D5169C00001, FLAURA2
    Sponzor: AstraZeneca AB

    Otvorené pre nábor: 2020-06-30
    Uzatvorené pre nábor:
    Uzatvorené:

    Pracoviská klinického skúšania:
    1. Názov: Fakultná nemocnica s poliklinikou F.D.Roosevelta, Oddelenie pneumológie a ftizeológie, Nám. L.Svobodu 1, 97401 Banská Bystrica
      Mesto: Banská Bystrica
      Zodpovedný skúšajúci: MUDr. Michal Urda
    2. Názov: POKO Poprad s.r.o., Mnoheľova 2, 058 01 Poprad
      Mesto: Poprad
      Zodpovedný skúšajúci: MUDr. Lenka Medvecová
    3. Názov: Špecializovaná nemocnica sv. Svorada Zobor, n,o., Oddelenie klinickej onkológie, Kláštorská 134, 949 88 Nitra
      Mesto: Nitra
      Zodpovedný skúšajúci: Doc. MUDr. CSc. Peter Beržinec
    4. Názov: Východoslovenský onkologický ústav, a.s., Oddelenie klinickej onkológie, Rastislavova 43, 041 91 Košice
      Mesto: Košice
      Zodpovedný skúšajúci: Doc. MUDr. CSc. Igor Andrašina
  • Otvorené, jednoramenné, multicentrické skúšanie na vyhodnotenie bezpečnosti atezolizumabu pri lokálne pokročilom alebo metastatickom uroteliálnom alebo non-uroteliálnom karcinóme močových ciest.
    Liečivo: ATEZOLIZUMAB (RO5541267/F03)
    Diagnóza: Urotelový karcinóm
    Kód skúšania: 2016-002625-11, MO29983
    Sponzor: F. Hoffmann-La Roche Ltd

    Otvorené pre nábor: 2017-06-15
    Uzatvorené pre nábor:
    Uzatvorené: 2020-11-11

    Pracoviská klinického skúšania:
    1. Názov: Národný onkologický ústav, II. Onkologická klinika LFUK a NOÚ, Klinika klinickej onkológie SZU a NOÚ, Klenová 1, 833 10 Bratislava
      Mesto: Bratislava
      Zodpovedný skúšajúci: Prof. MUDr.PhD Michal Mego
  • Randomizovaná, multicentrická, otvorená štúdia fázy III na vyhodnotenie účinnosti akalabrutinibu (ACP-196) v porovnaní s voľbou skúšajúceho medzi idelalisibom v kombinácii s rituximabom alebo bendamustínom v kombinácii s rituximabom u účastníkov s relapsujúcou alebo refraktérnou chronickou lymfocytovou leukémiou
    Liečivo: ACALABRUTINIB (ACP-196)
    Diagnóza: Leukémia
    Kód skúšania: 2015-004454-17, ACE-CL-309
    Sponzor: Acerta Pharma BV, NL

    Otvorené pre nábor: 2016-10-21
    Uzatvorené pre nábor:
    Uzatvorené: 2020-08-05

    Pracoviská klinického skúšania:
    1. Názov: HEMKO s.r.o., Hematologická a onkohematologická ambulancia NZZ Juh, Rastislavova 45
      Mesto: Košice
      Zodpovedný skúšajúci: MUDr. PhD. Adriana Kafková
  • PRESERVE 1: Randomizované, dvojito zaslepené skúšanie fázy 3 s trilaciklibom v porovnaní s placebom u pacientov dostávajúcich FOLFOXIRI/bevacizumab na liečbu metastatického kolorektálneho karcinómu
    Liečivo: Trilaciclib (G1T28)
    Diagnóza: Kolorektálny karcinóm
    Kód skúšania: 2019-003826-25, G1T28-207, PRESERVE 1
    Sponzor: G1 Therapeutics, Inc.

    Otvorené pre nábor: 2021-02-03
    Uzatvorené pre nábor:
    Uzatvorené:

    Pracoviská klinického skúšania:
    1. Názov: Fakultná nemocnica Trnava, Onkologická klinika, ul. A. Žarnova 11, 917 75 Trnava
      Mesto: Trnava
      Zodpovedný skúšajúci: MUDr. Marian Streško, PhD.
    2. Názov: UNsP Milosrdní bratia, spol. s r.o., Oddelenie klinickej onkológie, Námestie SNP 10, 814 65 Bratislava
      Mesto: Bratislava
      Zodpovedný skúšajúci: MUDr. Miriam Drahokoupilová
  • SERENA-4: Randomizované, multicentrické, dvojito zaslepené klinické skúšanie vo fáze III na zhodnotenie AZD9833 (perorálny SERD) + palbociklibu oproti anastrozolu + palbociklibu u pacientov s pokročilým ER-pozitívnym/HER-2 negatívnym karcinómom prsníka bez predchádzajúcej systémovej liečby pokročilého ochorenia.
    Liečivo: (AZD9833 - 25 mg), Palbociclib ( ), (AZD9833 - 75 mg)
    Diagnóza: Karcinóm prsníka
    Kód skúšania: 2020-002276-12, D8532C00001, SERENA-4
    Sponzor: AstraZeneca AB
    Kritéria:

    INCLUSION CRITERIA

    Full list of inclusion criteria

    Pre-/peri-menopausal women or men can be enrolled if amenable to be treated with concomitant, approved LHRH agonists for the duration of the study treatment.
    De novo Stage 4 disease, or recurrence from early stage disease after at least 24 months of standard adjuvant endocrine therapy. Note that at least 12 months must have elapsed since the patient's last dose of adjuvant AI therapy without disease progression on treatment. Note that a 2-week washout period is required after the last dose of tamoxifen prior to randomisation.
    Histologically or cytologically documented diagnosis of ER+, HER2-negative breast cancer based on local laboratory results.
    Previously untreated with any systemic anti-cancer therapy for their locoregionally recurrent or metastatic ER+ disease.
    Measurable disease as defined per RECIST v.1.1 OR at least one lytic or mixed (lytic + sclerotic) bone lesion with a soft tissue component that can be assessed by CT or MRI.
    Eastern Cooperative Oncology Group performance status of 0 or 1.
    Adequate organ and marrow function.
    Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
    INFORMATION FOR TRIAL PARTICIPANTS

    Participants can join the trial if they:

    Have breast cancer that cannot be treated with surgery or radiation
    Have breast cancer that has already spread into other parts of the body at the time of diagnosis, or has come back after at least 2 years of a standard endocrine treatment
    Have ER proteins but not overexpression of HER2 protein in their tumors
    Have never received any type of cancer therapy that affects the whole body for advanced breast cancer
    Are able to do their daily activities
    EXCLUSION CRITERIA

    Full list of exclusion criteria

    Previous neoadjuvant or adjuvant treatment with an AI treatment +/- CDK4/6 inhibitor with disease recurrence while on or within 12 months of completing treatment.
    Prior exposure to AZD9833, other investigational SERDs/endocrine agents or fulvestrant.
    Participation in another clinical study with a study treatment or investigational medicinal device administered in the last 4 weeks prior to randomization or concurrent enrollment in another clinical study, unless it is an observational (non-interventional) clinical study or during the follow-up period of an interventional study.
    Advanced, symptomatic, visceral spread, that are at risk of life-threatening complications in the short term and/or impending visceral crisis
    Known active uncontrolled or symptomatic CNS metastases, carcinomatous meningitis, or leptomeningeal disease.
    Any clinically important and symptomatic heart disease .
    Currently pregnant (confirmed with positive pregnancy test) or breast-feeding.
    As judged by the investigator, any evidence of diseases (such as severe or uncontrolled systemic diseases, renal transplant and active bleeding diseases) which, in the investigator's opinion, makes it undesirable for the participant to participate in the study or that would jeopardize compliance with the protocol.
    Any concurrent anti-cancer treatment.
    Active infection including tuberculosis, HBV and HCV.
    INFORMATION FOR TRIAL PARTICIPANTS

    Participants cannot join the trial if they:

    Have uncontrolled cancer that has spread to the brain or the spinal cord
    Have received certain treatments for cancer in the past but the cancer came back within 1 year
    Had certain types of tumors in the past, which the study doctors think could come back
    Are currently taking any treatment for cancer or are taking medications or supplements that affect certain proteins in the body
    Have any major health problem, infection, or surgery that could make it difficult or dangerous to participate in this trial, such as tuberculosis, HIV, heart problems, or a kidney transplant
    The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.


    Otvorené pre nábor: 2021-03-20
    Uzatvorené pre nábor: 2023-11-22
    Uzatvorené:

    Pracoviská klinického skúšania:
    1. Názov: Fakultná nemocnica s poliklinikou Žilina, Oddelenie klinickej a radiačnej onkológie, ul. Vojtecha Spanyola 43, Žilina
      Mesto: Žilina
      Zodpovedný skúšajúci: MUDr. MBA Dagmar Sudeková
    2. Názov: Fakultná nemocnica Trnava, Onkologická klinika, ul. A. Žarnova 11, 917 75 Trnava
      Mesto: Trnava
      Zodpovedný skúšajúci: MUDr.PhD. Marian Streško
      Referovať pacienta do klinického skúšania
    3. Názov: FNsP J.A. Reimana Prešov, Ambulancia klinickej onkológie, J. Hollého 14, 081 81 Prešov
      Mesto: Prešov
      Zodpovedný skúšajúci: MUDr. Jaroslava Lešková
      Referovať pacienta do klinického skúšania
    4. Názov: FNsP Trenčín, Onkologické oddelenie, Legionárska 28, 911 71 Trenčín
      Mesto: Trenčín
      Zodpovedný skúšajúci: MUDr. PhD. MPH Branislav Bystrický
      Referovať pacienta do klinického skúšania
    5. Názov: Mammacentrum sv. Agáty Banská Bystrica, a.s., Tibora Andrašovana 46, 974 01 Banská Bystrica
      Mesto: Banská Bystrica
      Zodpovedný skúšajúci: MUDr. Eva Pritzová
    6. Názov: Národný onkologický ústav, II. Onkologická klinika LFUK a NOÚ, Klinika klinickej onkológie SZU a NOÚ, Klenová 1, 833 10 Bratislava
      Mesto: Bratislava
      Zodpovedný skúšajúci: MUDr. PhD. Eva Oravcová
      Referovať pacienta do klinického skúšania
    7. Názov: Onkologický ústav sv. Alžbety, s.r.o., Chemoterapeutická ambulancia I., Heydukova 10, 812 50 Bratislava
      Mesto: Bratislava
      Zodpovedný skúšajúci: MUDr. Milada Mikulová
    8. Názov: Východoslovenský onkologický ústav, a.s., Oddelenie klinickej onkológie, Rastislavova 43, 041 91 Košice
      Mesto: Košice
      Zodpovedný skúšajúci: Doc. MUDr. CSc. Igor Andrašina
  • Multicentrické randomizované dvojito zaslepené placebom kontrolované klinické skúšanie fázy III porovnávajúce účinnosť a bezpečnosť tafasitamabu plus lenalidomid v kombinácii s R-CHOP v porovnaní s R-CHOP samostatne u predtým neliečených stredne-vysoko a vysoko rizikových pacientov s novo diagnostikovaným difúznym veľkobunečným B-lymfómom (DLBCL)
    Liečivo: Tafasitamab, Lenalidomide
    Diagnóza: Nádorové ochorenia
    Kód skúšania: 2020-002990-84, MOR208C310, frontMIND
    Sponzor: MorphoSys AG

    Otvorené pre nábor: 2021-05-02
    Uzatvorené pre nábor: 2023-02-14
    Uzatvorené:

    Pracoviská klinického skúšania:
    1. Názov: Univerzitná nemocnica L. Pasteura, Klinika hematológie a onkohematológie, Rastislavova 43, Pracovisko Trieda SNP 1, 041 66 Košice
      Mesto: Košice
      Zodpovedný skúšajúci: MUDr. Tomáš Guman, Ph.D.
    2. Názov: Východoslovenský onkologický ústav, a.s., Oddelenie klinickej onkológie, Rastislavova 43, 041 91 Košice
      Mesto: Košice
      Zodpovedný skúšajúci: MUDr. Martin Petrilák
  • PSMAfore: Otvorené, multicentrické, randomizované klinické skúšanie fázy III, porovnávajúce 177Lu-PSMA-617 so zmenou v sekvencii priamej antiandrogénnej liečby u pacientov s progredujúcim metastatickým kastračne rezistentným karcinómom prostaty, ktorí neboli predliečení taxánom.
    Liečivo: gallium (68Ga) gozetotide (AAA517), lutetium(177Lu) vipivotide tetraxetan (AAA617)
    Diagnóza: Karcinóm prostaty
    Kód skúšania: 2020-003969-19, CAAA617B12302, PSMAfore
    Sponzor: Novartis Pharma AG

    Otvorené pre nábor: 2021-05-28
    Uzatvorené pre nábor: 2023-03-03
    Uzatvorené:

    Pracoviská klinického skúšania:
    1. Názov: Národný onkologický ústav, II. Onkologická klinika LFUK a NOÚ, Klinika klinickej onkológie SZU a NOÚ, Klenová 1, 833 10 Bratislava
      Mesto: Bratislava
      Zodpovedný skúšajúci: Prof. MUDr. DrSc Michal Mego
  • Randomizované, kontrolované, multicentrické, odslepené skúšanie na preskúmanie účinnosti a bezpečnosti pridania apalutamidu k rádioterapii a agonistovi LHRH u vysokorizikových pacientov s PSMA-PET pozitívnym hormonálne senzitívnym karcinómom prostaty, s observačným ďalším sledovaním PSMA-PET negatívnych pacientov
    Liečivo: Apalutamide (JNJ-56021927)
    Diagnóza: Karcinóm prostaty
    Kód skúšania: 2019-002957-46, 56021927PCR3015, PRIMORDIUM
    Sponzor: Janssen Pharmaceutica N.V., Belgium
    Kritéria:

    Inclusion Criteria:

    Histologically confirmed adenocarcinoma of the prostate
    Previously treated with radical prostatectomy with or without lymph node dissection and either: a) for biochemical recurrence after radical prostatectomy (RP): any post-operative prostate-specific antigen (PSA) measurement of less than (<) 0.1 nanogram/milliliter (ng/mL) within 12 months after RP and without any PSA greater than and equal to (>=) 0.1 ng/mL within the 4 to 8-week period after RP or b) for persistent PSA after RP: PSA >=0.1 ng/mL within the 4 to 8-week period after RP, confirmed by additional measurement at least 3 weeks later
    Be able to swallow whole the study drug tablets or follow the instructions for admixing with apple sauce
    Results of the Prostate specific membrane antigen-positron emission tomography (PSMA-PET) at screening as determined by blinded independent, central review (BICR), must be: PSMA-PET-negative for any prostate cancer lesions (that is, no loco-regional lesion and no distant lesions); or PSMA-PET-positive for at least one loco-regional (pelvic) lesion without distant extra-pelvic lesion; or PSMA PET- positive for at least one loco--regional (pelvic) lesion with extra-pelvic lesion(s).
    High risk of developing metastasis defined as; a) for biochemical recurrence after RP: pathological Gleason score greater than or equal to (>=) 8 evaluated from prostate tissue specimen at radical prostatectomy, or prostate-specific antigen doubling time (PSADT) less than or equal to (<=) 12 months at the time of screening; b) for persistent PSA after RP: pathological Gleason score >=8, evaluated from prostate tissue specimen at radical prostatectomy
    Participants with evidence of distant metastasis on screening PSMA-PET scan must have no evidence of prostate cancer metastases on screening CT/MRI of the chest/abdomen/pelvis, Technetium 99m [99mTc] whole-body bone scan. Participants with a single bone lesion on 99mTc whole-body bone scan should have confirmatory imaging by CT or MRI; if the confirmatory scan confirms the bone lesion, the participant should be excluded from the study. Conventional images (99mTc-bone scan and CT/MRI) from the screening will be evaluated locally before randomization
    Eastern Cooperative Oncology Group Performance Status Grade 0 or 1

    Exclusion Criteria:
    History of pelvic radiation for malignancy
    Previous treatment with androgen deprivation therapy (ADT) for prostate cancer
    Previously treated for biochemical recurrence (BCR) or persistent PSA after RP (previous surgical treatment of one or more loco-regional lesions is allowed)
    Prior treatment with a CYP17 inhibitor (example, oral ketoconazole, orteronel, abiraterone acetate, galeterone) or any androgen receptor (AR) antagonist including bicalutamide, flutamide, nilutamide, apalutamide, enzalutamide or darolutamide and any other medications that may lower androgen levels (estrogens, progestins, aminoglutethimide, etc.), including bilateral orchiectomy
    Known or suspected contraindications or hypersensitivity to apalutamide, Luteinizing Hormone-Releasing Hormone (LHRH) agonist or any of the components of the formulations
    Prior chemotherapy for prostate cancer
    Any evidence of prostate cancer metastasis on computed tomography/magnetic resonance imaging (CT/MRI) of the chest/abdomen/pelvis or 99mTc whole-body bone scan, at any time prior to screening


    Otvorené pre nábor: 2021-07-14
    Uzatvorené pre nábor:
    Uzatvorené:

    Pracoviská klinického skúšania:
    1. Názov: CUIMED s.r.o., Urologická ambulancia, Strečianska 13, 851 05 Bratislava
      Mesto: Bratislava
      Zodpovedný skúšajúci: Doc. MUDr. PhD Frederico Goncalves
    2. Názov: MILAB, s.r.o., UROCENTRUM, Hollého 14/D, 080 01 Prešov
      Mesto: Prešov
      Zodpovedný skúšajúci: Doc. MUDr. PhD. Ivan Minčík
    3. Názov: Nemocnica Poprad a.s., Urologické oddelenie, Banícka 803/28, 058 45 Poprad
      Mesto: Poprad
      Zodpovedný skúšajúci: MUDr. MBA Erik Chorvát
    4. Názov: Privátna Urologická Ambulancia s.r.o., Piaristická ul č. 8, 911 01 Trenčín
      Mesto: Trenčín
      Zodpovedný skúšajúci: MUDr. MPH Roman Sokol
    5. Názov: Univerzitná nemocnica Martin, Urologická klinika, Kollárova 2, 036 59 Martin
      Mesto: Martin
      Zodpovedný skúšajúci: Prof. MUDr. Ján Kliment
    6. Názov: UROEXAM, spol. s.r.o., Urologická ambulancia, Špitálska 13, 949 01 Nitra
      Mesto: Nitra
      Zodpovedný skúšajúci: MUDr. Marek Brezovský
    7. Názov: Východoslovenský onkologický ústav, a.s., Oddelenie radiačnej onkológie, Rastislavova 43, 041 91 Košice
      Mesto: Košice
      Zodpovedný skúšajúci: Doc. MUDr. PhD. Pavol Dubinský
      Referovať pacienta do klinického skúšania
  • Randomizované, otvorené, multicentrické klinické skúšanie fázy 3 na vyhodnotenie účinnosti a bezpečnosti adjuvantného giredestrantu v porovnaní s vybranou adjuvantnou endokrinnou monoterapiou na základe voľby lekára u pacientov s HER2 negatívnym nádorom prsníka v ranom štádiu s pozitívnymi estrogénovými receptormi
    Liečivo: Giredestrant (RO7197597)
    Diagnóza: Karcinóm prsníka
    Kód skúšania: 2021-000129-28, GO42784, lidERA
    Sponzor: F. Hoffmann-La Roche Ltd
    Kritéria:

    Inclusion Criteria:

    Documented estrogen receptor (ER)-positive and HER2-negative breast tumor, as assessed locally on a primary disease specimen
    Participants who have multicentric (the presence of two of more tumor foci within different quadrants of the same breast) and/or multifocal (the presence of two or more tumor foci within a single quadrant of the breast) breast cancer are also eligible if all examined tumors meet pathologic criteria for ER positivity and HER2 negativity
    Participants must have undergone definitive surgery of their primary breast tumor(s) and axillary lymph nodes (axillary lymph node dissection [ALND] and/or sentinel lymph node biopsy [SLNB])
    Participants who received or will be receiving adjuvant chemotherapy must have completed adjuvant chemotherapy prior to randomization. Participants may also have received neoadjuvant chemotherapy. A washout period of at least 21 days is required between last adjuvant chemotherapy dose and randomization.
    Resolution of all acute toxic effects of prior anti-cancer therapy or surgical procedures to NCI CTCAE v5.0 Grade 1 or better (except alopecia, Grade ≤2 peripheral neuropathy, arthralgia or other toxicities not considered a safety risk for the participant per the investigator's judgment)
    Participants have received (neo)adjuvant chemotherapy and/or had surgery and had no prior endocrine therapy are eligible, provided that they are enrolled within 12 months following definitive breast cancer surgery
    Participants who have confirmed availability of an untreated primary breast tumor tissue specimen suitable for biomarker testing (i.e., representative archived formalin-fixed, paraffin-embedded [FFPE] tissue block [preferred] or 15-20 slides containing unstained, freshly cut, serial sections), with associated de-identified pathology report is required. Although 15-20 slides are preferred, if only 10-14 slides are available, the individual may still be eligible for the study.
    Participants with node-positive and node-negative disease are eligible provided they meet additional risk criteria as defined in the protocol
    Eastern Cooperative Oncology Group (ECOG) Performance Status 0, 1, or 2
    Able and willing to swallow, retain, and absorb oral medication
    Adequate organ function
    Exclusion Criteria:

    Pregnant or breastfeeding, or intending to become pregnant during the study or within 10 days after the final dose of giredestrant, or within the time period specified per local prescribing guidelines after the final dose of the endocrine therapy of physician's choice
    Received treatment with investigational therapy within 28 days prior to initiation of study treatment or is currently enrolled in any other type of medical research judged by the sponsor not to be scientifically or medically compatible with this study
    Receiving or planning to receive a CDK4/6 inhibitor as (neo)adjuvant therapy. A short course of up to 12 weeks of neoadjuvant or adjuvant treatment with CDK4/6 inhibitor therapy prior to randomization is allowed.
    Active cardiac disease or history of cardiac dysfunction
    Diagnosed with Stage IV breast cancer
    A history of any prior (ipsilateral and/or contralateral) invasive breast cancer or ductal carcinoma in situ (DCIS). Participants with a history of contralateral DCIS treated by only local regional therapy at any time may be eligible.
    A history of any other malignancy within 3 years prior to screening, except for appropriately treated carcinoma in situ of the cervix, nonmelanoma skin carcinoma, or Stage I uterine cancer
    Any prior endocrine treatment with selective ER modulators (e.g., tamoxifen), degraders, or aromatase inhibitors. A short course of neoadjuvant or adjuvant endocrine therapy (up to 12 weeks) is allowed.
    Clinically significant liver disease consistent with Child-Pugh Class B or C, including active hepatitis (e.g., hepatitis B virus [HBV] or hepatitis C virus [HCV]), current alcohol abuse, cirrhosis, or positive test for viral hepatitis
    Treatment with strong CYP3A4 inhibitors or inducers within 14 days or 5 drug elimination half-lives (whichever is longer) prior to initiation of study treatment
    Known allergy or hypersensitivity to any of the study drugs or any of their excipients
    Pre- and perimenopausal participants or male participants who have a known hypersensitivity to LHRH agonists
    A documented history of hemorrhagic diathesis, coagulopathy, or thromboembolism
    Renal dysfunction that requires dialysis
    A major surgical procedure unrelated to breast cancer within 28 days prior to randomization
    A serious infection requiring oral or IV antibiotics within 14 days prior to screening or other clinically significant infection (e.g., COVID-19) within 14 days prior to screening
    Any serious medical condition or abnormality in clinical laboratory tests that, in the investigator's judgment, precludes an individual's safe participation in and completion of the study
    Unable or unwilling to comply with the requirements of the protocol in the opinion of the investigator


    Otvorené pre nábor: 2021-07-13
    Uzatvorené pre nábor: 2023-08-15
    Uzatvorené:

    Pracoviská klinického skúšania:
    1. Názov: Národný onkologický ústav, II. Onkologická klinika LFUK a NOÚ, Klinika klinickej onkológie SZU a NOÚ, Klenová 1, 833 10 Bratislava
      Mesto: Bratislava
      Zodpovedný skúšajúci: MUDr. PhD. Eva Oravcová
    2. Názov: Onkologický ústav sv. Alžbety, s.r.o., Interná klinika VŚZ a SP a OÚSA, Heydukova 10, 812 50 Bratislava
      Mesto: Bratislava
      Zodpovedný skúšajúci: MUDr. PhD. Bibiána Vertáková Krakovská
    3. Názov: UNsP Milosrdní bratia, spol. s r.o., Oddelenie klinickej onkológie, Námestie SNP 10, 814 65 Bratislava
      Mesto: Bratislava
      Zodpovedný skúšajúci: MUDr. Miriam Drahokoupilová
    4. Názov: Východoslovenský onkologický ústav, a.s., Oddelenie klinickej onkológie, Rastislavova 43, 041 91 Košice
      Mesto: Košice
      Zodpovedný skúšajúci: MUDr. Mária Višňovská
  • EPIK-O: Multicentrické, randomizované (1:1), otvorené, aktívne kontrolované klinické skúšanie fázy III na zhodnotenie účinnosti a bezpečnosti alpelisibu (BYL719) v kombinácii s olaparibom v porovnaní s cytotoxickou chemoterapiou v monoterapii u pacientok so seróznym karcinómom vaječníkov s vysokým stupňom malignity bez potvrdenej zárodočnej mutácie BRCA, ktorý je rezistentný alebo refraktérny voči platine
    Liečivo: ALPELISIB (BYL719), OLAPARIB (AZD2281)
    Diagnóza: Nádorové ochorenia
    Kód skúšania: 2019-004682-40, CBYL719K12301, EPIK-O
    Sponzor: Novartis Pharma AG

    Otvorené pre nábor: 2021-07-23
    Uzatvorené pre nábor: 2023-01-15
    Uzatvorené:

    Pracoviská klinického skúšania:
    1. Názov: FNsP Trenčín, Onkologické oddelenie, Legionárska 28, 911 71 Trenčín
      Mesto: Trenčín
      Zodpovedný skúšajúci: MUDr. PhD. MPH Branislav Bystrický
    2. Názov: Národný onkologický ústav, II. Onkologická klinika LFUK a NOÚ, Klinika klinickej onkológie SZU a NOÚ, Klenová 1, 833 10 Bratislava
      Mesto: Bratislava
      Zodpovedný skúšajúci: MUDr. PhD. Jozef Šufliarsky
  • RANDOMIZOVANÉ, DVOJITO ZASLEPENÉ KLINICKÉ SKÚŠANIE FÁZY 3 HODNOTIACE TALAZOPARIB S ENZALUTAMIDOM OPROTI PLACEBU S ENZALUTAMIDOM U MUŽOV S METASTATICKÝM KASTRAČNE CITLIVÝM KARCINÓMOM PROSTATY S MUTOVANÝM GÉNOM DDR
    Liečivo: Talazoparib (PF-06944076)
    Diagnóza: Karcinóm prostaty
    Kód skúšania: 2021-000248-23, C3441052, TALAPRO-3
    Sponzor: Pfizer Inc.

    Otvorené pre nábor: 2021-07-15
    Uzatvorené pre nábor: 2023-03-15
    Uzatvorené:

    Pracoviská klinického skúšania:
    1. Názov: MILAB, s.r.o., UROCENTRUM, Hollého 14/D, 080 01 Prešov
      Mesto: Prešov
      Zodpovedný skúšajúci: Doc. MUDr. PhD. Ivan Minčík
    2. Názov: POKO Poprad s.r.o., Mnoheľova 2, 058 01 Poprad
      Mesto: Poprad
      Zodpovedný skúšajúci: MUDr. Juraj Beniak
    3. Názov: Privátna Urologická Ambulancia s.r.o., Piaristická ul č. 8, 911 01 Trenčín
      Mesto: Trenčín
      Zodpovedný skúšajúci: MUDr. Roman Sokol, PhD., MPH
    4. Názov: UROEXAM, spol. s.r.o., Urologická ambulancia, Špitálska 13, 949 01 Nitra
      Mesto: Nitra
      Zodpovedný skúšajúci: MUDr. Jozef Marko
    5. Názov: Východoslovenský onkologický ústav, a.s., Oddelenie radiačnej onkológie, Rastislavova 43, 041 91 Košice
      Mesto: Košice
      Zodpovedný skúšajúci: Doc. MUDr. PhD. Pavol Dubinský
    6. Názov: Fakultná nemocnica s poliklinikou F. D. Roosevelta Banská Bystrica , Onkologická klinika SZU, Námestie L.Svobodu 1
      Mesto: Banská Bystrica
      Zodpovedný skúšajúci: MUDr. PhD. Matej Hrnčár
  • Otvorené klinické skúšanie vo fáze 1b paralelných skupín na stanovenie farmakokinetiky, bezpečnosti a znášanlivosti viacnásobne perorálne podaného produktu Decitabine a Cedazuridine (ASTX727) pacientom s rakovinou so stredne ťažkým a ťažkým poškodením pečene
    Liečivo: CEDAZURIDINE, DECITABINE (ASTX727)
    Diagnóza: Nádorové ochorenia
    Kód skúšania: 2021-000966-13, ASTX727-18
    Sponzor: Astex Pharmaceuticals, Inc.
    Kritéria:

    Inclusion Criteria:

    Able to understand and comply with the study procedures, understand the risks involved in the study, and provide legally effective informed consent before the first study-specific procedure; specifically able to comply with the PK assessment schedule during the first treatment cycle.
    Participants must have histologically or cytologically confirmed solid tumor or hematologic malignancy that is metastatic or unresectable and for which standard life-prolonging measures are not available.
    For participants with AML/MDS only:

    Cytologically or histologically confirmed diagnosis of AML (except M3 acute promyelocytic leukemia) or MDS according to the 2008 World Health Organization (WHO) classification with the disease being refractory, relapsed, or unresponsive to standard treatment;
    Participants with frontline MDS or treatment naïve AML not suitable for induction therapy (eg, age of >75 years, Eastern Cooperative Oncology Group [ECOG] performance status ≥ 2, severe pulmonary disorder, total bilirubin > 1.5x upper limit of normal [ULN]);
    Platelet count ≥ 25,000/μL;
    Absolute neutrophil count (ANC) ≥ 100 cells/μL.
    For participants with solid tumors only:

    Platelet count ≥ 100,000/μL;
    ANC ≥ 1000 cells/μL.
    Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
    Hepatic function defined per the National Cancer Institute Cancer Therapy Evaluation Program (NCI CTEP) Organ Dysfunction Working Group (ODWG) as:

    Normal hepatic function: total bilirubin ≤1x ULN aspartate aminotransferase (AST): ≤1x ULN;
    Moderate hepatic impairment: total bilirubin >1.5x to 3x ULN AST: any value;
    Severe hepatic impairment: total bilirubin >3x ULN AST: any value.
    Adequate renal function defined as creatinine clearance (CLcr, according to the Cockcroft-Gault equation) >50mL/min.
    No major surgery within 30 days of first administration of oral decitabine and cedazuridine.
    Life expectancy of at least 3 months.
    Women of childbearing potential (according to recommendations of the Clinical Trial Facilitation Group) must not be pregnant or breastfeeding and must have a negative pregnancy test at Screening.
    Women of childbearing potential must agree to practice 1 highly effective contraceptive measure of birth control with low user dependency and must agree not to become pregnant for 6months after completing treatment
    Male participants with female partners of childbearing potential must agree to use a male condom and advise his partner to practice 1 highly effective contraceptive measure of birth control (user dependent or with low user dependency) and must agree not to father a child while receiving treatment with oral decitabine and cedazuridine and for at least 3 months after completing treatment.
    Exclusion Criteria:

    Treatment with azacitidine or decitabine within 4 weeks before Screening. Prior cytotoxic chemotherapy for AML except for hydroxyurea to control high white blood cell (WBC) counts.
    Hospitalization for more than 2 days for documented febrile neutropenia, pneumonia, sepsis, or systemic infection 30 days prior to first dose.
    Treatment with any investigational medicinal product (IMP), investigational therapy, chemotherapy, immunotherapy, or targeted therapy within 2 weeks or 5 half-lives, whichever is longer, before the first dose of study treatment, or ongoing clinically significant adverse events from previous treatment.
    Concurrent MDS therapies, including lenalidomide, cyclosporine/tacrolimus, granulocyte-colony-stimulating factor (G-CSF), granulocyte-macrophage colony-stimulating factor, etc. Prior treatment with these agents is permitted, provided that completion is at least 1 week before the first dose of study treatment. Short-term use of G-CSF for febrile neutropenia is permitted at the discretion of the treating physician and should be guided by accepted practice or institutional guidelines. Hematopoietic growth factors will not be routinely used unless cleared by Astex medical expert.
    Administration of live (attenuated) vaccines within 4 weeks before the first administration of oral decitabine and cedazuridine until after the follow-up visit. Other vaccines, eg, inactivated or RNA-based, may be administered but should not occur from 7 days before first administration of oral decitabine and cedazuridine until after the follow-up visit.
    High medical risk because of other conditions such as uncontrolled systemic diseases, active uncontrolled infections, or comorbidities that may put the participant at risk of not being able to complete at least 2 cycles of treatment.
    Conditions which likely promote delayed ventricular repolarization (QT prolongation):

    Corrected QT interval (QTc) using Bazett's correction (QTcB) or QTc using Fridericia correction (QTcF) at Screening or Day -1 > 450 ms;
    History or disposition for torsades des pointes (TdP) (eg, heart failure, hypokalemia, family history of long QT Syndrome);
    Concomitant medication that prolong the QT/QTc interval.
    Cardiac abnormalities or unstable cardiovascular conditions:

    Unstable ischemic heart disease or severe heart failure (New York Heart Association Class III or IV);
    Uncontrolled treated/untreated hypertension (defined as a mean of 3 repeated measurements for systolic blood pressure ≥ 180 mmHg and/or diastolic blood pressure ≥ 110 mmHg; current or documented history of repeated clinically significant hypotension or severe episodes of orthostatic hypotension (systolic blood pressure < 90 mmHg and/or diastolic blood pressure < 50 mmHg).
    Known significant mental illness or other condition, such as active alcohol or other substance abuse or addiction, that in the opinion of the investigator predisposes the participant to high risk of noncompliance with the protocol.
    In participants with AML/MDS, rapidly progressive or highly proliferative disease or other criteria that render the participant at high risk of requiring intensive cytotoxic chemotherapy within the next 3 months.
    Life-threatening illness or severe organ system dysfunction, such as uncontrolled congestive heart failure or chronic obstructive pulmonary disease, or other reasons including laboratory abnormalities, which, in the investigator's opinion, could compromise the participant's safety, interfere with the absorption or metabolism of oral decitabine and cedazuridine, or compromise completion of the study or integrity of the study outcomes.
    Untreated central nervous system (CNS) metastases. Participants with treated CNS metastases are eligible provided they have been clinically stable for at least 4 weeks before screening.
    Positive nasopharyngeal test for SARS-CoV-2 at Screening or Day -1. Participants may be rescreened if they become SARS-CoV-2 negative.
    Participants infected with human immunodeficiency virus (HIV).
    Positive blood screen for hepatitis C antibody (HCV+) and positive RNA polymerase chain reaction (PCR). Participant can be included if HCV+ but negative for RNA PCR.
    Positive blood screen for hepatitis B surface antigen (HBsAg+). Participants with positive blood screen for hepatitis B surface antibody (HBsAb+) and negative hepatitis B core antibody (HBcAb-) can be included if negative for hepatitis B surface antigen (HBsAg-).
    Average intake of more than 24 units of alcohol per week for male subjects and 17 units per week for female subjects (1 unit of alcohol equals 10 mL of pure alcohol, ie, approximately 250 mL of beer, 75 mL of wine, or 25 mL of spirits).
    Positive drugs of abuse or alcohol test at Screening and Day -1, except for the use of prescribed and medically indicated drugs (eg, benzodiazepines, opiates, or cannabinoids).
    Donation or loss of more than 500 mL of blood within 60 days prior to the first study drug administration.
    Hypersensitivity to decitabine, cedazuridine, or any of the excipients in oral decitabine and cedazuridine.


    Otvorené pre nábor: 2021-08-28
    Uzatvorené pre nábor:
    Uzatvorené:

    Pracoviská klinického skúšania:
    1. Názov: Summit Clinical Research, s.r.o., Bárdošova 2/A, Bratislava
      Mesto: Bratislava
      Zodpovedný skúšajúci: MUDr. Viera Skarbová
  • Otvorené klinické skúšanie vo fáze 1b paralelných skupín s viacnásobným perorálnym dávkovaním na stanovenie farmakokinetiky, bezpečnosti a znášanlivosti produktu Decitabine a Cedazuridine (ASTX727) u pacientov s rakovinou s ťažkým poškodením obličiek a u pacientov s rakovinou s normálnou funkciou obličiek
    Liečivo: CEDAZURIDINE, DECITABINE (ASTX727)
    Diagnóza: Karcinóm obličky
    Kód skúšania: 2021-000947-35, ASTX727-17
    Sponzor: Astex Pharmaceuticals, Inc.
    Kritéria:

    Principal inclusion criteria
    1) Previous participation in an Astex-sponsored ASTX727 clinical trial (including but not limited to studies ASTX727-01, ASTX727-02, ASTX727-04, ASTX727-17, ASTX727-18, and the food effect substudy of ASTX727-06) in which the subject was treated with ASTX727 and was still on active treatment with ASTX727 at the time of study completion as determined by Astex.
    2) Subject is considered to be benefitting from ASTX727 treatment in the opinion of the treating Investigator at the time of parent study completion. (Subjects must not be withdrawn from the parent study until eligibility for this study is confirmed.)
    3) Subject is able to understand and comply with the study procedures and understands the risks involved in the study.
    4) Subject provides legally effective informed consent before undergoing any study-specific procedure.

    FE Substudy inclusion criteria:
    1) Be 18 years of age or older, at the time of signing the informed consent.
    2) Have MDS, including all French-American-British subtypes (refractory anemia, refractory anemia with ringed sideroblasts, refractory anemia with excess blasts, refractory anemia with excess blasts in transformation, CMML), and subjects with MDS IPSS int-1, -2, or high-risk MDS, or AML, as diagnosed according to the 2016 World Health Organization (WHO) guidelines on acute leukemia, of any subtype except M3 (acute promyelocytic leukemia), who are not candidates for intensive chemotherapy, including subjects receiving HMA treatment, who have a confirmed diagnosis and a prior confirmatory bone marrow report. Subjects who are currently receiving HMA treatment must complete the ongoing (at the time of Screening) treatment cycle before enrolling in this study; timing of start of treatment cycle with ASTX727 is at the principal investigator’s discretion.
    3) Have Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
    4) Have adequate organ function defined as follows:
    a. Hepatic: Total bilirubin ≤1.5× upper limit of normal (ULN); aspartate aminotransferase/serum glutamicoxaloacetic transaminase (AST/SGOT) and alanine aminotransferase/serum glutamic-pyruvic transaminase (ALT/SGPT) ≤5× ULN.
    b. Renal: Calculated creatinine clearance ≥60 mL/min.
    5) Women of childbearing potential must not be pregnant or breastfeeding and must have a negative pregnancy test at screening. Women of childbearing potential must agree to practice 1 highly effective contraceptive measure of birth control (with a failure rate of <1% per year; with low user dependency) during the substudy and for 6 months after the last dose of study treatment and must agree not to become pregnant for 6 months after completing treatment; men with female partners of childbearing potential must agree to use a condom and advise their partners to practice 1 highly effective contraceptive measure of birth control (user dependent or with low user dependency) while receiving treatment with ASTX727 and for at least 3 months after completing treatment and must agree not to father a child while receiving ASTX727 and for at least 3 months after completing ASTX727 treatment.

    Principal exclusion criteria
    1) Any subject who, in the opinion of the investigator, may have other conditions, or for whom safety data from parent study participation suggests the risks of continuing treatment with ASTX727 may outweigh the benefits.

    FE Substudy Exclusion Criteria:
    1) Known or suspected hypersensitivity to decitabine, cedazuridine, or any of the excipients in the ASTX727 tablets.
    2) Poor medical risk because of other conditions such as uncontrolled systemic diseases or active uncontrolled infections.
    3) Life-threatening illness, medical condition or organ system dysfunction, or other reasons including laboratory abnormalities, which, in the Investigator’s opinion, could compromise the subject’s safety, interfere with the absorption or metabolism of decitabine + cedazuridine, or compromise the integrity of the study outcomes.
    4) Prior gastric surgery for ulcer disease, weight loss, etc., that would impair normal motility or absorption.
    5) Second malignancy currently requiring active chemotherapy. To clarify, patients with breast or prostate cancer stable on or responding to endocrine therapy, are eligible.
    6) Known history of human immunodeficiency virus or known seropositive for hepatitis C virus or hepatitis B virus.
    7) Active uncontrolled gastric or duodenal ulcer.
    8) Subjects with acute promyelocytic leukemia.
    9) Prior cytotoxic chemotherapy for AML except for hydroxyurea to control high white blood cell (WBC) counts.
    10) Treated with any investigational drug or therapy within 2 weeks of study treatment, or 5 half-lives, whichever is longer, before the protocol-defined first dose of study treatment, or ongoing clinically significant AEs from previous treatment with investigational drug or therapy.
    11) Sensitivity to any of the study interventions or components thereof, or drug or other allergy that, in the opinion of the Investigator or medical monitor, contraindicates participation in the study.
    12) Known significant mental illness or other condition such as active alcohol or other substance abuse or addiction that, in the opinion of the Investigator, predisposes the subject to high risk of noncompliance with the protocol.


    Otvorené pre nábor: 2021-08-28
    Uzatvorené pre nábor:
    Uzatvorené:

    Pracoviská klinického skúšania:
    1. Názov: Summit Clinical Research, s.r.o., Bárdošova 2/A, Bratislava
      Mesto: Bratislava
      Zodpovedný skúšajúci: MUDr. Viera Skarbová
  • NEZASLEPENÉ, MULTICENTRICKÉ, RANDOMIZOVANÉ KLINICKÉ SKÚŠANIE FÁZY 3 HODNOTIACE PRVÚ LÍNIU LIEČBY ENKORAFENIBOM A CETUXIMABOM S CHEMOTERAPIOU ALEBO BEZ NEJ V POROVNANÍ SO ŠTANDARDNOU LIEČBOU, S ÚVODNOU ČASŤOU NA HODNOTENIE BEZPEČNOSTI ENKORAFENIBU A CETUXIMABU S CHEMOTERAPIOU, U ÚČASTNÍKOV S METASTATICKÝM KOLOREKTÁLNYM KARCINÓMOM S MUTÁCIOU V600E GÉNU BRAF
    Liečivo: ENCORAFENIB (PF-07263896), CETUXIMAB (Cetuximab)
    Diagnóza: Kolorektálny karcinóm
    Kód skúšania: 2020-001288-99, C4221015, The BREAKWATER Study
    Sponzor: Pfizer Inc.
    Kritéria:

    Principal inclusion criteria
    Molecular Prescreening Inclusion Criteria
    Age and Sex:
    1. SLI: Male or female participants age ≥18 years at the time of informed consent.
    Phase 3 and Cohort 3: Male or female participants age ≥16 years at the time of informed consent/assent in all countries where permitted. In countries or sites where enrollment of adolescents is not permitted (eg, Germany), male or female participants age ≥18 years at the time of informed consent.
    Refer to Appendix 4 for reproductive criteria for male (Section 10.4.1) and female (Section 10.4.2) participants.
    Weight:
    2. Body weight ≥40 kg.
    Type of Participant and Disease Characteristics:
    3. Participants with histologically or cytologically confirmed colorectal adenocarcinoma.
    4. Participants with evidence of Stage IV metastatic disease.
    Note: Patients with oligometastatic disease previously treated with curative intent are eligible to participate in the study as long as they have baseline measurable disease per RECIST 1.1. Oligometastatic
    colorectal cancer is characterized by a limited metastatic spread of
    disease. Oligometastatic disease is defined as the involvement of up to 3
    sites with 5 or sometimes more metastases that for their anatomic
    localization is amenable to local therapies, thus rendering the patient
    free of disease.
    5. Able to provide a sufficient amount of representative tumor specimen for central testing of BRAF V600E mutation status and tumor tissue assessment
    Note: Tumor sample can be archival or de novo (newly collected fixed biopsy sample) and must be in an FFPE block, or provide a minimum of 15 unstained slides of analyzable tissue. This tissue specimen should be obtained from a biopsy or surgery that was performed within 2 years
    prior to study enrollment. Participants with fewer than the required number of slides with analyzable tissue may be considered eligible if the Sponsor determines that the slides are sufficient for central testing.
    Informed Consent/Assent:
    6. Capable of giving signed informed consent/assent as described in 54TAppendix 154T, which includes compliance with the requirements and restrictions listed in the ICD and in this protocol.
    Note: Participants ≥16 years old that are under guardianship may participate with the consent of their legally authorized guardian if permitted by local regulations. When appropriate, adolescent participants will be included in all discussions (see Section 10.1.3).
    5.1.2. Screening Inclusion Criteria
    Type of Participant and Disease Characteristics:
    7. Participants who have met all Molecular Prescreening inclusion criteria.
    8. Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.
    9. Presence of a BRAF V600E mutation in tumor tissue or blood (eg, ctDNA genetic testing). The following are acceptable:
    a. Local laboratory assay (PCR or NGS-based only) performed at any time prior to Screening using either tumor tissue or blood.
    b. Central laboratory assay performed during the Screening period using tumor tissue alone (not blood).
    Note: For participants enrolled on the basis of a local BRAF mutation assay, tumor samples must be submitted to the central laboratory for BRAF testing as soon as possible following signing of the ICD. The BRAF status must be confirmed no later than 30 days following first dose of study intervention.
    10. The Investigator must obtain prior to Cycle 1 Day 1 (SLI) or date of randomization (Phase 3 and Cohort 3) adequate tumor tissue (primary or metastatic, archival or newly obtained) for submission to a central laboratory for confirmation of BRAF V600E and tumor tissue assessment.
    Note: Once BRAF V600E mutation status is determined by the central laboratory (tumor tissue), the results will be considered definitive for eligibility. No repeat testing will be performed.
    Note: Lack of BRAF V600E confirmation by the central laboratory may be due to discordance between the local assay and central laboratory results (potential false positive local assay results), or due to inadequate or poor sample condition for central testing (indeterminate results). If at any time in the study there is lack of BRAF V600E confirmation in a total of 6% of the total planned enrollment of the randomized portion of the trial (42 participants) or a discordance between the local assay and the central laboratory of 3% of the total planned enrollment (21 participants), all subsequent participants will be required to have BRAF V600E determined by the central laboratory for treatment (ie, local BRAF testing will no longer be accepted for trial eligibility).
    Note: Participants whose sample is determined to be inadequate or who have an indeterminate result on central testing may have additional tumor samples submitted for testing.

    For a full list please see section 5.1 of the protocol.

    Principal exclusion criteria
    Molecular Prescreening Exclusion Criteria
    Medical Conditions:
    1. Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator’s judgment, make the participant inappropriate for the study.
    2. Presence of acute or chronic pancreatitis.
    3. Leptomeningeal disease.
    4. History of chronic inflammatory bowel disease requiring medical intervention (immunomodulatory or immunosuppressive medications or surgery) ≤12 months prior to randomization.
    5. Known DPD deficiency; refer to local fluorouracil or capecitabine label or local clinical guidances, for DPD status recommendation prior to starting treatment.
    6. Gilbert’s syndrome or known homozygous UGT1A1*28/*28 or UGT1A1*6/*6 genotypes or double heterozygous UGT1A1*6/*28 genotype:
    a. SLI: Participants with documented Gilbert’s syndrome or known homozygous UGT1A1*28/*28 or UGT1A1*6/*6 genotypes or double heterozygous UGT1A1*6/*28 genotype will be excluded from Cohort 1 (EC + FOLFIRI) of the SLI.
    b.Phase III: Participants with documented Gilbert's syndrome or known homozygous UGT1A1*28/*28 or UGT1A1*6/*6 genotypes or double heterozygous UGT1A1*6/*28 genotype may be enrolled, but may not receive FOLFOXIRI if randomized to the Control Arm.
    c. Cohort 3: Participants with documented Gilbert's syndrome or known homozygous UGT1A1*28/*28 or UGT1A1*6/*6 genotypes or double heterozygous UGT1A1*6/*28 genotype will be excluded from Cohort 3 Arm D and Arm E (EC + FOLFIRI and FOLFIRI ± bevacizumab).
    Other Exclusions:
    7. Investigator site staff or Pfizer employees directly involved in the conduct of the study, site staff otherwise supervised by the investigator, and their respective family members.
    8. Colorectal adenocarcinoma that is RAS mutant or for which RAS mutation status is unknown.
    9. Locally confirmed dMMR or MSI-H colorectal carcinoma or unknown MSI/MMR status. If participant is locally confirmed dMMR or MSI-H and unable to receive immune checkpoint inhibitors due to a pre existing medical condition, they may be enrolled.
    5.2.2. Screening Exclusion Criteria
    Medical Conditions:
    10. Impaired gastrointestinal function (eg, uncontrolled nausea, vomiting or diarrhea, malabsorption syndrome, small bowel resection) or disease which may significantly alter the absorption of oral study intervention or recent changes in bowel function suggesting current or impending bowel obstruction.
    11. Clinically significant cardiovascular diseases, including any of the following:
    a. History of acute myocardial infarction, acute coronary syndromes (including unstable angina, coronary artery bypass graft, coronary angioplasty or stenting) ≤6 months prior to randomization;
    b. Congestive heart failure requiring treatment (New York Heart Association Class II and above);
    c. Recent history (within 1 year prior to randomization) or presence of clinically significant cardiac arrhythmias (including uncontrolled atrial fibrillation or uncontrolled paroxysmal supraventricular tachycardia);
    d. History of thromboembolic or cerebrovascular events ≤12 weeks prior to randomization. Examples include transient ischemic attacks, cerebrovascular accidents, hemodynamically significant (ie, massive or sub-massive) deep vein thrombosis or pulmonary emboli.
    Note: Participants with either deep vein thrombosis or pulmonary emboli that do not result in hemodynamic instability are allowed to enroll as long as they are on a stable dose of anticoagulants for at least 4 weeks.
    Note: Participants with thromboembolic events related to indwelling catheters (including PICC lines) or other procedures may be enrolled.
    e. Triplicate average QTcF interval ≥480 ms or a history of prolonged QT syndrome.
    Note: Participants with bundle-branch block (BBB) or with an implanted cardiac pacemaker, may enroll into the study following consultation with the Sponsor.
    f. Congenital LQTS.
    12. Evidence of active noninfectious pneumonitis.
    13. Evidence of active and uncontrolled bacterial or viral infection, with certain exceptions, as noted below, for chronic infection with HIV,
    hepatitis B or hepatitis C, within 2 weeks prior to start of study
    intervention.
    14. Participants positive for HIV are ineligible unless they meet all of the following:
    a. A stable regimen of highly active anti-retroviral therapy that is not contraindicated (see Section 6.5);
    b. No requirement for concurrent antibiotics or antifungal agents for the prevention of opportunistic infections;
    c. A CD4 count >250 cells/mcL, and an undetectable HIV viral load on standard PCR-based tests.

    For a full list please see section 5.2 of the protocol.


    Otvorené pre nábor: 2021-08-23
    Uzatvorené pre nábor: 2024-06-07
    Uzatvorené:

    Pracoviská klinického skúšania:
    1. Názov: Národný onkologický ústav, II. Onkologická klinika LFUK a NOÚ, Klinika klinickej onkológie SZU a NOÚ, Klenová 1, 833 10 Bratislava
      Mesto: Bratislava
      Zodpovedný skúšajúci: MUDr. PhD. Štefan Pörsök
      Referovať pacienta do klinického skúšania
    2. Názov: POKO Poprad s.r.o., Mnoheľova 2, 058 01 Poprad
      Mesto: Poprad
      Zodpovedný skúšajúci: MUDr. Juraj Beniak
      Referovať pacienta do klinického skúšania
  • Nezaslepené, multicentrické, rozšírené klinické skúšanie pre účastníkov, ktorí sa zúčastnili v predchádzajúcich klinických skúšaniach ASTX727 (štandardná dávka)
    Liečivo: DECITABINE, CEDAZURIDINE (ASTX727)
    Diagnóza: Leukémia
    Kód skúšania: 2018-003942-18, ASTX727-06
    Sponzor: Astex Pharmaceuticals, Inc.
    Kritéria:

    Principal inclusion criteria
    1) Previous participation in an Astex-sponsored ASTX727 clinical trial (including but not limited to studies ASTX727-01, ASTX727-02, ASTX727-04, ASTX727-17, ASTX727-18, and the food effect substudy of ASTX727-06) in which the subject was treated with ASTX727 and was still on active treatment with ASTX727 at the time of study completion as determined by Astex.
    2) Subject is considered to be benefitting from ASTX727 treatment in the opinion of the treating Investigator at the time of parent study completion. (Subjects must not be withdrawn from the parent study until eligibility for this study is confirmed.)
    3) Subject is able to understand and comply with the study procedures and understands the risks involved in the study.
    4) Subject provides legally effective informed consent before undergoing any study-specific procedure.

    FE Substudy inclusion criteria:
    1) Be 18 years of age or older, at the time of signing the informed consent.
    2) Have MDS, including all French-American-British subtypes (refractory anemia, refractory anemia with ringed sideroblasts, refractory anemia with excess blasts, refractory anemia with excess blasts in transformation, CMML), and subjects with MDS IPSS int-1, -2, or high-risk MDS, or AML, as diagnosed according to the 2016 World Health Organization (WHO) guidelines on acute leukemia, of any subtype except M3 (acute promyelocytic leukemia), who are not candidates for intensive chemotherapy, including subjects receiving HMA treatment, who have a confirmed diagnosis and a prior confirmatory bone marrow report. Subjects who are currently receiving HMA treatment must complete the ongoing (at the time of Screening) treatment cycle before enrolling in this study; timing of start of treatment cycle with ASTX727 is at the principal investigator’s discretion.
    3) Have Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
    4) Have adequate organ function defined as follows:
    a. Hepatic: Total bilirubin ≤1.5× upper limit of normal (ULN); aspartate aminotransferase/serum glutamicoxaloacetic transaminase (AST/SGOT) and alanine aminotransferase/serum glutamic-pyruvic transaminase (ALT/SGPT) ≤5× ULN.
    b. Renal: Calculated creatinine clearance ≥60 mL/min.
    5) Women of childbearing potential must not be pregnant or breastfeeding and must have a negative pregnancy test at screening. Women of childbearing potential must agree to practice 1 highly effective contraceptive measure of birth control (with a failure rate of <1% per year; with low user dependency) during the substudy and for 6 months after the last dose of study treatment and must agree not to become pregnant for 6 months after completing treatment; men with female partners of childbearing potential must agree to use a condom and advise their partners to practice 1 highly effective contraceptive measure of birth control (user dependent or with low user dependency) while receiving treatment with ASTX727 and for at least 3 months after completing treatment and must agree not to father a child while receiving ASTX727 and for at least 3 months after completing ASTX727 treatment.

    Principal exclusion criteria
    1) Any subject who, in the opinion of the investigator, may have other conditions, or for whom safety data from parent study participation suggests the risks of continuing treatment with ASTX727 may outweigh the benefits.

    FE Substudy Exclusion Criteria:
    1) Known or suspected hypersensitivity to decitabine, cedazuridine, or any of the excipients in the ASTX727 tablets.
    2) Poor medical risk because of other conditions such as uncontrolled systemic diseases or active uncontrolled infections.
    3) Life-threatening illness, medical condition or organ system dysfunction, or other reasons including laboratory abnormalities, which, in the Investigator’s opinion, could compromise the subject’s safety, interfere with the absorption or metabolism of decitabine + cedazuridine, or compromise the integrity of the study outcomes.
    4) Prior gastric surgery for ulcer disease, weight loss, etc., that would impair normal motility or absorption.
    5) Second malignancy currently requiring active chemotherapy. To clarify, patients with breast or prostate cancer stable on or responding to endocrine therapy, are eligible.
    6) Known history of human immunodeficiency virus or known seropositive for hepatitis C virus or hepatitis B virus.
    7) Active uncontrolled gastric or duodenal ulcer.
    8) Subjects with acute promyelocytic leukemia.
    9) Prior cytotoxic chemotherapy for AML except for hydroxyurea to control high white blood cell (WBC) counts.
    10) Treated with any investigational drug or therapy within 2 weeks of study treatment, or 5 half-lives, whichever is longer, before the protocol-defined first dose of study treatment, or ongoing clinically significant AEs from previous treatment with investigational drug or therapy.
    11) Sensitivity to any of the study interventions or components thereof, or drug or other allergy that, in the opinion of the Investigator or medical monitor, contraindicates participation in the study.
    12) Known significant mental illness or other condition such as active alcohol or other substance abuse or addiction that, in the opinion of the Investigator, predisposes the subject to high risk of noncompliance with the protocol.


    Otvorené pre nábor: 2021-09-03
    Uzatvorené pre nábor:
    Uzatvorené:

    Pracoviská klinického skúšania:
    1. Názov: Summit Clinical Research, s.r.o., Bárdošova 2/A, Bratislava
      Mesto: Bratislava
      Zodpovedný skúšajúci: MUDr. Viera Skarbová
  • RANDOMIZOVANÉ, ODSLEPENÉ, MULTICENTRICKÉ SKÚŠANIE ENTREKTINIBU VO FÁZE III V POROVNANÍ S KRIZOTINIBOM U PACIENTOV S LOKÁLNE POKROČILÝM ALEBO METASTATICKÝM NEMALOBUNKOVÝM KARCINÓMOM PĽÚC S PRESKUPENÍM GÉNOV ROS1 A METASTÁZAMI V CENTRÁLNOM NERVOVOM SYSTÉME ALEBO BEZ NICH
    Liečivo: ENTRECTINIB (RO7102122 - F04/F06/F10/F14/F24)
    Diagnóza: Karcinóm pľúc
    Kód skúšania: 2019-003859-11, MO41552
    Sponzor: Roche
    Kritéria:

    Principal inclusion criteria
    •Age ≥ 18 years
    •Histologically- or cytologically-confirmed diagnosis of advanced or recurrent (Stage IIIB/C, not amenable for radical treatment) or metastatic (Stage IV) NSCLC that harbors a documented ROS1 gene rearrangement
    •No prior treatment with a ROS1 tyrosine kinase inhibitor, chemotherapy or other systemic therapy for advanced or recurrent (Stage IIIB/C not amenable for radical treatment) or metastatic (Stage IV) NSCLC
    •Prior radiotherapy is allowed if more than 14 days have elapsed between the end of treatment and randomization. Patients who received brain irradiation must have completed whole brain radiotherapy at least 14 days prior and/or stereotactic radiosurgery at least 7 days prior to the start of entrectinib treatment
    •Measurable systemic disease according to RECIST v1.1
    •Patients with measurable and non-measurable CNS lesions per RECIST v1.1, including leptomeningeal carcinomatosis, are eligible, provided that the patient is neurologically stable for at least 1 week prior to the first dose of study treatment.Note: Previously irradiated CNS lesions cannot be selected as target (measurable) lesions
    •Life expectancy of at least 12 weeks
    •Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2
    •Adequate hematologic, renal, liver function
    •Recovery from effects of any major surgery or significant traumatic injury at least 28 days before the first dose of study treatment
    •Patients must have recovered from effects of any major surgery or significant traumatic injury at least 28 days before the first dose of study treatment
    •Ability to comply with the study protocol, in the investigator’s judgment
    •Ability to swallow entrectinib and crizotinib intact without chewing, crushing, or opening the capsules
    •For women of childbearing potential: agreement to remain abstinent or use contraception, and agreement to refrain from donating eggs
    during the treatment period and for up to 5 weeks after the final dose of entrectinib or for at least 90 days after the final dose of crizotinib
    •For men: agreement to remain abstinent or use contraceptive measures, and agreement to refrain from donating sperm

    Principal exclusion criteria
    •Current participation in another therapeutic clinical trial
    •Prior treatment with a ROS1 tyrosine kinase inhibitor, chemotherapy or other systemic therapy for advanced or recurrent (Stage IIIB/C not amenable for radical treatment) or metastatic (Stage IV) NSCLC
    •NCI-CTCAE v5.0 Grade 3 or higher toxicities due to any prior therapy (excluding alopecia, fatigue, nausea and lack of appetite), which have not shown improvement and are strictly considered to interfere with current study drug
    •History of recent (within the past 3 months) symptomatic congestive heart failure or ejection fraction ≤ 50% observed during screening for the study
    •History of prolonged corrected QT interval
    •History of additional risk factors for torsades de pointes
    •Grade ≥2 peripheral sensory neuropathy
    •Known interstitial lung disease, interstitial fibrosis, or history of tyrosine kinase inhibitor-induced pneumonitis
    •Previous malignancy within the past 3 years (other than curatively treated basal cell carcinoma of the skin, early gastrointestinal (GI) cancer by endoscopic resection, in situ carcinoma of the cervix, or any cured cancer that is considered to have no impact on PFS and OS for the current NSCLC)
    •Incomplete recovery from any surgery prior to the start of study treatment that would interfere with the determination of safety or efficacy
    •Active GI disease or other malabsorption syndrome that would reasonably impact drug absorption
    •History of prior therapy-induced pneumonitis
    •Any condition (in the past 3 months) that would interfere with the determination of safety or efficacy of study treatments
    •Known active infections that would interfere with the assessment of safety or efficacy of study treatments (bacterial, fungal or viral) , with the exceptions of HIV, hepatitis B virus (HBV), and hepatitis C virus (HCV) infections
    •History of hypersensitivity to any of the additives in the entrectinib and/or crizotinib drug formulations
    •Pregnant or breastfeeding, or intending to become pregnant during the study or within 3 months after the final dose of entrectinib or crizotinib
    •Known human immunodeficiency virus (HIV) positivity or acquired immunodeficiency syndrome (AIDS)-related illness
    •Any clinically significant concomitant disease or condition that could interfere with, or for which the treatment might interfere with, the conduct of the study or the absorption of oral medications or that would, in the opinion of the Principal Investigator, pose an unacceptable risk to the patient in this study
    •Any psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol requirements and/or follow-up procedures; those conditions should be discussed with the patient before trial entry


    Otvorené pre nábor: 2021-09-23
    Uzatvorené pre nábor:
    Uzatvorené:

    Pracoviská klinického skúšania:
    1. Názov: Univerzitná nemocnica Bratislava – Nemocnica Ružinov, Klinika pneumológie, ftizeológie a funkčnej diagnostiky SZU a UNB, Ružinovská 6
      Mesto: Bratislava
      Zodpovedný skúšajúci: MUDr. Zuzana Švihelová Lišková
      Referovať pacienta do klinického skúšania
  • Multicentrická, otvorená, randomizovaná štúdia fázy III hodnotiaca perorálny asciminib versus TKI podľa výberu investigátora u pacientov s novodiagnostikovanou chronickou myelocytovou leukémiou pozitívnou na Philadelphia chromozóm v chronickej fáze
    Liečivo: ASCIMINIB (ABL001)
    Diagnóza: Leukémia
    Kód skúšania: 2021-000678-27, CABL001J12301
    Sponzor: Novartis Pharma AG
    Kritéria:

    Inclusion Criteria:

    Participants eligible for inclusion in this study must meet all of the following criteria:

    Male or female patients ≥ 18 years of age.
    Participants with CML-CP within 3 months of diagnosis.
    Diagnosis of CML-CP (ELN 2020 criteria) with cytogenetic confirmation of Philadelphia chromosome
    Documented chronic phase CML will meet all the below criteria (Hochhaus et al 2020):

    < 15% blasts in peripheral blood and bone marrow,
    < 30% blasts plus promyelocytes in peripheral blood and bone marrow,
    < 20% basophils in the peripheral blood,
    Platelet count ≥ 100 x 109/L (≥ 100,000/mm3),
    No evidence of extramedullary leukemic involvement, with the exception of hepatosplenomegaly.

    4. Eastern Cooperative Oncology Group (ECOG) performance status of 0,or 1. 5. Adequate end organ function as defined by:

    Total bilirubin < 3 x ULN; patients with Gilbert's syndrome may only be included if total bilirubin ≤ 3.0 x ULN or direct bilirubin ≤ 1.5 x ULN
    Creatinine clearance (CrCl) ≥ 30 mL/min as calculated using Cockcroft-Gault formula,
    Serum lipase ≤ 1.5 x ULN. For serum lipase > ULN - ≤ 1.5 x ULN, value must be considered not clinically significant and not associated with risk factors for acute pancreatitis 6. Participants must have the following laboratory values within normal limits or corrected to within normal limits with supplements prior to randomization:
    Potassium (potassium increase of up to 6.0 mmol/L is acceptable if associated with CrCl* ≥ 90 mL/min)
    Total calcium (corrected for serum albumin); (calcium increase of up to 12.5 mg/dl or 3.1 mmol/L is acceptable if associated with CrCl* ≥ 90 mL/min)
    Magnesium (magnesium increase of up to 3.0 mg/dL or 1.23 mmol/L if associated with CrCl* ≥ 90 mL/min)
    For patients with mild to moderate renal impairment (CrCl* ≥ 30 mL/min and <90 mL/min) - potassium, total calcium (corrected for serum albumin) and magnesium should be ≥ LLN or corrected to within normal limits with supplements prior to randomization.
    *CrCl as calculated using Cockcroft-Gault formula 7. Ability to provide written informed consent prior to any study related screening procedures being performed.

    8. Evidence of typical BCR-ABL1 transcript [e14a2 and/or e13a2] at the time of screening which is amenable to standardized Real time quantitative polymerase chain reaction (RQ-PCR) quantification.

    Exclusion Criteria:

    Previous treatment of CML with any other anticancer agents including chemotherapy and/or biologic agents or prior stem cell transplant, with the exception of hydroxyurea and/or anagrelide. Treatment with either imatinib, or nilotinib, or dasatinib or bosutinib for ≤2 weeks is allowed, but no other treatment with other tyrosine kinase inhibitors prior to randomization is permitted.
    Known cytopathologically confirmed CNS infiltration (in absence of suspicion of CNS involvement, lumbar puncture not required).
    Impaired cardiac function or cardiac repolarization abnormality including but not limited to any one of the following:

    History within 6 months prior to starting study treatment of myocardial infarction (MI), angina pectoris, coronary artery bypass graft (CABG)
    Clinically significant cardiac arrhythmias (e.g., ventricular tachycardia), complete left bundle branch block, high-grade AV block (e.g., bifascicular block, Mobitz type II and third degree AV block)
    QTc ≥ 450 ms (male patients), ≥460 ms (female patients) on the average of three serial baseline ECG (using the QTcF formula) as determined by central reading. If QTcF ≥ 450 ms and electrolytes are not within normal ranges, electrolytes should be corrected and then the patient re-screened for QTc.
    Long QT syndrome, family history of idiopathic sudden death or congenital long QT syndrome, or any of the following:
    Risk factors for Torsades de Pointes (TdP) including uncorrected hypokalemia or hypomagnesemia, history of cardiac failure, or history of clinically significant/symptomatic bradycardia
    Concomitant medication(s) with a "Known risk of Torsades de Pointes" per www.crediblemeds.org/ that cannot be discontinued or replaced 7 days prior to starting study drug by safe alternative medication.•Inability to determine the QTcF interval
    Severe and/or uncontrolled concurrent medical disease that in the opinion of the investigator could cause unacceptable safety risks or compromise compliance with the protocol (e.g. uncontrolled diabetes, active or uncontrolled infection; uncontrolled arterial or pulmonary hypertension, uncontrolled clinically significant hyperlipidemia). Please refer to Section 6.3.1
    History of significant congenital or acquired bleeding disorder unrelated to cancer.
    Major surgery within 4 weeks prior to study entry or who have not recovered from prior surgery.
    History of other active malignancy within 3 years prior to study entry with the exception of previous or concomitant basal cell skin cancer and previous carcinoma in situ treated curatively
    History of acute pancreatitis within 1 year prior to randomization or medical history of chronic pancreatitis.
    History of chronic liver disease leading to severe hepatic impairment, or ongoing acute liver disease.
    Other protocol-defined Inclusion/exclusion criteria will apply.


    Otvorené pre nábor: 2021-10-19
    Uzatvorené pre nábor: 2023-08-15
    Uzatvorené: 2023-08-15

    Pracoviská klinického skúšania:
    1. Názov: Národný onkologický ústav, Klinika onkohematológie LFUK a NOÚ, Oddelenie onkohematológie II., Klenová 1, 833 10 Bratislava
      Mesto: Bratislava
      Zodpovedný skúšajúci: MUDr. PhD. Ľudmila Demitrovičová
    2. Názov: Univerzitná nemocnica L. Pasteura, Klinika hematológie a onkohematológie, Rastislavova 43, Pracovisko Trieda SNP 1, 041 66 Košice
      Mesto: Košice
      Zodpovedný skúšajúci: MUDr. PhD. Tomáš Guman
  • Skúšanie 3. fázy na vyhodnotenie zimberelimabu (AB122) v monoterapii v porovnaní so štandardnou chemoterapiou alebo zimberelimabom v kombinácii s AB154 v prvej línii liečby lokálne pokročilého alebo metastatického nemalobunkového karcinómu pľúc pozitívneho na PD-L1
    Liečivo: Zimberelimab (AB122), Domvanalimab (AB154)
    Diagnóza: Karcinóm pľúc
    Kód skúšania: 2020-003562-39, ARC-10
    Sponzor: Arcus Biosciences, Inc
    Kritéria:

    Inclusion Criteria:

    Histologically confirmed, treatment naïve, locally advanced or metastatic (stage IIIB IV per AJCC version 8), squamous or non-squamous NSCLC with documented high PD L1 expression (TC ≥ 50%) as determined by the VENTANA SP263 IHC assay, as assessed by central laboratories).
    Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
    Must have at least 1 measurable lesion per RECIST v1.1
    Adequate organ and marrow function
    If a participant has brain or meningeal metastases, the participant must meet the following criteria:

    Have no evidence of progression by neurologic symptoms or signs for at least 4 weeks prior to the first dose.
    Participants with previously treated brain metastases may participate provided they have stable central nervous system (CNS) disease for at least 4 weeks prior to enrollment. Stable CNS disease is defined as resolution of all neurologic symptoms to baseline, having no evidence of new or enlarging brain metastases, and not requiring use of corticosteroids for CNS disease for at least 14 days prior to the start of study treatment. Participants who have had brain metastases resected or have received whole brain radiotherapy ending at least 4 weeks (or stereotactic radiotherapy ending at least 2 weeks) prior to initiation of study treatment are permitted.
    Carcinomatous meningitis is excluded regardless of clinical stability.
    Exclusion Criteria:

    Presence of any tumor genomic aberration or driver mutation for which a targeted therapy is approved by local health authority and available
    Use of any live vaccines against infectious diseases within 28 days of first dose
    Any active autoimmune disease or a documented history of autoimmune disease or syndrome that required systemic treatment in the past 2 years (ie, with use of disease-modifying agents, corticosteroids, or immunosuppressive drugs), except for vitiligo or resolved childhood asthma/atopy.
    Prior malignancy active within the previous 2 years except for locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the cervix, breast, or prostate cancer
    Prior treatment with any anti-PD-1, anti-PD-L1 or any other antibody targeting an immune checkpoint.
    Other protocol defined Inclusion/Exclusion criteria may apply.


    Otvorené pre nábor: 2021-10-01
    Uzatvorené pre nábor: 2022-06-01
    Uzatvorené: 2023-10-02

    Pracoviská klinického skúšania:
    1. Názov: Východoslovenský onkologický ústav, a.s., Oddelenie klinickej onkológie, Rastislavova 43, 041 91 Košice
      Mesto: Košice
      Zodpovedný skúšajúci: Doc. MUDr. CSc. Igor Andrašina
  • RANDOMIZOVANÉ, DVOJITO ZASLEPENÉ KLINICKÉ SKÚŠANIE FÁZY 3 HODNOTIACE LIEČBU ENKORAFENIBOM A BINIMETINIBOM S PEMBROLIZUMABOM OPROTI PLACEBU S PEMBROLIZUMABOM U ÚČASTNÍKOV S METASTATICKÝM MELANÓMOM ALEBO S NERESEKOVATEĽNÝM LOKÁLNE POKROČILÝM MELANÓMOM POZITÍVNYM NA MUTÁCIU V600E/K GÉNU BRAF
    Liečivo: ENCORAFENIB, BINIMETINIB
    Diagnóza: Melanóm
    Kód skúšania: 2020-004850-31, C4221016, The STARBOARD Study
    Sponzor: Pfizer Inc.
    Kritéria:

    Principal inclusion criteria
    1. Male or female participants ≥ 18 years at the time of informed consent. Refer to protocol appendix 4 for reproductive criteria for male (protocol section 10.4.1) and female (protocol section 10.4.2) participants.
    2. Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.
    3. Histologically confirmed unresectable (Stage IIIB, IIIC, or IIID) or metastatic (Stage IV) cutaneous melanoma, according to the AJCC 8th edition.
    Note: Locally advanced disease must not be amenable for treatment with curative intent.
    4. Presence of at least 1 measurable lesion as detected by radiological and/or photographic methods according to RECIST v1.1.
    Note: Tumor lesions situated in a previously irradiated area, or in an area subjected to other locoregional therapy, are not considered measurable unless there has been documented progression of the lesion.
    Note: If baseline scans from an institution other than the investigational site are used, the site must obtain copies of the scans prior to enrolment of the participant, or the scans must be repeated at the investigational site and submitted for independent review (Phase 3 only).
    Note: Clinical lesions will only be considered measurable when they are superficial and ≥ 10 mm diameter as assessed using calipers (eg, skin nodules). When lesions can be evaluated by both clinical exam and imaging, imaging evaluation should be performed and submitted for independent review (Phase 3 only).
    5. ECOG performance status 0 or 1.
    6. Documented evidence of a BRAF V600E or V600K mutation in melanoma tumor tissue as previously determined by either PCR or NGS-based local laboratory assay (eg, US FDA-approved test, CE-marked [European conformity] in vitro diagnostic in EU countries, or equivalent), obtained during the course of normal clinical care, in a CLIA- or similarly certified laboratory.
    7. Submission of adequate tumor tissue (archival or newly obtained; block or slides; see protocol section 8.7.2) to the sponsor central laboratory(ies) during the screening period and prior to enrollment (SLI)/randomization (Phase 3).
    Note: Whenever possible, the archival sample should be from the same tumor block that was used for local BRAF V600E/K mutation testing.
    Note: A newly obtained tumour tissue biopsy must be provided prior to enrolment (SLI)/ randomization (Phase 3) for participants unable to provide adequate archival tumour tissue. If a newly obtained biopsy is taken, the biopsy should be taken from a nontarget lesion when possible.
    Note: Confirmation of the BRAF V600E/K mutation from the central laboratory is required (see protocol section 8.7.2). If results from the central laboratory are indeterminate or indicate insufficient tissue, additional samples must be submitted (see protocol section 8.7.2).
    8. SLI Participants: Have not received more than 1 prior systemic therapy for metastatic or locally advanced melanoma.
    Note: Prior neoadjuvant therapy for early-stage disease does not count as prior systemic therapy.
    Note: Participants who receive adjuvant therapy and had evidence of disease recurrence ≤ 6 months after the last dose of adjuvant treatment will be considered as having received prior first line therapy.
    Phase 3 Participants: Have not received prior first-line systemic therapy for metastatic or unresectable locally advanced melanoma.
    Note: Participants with complete surgical resection of locally advanced or metastatic disease (eg, definitive treatment of all sites of metastases), who receive up to 12 months of systemic adjuvant therapy are eligible for the study provided there is no evidence of disease recurrence ≤ 6 months after the last dose of adjuvant treatment.
    Note: Participants who receive any neoadjuvant therapy for early stage disease are eligible for the study.
    Note: Prior adjuvant therapy with a BRAFi and/or MEKi or anti-PD-1 or CTLA-4 agents is permitted.
    Note: Participants who receive adjuvant treatment for up to 12 months, and have evidence of disease recurrence during treatment or ≤ 6 months after the last dose of treatment would be considered as receiving first-line therapy and are therefore not eligible for study participation.
    9. Adequate bone marrow, hepatic and renal function, characterized by screening results specified in protocol section 5.1.
    For a full list please see protocol section 5.1.

    Principal exclusion criteria
    1. Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study (including, but not limited to, a participant who is rapidly progressing or has
    clinically significant tumor related symptoms, in the judgment of the investigator).
    2. Mucosal or ocular melanoma.
    3. Diagnosis of immunodeficiency or an active autoimmune disease that required systemic treatment in the past 2 years (ie, with use of disease modifying agents, corticosteroids, or immunosuppressive drugs).
    Note: Participants with diabetes type I, controlled asthma, Graves’ disease, Hashimoto’s disease or hypo- or hyperthyroid disease are exceptions and may participate.
    Note: Replacement and symptomatic therapies (eg, levothyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) are not considered a form of immunosuppressive agents and are permitted.
    4. Clinically significant multiple or severe drug allergies, intolerance to topical corticosteroids, or severe post-treatment hypersensitivity reactions (including, but not limited to, erythema multiforme major, linear IgA dermatosis, toxic epidermal necrolysis, and exfoliative dermatitis).
    5. Unable to swallow, retain, and absorb oral medications.
    6. Impairment of GI function or disease which may significantly alter the absorption of oral study intervention (eg, uncontrolled nausea, vomiting or diarrhea, malabsorption syndrome, including malabsorption syndrome secondary to prior GI surgery).
    7. Clinically significant cardiovascular diseases, including any of the following:
    a. History of acute myocardial infarction, acute coronary syndromes (including unstable angina, coronary artery bypass graft, coronary angioplasty or stenting) ≤ 6 months prior to enrollment (SLI)/randomization (Phase 3);
    b. Congestive heart failure requiring treatment (New York Heart Association Grade ≥ 2);
    c. LVEF < 50% as determined by ECHO or MUGA scan;
    d. Uncontrolled hypertension, defined as persistent systolic blood pressure ≥ 150 mmHg or diastolic blood pressure ≥ 100 mmHg, despite therapy;
    e. History or presence of clinically significant cardiac arrhythmias (including uncontrolled atrial fibrillation or uncontrolled paroxysmal supraventricular tachycardia);
    f. Triplicate average QTcF interval ≥ 480 ms at Screening or a history of prolonged QT syndrome.
    8. History of thromboembolic or cerebrovascular events ≤ 12 weeks prior to enrollment (SLI)/randomization (Phase 3). Examples include transient ischemic attacks, cerebrovascular accidents, hemodynamically significant (ie, massive or sub-massive) deep vein thrombosis or pulmonary emboli.
    9. History or current evidence of RVO or current risk factors for RVO (eg, uncontrolled glaucoma or ocular hypertension, history of hyperviscosity or hypercoagulability syndromes).
    10. Concurrent neuromuscular disorder that is associated with the potential of elevated CK (eg, inflammatory myopathies, muscular dystrophy, amyotrophic lateral sclerosis, spinal muscular atrophy).
    11. Current noninfectious pneumonitis/interstitial lung disease or history of noninfectious pneumonitis/interstitial lung disease requiring steroids, or history of radiation pneumonitis.
    12. Evidence of HBV or HCV infection.
    13. Known history of a positive test for HIV or known AIDS. Testing for HIV must be performed at sites where mandated locally.
    14. Any active infection requiring systemic therapeutic treatment within 2 weeks prior to enrollment (SLI)/ randomization (Phase 3).
    15. Participants with prior or current symptomatic brain metastasis, leptomeningeal disease or other active CNS metastases.
    16. Concurrent or previous other malignancy within 2 years of study entry, except curatively treated basal or squamous cell skin cancer, prostate intraepithelial neoplasm, carcinoma in-situ of the cervix, Bowen’s disease and Gleason ≤ 6 prostate cancer. Participants with a history of other curatively treated cancers must be reviewed with the sponsor or designee prior to entering the study.

    For a full list please see section 5.2 of the protocol.


    Otvorené pre nábor: 2021-12-02
    Uzatvorené pre nábor: 2024-01-30
    Uzatvorené:

    Pracoviská klinického skúšania:
    1. Názov: Národný onkologický ústav, II. Onkologická klinika LFUK a NOÚ, Klinika klinickej onkológie SZU a NOÚ, Klenová 1, 833 10 Bratislava
      Mesto: Bratislava
      Zodpovedný skúšajúci: MUDr Róbert Godál
    2. Názov: Nemocnica na okraji mesta n.o., Ambulancia klinickej onkológie, Nová Nemocnica 511, 958 01 Partizánske
      Mesto: Partizánske
      Zodpovedný skúšajúci: MUDr. Alexandra Szabová
      Referovať pacienta do klinického skúšania
    3. Názov: Onkologický ústav sv. Alžbety, s.r.o., Chemoterapeutická ambulancia I., Heydukova 10, 812 50 Bratislava
      Mesto: Bratislava
      Zodpovedný skúšajúci: MUDr. Milada Mikulová
    4. Názov: POKO Poprad s.r.o., Mnoheľova 2, 058 01 Poprad
      Mesto: Poprad
      Zodpovedný skúšajúci: MUDr. Juraj Beniak
      Referovať pacienta do klinického skúšania
    5. Názov: Východoslovenský onkologický ústav, a.s., Oddelenie klinickej onkológie, Rastislavova 43, 041 91 Košice
      Mesto: Košice
      Zodpovedný skúšajúci: MUDr. Mária Višňovská
    6. Názov: Fakultná nemocnica s poliklinikou F.D. Roosevelta Banská Bystrica , Dermatovenerologická klinika SZU, Námestie L. Svobodu 1
      Mesto: Banská Bystrica
      Zodpovedný skúšajúci: MUDr. PhD. Slavomír Urbanček
  • EPIK-B5: Randomizované, dvojito zaslepené, placebom kontrolované klinické skúšanie fázy III hodnotiace účinnosť alpelisibu (BYL719) v kombinácii s fulvestrantom v liečbe mužov a postmenopauzálnych žien s HR-pozitívnym, HER2-negatívnym pokročilým karcinómom prsníka a prítomnou mutáciou PIK3CA, ktorých ochorenie sprogredovalo počas alebo po liečbe inhibítorom aromatázy a inhibítorom CDK4/6
    Liečivo: ALPELISIB (BYL719)
    Diagnóza: Karcinóm prsníka
    Kód skúšania: 2021-001966-39, CBYL719C2303, EPIK-B5
    Sponzor: Novartis Pharma AG
    Kritéria:

    Principal inclusion criteria
    - Participant is an adult ≥ 18 years old at the time of informed consent and has signed informed consent before any trial related activities and according to local guidelines
    - Participant has a histologically and/or cytologically confirmed diagnosis of ER+ and/or PgR+ breast cancer by local laboratory.
    - Participant has HER2-negative breast cancer defined as a negative in situ hybridization test or an IHC status of 0, 1+ or 2+. If IHC is 2+, a negative in situ hybridization (Fluorescent in situ hybridization (FISH), Chromogenic in situ hybridization (CISH), or Silver-enhanced in situ hybridization (SISH)) test is required by local laboratory testing.
    - Participant has at least one measurable lesion as per RECIST v1.1 criteria as assessed by Investigator (a lesion at a previously irradiated site may only be counted as a target lesion if there is clear sign of progression since the irradiation).
    - Participant has recurrence or progression of disease during or after combined AI (i.e. letrozole, anastrozole, exemestane) and CDK4/6 inhibitor therapy. The combined AI and CDK4/6 inhibitor therapy does not need to be the latest treatment regimen (including adjuvant setting).
    - Participant has received ≤ 2 prior lines of systemic therapies overall in
    the metastatic setting, of which a maximum of 1 line of prior treatment with chemotherapy (except for neoadjuvant/ adjuvant chemotherapy) is
    permitted.
    - The presence of a PIK3CA mutation(s) determined in tumor tissue prior
    to enrollment either by a Novartis designated laboratory or in tumor
    tissue or plasma ctDNA by a local laboratory usinga Food and Drug
    Administration (FDA)-approved PIK3CA Companion Diagnostics (CDx)
    test for alpelisib or the CE IVD QIAGEN Therascreen® PIK3CA RGQ PCR test.
    - If female, then the participant must be in postmenopausal status

    Further inclusion criteria and details are described in the protocol

    Principal exclusion criteria
    - Participant with symptomatic visceral disease or any disease burden that makes the participant ineligible for endocrine therapy (ET) per the investigator’s best judgment.
    - Participant who relapsed with documented evidence of progression more than 12 months from completion of (neo)adjuvant endocrine/endocrine-based therapy with no treatment for metastatic disease
    - Participant has received prior treatment with fulvestrant, any oral
    selective estrogen receptor degrader (SERD), any Phosphatidylinositol-3-Kinase (PI3K), mammalian Target of Rapamycin (mTOR) or Protein Kinase B (AKT) inhibitor

    Further exclusion criteria and details are described in the protocol


    Otvorené pre nábor: 2021-11-05
    Uzatvorené pre nábor:
    Uzatvorené:

    Pracoviská klinického skúšania:
    1. Názov: Národný onkologický ústav, II. Onkologická klinika LFUK a NOÚ, Klinika klinickej onkológie SZU a NOÚ, Klenová 1, 833 10 Bratislava
      Mesto: Bratislava
      Zodpovedný skúšajúci: MUDr. Eva Oravcová
      Referovať pacienta do klinického skúšania
    2. Názov: Onkologický ústav sv. Alžbety, s.r.o., Interná klinika VŚZ a SP a OÚSA, Heydukova 10, 812 50 Bratislava
      Mesto: Bratislava
      Zodpovedný skúšajúci: MUDr. Bela Mriňáková
      Referovať pacienta do klinického skúšania
    3. Názov: Východoslovenský onkologický ústav, a.s., Oddelenie klinickej onkológie, Rastislavova 43, 041 91 Košice
      Mesto: Košice
      Zodpovedný skúšajúci: MUDr. Andrea Cipková
  • Randomizované, dvojito zaslepené klinické skúšanie fázy III porovnávajúce NIS793 v kombinácii s gemcitabínom a nab-paklitaxelom verzus placebo kombinované s gemcitabínom a nab-paklitaxelom v prvej línii liečby metastatického duktálneho adenokarcinómu pankreasu (mPDAC)
    Liečivo: (NIS793), Paclitaxel (nab-paclitaxel), GEMCITABINE (gemcitabine)
    Diagnóza: Karcinóm pankreasu
    Kód skúšania: 2021-000591-10, CNIS793B12301
    Sponzor: Novartis Pharma AG

    Otvorené pre nábor: 2021-12-13
    Uzatvorené pre nábor: 2023-02-28
    Uzatvorené:

    Pracoviská klinického skúšania:
    1. Názov: Východoslovenský onkologický ústav, a.s., Oddelenie klinickej onkológie, Rastislavova 43, 041 91 Košice
      Mesto: Košice
      Zodpovedný skúšajúci: MUDr. MPH Andrea Cipková
    2. Názov: Fakultná nemocnica s poliklinikou F. D. Roosevelta Banská Bystrica , Onkologická klinika SZU, Námestie L.Svobodu 1
      Mesto: Banská Bystrica
      Zodpovedný skúšajúci: MUDr. PhD. Matej Hrnčár
  • Klinické skúšanie fázy 1/1b hodnotiace bezpečnosť, znášanlivosť, farmakokinetiku, farmakodynamiku a protinádorovú aktivitu skúšaného produktu PF-07220060 v monoterapii a v kombinovanej liečbe u účastníkov s pokročilými solídnymi nádormi
    Liečivo: MONOHYDRATE (PF-07220060), FULVESTRANT, LETROZOLE
    Diagnóza: Nádorové ochorenia
    Kód skúšania: 2020-002938-33, C4391001
    Sponzor: Pfizer Inc.
    Kritéria:

    Inclusion Criteria
    • Part 1: Breast Cancer (BC)
    o Refractory Hormone Receptor Positive (HR+), Human Epidermal Growth Factor Receptor 2 Negative (HER2-) BC
    o Part 1A/Part 1D/Part1E also include: Refractory HR-positive/HER2-positive BC
    • Part 1: Tumors other than BC (Part 1A/Part 1D/Part 1E): NSCLC, prostate, CRC, liposarcoma, or tumors with previously confirmed CDK4 or CCND1 amplification according to local standard tests
    • Part 1F: prostate cancer
    • Part 2A, 2B and 2C:
    o HR-positive/HER2-negative BC
    o Patients who are either postmenopausal women or pre/peri-menopausal (Part 2C only)
    • Part 1D: metastatic castration resistant prostate cancer
    • Lesion:
    o Part 1: evaluable lesion (including skin or bone lesion only)
    o Part 2A, 2B and 2C: measurable lesion per RECIST v1.1
    o Part 2D: Participants with evaluable disease as per PCWG3; participants with bone metastases only are allowed. Participants with biochemical recurrence only are excluded.
    • Prior systemic Treatment
    o Part 1: HR-positive/HER2-negative BC
     At least 1 line of SOC, including CD4/6 inhibitor therapy for advanced or metastatic disease, or if CDK4/6 inhibitors are not considered appropriate in the opinion of the investigator
     At least 1 line of anti-endocrine in countries without CDK4/6 inhibitor approval or reimbursement, for advanced or metastatic disease
     HR-positive/HER2-positive BC (Parts 1A/1D/1E): at least 1 prior treatment of approved HER2 targeting therapy
     Tumors other than BC (Parts 1A/1D/1E/1F): tumor that is resistant to at least 2 lines of SOC for advanced or recurrent disease or for which no standard therapy is available
    o Part 2A: participants must have received at least 1 line of standard of care (including prior CDK4/6i) for advanced/metastatic disease; Prior chemo is allowed; Prior fulvestrant, mTOR and/or PI3K inhibitors are allowed
    o Part 2B: participants who have not received any prior systemic anti-cancer therapies for advanced/metastatic BC
    o Part 2C:
     Progressed during treatment or within 12 months of completion of adjuvant therapy with an aromatase inhibitor if postmenopausal, or tamoxifen if pre or perimenopausal, or
     Progressed while on or within 1 month after the endo the prior aromatase inhibitor therapy for advanced/metastatic BC if postmenopausal or prior endocrine treatment for advanced/metastatic BC if pre or perimenopausal
     One previous line of chemotherapy for advanced/metastatic disease is allowed in addition to endocrine therapy
    o Part 2D:
     Received prior abiraterone; enzalutamide and CDK4i naive
     0-1 line of chemotherapy is allowed General Inclusion Criteria
    • All participants must be refractory to or intolerant of existing therapies known to provide clinical benefit for their condition.
    • Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 or 1
    • Adequate renal, liver, and bone marrow function
    Exclusion Criteria:
    • Part 1D: participants who have had a gastrectomy or have dietary or other restrictions that preclude a 10 hour overnight fast or consumption of the high fat, high calorie meal
    • Part 2B: prior neoadjuvant or adjuvant treatment with a non-steroidal aromatase inhibitor with disease recurrence while on or within 12 months of completing treatment. Prior treatment with any CDK4/6 inhibitor
    • Part 2C: prior treatment with any CDK inhibitor, fulvestrant, everolimus, or any agent whose mechanism of action is to inhibit the PI3K-mTOR pathway
    • Known active uncontrolled or symptomatic Central Nervous System (CNS) metastases carcinomatous meningitis, or leptomeningeal disease
    • Other active malignancy within 3 years prior to randomization, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ
    • Major surgery or radiation within 4 weeks prior to study intervention
    • Last anti-cancer treatment within 2 weeks prior to study intervention
    • Participation in other studies involving investigational drug(s) within 4 weeks prior to study entry
    • Pregnant or breastfeeding female participant
    • Active inflammatory gastrointestinal (GI) disease, known diverticular disease or previous gastric resection or lap band surgery including impairment of gastrointestinal function or GI disease


    Otvorené pre nábor: 2021-12-22
    Uzatvorené pre nábor: 2024-06-21
    Uzatvorené:

    Pracoviská klinického skúšania:
    1. Názov: Národný onkologický ústav, II. Onkologická klinika LFUK a NOÚ, Klinika klinickej onkológie SZU a NOÚ, Klenová 1, 833 10 Bratislava
      Mesto: Bratislava
      Zodpovedný skúšajúci: Prof. MUDr. DrSc. Michal Mego
      Referovať pacienta do klinického skúšania
    2. Názov: Onkologický ústav sv. Alžbety, s.r.o., Interná klinika VŚZ a SP a OÚSA, Heydukova 10, 812 50 Bratislava
      Mesto: Bratislava
      Zodpovedný skúšajúci: MUDr. PhD. MHA MPH Bela Mriňáková
      Referovať pacienta do klinického skúšania
    3. Názov: POKO Poprad s.r.o., Mnoheľova 2, 058 01 Poprad
      Mesto: Poprad
      Zodpovedný skúšajúci: MUDr. Juraj Beniak
      Referovať pacienta do klinického skúšania
    4. Názov: Fakultná nemocnica s poliklinikou Nové Zámky, Onkologická ambulancia II, Slovenská ulica 11 A, 940 34 Nové Zámky
      Mesto: Nové Zámky
      Zodpovedný skúšajúci: MUDr. Pavol Demo
  • KLINICKÉ SKÚŠANIE FÁZY 1 HODNOTIACE BEZPEČNOSŤ, FARMAKOKINETIKU A FARMAKODYNAMIKU ZVYŠUJÚCICH SA DÁVOK SKÚŠANÉHO PRODUKTU PF-06940434 U ÚČASTNÍKOV S POKROČILÝMI ALEBO METASTATICKÝMI SOLÍDNYMI NÁDORMI
    Liečivo: PF-06940434 (PF-06940434), Sasanlimab (PF-06801591)
    Diagnóza: Nádorové ochorenia
    Kód skúšania: 2020-004009-29, C3891001
    Sponzor: Pfizer Inc.
    Kritéria:

    Inclusion Criteria:

    - Histological or cytological diagnosis of SCCHN, RCC (clear cell and papillary cell), ovarian, gastric, esophageal (adeno and squamous), lung squamous cell, pancreatic and biliary duct, endometrial, melanoma, or urothelial cancer.

    Part 2:

    Arm A SCCHN:

    Primary tumor location of the oral cavity, oropharynx, hypopharynx or larynx.
    PDL-1 expression positive and CPS ≥1. No prior systemic therapy administered in the recurrent or metastatic setting (except for systemic therapy given as part of a multimodal treatment for locally advanced disease).
    Arm B RCC (clear cell):

    1 or 2 prior lines of therapy including PD-L1/PD-1 immunotherapy in combination or sequentially with antiangiogenic directed treatment
    Adequate bone marrow, kidney and liver function.
    Performance status of 0 or 1.
    Exclusion Criteria:

    Participant disease status is suitable for local therapy administered with curative intent.
    Hypertension that cannot be controlled by medications.
    Active or prior autoimmune disease
    Active, uncontrolled bacterial, fungal, or viral infection, including (but not limited to) Hepatitis B, Hepatitis C, and known Human Immunodeficiency Virus infection or Acquired Immunodeficiency Syndrome-related illness


    Otvorené pre nábor: 2021-12-17
    Uzatvorené pre nábor: 2023-11-28
    Uzatvorené:

    Pracoviská klinického skúšania:
    1. Názov: Onkologický ústav sv. Alžbety, s.r.o., Interná klinika VŚZ a SP a OÚSA, Heydukova 10, 812 50 Bratislava
      Mesto: Bratislava
      Zodpovedný skúšajúci: MUDr. PhD. Klaudia Gočárová
      Referovať pacienta do klinického skúšania
    2. Názov: POKO Poprad s.r.o., Mnoheľova 2, 058 01 Poprad
      Mesto: Poprad
      Zodpovedný skúšajúci: MUDr. Juraj Beniak
      Referovať pacienta do klinického skúšania
  • Otvorené randomizované kontrolované globálne skúšanie fázy 3 porovnávajúce telisotuzumab vedotin (ABBV-399) a docetaxel u účastníkov s predtým liečeným lokálne pokročilým/metastatickým neskvamóznym nemalobunkovým karcinómom pľúc s nadmernou expresiou c-Met, bez prítomnosti mutácie EGFR
    Liečivo: TELISOTUZUMAB VEDOTIN (ABBV-399)
    Diagnóza: Karcinóm pľúc
    Kód skúšania: 2021-001811-94, M18-868
    Sponzor: AbbVie Inc.
    Kritéria:

    Inclusion Criteria:

    Participants must have c-Met overexpressing non-small cell lung cancer (NSCLC) as assessed by an AbbVie designated immunohistochemistry (IHC) laboratory using the VENTANA MET (SP44) RxDx assay.
    Archival or fresh tumor material must be submitted for assessment of c-Met levels during the Pre-Screening period. Tumor material from the primary tumor site and/or metastatic sites are allowed.

    If a participant was prescreened for Study M14-239 but did not enroll, tumor material previously submitted for Study M14-239 may be used for Study M18-868 Pre-Screening upon confirmation from AbbVie that sufficient evaluable tumor material is available (Except China).
    A histologically documented non-squamous cell NSCLC that is locally advanced or metastatic.
    A known epidermal growth factor receptor (EGFR) activating mutation status.
    Actionable alterations in genes other than EGFR .
    Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
    An Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1.
    Have received no more than 1 line of prior systemic cytotoxic chemotherapy in the locally advanced or metastatic setting.

    Neoadjuvant and adjuvant systemic cytotoxic chemotherapy will count as a prior line for eligibility purposes if progression occurred within 6 months of the end of therapy.
    Have progressed on at least 1 line of prior therapy for locally advanced/metastatic NSCLC:

    Participants WITHOUT an actionable gene alteration: must have progressed on (or be considered ineligible for) platinum-based chemotherapy and immune checkpoint inhibitor (as monotherapy or in combination with chemotherapy).
    Participants WITH an actionable gene alteration for which immune checkpoint inhibitor therapy is not standard of care (e.g., anaplastic lymphoma kinase [ALK] translocation): must have progressed on (or be considered ineligible for) anti-cancer therapy targeting driver gene alterations and platinum-based chemotherapy.

    Participants with actionable gene alterations for which immune checkpoint inhibitor is standard of care must have also progressed on (or be considered ineligible for) immune checkpoint inhibitor (as monotherapy or in combination with chemotherapy).
    Must be considered appropriate for docetaxel therapy based on the assessment of the treating physician.
    Participants with metastases to the central nervous system (CNS) are eligible only after definitive therapy (such as surgery or radiotherapy) is provided and:

    There is no evidence of progression of CNS metastases at least 2 weeks after definitive therapy.
    They are asymptomatic and off or on a stable or reducing dose of systemic steroids and/or anticonvulsants for at least 2 weeks prior to first dose of telisotuzumab vedotin.

    Exclusion Criteria:
    Participants with adenosquamous histology.
    Actionable epidermal growth factor receptor (EGFR) activating mutations.
    Participants who have received prior c-Met-targeted antibodies, prior telisotuzumab vedotin, or prior antibody-drug conjugates either targeting c-Met or consisting of monomethylauristatin E..
    Participants who have received prior docetaxel therapy.
    A history of other malignancies except:

    Malignancy treated with curative intent and with no known active disease present for >=2 years before the first dose of study drug and felt to be at low risk for recurrence by investigator.
    Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease.
    Adequately treated carcinoma in situ without current evidence of disease.
    A history of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan. A history of prior radiation pneumonitis in the radiation field (fibrosis) is permitted.
    Unresolved adverse event (AE) >= Grade 2 from prior anticancer therapy, except for alopecia or anemia.
    Major surgery within 21 days prior to the first dose of telisotuzumab vedotin.
    Clinically significant condition(s) as listed in the protocol.


    Otvorené pre nábor: 2022-01-28
    Uzatvorené pre nábor: 2024-02-27
    Uzatvorené:

    Pracoviská klinického skúšania:
    1. Názov: Fakultná nemocnica s poliklinikou F.D.Roosevelta, Oddelenie pneumológie a ftizeológie, Nám. L.Svobodu 1, 97401 Banská Bystrica
      Mesto: Banská Bystrica
      Zodpovedný skúšajúci: MUDr. Michal Urda
  • Alogénna transplantácia krvotvorných buniek u detí a dospievajúcich s akútnou lymfoblastovou leukémiou - FORUM vrátane prídavnej štúdie: Skúšanie fázy II lieku Blincyto u detí s CD19+ prekurzorovou B-líniovou ALL a MRD pozitivitou pred a/alebo po prvej alogénnej HSCT
    Liečivo: Blincyto
    Diagnóza: Leukémia
    Kód skúšania: 2012-00032-22, ALL-SCT-ped-FORUM
    Sponzor: St. Anna Kinderkrebsforschung, Zimmermannplatz 10, A-1090 Vienna, Austria, Represented by Wolfgang Holter, tel: +43-1-40170-1250; fax: +43-1-40170-7000
    Link:
    Kritéria:

    Inclusion Criteria:
    patients with ALL (except for patients with mature B-ALL) who fulfil the following criteria:
    • Age at diagnosis ≤ 18 years or age at HSCT ≤ 21 years
    • Indication for allogeneic HSCT
    • Complete remission (CR) before SCT
    • Written consent of the parents (legal guardian) and, if necessary, with minor patients via “Informed Consent Form“
    • No pregnancy
    • No secondary malignancy
    • No previous HSCT
    • HSCT is performed in a study participating centre
    Exclusion Criteria:
    • Patients who do not fulfill the inclusion criteria
    • Non-Hodgkin-Lymphoma
    • The whole protocol or essential parts are declined either by patient himself/ herself or the respective guardian
    • No consent in given for saving and propagation of anonymous medical data for study success
    • Severe concomitant disease that doesn’t allow treatment according the protocol at the investigators discretion (e.g. malformation syndromes, cardiac malformations, metabolic disorders)
    • Karnofsky/ Lansky score < 50%
    • Subject unwilling or unable to comply with the study procedures


    Otvorené pre nábor: 2021-09-29
    Uzatvorené pre nábor:
    Uzatvorené:

    Pracoviská klinického skúšania:
    1. Názov: Národný ústav detských chorôb, Klinika detskej hematológie a onkológie LF UK a NÚDCH, Limbová 1, Bratislava
      Mesto: Bratislava
      Zodpovedný skúšajúci: MUDr. Švec Peter , PhD.
  • KLINICKÉ SKÚŠANIE FÁZY 1/2 HODNOTIACE LIEČBU PALBOCIKLIBOM (IBRANCE®) V KOMBINÁCII S IRINOTEKÁNOM A TEMOZOLOMIDOM A/ALEBO V KOMBINÁCII S TOPOTEKÁNOM A CYKLOFOSFAMIDOM U PEDIATRICKÝCH PACIENTOV S RECIDIVUJÚCIMI ALEBO REFRAKTÉRNYMI SOLÍDNYMI NÁDORMI
    Liečivo: Palbociclib (PD-0332991)
    Diagnóza: Sarkómy
    Kód skúšania: 2021-003444-25, A5481092
    Sponzor: Pfizer Inc.
    Kritéria:

    Principal inclusion criteria
    Patients must meet all the following inclusion criteria to be eligible for
    enrollment in the study:
    1. Histologically confirmed relapsed or refractory solid tumor as follows:
    •For dose escalation and dose determination parts: Histologically
    confirmed relapsed or refractory solid tumor (including CNS tumors but
    not lymphomas). Patients with Diffuse Intrinsic Pontine Glioma do not
    require histological only radiographic confirmed relapse to enroll.
    •For dose expansion cohorts: Histologically confirmed relapsed or
    refractory solid tumor including but not limited to EWS, rhabdoid tumor,
    rhabdomyosarcoma, neuroblastoma, and medulloblastoma. Patients with
    Diffuse Intrinsic Pontine Glioma do not require histological only
    radiographic confirmed relapse to enroll.
    •For tumor-specific cohorts: Histologically confirmed relapsed or
    refractory solid tumor including but not limited to EWS, rhabdoid tumor,
    rhabdomyosarcoma, neuroblastoma, and medulloblastoma. Patients with
    Diffuse Intrinsic Pontine Glioma do not require histological only
    radiographic confirmed relapse to enroll.
    • For randomized Phase 2 part: Histologically confirmed Ewing sarcoma
    at diagnosis or at relapse, with presence of EWSR1-ETS or FUS-ETS
    rearrangement. Histopathology confirmation of both EWSR1-ETS or
    FUSETS rearrangement partners is required OR availability of formalin
    fixed paraffin embedded (FFPE) tumor tissue sample for central testing.
    Patient must have relapsed or have refractory disease and at least
    evaluable disease in at least one site other than bone marrow that can
    be followed by imaging.
    2. Age ≥2 and <21 years at the time of study entry. Refer to Section 4.3
    for reproductive criteria for male and female participants.
    3. Lansky performance status ≥50% for patients ≤16 years of age, or
    Eastern Cooperative Oncology Group (ECOG) 0, 1 or 2 for patients >16
    years of age.
    4. Adequate bone marrow function.
    •Absolute neutrophil count ≥1000/mm3;
    •Platelet count ≥75,000/mm3 (transfusion independent, no platelet
    transfusion in
    past 7 days prior study entry);
    • Hemoglobin ≥8.5 g/dL (transfusion allowed).
    5. Adequate renal function: Serum creatinine level based on age/gender
    must be less than or equal to the following maximum upper limits as
    shown in Table 10:
    Table 10. Maximum Allowed Creatinine Levels
    Age Maximum Serum Creatinine (mg/dL)
    Male Female
    2 to <6 years 0.8 0.8
    6 to <10 years 1.0 1.0
    10 to <13 years 1.2 1.2
    13 to <16 years 1.5 1.4
    16 to <21 years 1.7 1.4
    The threshold creatinine values in this table were derived from the
    Schwartz formula for estimating glomerular filtration rate utilizing child
    length and stature data published by the CDC.
    6. Adequate liver function, including:
    •Aspartate aminotransferase (AST) and alanine aminotransferase (ALT)
    ≤2.5 × upper limit of normal (ULN) or ≤5 × ULN for age, if attributable
    to disease involvement of the liver;
    •Total bilirubin ≤1.5 × ULN for age unless the patient has documented
    Gilbert's syndrome. Patients with documented Gilbert's syndrome are
    eligible if direct bilirubin is within normal ranges (≤ULN).
    7. Patients enrolled to Phase 1 portion of the study and tumor specific
    cohorts must have measurable disease as defined by RECIST version 1.1
    or modified RANO criteria for CNS disease or at least evaluable disease
    by INRC for neuroblastoma.
    The eligible patients with neuroblastoma must have at least one of the
    following at the time of study entry:
    •Measurable tumor by CT or MRI that is avid on MIBG scan or
    demonstrates increased FDG uptake on PET scan;
    •Avid lesion on MIBG scan with positive uptake at a minimum of one
    site;
    •For disease that is not avid by MIBG-scan, at least one lesion that
    demonstrates increased FDG uptake on PET scan AND viable
    neuroblastoma confirmed by current or prior biopsy;
    •bone marrow involvement with more than 5% neuroblastoma cells in at
    least one sample from bilateral bone marrow biopsies;
    •In non MIBG-avid refractory soft tissue disease that does not demonstrate increased FDG uptake; lesion biopsy is required to
    document the presence of viable neuroblastoma, unless patient has a
    new soft tissue lesion (radiographic
    evidence of disease progression). Patients with EWS enrolled to Phase 2
    portion of the study are eligible with at least evaluable disease (eg, bone
    only disease with no soft tissue component).
    8. Recovered to CTCAE Grade ≤1, or to baseline, from any nonhematological
    acute toxicities of prior surgery, chemotherapy,
    immunotherapy, radiotherapy, differentiation therapy or biologic
    therapy, with the exception of alopecia.
    9. Serum/urine pregnancy test (for all girls ≥8 years of age) negative at
    screening and at the baseline visit.

    Principal exclusion criteria
    Patients with any of the following characteristics/conditions will not be
    included in the study:
    1. Phase 1 portion and tumor specific cohorts: For palbociclib with IRN
    and TMZ combination, prior treatment with a CDK4/6 inhibitor or
    progression while on treatment with an IRN-containing regimen that
    includes TMZ. Patients who have
    received the combination of IRN and TMZ and did not progress while on
    these medications are eligible. For patients enrolling in the palbociclib
    with TOPO and CTX combination, prior treatment with a CDK4/6 inhibitor
    or progression while on treatment with a TOPO-containing regimen that
    includes CTX. Patients who have received the combination of TOPO and
    CTX and did not progress while on thesemedications are eligible. Phase 2
    portion: prior treatment with a CDK4/6 inhibitor or progression while on
    treatment with an IRN-containing or TMZ-containing regimen. Patients
    who have received IRN and/or TMZ and did not progress while on these
    medications are eligible.
    2. Prior intolerability to IRN and/or TMZ for IRN and TMZ plus/minus
    palbociclib combinations and prior intolerability to TOPO and/or CTX for
    TOPO and CTX combination. For patients enrolled in the UK, any
    contraindication for IRN and/or TMZ treatment, as per the local SmPC.
    3. Use of strong cytochrome P450 (CYP) 3A inhibitors or inducers within
    12 days of study entry. Patients who are receiving strong uridine
    diphosphate-glucuronosyl transferase 1A1 (UGT1A1) inhibitors within 12
    days of C1D1 are not eligible for the palbociclib with IRN and TMZ
    combination. Patients who are receiving strong UGT1A1 inhibitors within
    12 days of C1D1 are eligible for the palbociclib with TOPO and CTX
    combination
    4. Systemic anticancer therapy within 2 weeks prior to study entry and 6
    weeks for nitrosoureas.
    5. Prior irradiation to >50% of the bone marrow
    6. Participation in other studies involving investigational drug(s) within
    2 weeks or 5 halflives, whichever is longer, prior to study entry
    7. Major surgery within 4 weeks prior to study entry. Surgical biopsies or
    central line placement are not considered major surgeries.
    8. For IRN and TMZ with/without palbociclib combinations: known or
    suspected hypersensitivity to palbociclib, dacarbazine, IRN and/or TMZ.
    For combination of palbociclib with TOPO and CTX: known or suspected
    hypersensitivity to palbociclib, TOPO and/or CTX.
    9. Patients with known symptomatic brain tumors or brain metastases
    and require steroids, unless they have been on a stable or on a
    decreasing steroid dose for >14 days.
    10. Patients with previously diagnosed brain metastases are eligible if
    they have completed their prior treatment and have recovered from the
    acute effects of radiation therapy or surgery prior to study entry for
    these metastases for at least 14 days postradiation and 4 weeks post surgery and are neurologically stable.
    11. Hereditary bone marrow failure disorder.
    12. QTc >470 msec.
    13. History of clinically significant or uncontrolled cardiac disease,
    including:
    History of or active congestive heart failure; if patient had congestive
    heart failure
    resolve and >1 year from resolution, patient will be considered eligible;
    •Clinically significant ventricular arrhythmia (such as ventricular
    tachycardia,
    ventricular fibrillation or Torsades de Pointes);
    •Diagnosed or suspected congenital or acquired prolonged QT syndrome;
    •Need for medications known to prolong the QT interval;
    •Uncorrected hypomagnesemia or hypokalemia because of potential
    effects on the QT interval;
    •Left ventricular ejection fraction <50% or shortening fraction <28%.
    14. Recent or ongoing clinically significant gastrointestinal disorder that
    may interfere with absorption of orally administered drugs (eg,
    gastrectomy).
    15. Evidence of serious active or uncontrolled bacterial, fungal or viral
    infection or known history of hepatitis B virus, hepatitis C virus, or
    human immunodeficiency virus infection or acquired immunodeficiency
    syndrome-related illness. Screening for viral hepatitis and HIV is under
    discretion of investigator unless required by local regulation.
    16. Severe acute or chronic medical or laboratory test abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results, and in the judgment of the Investigator, would make the patient inappropriate for entry into this study.
    17. Investigator site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the investigator, or patients who are Pfizer employees, including their family members, directly involved in the conduct of the study.
    18. Fertile male patients or female patients of childbearing potential who are unwilling or unable to follow contraceptive requirements as detailed in Section 4.3.
    19. Pregnant or breastfeeding women.


    Otvorené pre nábor: 2022-02-23
    Uzatvorené pre nábor: 2023-10-21
    Uzatvorené:

    Pracoviská klinického skúšania:
    1. Názov: Detská fakultná nemocnica s poliklinikou Banská Bystrica, Klinika pediatrickej onkológie a hematológie SZU, Námestie L. Svobodu 4, Banská Bystrica
      Mesto: Banská Bystrica
      Zodpovedný skúšajúci: MUDr. Ivana Fedoráková
    2. Názov: Národný ústav detských chorôb, Klinika detskej hematológie a onkológie LF UK a NÚDCH, Limbová 1, Bratislava
      Mesto: Bratislava
      Zodpovedný skúšajúci: prof. MUDr. Kolenová Alexandra, PhD.
  • RANDOMIZOVANÉ, NEZASLEPENÉ KLINICKÉ SKÚŠANIE FÁZY 2 HODNOTIACE ENKORAFENIB A CETUXIMAB V KOMBINÁCII S PEMBROLIZUMABOM OPROTI SAMOTNÉMU PEMBROLIZUMABU U ÚČASTNÍKOV S PREDTÝM NELIEČENÝM METASTATICKÝM KOLOREKTÁLNYM KARCINÓMOM S MUTÁCIOU V600E GÉNU BRAF A S MSI-H/DMMR
    Liečivo: Encorafenib (PF-07263896), Cetuximab, Pembrolizumab
    Diagnóza: Kolorektálny karcinóm
    Kód skúšania: 2021-003715-26, C4221022, Seamark
    Sponzor: Pfizer Inc.
    Kritéria:

    Inclusion Criteria:

    Locally confirmed microsatellite instability-high/ deficient mismatch repair (MSI-H/dMMR) stage IV colorectal carcinoma
    Locally confirmed BRAF V600E mutation in tumor tissue or blood
    Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
    Have not received prior systemic regimens for metastatic disease.
    Measurable disease per RECIST 1.1
    Adequate organ function

    Exclusion Criteria:

    Colorectal adenocarcinoma that is RAS mutant or for which RAS mutation status is unknown
    Known active central nervous system metastases and/or carcinomatous meningitis; leptomeningeal disease
    Immunodeficiency or active autoimmune disease requiring systemic treatment in the past 2 years
    Presence of acute or chronic pancreatitis
    Clinically significant cardiovascular diseases (eg, thromboembolic or cerebrovascular accident events ≤ 12 wks prior)
    Received a live or live-attenuated vaccine within 30 days of planned start of study medication
    Previous treatment with any selective BRAF inhibitor (eg, encorafenib, dabrafenib, vemurafenib, XL281/BMS-908662) or any epidermal growth factor receptor (EGFR) inhibitor (eg, cetuximab, panitumumab).
    Previous treatment with an immune checkpoint inhibitor (eg, anti-programmed cell death [PD-1], anti-PD-L1 or anti-PD-L2 agent); or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX 40, CD137).


    Otvorené pre nábor: 2022-05-30
    Uzatvorené pre nábor:
    Uzatvorené:

    Pracoviská klinického skúšania:
    1. Názov: Národný onkologický ústav, II. Onkologická klinika LFUK a NOÚ, Klinika klinickej onkológie SZU a NOÚ, Klenová 1, 833 10 Bratislava
      Mesto: Bratislava
      Zodpovedný skúšajúci: MUDr. PhD. Štefan Pörsök
      Referovať pacienta do klinického skúšania
    2. Názov: Východoslovenský onkologický ústav, a.s., Oddelenie klinickej onkológie, Rastislavova 43, 041 91 Košice
      Mesto: Košice
      Zodpovedný skúšajúci: MUDr. MPH Andrea Cipková
  • EPIK-B2: Multicentrické randomizované (1:1) dvojito zaslepené placebom kontrolované klinické skúšanie fázy III pozostávajúce z dvoch častí na zhodnotenie účinnosti a bezpečnosti alpelisibu (BYL719) v kombinácii s trastuzumabom a pertuzumabom v udržiavacej liečbe pacientov s HER2-pozitívnym pokročilým karcinómom prsníka s mutáciou PIK3CA
    Liečivo: ALPELISIB, TRASTUZUMAB, PERTUZUMAB
    Diagnóza: Karcinóm prsníka
    Kód skúšania: 2019-002741-37, CBYL719G12301, EPIK-B2
    Sponzor: Novartis Pharma AG

    Otvorené pre nábor: 2022-07-15
    Uzatvorené pre nábor:
    Uzatvorené:

    Pracoviská klinického skúšania:
    1. Názov: Národný onkologický ústav, II. Onkologická klinika LFUK a NOÚ, Klinika klinickej onkológie SZU a NOÚ, Klenová 1, 833 10 Bratislava
      Mesto: Bratislava
      Zodpovedný skúšajúci: Prof. MUDr. DrSc. Michal Mego
    2. Názov: Onkologický ústav sv. Alžbety, s.r.o., Interná klinika VŚZ a SP a OÚSA, Heydukova 10, 812 50 Bratislava
      Mesto: Bratislava
      Zodpovedný skúšajúci: MUDr. Bibiána Vertáková Krakovská
    3. Názov: Východoslovenský onkologický ústav, a.s., Oddelenie klinickej onkológie, Rastislavova 43, 041 91 Košice
      Mesto: Košice
      Zodpovedný skúšajúci: MUDr. Andrea Cipková
  • JEDNORAMENNÉ KLINICKÉ SKÚŠANIE FÁZY 2 S ATEZOLIZUMABOM U PACIENTOV S LOKÁLNE POKROČILÝM, NERESEKOVATEĽNÝM NEMALOBUNKOVÝM KARCINÓMOM PĽÚC V III. ŠTÁDIU, U KTORÝCH NEDOŠLO K PROGRESII PO SÚBEŽNEJ CHEMORÁDIOTERAPII NA BÁZE PLATINY
    Liečivo: Atezolizumab
    Diagnóza: Karcinóm pľúc
    Kód skúšania: 2021-002695-40, MO43156
    Sponzor: F. Hoffmann La-Roche Ltd

    Otvorené pre nábor: 2022-07-27
    Uzatvorené pre nábor:
    Uzatvorené:

    Pracoviská klinického skúšania:
    1. Názov: Východoslovenský onkologický ústav, a.s., Oddelenie klinickej onkológie, Rastislavova 43, 041 91 Košice
      Mesto: Košice
      Zodpovedný skúšajúci: Doc. MUDr. CSc. Igor Andrašina
    2. Názov: Univerzitná nemocnica Bratislava – Nemocnica Ružinov, Klinika pneumológie, ftizeológie a funkčnej diagnostiky SZU a UNB, Ružinovská 6
      Mesto: Bratislava
      Zodpovedný skúšajúci: MUDr. Zuzana Šviheľová Lišková
  • Otvorené randomizované klinické skúšanie fázy 3 tukatinibu v kombinácii s trastuzumabom a produktom mFOLFOX6 v porovnaní s produktom mFOLFOX6 podávaným s cetuximabom alebo bevacizumabom alebo bez nich ako liečba prvej línie u pacientov s HER2-pozitívnym metastatickým kolorektálnym karcinómom
    Liečivo: Tucatinib (ONT-380), Trastuzumab
    Diagnóza: Kolorektálny karcinóm
    Kód skúšania: 2021-002672-40, SGNTUC-029, MOUNTAINEER-03
    Sponzor: Seagen Inc.
    Kritéria:

    Inclusion Criteria:

    Histologically and/or cytologically confirmed adenocarcinoma of the colon or rectum which is metastatic and/or unresectable
    Able to provide the most recently available formalin-fixed paraffin-embedded (FFPE) tumor tissue blocks (or freshly sectioned slides) obtained prior to treatment initiation to a central laboratory

    If archival tissue is not available, a newly-obtained baseline biopsy of an accessible tumor lesion is required within 35 days prior to start of study treatment
    HER2+ disease as determined by a tissue based assay performed at a central laboratory.
    Participant has rat sarcoma viral oncogene homolog wild-type (RAS WT) disease as determined by local or central testing
    Radiographically measurable disease per RECIST v1.1 with:

    At least one site of disease that is measurable and that has not been previously irradiated, or
    If the participant has had previous radiation to the target lesion(s), there must be evidence of progression since the radiation
    Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
    CNS Inclusion - based on contrast brain magnetic resonance imaging, participants may have any of the following:

    No evidence of brain metastases
    Previously treated brain metastases which are asymptomatic
    Exclusion Criteria:

    Prior systemic anticancer therapy for colorectal cancer (CRC) in the metastatic setting

    May have received chemotherapy for CRC in the adjuvant setting if it was completed >6 months prior to enrollment
    Radiation therapy within 14 days prior to enrollment (or within 7 days in the setting of stereotactic radiosurgery)
    Previous treatment with anti-HER2 therapy
    Ongoing Grade 3 or higher neuropathy
    GI perforation within 12 months of enrollment


    Otvorené pre nábor: 2022-07-28
    Uzatvorené pre nábor:
    Uzatvorené:

    Pracoviská klinického skúšania:
    1. Názov: Národný onkologický ústav, II. Onkologická klinika LFUK a NOÚ, Klinika klinickej onkológie SZU a NOÚ, Klenová 1, 833 10 Bratislava
      Mesto: Bratislava
      Zodpovedný skúšajúci: MUDr. Štefan Pörsök
      Referovať pacienta do klinického skúšania
    2. Názov: POKO Poprad s.r.o., Mnoheľova 2, 058 01 Poprad
      Mesto: Poprad
      Zodpovedný skúšajúci: MUDr. Juraj Beniak
      Referovať pacienta do klinického skúšania
  • Otvorené skúšanie fázy 3 na posúdenie bezpečnosti a účinnosti epkoritamabu v kombinácii s rituximabom a lenalidomidom (R2) v porovnaní s R2 u účastníkov s relabujúcim alebo refraktérnym folikulárnym lymfómom (EPCORE™ FL-1)
    Liečivo: Epcoritamab (ABBV-GMAB-3013)
    Diagnóza: Lymfómy
    Kód skúšania: 2021-000169-34, M20-638, EPCORE™ FL-1
    Sponzor: AbbVie Deutschland GmbH & Co. KG
    Kritéria:

    Inclusion Criteria:

    Eastern Cooperative Oncology Group (ECOG) performance status score 0 to 2.
    Participant has:

    Fluorodeoxyglucose-positron emission tomography (FDG-PET) scan demonstrating positive lesion compatible with computed tomography (CT) or magnetic resonance image (MRI)-defined anatomical tumor sites AND
    >= 1 measurable nodal lesion (long axis > 1.5 cm) or >= 1 measurable extra-nodal lesion (long axis > 1.0 cm) on CT scan or MRI.
    Histologically confirmed classic follicular lymphoma (FL) [previously Grade 1 to 3a FL] stage II, III, or IV with no evidence of histologic transformation to an aggressive lymphoma and CD20+ disease on most recent representative tumor biopsy based on the pathology report.
    Relapsed or refractory (R/R) disease to at least one prior systemic regimen that contained an anti-CD20 monoclonal antibody (mAb) in combination with chemotherapy. (Participant who received only prior anti-CD20 mAb monotherapy and/or radiation therapy is not eligible.)
    Eligible to receive R2 per investigator determination.
    Exclusion Criteria:

    Documented refractoriness to lenalidomide.
    Have lenalidomide exposure within 12 months prior to randomization.


    Otvorené pre nábor: 2022-10-12
    Uzatvorené pre nábor:
    Uzatvorené:

    Pracoviská klinického skúšania:
    1. Názov: Národný onkologický ústav, Klinika onkohematológie LFUK a NOÚ, Oddelenie onkohematológie, Klenová 1, 833 10 Bratislava
      Mesto: Bratislava
      Zodpovedný skúšajúci: doc. MUDr. Ľuboš Drgoňa, CSc., MHA, FECMM
  • Randomizované, otvorené klinické skúšanie fázy 3 porovnávajúce sacituzumab govitekan s liečbou podľa voľby lekára u pacientov s predtým neliečeným, lokálne pokročilým, neoperovateľným alebo metastatickým trojito negatívnym karcinómom prsníka, ktorí majú nádory bez expresie PD-L1, alebo u pacientov predtým liečených látkami proti PD-(L)1 v skorom štádiu, ktorí majú nádory s expresiou PD-L1
    Liečivo: SACITUZUMAB GOVITECAN (IMMU-132)
    Diagnóza: Karcinóm prsníka
    Kód skúšania: 2021-005743-79, GS-US-592-6238
    Sponzor: Gilead Sciences, Inc.
    Kritéria:

    Key Inclusion Criteria:

    Individuals, regardless of race and ethnic group, with previously untreated locally advanced, inoperable or metastatic triple-negative breast cancer (TNBC)

    Individuals whose tumors are programmed cell death ligand 1 (PD-L1) negative at screening or individuals whose tumors are PD-L1 positive at screening if they have received an anti-PD-(L)1 inhibitor in the (neo)adjuvant setting
    Centrally confirmed TNBC and PD-L1 status on fresh or archival tissue
    Individuals must have completed treatment for Stage I-III breast cancer, if indicated, and ≥ 6 months must have elapsed between completion of treatment with curative intent and first documented local or distant disease recurrence
    Individuals presenting with de novo metastatic TNBC are eligible
    Measurable disease based on computed tomography (CT) or magnetic resonance imaging (MRI) in accordance with per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1. as evaluated locally
    Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
    Demonstrates adequate organ function
    Male individuals and female individuals of childbearing potential who engage in heterosexual intercourse must agree to use protocol-specified method(s) of contraception
    Individuals with human immunodeficiency virus (HIV) must be on antiretroviral therapy (ART) and have a well-controlled HIV infection/disease
    Key Exclusion Criteria:

    Positive serum pregnancy test or women who are lactating
    Received systemic anticancer treatment within the previous 6 months or radiation therapy within 2 weeks prior to enrollment
    Have not recovered from adverse events (AEs) due to a previously administered agent at the time study entry
    May not be participating in a study with an investigational agent or investigational device within 4 weeks prior to randomization. Individuals participating in observational studies are eligible
    Previously received topoisomerase 1 inhibitors or antibody drug conjugates containing a topoisomerase inhibitor
    Active second malignancy
    Active serious infection requiring antibiotics
    Positive for HIV-1 or 2 with a history of Kaposi sarcoma and/or Multicentric Castleman Disease
    Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection
    Note: Other protocol defined Inclusion/Exclusion criteria may apply.


    Otvorené pre nábor: 2022-11-15
    Uzatvorené pre nábor: 2024-06-21
    Uzatvorené:

    Pracoviská klinického skúšania:
    1. Názov: Národný onkologický ústav, II. Onkologická klinika LFUK a NOÚ, Klinika klinickej onkológie SZU a NOÚ, Klenová 1, 833 10 Bratislava
      Mesto: Bratislava
      Zodpovedný skúšajúci: Prof. MUDr. DrSc. Michal Mego
      Referovať pacienta do klinického skúšania
    2. Názov: Nemocnica na okraji mesta n.o., Ambulancia klinickej onkológie, Nová Nemocnica 511, 958 01 Partizánske
      Mesto: Partizánske
      Zodpovedný skúšajúci: MUDr. MPH Alexandra Szabová
      Referovať pacienta do klinického skúšania
    3. Názov: Onkologický ústav sv. Alžbety, s.r.o., Interná klinika VŚZ a SP a OÚSA, Heydukova 10, 812 50 Bratislava
      Mesto: Bratislava
      Zodpovedný skúšajúci: MUDr. Ph.D. Bibiána Vertaková Krakovská
  • Randomizované, dvojito zaslepené klinické skúšanie fázy III na porovnanie prechodu na liečbu AZD9833 (nová generácia perorálneho SERD) + inhibítorom CDK4/6 (palbociklib alebo abemaciklib) oproti pokračujúcej liečbe AI (letrozol alebo anastrozol) + inhibítorom CDK4/6 u pacientov s metastatickým HR-pozitívnym/HER2-negatívnym karcinómom prsníka s potvrdenou mutáciou ESR1 bez progresie ochorenia počas prvej línie liečby AI + inhibítorom CDK4/6 Klinické skúšanie so skorou zmenou liečby v závislosti od ctDNA
    Liečivo: (AZD9833 - 25 mg), (AZD9833 - 75 mg), Palbociclib, Abemaciclib
    Diagnóza: Karcinóm prsníka
    Kód skúšania: 2021-000546-17, D8534C00001,SERENA-6
    Sponzor: ASTRAZENECA AB
    Kritéria:

    INCLUSION CRITERIA:

    INFORMATION FOR TRIAL PARTICIPANTS - Participants can join the trial if they:

    Have advanced breast cancer that is not able to be treated with surgery or radiation;
    Have an ESR1 mutation in their cancer;
    Have breast cancer that is HR-positive and HER2-negative;
    Are currently being treated with a CDK4/6 inhibitor and an AI and have been taking these drugs for at least 6 months;
    Have not had their cancer get worse after taking an AI and CDK4/6 inhibitor;
    Are able to do their daily activities;
    Are at least 18.
    Full list of inclusion criteria:

    Proven diagnosis of adenocarcinoma of the breast with evidence of locoregionally recurrent or metastatic disease not amenable to resection or radiation therapy with curative intent;
    Documentation of histologically confirmed diagnosis of estrogen receptor positive (ER+) /HER2- breast cancer based on local laboratory results;
    Currently on AI (letrozole or anastrozole) + CDK4/6 inhibitor (palbociclib or abemaciclib) ± LHRH as the initial endocrine based treatment for advanced disease;
    Eastern Cooperative Oncology Group performance status of 0 or 1;
    ESR1m detected by central testing of ctDNA;
    Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures;
    Adequate organ and marrow function.
    EXCLUSION CRITERIA:

    INFORMATION FOR TRIAL PARTICIPANTS - Participants cannot join the trial if they:

    Had certain types of tumors in the past that may come back;
    Are currently taking any other treatments for their cancer or other conditions including hormone replacements, medications, or supplements that could interfere with the trial treatment;
    Have or have had any major health problem, infection, or recent surgery that could make it difficult or dangerous to participate in this trial.
    Full list of exclusion criteria:

    Advanced, symptomatic, visceral spread, that are at risk of life-threatening complications in the short term;
    Known active uncontrolled or symptomatic CNS metastases, carcinomatous meningitis, or leptomeningeal disease;
    Any evidence of severe or uncontrolled systemic diseases which, in the investigator's opinion, makes it undesirable for the participant to participate in the study or that would jeopardize compliance with the protocol;
    Patient with known or family history of severe heart disease;
    Previous treatment with AZD9833, investigational SERDs or fulvestrant;
    Currently pregnant (confirmed with positive pregnancy test) or breastfeeding;
    Persistent non-haematological toxicities (CTCAE Grade > 2) caused by CDK4/6 inhibitor and/or AI treatment.


    Otvorené pre nábor: 2022-11-18
    Uzatvorené pre nábor:
    Uzatvorené:

    Pracoviská klinického skúšania:
    1. Názov: Mammacentrum sv. Agáty Banská Bystrica, a.s., Tibora Andrašovana 46, 974 01 Banská Bystrica
      Mesto: Banská Bystrica
      Zodpovedný skúšajúci: MUDr. Eva Pritzová
    2. Názov: Národný onkologický ústav, II. Onkologická klinika LFUK a NOÚ, Klinika klinickej onkológie SZU a NOÚ, Klenová 1, 833 10 Bratislava
      Mesto: Bratislava
      Zodpovedný skúšajúci: MUDr.PhD. Eva Oravcová
      Referovať pacienta do klinického skúšania
    3. Názov: Nemocnica na okraji mesta n.o., Ambulancia klinickej onkológie, Nová Nemocnica 511, 958 01 Partizánske
      Mesto: Partizánske
      Zodpovedný skúšajúci: MUDr. Alexandra Szabová
      Referovať pacienta do klinického skúšania
    4. Názov: NsP Štefana Kukuru Michalovce, a.s., Ambulancia klinickej onkológie, Špitálska 2, 071 01 Michalovce
      Mesto: Michalovce
      Zodpovedný skúšajúci: MUDr.PhD. Lenka Rušinová
      Referovať pacienta do klinického skúšania
  • RANDOMIZOVANÉ, ODSLEPENÉ, MULTICENTRICKÉ SKÚŠANIE II. FÁZY S VIACERÝMI DÁVKAMI RO7247669 U ÚČASTNÍKOV S PREDTÝM NELIEČENÝM NERESEKOVATEĽNÝM ALEBO METASTATICKÝM MELANÓMOM
    Liečivo: (RO7247669/F01-01)
    Diagnóza: Melanóm
    Kód skúšania: 2022-000631-23, BP43963
    Sponzor: F. Hoffmann-La Roche Ltd
    Kritéria:

    Inclusion Criteria:

    Histologically confirmed unresectable or metastatic melanoma, per the American Joint Committee on Cancer (AJCC) staging system (unresectable Stage III or Stage IV)
    Radiologically measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
    Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1
    Known v-Raf murine sarcoma viral oncogene homolog B1 (BRAF) V600 mutation status
    Adequate cardiovascular, hematological, hepatic and renal function
    Willingness to abide by contraceptive measures for the duration of the study
    Participants must have known PD-L1 status
    Exclusion Criteria:

    Pregnancy, lactation, or breastfeeding
    Known hypersensitivity to any of the components of RO7247669
    Participants must not have ocular melanoma
    Symptomatic central nervous system (CNS) metastases
    Significant cardiovascular/cerebrovascular disease within 6 months prior to randomization
    Known active or uncontrolled bacterial, viral, fungal, mycobacterial, parasitic, or other infection or any major episode of infection requiring treatment with intravenous (IV) antibiotics or hospitalization within 28 days prior to randomization
    Major surgical procedure or significant traumatic injury (excluding biopsies) within 28 days prior to randomization, or anticipation of the need for major surgery during the course of the study
    Active or history of autoimmune disease or immune deficiency with some exceptions
    Prior systemic anticancer therapy for unresectable or metastatic melanoma
    Prior anticancer therapy with any-immunomodulatory agents including CPIs (such as anti-programmed death-ligand 1[PD-L1]/PD-1 and anti-cytotoxic T lymphocyte-associated antigen [CTLA-4]) with some exceptions if used as prior adjuvant or neoadjuvant melanoma therapies
    Prior treatment with anti-LAG3 therapy


    Otvorené pre nábor: 2022-11-08
    Uzatvorené pre nábor: 2023-07-31
    Uzatvorené:

    Pracoviská klinického skúšania:
    1. Názov: Národný onkologický ústav, II. Onkologická klinika LFUK a NOÚ, Klinika klinickej onkológie SZU a NOÚ, Klenová 1, 833 10 Bratislava
      Mesto: Bratislava
      Zodpovedný skúšajúci: MUDr. Róbert Godál
    2. Názov: POKO Poprad s.r.o., Mnoheľova 2, 058 01 Poprad
      Mesto: Poprad
      Zodpovedný skúšajúci: MUDr. Juraj Beniak
  • PROSPEKTÍVNE, RANDOMIZOVANÉ, NEZASLEPENÉ KLINICKÉ SKÚŠANIE FÁZY 2 HODNOTIACE NADRADENOSŤ MONOTERAPIE INOTUZUMAB OZOGAMICÍNOM V POROVNANÍ SO SCHÉMOU ALLR3 PRI INDUKČNEJ LIEČBE DETSKEJ VYSOKORIZIKOVEJ AKÚTNEJ LYMFOBLASTOVEJ LEUKÉMIE Z PREKURZOROVÝCH B-BUNIEK V PRVOM RELAPSE
    Liečivo: INOTUZUMAB OZOGAMICIN
    Diagnóza: Leukémia
    Kód skúšania: 2022-000186-40, B1931036
    Sponzor: Pfizer Inc.
    Kritéria:

    Inclusion Criteria:

    Male or female participants between 1 and <18 years of age.
    Morphologically confirmed diagnosis of first relapse HR BCP ALL; HR first relapse is defined as relapse occurring within 18 to 30 months of original diagnosis of ALL or within 6 months of completion of primary therapy, and lacking any identified very high-risk genetic abnormalities (ie, KMT2A-rearrangements, TCF3-HLF, TCF3-PBX1, hypodiploidy, TP53 alteration)

    CD22-positive ALL as defined by local institution;
    Bone marrow involvement of ≥ 5% leukemic blasts (≥ M2 status).
    Adequate serum chemistry parameters:

    An eGFR in participants 1 to <2 years of age, or eCrCl in those 2 to <18 years of age, ≥30 mL/min using the recommended formula in Section 10.10.2.
    AST and ALT ≤5 × institutional ULN at the time of randomization or pre-cytoreduction/general anesthesia;
    Total bilirubin ≤1.5 × institutional ULN unless the participant has documented Gilbert's syndrome;
    Prior history of thrombosis during corticosteroid use and/or asparaginase are eligible provided the patient receives anti-coagulant prophylaxis per institutional guidelines.
    Cardiac shortening fraction ≥ 30% by echocardiogram or ejection fraction >50% by MUGA.

    Exclusion Criteria

    Any history of prior or ongoing hepatic SOS or prior liver failure [defined as severe acute liver injury with encephalopathy and impaired synthetic function (INR of ≥1.5)].
    Prior allo-HSCT or CAR T-cell therapy.
    Isolated extramedullary leukemia.
    Philadelphia-chromosome positive ALL, ie. BCR-ABL/t(9;22) present.
    Prior therapy with a calicheamicin-conjugated antibody (eg, InO or gemtuzumab ozogamicin).
    Participants with active, uncontrolled bacterial, fungal, or viral infection.


    Otvorené pre nábor: 2022-12-01
    Uzatvorené pre nábor:
    Uzatvorené:

    Pracoviská klinického skúšania:
    1. Názov: Národný ústav detských chorôb, Klinika detskej hematológie a onkológie LF UK a NÚDCH, Limbová 1, Bratislava
      Mesto: Bratislava
      Zodpovedný skúšajúci: prof. MUDr. Kolenová Alexandra, PhD
  • Odslepené, nekontrolované, multicentrické hodnotenie II. fázy s MK-3475 (pembrolizumab) u detí a mladých dospelých s novo diagnostikovaným klasickým Hodgkinovým lymfómom s nedostatočnou (pomalou včasnou) odpoveďou na prvolíniovú chemoterapiu (hodnotenie KEYNOTE 667)
    Liečivo: PEMBROLIZUMAB
    Diagnóza: Hodgkinov lymfóm
    Kód skúšania: 2017-001123-53, MK-3475-667
    Sponzor: Merck Sharp & Dohme LLC
    Kritéria:

    Inclusion Criteria:

    Group 1: Must have newly diagnosed, pathologically confirmed classical Hodgkin Lymphoma (cHL) at Stages IA, IB and IIA without bulky disease. Group 2: Must have newly diagnosed, pathologically confirmed cHL at Stages IIEB, IIIEA,IIIEB, IIIB, IVA and IVB
    Has measurable disease per investigator assessment.
    Male participants are eligible to participate if they agree to the following during the intervention period: refrain from donating sperm plus either be abstinent from heterosexual intercourse as their preferred and usual lifestyle and agree to remain abstinent or must agree to use contraception per protocol unless confirmed to be azoospermic.
    Female participants who are not pregnant or breastfeeding, and who are either not a woman of childbearing potential (WOCBP), or are a WOCBP who agrees to use approved contraception during the intervention period and for at least 120 days after the last dose of study intervention and agrees not to donate eggs (ova, oocytes) to others or freeze/store for her own use for the purpose of reproduction during this period.
    Performance status: Lansky Play-Performance Scale ≥50 for children up to 16 years of age OR Karnofsky score ≥50 for participants ≥ 16 years of age
    Has adequate organ function

    Exclusion Criteria:

    Has undergone solid organ transplant at any time, or prior allogeneic hematopoietic stem cell transplantation within the last 5 years
    WOCBP who has a positive urine pregnancy test within 24 hours before the first dose of study treatment
    Baseline left ventricular ejection fraction value <50% or shortening fraction of <27%
    Has received prior therapy with an anti-Programmed Death (PD)-1, anti-Programmed Death-Ligand 1 (PD-L1), or anti-PD-L2 agent or with an agent directed to another co-inhibitory T-cell receptor or has previously participated in a MSD pembrolizumab (MK-3475) clinical study
    Has received any prior systemic anti-cancer therapy,including investigational agents for current diagnosis before randomization
    Has received a live vaccine or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines are allowed
    Has received an investigational agent or has used an investigational device within 4 weeks prior to study intervention administration
    Has a diagnosis of lymphocyte-predominant Hodgkin Lymphoma (HL)
    Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of pembrolizumab
    Has a known additional malignancy that is progressing or requires active treatment within the past 3 years
    Has radiographically detectable central nervous system metastases and/or carcinomatous meningitis as assessed by local site investigator at the time of diagnosis
    Has severe hypersensitivity (≥Grade 3) to any study therapies including any excipients
    An active autoimmune disease that has required systemic treatment in past 2 years
    Has a history of (non-infectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease
    Has an active infection requiring systemic therapy
    Has a known history of human immunodeficiency virus (HIV) infection
    Has a known history of Hepatitis B or known active Hepatitis C virus infection
    Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the participant's participation for the full duration of the study, or is not in the best interest of the participant to participate, in the opinion of the treating investigator
    Has known psychiatric or substance abuse disorders that would interfere with cooperating with the requirements of the study
    Participants who have not adequately recovered from major surgery or have ongoing surgical complications


    Otvorené pre nábor: 2022-12-02
    Uzatvorené pre nábor: 2023-11-21
    Uzatvorené:

    Pracoviská klinického skúšania:
    1. Názov: Národný ústav detských chorôb, Klinika detskej hematológie a onkológie LF UK a NÚDCH, Limbová 1, Bratislava
      Mesto: Bratislava
      Zodpovedný skúšajúci: MUDr. Hrašková Andrea
  • AD ASTRA (Androgénna Deprivácia s Apalutamidom a STereotaktickou RÁdioterapiou) Prospektívna inštitucionálna štúdia fázy II účinnosti a bezpečnosti androgénnej deprivácie s apalutamidom u pacientov s karcinómom prostaty s vysokým rizikom liečených ultra- hypofrakcionovanou stereotaktickou rádioterapiou.
    Liečivo: Apalutamide
    Diagnóza: Karcinóm prostaty
    Kód skúšania: 2021-006674-22, 56021927PCR2046, AD ASTRA
    Sponzor: Janssen
    Kritéria:

    Principal inclusion criteria
    1. Subject must be a man in the age of 18 – 79 years
    2. Each subject must sign an informed consent form (ICF) indicating that he understands the purpose and procedures required for the study and is willing to participate in the study. Subjects must be willing and able to adhere to the prohibitions and restrictions specified in this protocol
    3. Indicated and planned to receive primary RT for prostate cancer.
    4. Histologically confirmed adenocarcinoma of an intact prostate and one of the following risk factors for EUA high-risk localized or locally prostate cancer (see Attachment 1) 14 at diagnosis:
    • Localized high-risk prostate cancer: PSA >20 ng/ml or GS >7 (ISUP grade 4/5) or cT2c
    • Locally advanced high-risk prostate cancer: cT3 – 4 or cN+, any PSA, any ISUP grade
    5. Modified Charlson comorbidity index (CCI) ≤4 (Attachment 2)
    6. Eastern Cooperative Oncology Group (ECOG) performance status (PS) grade 0 or 1 (Attachment 2)
    7. Adequate organ function determined by the following local laboratory values:
    • Aspartate aminotransferase (AST), alanine aminotransferase (ALT) and bilirubin within normal limits (WNL)
    • Serum creatinine <133 umol/l
    • Thrombocytes ≥140x109/l
    • Hemoglobin ≥120 g/l (no transfusion is allowed within 3 months prior to enrollment)
    8. To avoid risk of drug exposure through the ejaculate (even men with vasectomies), subjects must use a condom during sexual activity while on study drug and for 3 months following the last dose of study drug. Donation of sperm is not allowed during the Treatment Phase and for 3 months following the last dose of study drug.
    9. Be able to swallow whole study drug tablets, undergo prostate MR, prostate seeds implantation and prostate radiotherapy in supine position.

    Principal exclusion criteria
    1. Presence of distant metastasis on conventional imaging or 68Ga PSMA/PET (clinical stage M1). Isolated pelvic nodal disease below the iliac vessels bifurcation (clinical stage N1) is not an exclusion.
    2. Prior treatment with LHRH agonist/antagonist analogue or anti-androgen or both for >3 months prior to enrollment.
    3. Bilateral orchiectomy
    4. History of pelvic radiation
    5. Prior systemic (e.g., chemotherapy) or local (e.g., radical prostatectomy, cryotherapy) treatment for prostate cancer.
    6. Prior treatment with enzalutamide, abiraterone acetate, orteronel, galeterone, ketoconazole, aminoglutethimide, estrogens, megestrol acetate, and progestational agents (including cyproterone acetate) for prostate cancer.
    7. Prior treatment with systemic glucocorticoids ≤4 weeks prior to enrollment or subject expected to require long-term use of corticosteroids during the study.
    8. Use of first-generation antiandrogen (e.g., bicalutamide) ≤4 weeks prior to enrollment.
    9. Use of 5-α reductase inhibitors (e.g., dutasteride, finasteride) ≤4 weeks prior to enrollment.
    10. Use of any investigational agent ≤4 weeks prior to enrollment.
    11. Current chronic use of opioid analgesics, for ≥3 weeks for oral or ≥7 days for non-oral formulations.
    12. Major surgery ≤4 weeks prior to enrollment
    13. History of seizure or any condition that may predispose to seizure (including, but not limited to prior stroke, transient ischemic attack or loss of consciousness ≤1 year prior to enrollment; brain arteriovenous malformation; or intracranial masses such as schwannomas and meningiomas that are causing edema or mass effect).
    14. Current or prior treatment with anti-epileptic medications for the treatment of seizures.
    15. Gastrointestinal conditions affecting absorption.
    16. Known or suspected contraindications or hypersensitivity to apalutamide or LHRH agonists/antagonist or any of the components of the formulations.
    17. Any condition for which, in the opinion of the investigator, participation would not be in the best interest of the subject.


    Otvorené pre nábor: 2022-12-12
    Uzatvorené pre nábor:
    Uzatvorené:

    Pracoviská klinického skúšania:
    1. Názov: Východoslovenský onkologický ústav, a.s., Oddelenie radiačnej onkológie, Rastislavova 43, 041 91 Košice
      Mesto: Košice
      Zodpovedný skúšajúci: Doc. MUDr. PhD. MHA Pavol Dubinský
      Referovať pacienta do klinického skúšania
  • Randomizované, kontrolované, odslepené, multicentrické, inferenčne súvislé skúšanie 2./3. fázy na vyhodnotenie ibrutinibu v kombinácii s rituximabom v porovnaní s lenalidomidom plus rituximabom alebo bortezomibom plus rituximabom podľa voľby lekára u účastníkov s recidivujúcim alebo refraktérnym lymfómom z plášťových buniek
    Liečivo: ibrutinib (JNJ-54179060)
    Diagnóza: Lymfómy
    Kód skúšania: 2022-000364-21, 54179060MCL3004, VEGA
    Sponzor: Janssen-Cilag International NV

    Otvorené pre nábor: 2023-02-02
    Uzatvorené pre nábor:
    Uzatvorené: 2023-05-02

    Pracoviská klinického skúšania:
    1. Názov: Fakultná nemocnica s poliklinikou F. D. Roosevelta, Hematologické oddelenie, Námestie L. Svobodu 1, 975 17 Banská Bystrica
      Mesto: Banská Bystrica
      Zodpovedný skúšajúci: MUDr. Alexander Wild
    2. Názov: FNsP J.A. Reimana Prešov, Ambulancia klinickej onkológie, J. Hollého 14, 081 81 Prešov
      Mesto: Prešov
      Zodpovedný skúšajúci: MUDr. Ľubica Lukáčová
    3. Názov: Národný onkologický ústav, Klinika onkohematológie LFUK a NOÚ, Oddelenie onkohematológie II., Klenová 1, 833 10 Bratislava
      Mesto: Bratislava
      Zodpovedný skúšajúci: MUDr. Andrej Vranovský PhD.
  • RANDOMIZOVANÉ, NEZASLEPENÉ KLINICKÉ SKÚŠANIE FÁZY 2 HODNOTIACE LIEČBU ENKORAFENIBOM A BINIMETINIBOM S PEMBROLIZUMABOM OPROTI NIVOLUMABU A IPILIMUMABU U ÚČASTNÍKOV S MELANÓMOM POZITÍVNYM NA MUTÁCIU V600E/K GÉNU BRAF S PROGRESIOU POČAS ALEBO PO PREDCHÁDZAJÚCEJ LIEČBE ANTI-PD-1
    Liečivo: Encorafenib (PF-07263896), Binimetinib (PF-06811462), Pembrolizumab (Pembrolizumab)
    Diagnóza: Melanóm
    Kód skúšania: 2021-003640-24, C4221023, Portside
    Sponzor: Pfizer Inc.
    Kritéria:

    Inclusion Criteria:

    Male or female participants ≥18 years of age at the time of informed consent.
    Histologically confirmed unresectable (Stage IIIB, IIIC, or IIID) or metastatic (Stage IV) cutaneous melanoma, according to the AJCC 8th edition.
    Documented evidence of a BRAF V600E or V600K mutation.
    Submission of adequate tumor tissue for central laboratory testing of BRAF V600E-mutation and biomarkers is required for all participants during the screening period and prior to randomization.
    Must have received only 1 prior line of systemic therapy for melanoma (either adjuvant therapy or first-line anti-PD-1 monotherapy (ie, nivolumab or pembrolizumab)
    Must have anti-PD-1 resistant disease (primary or secondary) with confirmed disease progression per RECIST v1.1 either during or after receipt of an approved anti-PD-1 monotherapy (ie, nivolumab or pembrolizumab) for melanoma, defined according to the SITC Immunotherapy Resistance Taskforce (Kluger et al, 2020).
    Have at least one measurable lesion per RECIST v1.1.
    ECOG PS of 0-1, and adequate organ and cardiac function, including LVEF ≥50% by cardiac imaging.

    Exclusion Criteria:

    Mucosal or ocular melanoma.
    Diagnosis of immunodeficiency or an active autoimmune disease that required systemic treatment with chronic systemic steroid therapy or any other form of immunosuppressive therapy within the past 2 years.
    Clinically significant cardiovascular diseases.
    History of thromboembolic or cerebrovascular events ≤12 weeks prior to randomization.
    History or current evidence of RVO or current risk factors for RVO.
    Concurrent neuromuscular disorder that is associated with the potential of elevated CK.
    Active bacterial, fungal, or viral infection requiring systemic therapeutic treatment within 2 weeks prior to randomization.
    Current non-infectious pneumonitis/interstitial lung disease or history of noninfectious pneumonitis/interstitial lung disease requiring steroids.
    Prior or current symptomatic brain metastasis, leptomeningeal disease or other active CNS metastases.
    Participants who permanently discontinued prior anti-PD-1 therapy due to toxicity or will be unable to tolerate combination therapy based on investigator judgement are excluded.
    Prior treatment with ipilimumab; prior combined immunotherapy blockade with anti-PD-1/L-1; prior treatment with a BRAFi and/or MEKi; or previous administration of an investigational anti-cancer agent for the adjuvant or first-line treatment of melanoma prior to randomization.


    Otvorené pre nábor: 2023-01-16
    Uzatvorené pre nábor: 2024-05-10
    Uzatvorené:

    Pracoviská klinického skúšania:
    1. Názov: Národný onkologický ústav, II. Onkologická klinika LFUK a NOÚ, Klinika klinickej onkológie SZU a NOÚ, Klenová 1, 833 10 Bratislava
      Mesto: Bratislava
      Zodpovedný skúšajúci: MUDr. Róbert Godál
  • HLAVNÝ PROTOKOL PRE ENKORAFENIB/BINIMETINIB: NEZASLEPENÉ POKRAČOVACIE KLINICKÉ SKÚŠANIE PRE ÚČASTNÍKOV, KTORÍ POKRAČUJÚ Z KLINICKÝCH SKÚŠANÍ ENKORAFENIBU/BINIMETINIBU
    Liečivo: Binimetinib, Encorafenib (PF-07263896)
    Diagnóza: Nádorové ochorenia
    Kód skúšania: 2021-004395-34, C4221026, Master Protocol for Encorafenib/Binimetinib Continuation Sub-Studies (FLOTILLA Study)
    Sponzor: Pfizer Inc.
    Kritéria:

    Inclusion Criteria:

    Any participant who is receiving study intervention and deriving clinical benefit (as determined by the principal investigator) in an encorafenib/binimetinib Parent Study, with no ongoing NCI CTCAE version 4.03 Grade ≥3 or intolerable Grade 2 AEs considered to be related to study treatment.
    Participants must agree to follow the reproductive criteria as outlined in the applicable Encorafenib/Binimetinib Continuation Sub-Study Protocol.

    Exclusion Criteria:

    Any medical reason that, in the opinion of the investigator or sponsor, precludes the participant from inclusion in the study.


    Otvorené pre nábor: 2023-01-16
    Uzatvorené pre nábor: 2023-05-03
    Uzatvorené:

    Pracoviská klinického skúšania:
    1. Názov: Národný onkologický ústav, II. Onkologická klinika LFUK a NOÚ, Klinika klinickej onkológie SZU a NOÚ, Klenová 1, 833 10 Bratislava
      Mesto: Bratislava
      Zodpovedný skúšajúci: MUDr. Tomáš Šálek
  • DVOJITO ZASLEPENÉ, RANDOMIZOVANÉ, PLACEBOM KONTROLOVANÉ KLINICKÉ SKÚŠANIE FÁZY 2 HODNOTIACE BEZPEČNOSŤ, ÚČINNOSŤ A ZNÁŠANLIVOSŤ PONSEGROMABU U ÚČASTNÍKOV S NÁDOROVÝM OCHORENÍM, KACHEXIOU A ZVÝŠENOU HLADINOU GDF-15, NASLEDOVANÉ VOLITEĽNÝM OBDOBÍM NEZASLEPENEJ LIEČBY
    Liečivo: Ponsegromab (PF-06946860)
    Diagnóza: Nádorové ochorenia
    Kód skúšania: 2022-003016-87, C3651003
    Sponzor: Pfizer Inc.
    Kritéria:

    Key Inclusion Criteria:

    Documented active diagnosis of non-small cell lung, pancreatic, colorectal cancer
    Cachexia defined by Fearon criteria of weight loss
    Serum GDF-15 concentrations
    Signed informed consent
    ECOG PS ≤3 with life expectancy of at least 4 months to be able to complete Part A.

    Key Exclusion Criteria:

    Receiving tube feedings or parenteral nutrition at the time of Screening or Randomization.
    Current active reversible causes of decreased food intake.
    Cachexia caused by other reasons.
    History of allergic or anaphylactic reaction to any therapeutic or diagnostic monoclonal antibody.
    inadequate liver function
    renal disease requiring dialysis


    Otvorené pre nábor: 2023-03-13
    Uzatvorené pre nábor: 2023-11-14
    Uzatvorené:

    Pracoviská klinického skúšania:
    1. Názov: Fakultná nemocnica Trnava, Onkologická klinika, ul. A. Žarnova 11, 917 75 Trnava
      Mesto: Trnava
      Zodpovedný skúšajúci: MUDr. PhD. Marian Streško
      Referovať pacienta do klinického skúšania
    2. Názov: Národný onkologický ústav, II. Onkologická klinika LFUK a NOÚ, Klinika klinickej onkológie SZU a NOÚ, Klenová 1, 833 10 Bratislava
      Mesto: Bratislava
      Zodpovedný skúšajúci: MUDr. PhD. Andrea Škripeková
    3. Názov: Nemocnica na okraji mesta n.o., Ambulancia klinickej onkológie, Nová Nemocnica 511, 958 01 Partizánske
      Mesto: Partizánske
      Zodpovedný skúšajúci: MUDr. Alexandra Szabová
      Referovať pacienta do klinického skúšania
    4. Názov: Špecializovaná nemocnica sv. Svorada Zobor, n,o., Oddelenie klinickej onkológie, Kláštorská 134, 949 88 Nitra
      Mesto: Nitra
      Zodpovedný skúšajúci: MUDr. Gabriela Chowaniecová
    5. Názov: Fakultná nemocnica s poliklinikou Nové Zámky, Onkologická ambulancia II, Slovenská ulica 11 A, 940 34 Nové Zámky
      Mesto: Nové Zámky
      Zodpovedný skúšajúci: MUDr. Pavol Demo
    6. Názov: Fakultná nemocnica s poliklinikou F. D. Roosevelta Banská Bystrica , Onkologická klinika SZU, Námestie L.Svobodu 1
      Mesto: Banská Bystrica
      Zodpovedný skúšajúci: MUDr. PhD. Matej Hrnčár
    7. Názov: Univerzitná nemocnica Bratislava – Nemocnica Ružinov, Klinika pneumológie, ftizeológie a funkčnej diagnostiky SZU a UNB, Ružinovská 6
      Mesto: Bratislava
      Zodpovedný skúšajúci: MUDr. Zuzana Šviheľová Lišková
      Referovať pacienta do klinického skúšania
  • Randomizované, placebom kontrolované, dvojito zaslepené, multicentrické klinické skúšanie fázy 3 so selinexorom v udržiavacej liečbe po systémovej liečbe u pacientok s pokročilým alebo recidivujúcim karcinómom endometria p53 „wild-type“
    Liečivo: Selinexor (KPT-330)
    Diagnóza: Karcinóm endometria
    Kód skúšania: 2022-002540-42, XPORT-EC-042, XPORT-EC
    Sponzor: Karyopharm Therapeutics Inc.
    Kritéria:

    Inclusion Criteria:

    At least 18 years of age at the time of signing informed consent.
    Histologically confirmed EC including: endometrioid, serous, undifferentiated, and carcinosarcoma.
    TP53 wt assessed by next generation sequencing (NGS), evaluated by a central vendor.
    Completed a single line, at least 12 weeks of platinum-based therapy (not including adjuvant or neoadjuvant therapy for Stage I-III disease) and achieved confirmed partial or complete response (PR or CR) by imaging, according to RECIST version 1.1. The participants should have received treatment for:
    Primary Stage IV disease, defined as:

    had a primary or later debulking surgery during first-line platinum-based therapy with R0 resection (R0 resection indicates a macroscopic complete resection of all visible tumor) and achieved CR after at least 12 weeks platinum-based therapy, OR
    had a primary or later debulking surgery during first-line platinum-based therapy with R1 resection (R1 resection indicates incomplete removal of all macroscopic disease) and achieved PR or CR after at least 12 weeks platinum-based chemotherapy, OR
    had no surgery and achieved PR or CR after at least 12 weeks platinum-based chemotherapy
    OR

    At first relapse (i.e., relapse after primary therapy including surgery and/or chemotherapy and/or immunotherapy for Stage I-IV disease), defined as:

    had Stage I - III disease at diagnosis and received, at initial diagnosis, adjuvant chemotherapy and relapsed later. Participants should have PR or CR after at least 12 weeks of platinum-based chemotherapy compared with the start of this chemotherapy at the time of relapse,
    had Stage I-III disease at diagnosis and did not receive adjuvant chemotherapy at initial diagnosis and relapsed later. Participants should have PR or CR after at least 12 weeks of platinum-based chemotherapy compared with the start of this chemotherapy at the time of relapse, OR
    had Stage IV disease at diagnosis and received initially chemotherapy with or without surgery and relapsed later. At the time of relapse, participants should have PR or CR after at least 12 weeks of platinum-based chemotherapy compared with the start of this chemotherapy at the time of relapse.

    Previous treatment with anti-programmed cell death protein 1(PD-1) or anti-programmed death-ligand 1(PD-L1) monoclonal antibody and concomitant biologic agents (e.g., bevacizumab, trastuzumab) is allowed.
    Must be able to initiate study drug 3 to 8 weeks after completion of their final dose of chemotherapy.
    Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
    Participants must have adequate bone marrow function and organ function within 2 weeks before starting study drug as defined by the following laboratory criteria:
    Hepatic function: total bilirubin up to less than (<) 3*upper limit of normal (ULN); alanine aminotransferase (ALT) and aspartate aminotransferase (AST) less than or equal to (<=) 2.5*ULN in participants without liver metastasis. For participants with known liver involvement of their tumor: AST and ALT (<=) 5*ULN
    Hematopoietic function within 1 week: Absolute neutrophil count (ANC) greater than or equal to (>=) 1.5*10^9/liter (L); platelet count >= 100*10^9/L; hemoglobin >= 9.0 gram per deciliter (g/dL) per local laboratory results
    Renal function: estimated creatinine clearance (CrCl) of >= 20 milliliter per minute (mL/min), calculated using the standard local formula, as applicable

    - In the opinion of the Investigator, the participant must:

    Have a life expectancy of at least 12 weeks, and
    Be fit to receive investigational therapy

    Premenopausal females of childbearing potential must have a negative pregnancy test (serum β-human chorionic gonadotropin test) prior to the first dose of study drug. Female participants of childbearing potential must agree to use highly effective methods of contraception throughout the study and for 90 days following the last dose of study drug.
    Written informed consent signed in accordance with federal, local, and institutional guidelines prior to the first screening procedure.
    Exclusion Criteria:

    Participants meeting any of the following exclusion criteria are not eligible to enroll in this study:
    Has any uterine sarcomas (carcinosarcomas - not excluded), clear cell or small cell carcinoma with neuroendocrine differentiation
    Received a blood or platelet transfusion during the 2 weeks prior to Cycle 1 Day 1 (C1D1). Participants' hemoglobin must be assessed within 2 weeks of screening and at least 1 week post transfusion
    Concurrent systemic steroid therapy higher than physiologic dose (> 10 milligram per day [mg/day] of prednisone or equivalent). Systemic steroid therapy as pre-medication for taxane is allowed
    Insufficient time since or not recovered from procedures or anti-cancer therapy, defined as:

    Not recovered from major surgery <= 28 days prior to Day 1 dosing. Minor procedures, such as biopsies, dental work, or placement of a port or intravenous (IV) line for infusion are permitted
    Having ongoing clinically significant anti-cancer therapy-related toxicities CTCAE Grade > 1, with the exception of alopecia. In specific cases, participants whose toxicity has stabilized or with Grade 2 non-hematologic toxicities can be allowed following documented approval by the Sponsor's Medical Monitor
    Palliative radiotherapy within 14 days of the intended C1D1. Palliative radiotherapy may be permitted for symptomatic control of pain from bone metastases, provided that the radiotherapy does not involve target lesions, and the reason for the radiotherapy does not reflect evidence of disease progression.
    Any gastrointestinal dysfunctions that could interfere with the absorption of selinexor (e.g., bowel obstruction, inability to swallow tablets, malabsorption syndrome, unresolved nausea, vomiting, diarrhea CTCAE v 5.0 > grade 1).
    Participants unable to tolerate two forms of antiemetics for at least 2 cycles will not be eligible for the trial.
    Active, ongoing or uncontrolled active infection requiring parenteral antibiotics, antivirals, or antifungals within 1 week of screening.
    Serious psychiatric or medical condition that could interfere with participation in the study or in the opinion of the Investigator would make study involvement unreasonably hazardous.
    Previous treatment with an XPO1 inhibitor.
    Stable disease or PD on the post-chemotherapy scan or clinical evidence of progression prior to randomization.
    Participants who received any systemic anticancer therapy including investigational agents <= 3 weeks (or <= 5 half-lives of the drug [whichever is shorter]) prior to C1D1.
    Major injuries or surgery within 14 days prior to C1D1 and/or planned major surgery during the on-treatment study period.
    Other malignant disease with disease-free <= 3 years except: curatively treated carcinoma in situ of the cervix, basal cell carcinoma of the skin, or ductal carcinoma in situ (DCIS) of the breast.
    History of allergic reactions attributed to compounds of similar chemical or biologic composition to selinexor, or other agents used in the study.
    Active brain metastases (e.g., stable for < 8 weeks, no adequate previous treatment with radiotherapy and/or surgery, symptomatic, requiring treatment with anti-convulsant therapy. Corticoid therapy is allowed if administered as stable dose for at least 1 month before randomization).
    Females who are pregnant or lactating.
    Any other life-threatening illness, active medical condition, organ system dysfunction, or serious active psychiatric issue which, in the Investigator's opinion, could compromise the participant's safety or the participant's ability to remain compliant with study procedures.


    Otvorené pre nábor: 2023-04-27
    Uzatvorené pre nábor:
    Uzatvorené:

    Pracoviská klinického skúšania:
    1. Názov: FNsP Trenčín, Onkologické oddelenie, Legionárska 28, 911 71 Trenčín
      Mesto: Trenčín
      Zodpovedný skúšajúci: MUDr. PhD Branislav Bystrický
      Referovať pacienta do klinického skúšania
    2. Názov: Národný onkologický ústav, II. Onkologická klinika LFUK a NOÚ, Klinika klinickej onkológie SZU a NOÚ, Klenová 1, 833 10 Bratislava
      Mesto: Bratislava
      Zodpovedný skúšajúci: MUDr. PhD Jozef Šufliarsky
    3. Názov: Onkologický ústav sv. Alžbety, s.r.o., Interná klinika VŚZ a SP a OÚSA, Heydukova 10, 812 50 Bratislava
      Mesto: Bratislava
      Zodpovedný skúšajúci: MUDr. PhD Marcela Tkáčová
  • Nezaslepené, randomizované skúšanie fázy 3 na posúdenie bezpečnosti a účinnosti epkoritamabu v kombinácii s R-CHOP v porovnaní s R-CHOP u účastníkov s novodiagnostikovaným difúznym veľkobunkovým B-lymfómom (DLBCL)
    Liečivo: Epcoritamab (ABBV-GMAB-3013)
    Diagnóza: Lymfómy
    Kód skúšania: 2021-000168-31, M20-621
    Sponzor: AbbVie Deutschland GmbH & Co. KG
    Kritéria:

    Inclusion Criteria:

    Planned to receive treatment with 6 cycles of standard rituximab, cyclophosphamide, doxorubicin hydrochloride, vincristine, and prednisone (R-CHOP) per investigator determination.
    Must have newly diagnosed, histologically confirmed CD20+ diffuse large b-cell lymphoma [DLBCL] (de novo or histologically transformed from a diagnosis of follicular lymphoma) at most recent representative tumor biopsy based on the pathology report, with a World Health Organization (WHO) 2016 classification and including:

    DLBCL, Not Otherwise Specified (NOS).
    High grade B-cell lymphoma with MYC and BCL-2 and/or BCL-6 rearrangement with DLBCL morphology.
    T-cell/histiocyte-rich large B-cell lymphoma.
    Epstein Barr virus-positive DLBCL, NOS.
    Follicular lymphoma Grade 3b.
    Note: The local pathology report must be available at Screening to support CD20+ DLBCL histology.

    Composite/intermediate histology with any of the following components is not allowed: high grade B-cell lymphoma, NOS; Hodgkin's lymphoma; primary mediastinal (thymic) large B-cell lymphoma; Burkitt; plasmablastic lymphoma or any CD20- lymphoma, such as anaplastic lymphoma kinase-positive large B-cell lymphoma, human herpesvirus type 8-positive DLBCL, or primary effusion lymphoma.

    Availability of archival or freshly collected tumor tissue at Screening. Archival paraffin-embedded tissue must be obtained within 8 weeks prior to Cycle 1 Day 1.
    Must have an IPI score of 2-5. The number of participants with IPI 2 will not exceed approximately 30% of the overall sample size.
    Must have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2 prior to initiating R-CHOP treatment. Note that participant with an initial ECOG performance status >= 3 may be screened if pre-phase treatment is planned. Participant may be eligible if ECOG performance status were to improve to 0-2 during pre-phase treatment.
    Has at least one target lesion defined as:

    >= 1 measurable nodal lesion (long axis > 1.5 cm ) or >= 1 measurable extra-nodal lesion (long axis > 1 cm) on computed tomography (CT) scan or magnetic resonance imaging (MRI). AND
    Positron emission tomography (PET)-positive on PET-CT scan.
    Laboratory values meeting the criteria laid out in the protocol.
    Left ventricular ejection fraction must be >= 50% by multi-gated acquisition or transthoracic echocardiography at Screening.
    Exclusion Criteria:

    History of prior systemic anti-lymphoma therapy for diagnosed diffuse large b-cell lymphoma (DLBCL) including any definitive radiotherapy with curative intent] other than corticosteroids with or without vincristine during prephase treatment, or non-curative intent palliative radiotherapy with the stipulation that radiated lesions cannot be selected as target lesion for response assessment.
    Clinically significant cardiovascular disease as per the protocol.


    Otvorené pre nábor: 2023-04-18
    Uzatvorené pre nábor: 2024-06-27
    Uzatvorené: 2024-06-27

    Pracoviská klinického skúšania:
    1. Názov: Národný onkologický ústav, Klinika onkohematológie LFUK a NOÚ, Oddelenie onkohematológie, Klenová 1, 833 10 Bratislava
      Mesto: Bratislava
      Zodpovedný skúšajúci: MUDr. PhD. Andrej Vranovský
    2. Názov: Univerzitná nemocnica Martin, Klinika hematológie a transfuziológie, Kollárova 2, 036 59 Martin
      Mesto: Martin
      Zodpovedný skúšajúci: doc. MUDr. PhD. Juraj Sokol
  • EMBER-4: Randomizovaná, otvorená štúdia fázy 3 skúmajúca adjuvantný imlunestrant v porovnaní so štandardnou adjuvantnou endokrinnou liečbou u pacientok, ktoré predtým dostávali 2 až 5 rokov adjuvantnú endokrinnú liečbu na ER+, HER2- včasný karcinóm prsníka so zvýšeným rizikom recidívy
    Liečivo: Imlunestrant (LY3484356)
    Diagnóza: Karcinóm prsníka
    Kód skúšania: 2022-501007-28-00, J2J-MC-JZLH, EMBER-4
    Sponzor: Eli Lilly and Company
    Kritéria:

    Inclusion Criteria:

    Have a diagnosis of ER+, HER2- early-stage, resected, invasive breast cancer without evidence of distant metastasis.
    Participants must have received at least 24 months but not more than 60 months of any adjuvant ET, from time of adjuvant ET initiation.
    Participants may have received (neo) adjuvant chemotherapy and/or targeted therapy with a CDK4/6- or PARP- inhibitor.
    Must have an increased risk of disease recurrence based on clinical-pathological risk features.
    Have a Performance Status of 0 or 1 on the Eastern Cooperative Oncology Group scale.
    Have adequate organ function.

    Exclusion Criteria:
    Have any evidence of metastatic disease (including contralateral ALN) or inflammatory breast cancer at primary breast cancer diagnosis.
    Participants with more than a 6-month consecutive gap in therapy during the course of prior adjuvant ET.
    Participants who have completed or discontinued prior adjuvant ET >6 months prior to screening.
    Participants with a history of previous breast cancer are excluded, with the exception of ipsilateral DCIS treated by locoregional therapy alone ≥5 years ago.
    Pregnant, breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the screening visit through 180 days after the last dose of study intervention.
    Participant has previously received ET of any duration for breast cancer prevention (tamoxifen or AIs) or raloxifene.
    Participants with a history of any other cancer.
    Have serious preexisting medical conditions that, in the judgment of the investigator, would preclude participation in this study.


    Otvorené pre nábor: 2023-03-06
    Uzatvorené pre nábor:
    Uzatvorené:

    Pracoviská klinického skúšania:
    1. Názov: Národný onkologický ústav, II. Onkologická klinika LFUK a NOÚ, Klinika klinickej onkológie SZU a NOÚ, Klenová 1, 833 10 Bratislava
      Mesto: Bratislava
      Zodpovedný skúšajúci: prof. MUDr. Michal Mego, DrSc.
      Referovať pacienta do klinického skúšania
    2. Názov: Onkologický ústav sv. Alžbety, s.r.o., Interná klinika VŚZ a SP a OÚSA, Heydukova 10, 812 50 Bratislava
      Mesto: Bratislava
      Zodpovedný skúšajúci: MUDr. Bela Mriňáková, PhD, MPH, MHA
      Referovať pacienta do klinického skúšania
  • RANDOMIZOVANÉ, NEZASLEPENÉ, MULTICENTRICKÉ KLINICKÉ SKÚŠANIE FÁZY 3 HODNOTIACE ARV-471 (PF-07850327) OPROTI FULVESTRANTU U ÚČASTNÍKOV S POKROČILÝM HER-2 NEGATÍVNYM KARCINÓMOM PRSNÍKA POZITÍVNYM NA ESTROGÉNOVÉ RECEPTORY, U KTORÝCH DOŠLO K PROGRESII OCHORENIA PO PREDCHÁDZAJÚCEJ ENDOKRINNEJ LIEČBE POKROČILÉHO OCHORENIA (VERITAC-2)
    Liečivo: ARV-471 (PF-07850327)
    Diagnóza: Karcinóm prsníka
    Kód skúšania: 2022-500544-38-00,C4891001,VERITAC-2
    Sponzor: Pfizer Inc.
    Kritéria:

    Inclusion Criteria:

    Adult participants with loco-regional recurrent or metastatic breast disease not amenable to surgical resection or radiation therapy
    Confirmed diagnosis of ER+/HER2- breast cancer
    Prior therapies for locoregional recurrent or metastatic disease must fulfill all the following criteria:
    One line of CDK4/6 inhibitor therapy in combination with endocrine therapy. Only one line of CDK4/6 inhibitor is allowed in any setting.
    ≤ 1 endocrine therapy in addition to CDK4/6 inhibitor with ET
    Most recent endocrine treatment duration must have been given for ≥6 months prior to disease progression. This may be the endocrine treatment component of the CDK4/6 inhibitor line of therapy.
    Radiological progression during or after the last line of therapy.
    Measurable disease evaluable per Response Evaluation Criterion in Solid Tumors (RECIST) v.1.1 or non-measurable bone-only disease
    Eastern Cooperative Oncology Group (ECOG) performance status 0-1
    Participants should be willing to provide blood and tumor tissue

    Exclusion Criteria:
    Participants with advanced, symptomatic visceral spread, that are at risk of life-threatening complications in the short term
    Prior treatment with:
    ARV-471, fulvestrant, elacestrant, mTOR, PI3K, AKT pathway inhibitors, PARP inhibitor for any setting
    other investigational agents (including novel endocrine therapy any SERDs, SERCAs, CERANs) for any setting
    prior chemotherapy for advanced/metastatic disease
    Inadequate liver, kidney and bone marrow function
    Active brain metastases
    Participants with significant concomitant illness


    Otvorené pre nábor: 2023-05-04
    Uzatvorené pre nábor:
    Uzatvorené:

    Pracoviská klinického skúšania:
    1. Názov: Fakultná nemocnica Trnava, Onkologická klinika, ul. A. Žarnova 11, 917 75 Trnava
      Mesto: Trnava
      Zodpovedný skúšajúci: MUDr. PhD. Marian Streško
      Referovať pacienta do klinického skúšania
    2. Názov: FNsP J.A. Reimana Prešov, Ambulancia klinickej onkológie, J. Hollého 14, 081 81 Prešov
      Mesto: Prešov
      Zodpovedný skúšajúci: MUDr Jaroslava Lešková
      Referovať pacienta do klinického skúšania
    3. Názov: Národný onkologický ústav, II. Onkologická klinika LFUK a NOÚ, Klinika klinickej onkológie SZU a NOÚ, Klenová 1, 833 10 Bratislava
      Mesto: Bratislava
      Zodpovedný skúšajúci: Prof. MUDr. Michal Mego, DrSc.
      Referovať pacienta do klinického skúšania
    4. Názov: Nemocnica na okraji mesta n.o., Ambulancia klinickej onkológie, Nová Nemocnica 511, 958 01 Partizánske
      Mesto: Partizánske
      Zodpovedný skúšajúci: MUDr. Alexandra Szabová
      Referovať pacienta do klinického skúšania
    5. Názov: Nemocnica s poliklinikou Štefana Kukuru Michalovce, a.s., Oddelenie onkológie a radioterapie, Špitálska 2, 071 01 Michalovce
      Mesto: Michalovce
      Zodpovedný skúšajúci: MUDr. Lenka Rušinová
      Referovať pacienta do klinického skúšania
    6. Názov: Onkologický ústav sv. Alžbety, s.r.o., Interná klinika VŚZ a SP a OÚSA, Heydukova 10, 812 50 Bratislava
      Mesto: Bratislava
      Zodpovedný skúšajúci: MUDr. Bela Mriňáková
      Referovať pacienta do klinického skúšania
    7. Názov: Východoslovenský onkologický ústav, a.s., Oddelenie klinickej onkológie, Rastislavova 43, 041 91 Košice
      Mesto: Košice
      Zodpovedný skúšajúci: MUDr. Andrea Cipková, PhD.
  • Randomizované otvorené multicentrické klinické skúšanie fázy III na porovnanie tisagenlekleucelu so štandardnou liečbou u dospelých pacientov s relabujúcim alebo refraktérnym folikulárnym lymfómom
    Liečivo: Tisagenlecleucel
    Diagnóza: Lymfómy
    Kód skúšania: 2023-503452-27-00, CCTL019E2301, LEDA
    Sponzor: Novartis Pharma AG
    Kritéria:

    Inclusion Criteria:

    Age ≥ 18 years at the date of signing the informed consent form.
    Follicular lymphoma grade 1, 2, or 3A confirmed histologically after latest relapse (local assessment).
    Relapsed or refractory disease after a second or later line of systemic therapy including an anti-CD20 antibody and an alkylating agent.
    Disease that is both active on Positron emission tomography (PET) scan (defined as a score of 4 or 5 on the Deauville 5-point scale) and measurable on Computed tomography (CT) scan.
    ECOG performance status of 0, 1 or 2 at screening.
    Adequate hematologic, renal, hepatic and pulmonary organ function at screening.
    Must meet the institutional criteria to undergo leukapheresis (unless historical leukapheresis is available).
    Must be eligible for treatment with the selected standard of care regimen.

    Exclusion Criteria:
    Follicular lymphoma grade 3B or evidence of histologic transformation.
    Prior treatment with anti-CD19 therapy, gene therapy, or adoptive T-cell therapy.
    Active CNS involvement by malignancy.
    Clinically significant active infection, presence of Human immunodeficiency virus (HIV) antibody or active hepatitis B or C.
    Active neurological autoimmune or inflammatory disorders (e.g., Guillain-Barré syndrome).
    Investigational medicinal product within the last 30 days or five half-lives (whichever is longer) prior to randomization.
    Clinically significant cardiovascular conditions such as acute coronary syndrome, significant cardiac arrhythmias, heart failure or decreased LVEF.
    Other protocol defined inclusion/exclusion criteria may apply


    Otvorené pre nábor: 2023-08-22
    Uzatvorené pre nábor:
    Uzatvorené:

    Pracoviská klinického skúšania:
    1. Názov: Národný onkologický ústav, Klinika onkohematológie LFUK a NOÚ, Oddelenie onkohematológie, Klenová 1, 833 10 Bratislava
      Mesto: Bratislava
      Zodpovedný skúšajúci: MUDr. Andrej Vranovský, PhD.
  • Randomizované otvorené klinické skúšanie fázy 3 sledujúce kombináciu XL092 + nivolumabu v porovnaní so sunitinibom u účastníkov s pokročilým alebo metastatickým nesvetlobunkovým karcinómom obličky
    Liečivo: XL092
    Diagnóza: Karcinóm obličky
    Kód skúšania: 2022-501703-27-00, XL092-304, STELLAR-304
    Sponzor: Exelixis Clinical Trials
    Kritéria:

    Inclusion Criteria:
    Histologically confirmed nccRCC that is unresectable, advanced or metastatic. Histologic subtypes including papillary, unclassified, and translocation-associated are allowed. Among the eligible histologic subtypes, sarcomatoid features are allowed.
    Measurable disease according to RECIST v1.1 as determined by the Investigator.
    Available archival tumor biopsy material.
    Recovery to baseline or ≤ Grade 1 per CTCAE v5 from AE(s) related to any prior treatments unless AE(s) are deemed clinically nonsignificant by the Investigator and/or stable on supportive therapy.
    Age 18 years or older on the day of consent.
    Karnofsky Performance Status (KPS) ≥ 70%.
    Adequate organ and marrow function within 14 days prior to randomization.
    Sexually active fertile subjects and their partners must agree to use highly effective methods of contraception.
    Female subjects of childbearing potential must not be pregnant at screening.

    Exclusion Criteria:

    Chromophobe, renal medullary carcinoma, and pure collecting duct histologic subtypes of nccRCC.
    Prior systemic anticancer therapy for unresectable locally advanced or metastatic nccRCC including investigational agents.

    Note: One prior systemic adjuvant therapy, including immune checkpoint inhibitor therapy and excluding sunitinib, is allowed for completely resected RCC and if recurrence occurred at least 6 months after the last dose of adjuvant therapy.
    Radiation therapy for bone metastases within 2 weeks, any other radiation therapy within 4 weeks prior to randomization.
    Known brain metastases or cranial epidural disease unless adequately treated with radiotherapy (including radiosurgery) or surgically removed and stable for at least 4 weeks before randomization.
    Concomitant anticoagulation with oral anticoagulants and platelet inhibitors. Subjects who are receiving oral anticoagulants at the time of screening must be transitioned to LMWH prior to randomization. Subjects who require treatment with platelet inhibitors are not eligible.
    Major surgery (eg, GI surgery, removal or biopsy of brain metastasis) within 8 weeks prior to randomization. Prior laparoscopic nephrectomy within 4 weeks prior to randomization. Minor surgery (eg, simple excision, tooth extraction) within 10 days before randomization. Complete wound healing from major or minor surgery must have occurred at least prior to randomization.

    Note: Fresh tumor biopsies should be performed at least 7 days before randomization. Subjects with clinically relevant ongoing complications from prior surgical procedures, including biopsies, are not eligible.
    Corrected QT interval calculated by the Fridericia formula (QTcF) > 480 ms per electrocardiogram (ECG) within 14 days before randomization.
    Pregnant or lactating females.
    Administration of a live, attenuated vaccine within 30 days before randomization.

    Note: If feasible, approved non-live vaccines for SARS-CoV-2 should be administered at least 2 weeks before randomization


    Otvorené pre nábor: 2023-09-04
    Uzatvorené pre nábor:
    Uzatvorené:

    Pracoviská klinického skúšania:
    1. Názov: Národný onkologický ústav, II. Onkologická klinika LFUK a NOÚ, Klinika klinickej onkológie SZU a NOÚ, Klenová 1, 833 10 Bratislava
      Mesto: Bratislava
      Zodpovedný skúšajúci: Asocc prof. Michal Chovanec, MD., PhD.
    2. Názov: Východoslovenský onkologický ústav, a.s., Oddelenie klinickej onkológie, Rastislavova 43, 041 91 Košice
      Mesto: Košice
      Zodpovedný skúšajúci: MUDr. Monika Žák
    3. Názov: Fakultná nemocnica s poliklinikou F. D. Roosevelta Banská Bystrica , Onkologická klinika SZU, Námestie L.Svobodu 1
      Mesto: Banská Bystrica
      Zodpovedný skúšajúci: MUDr. Matej Hrnčar, PhD.
  • Multicentrické otvorené randomizované klinické skúšanie fázy IIIb hodnotiace znášanlivosť a účinnosť perorálneho asciminibu oproti nilotinibu u pacientov s novodiagnostikovanou chronickou myelocytovou leukémiou s pozitívnym chromozómom Philadelphia v chronickej fáze
    Liečivo: ASCIMINIB (ABL001)
    Diagnóza: Leukémia
    Kód skúšania: 2022-000995-21, CABL001J12302, ASC4START
    Sponzor: Novartis Pharma AG
    Kritéria:

    Inclusion Criteria:

    Patients with CML-CP within 3 months of diagnosis.
    Diagnosis of CML-CP (ELN 2020 criteria) with cytogenetic confirmation of the Philadelphia chromosome

    Documented chronic phase CML will meet all the below criteria Baccarani et al 2013:

    < 15% blasts in peripheral blood and bone marrow,
    < 30% blasts plus promyelocytes in peripheral blood and bone marrow,
    < 20% basophils in the peripheral blood,
    PLT count ≥ 100 x 10^9/L (≥ 100,000/mm3), except treatment induced thrombocytopenia
    No evidence of extramedullary leukemic involvement, with the exception of hepatosplenomegaly.
    Evidence of typical BCR::ABL1 transcript [e14a2 and/or e13a2] which is amenable to standardized RQ-PCR quantification by the central laboratory assessment.
    ECOG performance status of 0 or 1.
    Adequate end organ function as defined by:

    Total bilirubin (TBL) < 3 x ULN; patients with Gilbert's syndrome may only be included if TBL ≤ 3.0 x ULN or direct bilirubin ≤ 1.5 x ULN,
    CrCl ≥ 30 mL/min as calculated using Cockcroft-Gault formula, Serum lipase ≤ 1.5 x ULN. For serum lipase > ULN - ≤ 1.5 x ULN, value must be considered not clinically significant and not associated with risk factors for acute pancreatitis.
    Patients must have the following laboratory values within normal limits or corrected to within normal limits with supplements prior to randomization:

    Potassium (potassium increase of up to 6.0 mmol/L is acceptable if associated with CrCl* ≥ 90 mL/min),
    Total calcium (corrected for serum albumin); (calcium increase of up to 12.5 mg/dl or 3.1 mmol/L is acceptable if associated with CrCl* ≥ 90 mL/min),
    Magnesium (magnesium increase of up to 3.0 mg/dL or 1.23 mmol/L if associated with CrCl* ≥ 90 mL/min),
    For patients with mild to moderate renal impairment (CrCl* ≥ 30 mL/min and <90 mL/min) - potassium, total calcium (corrected for serum albumin) and magnesium should be within normal limits or corrected to within normal limits with supplements prior to randomization.

    CrCl as calculated using Cockcroft-Gault formula.
    Exclusion Criteria:

    Previous treatment of CML with any other anticancer agents including chemotherapy and/or biologic agents or prior stem cell transplant, with the exception of hydroxyurea and/or anagrelide.
    Known cytopathologically confirmed CNS infiltration (in absence of suspicion of CNS involvement, lumbar puncture not required).
    Impaired cardiac function or cardiac repolarization abnormality including but not limited to any one of the following:

    History of myocardial infarction (MI), angina pectoris, coronary artery bypass graft (CABG) within 6 months prior to starting study treatment.
    Clinically significant cardiac arrhythmias (e.g., ventricular tachycardia), complete left bundle branch block, high-grade AV block (e.g., bifascicular block, Mobitz type II and third degree AV block).
    QTcF ≥ 450 ms (male patients), ≥460 ms (female patients) on the average of three serial baseline ECG (using the QTcF formula). If QTcF ≥ 450 ms and electrolytes are not within normal ranges, electrolytes should be corrected and then the patient re-screened for QTcF.
    Long QT syndrome, family history of idiopathic sudden death or congenital long QT syndrome, or any of the following:
    Risk factors for Torsades de Pointes (TdP) including uncorrected hypokalemia or hypomagnesemia, history of cardiac failure, or history of clinically significant/symptomatic bradycardia.
    Concomitant medication(s) with a "Known risk of Torsades de Pointes" per www.crediblemeds.org that cannot be discontinued or replaced 7 days prior to starting study drug by safe alternative medication.
    Inability to determine the QTcF interval.
    Severe and/or uncontrolled concurrent medical disease that in the opinion of the Investigator could cause unacceptable safety risks or compromise compliance with the protocol (e.g. uncontrolled diabetes, active or uncontrolled infection; uncontrolled arterial or pulmonary hypertension, uncontrolled clinically significant hyperlipidemia).
    History of significant congenital or acquired bleeding disorder unrelated to cancer.
    Major surgery within 4 weeks prior to study entry or patients who have not recovered from prior surgery.
    History of other active malignancy within 3 years prior to study entry with the exception of previous or concomitant basal cell skin cancer and previous carcinoma in situ treated curatively.
    History of acute pancreatitis within 1 year prior to randomization or medical history of chronic pancreatitis.
    History of chronic liver disease leading to severe hepatic impairment, or ongoing acute liver disease.
    Known history of chronic Hepatitis B (HBV), or chronic Hepatitis C (HCV) infection. Testing for Hepatitis B surface antigen (HBs Ag) and Hepatitis B core antibody (HBc Ab/anti HBc) will be performed at screening. If anti-HBc is positive, HBV-DNA evaluation will be carried out at screening. A patient having positive HBV-DNA will not be enrolled in the study. Also, a patient with positive HBsAg will not be enrolled in the study. HCV Ab testing will also be performed at screening. For details on the criteria see Appendix 4.
    History of Human Immunodeficiency Virus (HIV) unless well-controlled on a stable dose of anti-retroviral therapy at the time of screening.
    Other protocol-defined Inclusion/exclusion criteria will apply.


    Otvorené pre nábor: 2022-11-07
    Uzatvorené pre nábor: 2024-06-11
    Uzatvorené:

    Pracoviská klinického skúšania:
    1. Názov: Univerzitná nemocnica Bratislava, Nemocnica sv. Cyrila a Metoda, Klinika hematológie a trasfuziológie LF UK SZU a UNB, Antolská 11, 851 07, Bratislava
      Mesto: Bratislava
      Zodpovedný skúšajúci: MUDr. PhD. Zuzana Sninská
    2. Názov: Univerzitná nemocnica L. Pasteura, Klinika hematológie a onkohematológie, Rastislavova 43, Pracovisko Trieda SNP 1, 041 66 Košice
      Mesto: Košice
      Zodpovedný skúšajúci: MUDr. PhD. Tomáš Guman
  • Medzinárodné prospektívne otvorené multicentrické randomizované klinické skúšanie fázy III, porovnávajúce lutécium (177Lu) vipivotid tetraxetán (AAA617) s observáciou na oddialenie kastrácie alebo recidívy choroby u dospelých mužských pacientov s oligometastatickým karcinómom prostaty (OMPC) pozitívnym na prostatický špecifický membránový antigén (PSMA)
    Liečivo: AAA617
    Diagnóza: Karcinóm prostaty
    Kód skúšania: 2022-502956-29-00, CAAA617D12302, PSMA DC
    Sponzor: Novartis Pharma AG
    Kritéria:

    Inclusion Criteria:

    Signed informed consent must be obtained prior to participation in the study
    Participants must be adults ≥18 years of age at the time of informed consent
    ECOG performance status of 0 or 1 at screening
    Participants must have a life expectancy ≥24 months as determined by the Investigator at screening
    Histologically confirmed prostate cancer prior to randomization
    Participants must have biochemically recurrent disease after definitive treatment to prostate by RP, (alone or with post-operative radiation to prostate bed/pelvic nodes) or XRT, (prostate alone or prostate with seminal vesicle and/or pelvic nodes) and/or brachytherapy prior to randomization. Biochemical recurrence is defined as: nadir PSA + 2 ng/mL post XRT (if participant received-radiation therapy to intact prostate) and PSA > 0.2 ng/mL and rising post RP (with or without post-operation RT)
    Participants must have OMPC with ≤5 PSMA-positive metastatic lesions on screening PSMA PET/CT scan (with either gallium (68Ga) gozetotide or piflufolastat (18F)) as visually assessed by BIRC based on the methodology proposed in the Prostate Cancer Molecular Imaging Standardized Evaluation (PROMISE) (Eiber et al 2018); for further details, please refer to Section 8.1 and Imaging Manual. Metastatic lesions may include regional/pelvic lymph nodes (N1), distant lymph nodes (M1a), bone (M1b), lung and others visceral (M1c) except liver and brain classified using AJCC 8. When counting the number of oligometastatic lesions, each lesion is counted as distinct metastasis irrespective of its anatomical location (e.g., one pelvic and one extra-pelvic lymph node will be counted as two metastatic lesions)
    At least 1 PSMA-positive lesion should be a distant metastasis (M1) per AJCC8 classification at screening. For AJCC M staging, PSMA PET information should be used
    Participants must have a negative conventional imaging for M1 disease at screening. Note:

    For a participant not to be eligible, CI positive M1 lesions should be unequivocal in CI scans, i.e., potentially not attributable to findings thought to represent something other than tumor (e.g., degenerative, or post-traumatic changes or Paget's disease in bone lesions).
    Prior knowledge of PSMA PET positivity should not influence the radiologist (reader) in determination of CI positivity. Two different readers will be involved, one reader for PSMA PET scan and one reader for CI: Reader will be blinded to PSMA PET scan results while reading CI scans. Readers should not modify their assessment of CI scans (e.g. changing a lesion previously identified as equivocal in CI to unequivocal) after reading the PSMA PET scan. Similarly, biopsy positivity should not influence the reader in the assessment of CI positivity. More details on the reading paradigm will be provided in the imaging charter.
    MRI for radiation treatment planning may show M1 disease but this will not exclude the participant from the study if the lesion is deemed negative per baseline CT or bone scans.
    Participants with pelvic disease (N1) seen in conventional imaging are allowed if the local spread is below common iliac bifurcation (per AJCC 8 definition of local disease).
    Distant lymph node disease (M1a) that is visible per CI and less than 10mm in the short axis are not exclusionary irrespective of PSMA PET positivity.
    All metastatic lesions detected at screening should be amenable to SBRT
    If participants previously received SBRT for OMPC, progressive disease must be demonstrated prior to randomization (e.g., a new PSMA PET lesion). Previously treated lesions must be stable in baseline imaging scans and will not be counted towards 1-5 lesions required in this study. If a previously treated lesion was unequivocal for M1 by bone scan or CT before the previous SBRT, the participant is not eligible.
    Confirmation of Controlled primary tumor at screening: If local recurrence is suspected, MRI is required to rule out local relapse. Participants with MRI or PET positive local lesions require biopsy to rule out local progression. These locally recurrent participants (with biopsy proven local disease or with MRI or PET positive local lesions without biopsy) may be eligible for the study after salvage therapy to local disease. Note: Participants who previously undergone pelvic RT (salvage pelvic RT) at local recurrence after RP are allowed in the study.
    PSADT <10 months at screening [PSADT will be calculated using a linear regression model of the normal logarithm of PSA and time (Pound et al 1999)]
    Non-castration testosterone level >100 ng/dL at screening
    Human immunodeficiency virus (HIV)-infected participants at screening and during the study who are healthy and have a low risk of acquired immune deficiency syndrome (AIDS)-related outcomes can participate in this trial
    Participants must have adequate organ functions including the following laboratory values at the screening visit:
    Bone marrow reserve

    ANC ≥1.5 x 109/L
    Platelets ≥100 x 109/L
    Hemoglobin ≥9 g/dL Hepatic
    Total bilirubin (TBIL) ≤2 x the institutional upper limit of normal (ULN). For participants with known Gilbert's Syndrome ≤3 x ULN is permitted
    Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≤3.0 x ULN.
    Albumin ≥2.5 g/dL Renal
    eGFR ≥ 60mL/min/1.73m2 using the Modification of Diet in Renal Disease (MDRD) equation
    Exclusion Criteria:

    Participants with de novo OMPC at screening
    Unmanageable concurrent bladder outflow obstruction or urinary incontinence at screening. Note: participants with bladder outflow obstruction or urinary incontinence, which is manageable and controlled with best available standard of care (incl. pads, drainage) are allowed
    Prior therapy with:

    ADT including bilateral orchiectomy

    Participants who had XRT or RP and completed adjuvant ADT (or ADT+ Androgen Receptor Pathway Inhibitor (ARPI)) prior to recurrence are eligible to participate if the last dose of ADT (or ADT+ARPI) was before 12 months from randomization
    Participants who discontinued ADT due to disease progression are not allowed (i.e., CRPC participants)
    Other hormonal therapy. e.g.,

    Use of estrogens, 5-α reductase inhibitors (finasteride, dutasteride), other steroidogenesis inhibitors (aminoglutethamide)
    First-generation anti-androgens (bicalutamide, flutamide, nilutamide, cyproterone).
    Second generation anti-androgens (e.g., enzalutamide, apalutamide and darolutamide)
    CYP17 inhibitors (e.g., abiraterone acetate, orteronel, galeterone, ketoconazole). Short term ketoconazole treatment (<28 days) is permitted.
    Radiopharmaceutical agents (e.g., Strontium-89, PSMA-targeted radioligand therapy)
    Immunotherapy (e.g., sipuleucel-T)
    Chemotherapy, except if administered in the adjuvant/neoadjuvant setting completed > 12 months before randomization
    Any other investigational or systemic agents for metastatic disease
    Herbal and non-herbal products that may decrease PSA levels (i.e., saw palmetto, pomegranate juice) within 28 days before randomization
    Use of other investigational drugs within 28 days prior to day of randomization
    Radiation therapy, external beam radiation therapy (EBRT), and brachytherapy within 28 days before randomization
    Systemic (oral/i.v./Intramuscular (IM)) corticosteroids within 28 days before randomization. Note: Short term use (≤ 4 weeks) of corticosteroids during the study is allowed if clinically indicated
    Concurrent cytotoxic chemotherapy, immunotherapy, radioligand therapy, hormonal therapy (see ADT initiation guidance in Section 6.8.2), PARP inhibitor, biological therapy, or investigational therapy
    Known hypersensitivity to any of the study treatments or its excipients or to drugs of similar chemical classes
    Transfusion during screening procedures for the sole purpose of making a participant eligible for study inclusion
    Diagnosed at screening with other malignancies that are expected to alter life expectancy or may interfere with disease assessment. However, participants with a prior history of malignancy that has been adequately treated and who have been disease/treatment free for more than 3 years are eligible, as are participants with adequately treated non-melanoma skin cancer and superficial bladder cancer
    Concurrent serious (as determined by the Investigator) medical conditions, including, but not limited to, uncontrolled infection, known active hepatitis B or C, or other significant co-morbid conditions that in the opinion of the Investigator would impair study participation or cooperation. Participants with an active documented COVID-19 infection (any grade of disease severity) at time of informed consent may be included only when completely recovered (in accordance with local guidance)
    History or current diagnosis of ECG abnormalities indicating significant risk of safety for participants participating in the study such as:

    Concomitant clinically significant cardiac arrhythmias, e.g. sustained ventricular tachycardia, and clinically significant second- or third-degree AV block without a pacemaker
    History of familial long QT syndrome or known family history of Torsades de Pointe
    Resting heart rate (physical exam or 12 lead ECG) <60 bpm
    History of somatic or psychiatric disease/condition that may interfere with the objectives and assessments of the study
    Any condition that precludes raised arms position
    Sexually active males unwilling to use a condom during intercourse


    Otvorené pre nábor:
    Uzatvorené pre nábor:
    Uzatvorené:

    Pracoviská klinického skúšania:
    1. Názov: Národný onkologický ústav, II. Onkologická klinika LFUK a NOÚ, Klinika klinickej onkológie SZU a NOÚ, Klenová 1, 833 10 Bratislava
      Mesto: Bratislava
      Zodpovedný skúšajúci: Prof., MUDr., DrSc. Michal Mego
      Referovať pacienta do klinického skúšania
    2. Názov: PRIVÁTNA UROLOGICKÁ AMBULANCIA s.r.o., Piaristická 7834/19, 911 01 Trenčín
      Mesto: Trenčín
      Zodpovedný skúšajúci: MUDr. Roman Sokol, PhD., MPH
    3. Názov: UROEXAM, spol. s.r.o., Urologická ambulancia, Špitálska 13, 949 01 Nitra
      Mesto: Nitra
      Zodpovedný skúšajúci: MUDr. Marek Brezovský, PhD.
  • RANDOMIZOVANÉ, NEZASLEPENÉ, MULTICENTRICKÉ KLINICKÉ SKÚŠANIE FÁZY 3 HODNOTIACE ARV-471 (PF[1]07850327) S PALBOCIKLIBOM OPROTI LETROZOLU S PALBOCIKLIBOM PRI LIEČBE ÚČASTNÍKOV S HER2- NEGATÍVNYM KARCINÓMOM PRSNÍKA POZITÍVNYM NA ESTROGÉNOVÉ RECEPTORY, KTORÍ NEDOSTÁVALI ŽIADNU PREDCHÁDZAJÚCU SYSTÉMOVÚ PROTINÁDOROVÚ LIEČBU POKROČILÉHO OCHORENIA (VERITAC-3)
    Liečivo: ARV-471 (PF-07850327) Vepdegestrant
    Diagnóza: Karcinóm prsníka
    Kód skúšania: 2022-500545-24-00, C4891002, VERITAC-3
    Sponzor: Pfizer Inc.
    Kritéria:

    Inclusion Criteria:

    Adult participants with loco-regional recurrent or metastatic disease not amenable to curative treatment
    Confirmed diagnosis of ER+/HER2- breast cancer
    No prior systemic treatment for loco-regional recurrent or metastatic disease
    Measurable disease evaluable per Response Evaluation Criterion in Solid Tumors (RECIST) v.1.1 or non-measurable bone-only disease
    Eastern Cooperative Oncology Group (ECOG) performance status 0-2
    Phase 3 only: Participants should be willing to provide blood and tumor tissue
    Exclusion Criteria:

    Disease recurrence while on, or within 12 months of completion of adjuvant endocrine therapy
    Prior treatment with cyclin dependent kinase 4/6 inhibitors (CDK4/6i), fulvestrant, elacestrant and other investigational drugs including novel endocrine therapies, any selective estrogen receptor degraders (SERDs), covalent antagonists (SERCAs) and complete ER antagonists (CERANs).
    Inadequate liver, kidney and bone marrow function
    Impaired cardiovascular function or clinically significant cardiovascular diseases
    Refractory nausea and vomiting, inability to swallow capsules and tablets whole, chronic gastrointestinal diseases, significant gastric (total or partial) or bowel resection that would preclude adequate absorption of study interventions.
    Current use or anticipated need for food, herbal supplements or drugs that are known strong CYP3A4 inhibitors or inducers.


    Otvorené pre nábor:
    Uzatvorené pre nábor: 2024-06-21
    Uzatvorené:

    Pracoviská klinického skúšania:
    1. Názov: FNsP J.A. Reimana Prešov, Ambulancia klinickej onkológie, J. Hollého 14, 081 81 Prešov
      Mesto: Prešov
      Zodpovedný skúšajúci: MUDr.Jaroslava Lešková, PhD.
      Referovať pacienta do klinického skúšania
    2. Názov: Nemocnica na okraji mesta n.o., Ambulancia klinickej onkológie, Nová Nemocnica 511, 958 01 Partizánske
      Mesto: Partizánske
      Zodpovedný skúšajúci: MUDr. Alexandra Szabová
      Referovať pacienta do klinického skúšania
  • HR-NBL2 Vysokoriziková neuroblastómová štúdia 2.0 SIOP-Europe-Neuroblastoma/SIOPEN Randomizovaná, medzinárodná, multicentrická štúdia fázy 3, ktorá hodnotí a porovnáva 2 liečebné stratégie v 3 liečebných fázach (indukčná, vysokodávková chemoterapia a rádioterapia) u pacientov s vysokorizikovým neuroblastómom
    Liečivo: NA (chemotherapies and radiotherapy)
    Diagnóza: Nádorové ochorenia
    Kód skúšania: 2019-001068-31, 2019/2894, HRNBL2, SIOPEN
    Sponzor: Gustave Roussy, Cancer Campus, Grand Paris
    Kritéria:

    Inclusion Criteria:
    At diagnosis (or up to 21 days after one cycle of chemotherapy for patients with localized neuroblastoma with MYCN amplification).
    R-I eligibility criteria:
    Established diagnosis of neuroblastoma according to the SIOPEN-modified International Neuroblastoma Risk Group (INRG) criteria, High-risk neuroblastoma defined as:
    Stage M neuroblastoma above 365 days of age at diagnosis (no upper age limit) and Ms neuroblastoma 12-18 months old, any MYCN status* or
    L2, M or Ms neuroblastoma any age with MYCN amplification or focal high level MYC or MYCL amplification * In Germany, patients aged less than 18 months with stage M and without MYCN amplification will not be enrolled in HR-NBL2 trial.
    No previous chemotherapy or up to 21days one cycle of chemotherapy for patients with localized neuroblastoma with MYCN amplification or patients with metastatic neuroblastoma treated in emergency
    Females of childbearing potential must have a negative serum or urine pregnancy test within 7 days prior to initiation of treatment. Sexually active patients must agree to use acceptable and appropriate contraception while on HRNBL2 study drug and for one year after stopping the study . Acceptable contraception is defined in CTFG Guidelines "Recommendations related to contraception and pregnancy testing in clinical trials". Female patients who are lactating must agree to stop breast-feeding.
    Written informed consent to enter the R-I randomization from patient or parents/legal representative, patient, and age-appropriate assent.
    Patient affiliated to a social security regimen or beneficiary of the same according to local requirements.
    Patients should be able and willing to comply with study visits and procedures as per protocol.
    In case of parents'/patient's refusal to R-I, or organ toxicity, exclusion criteria at diagnosis, patients can still be enrolled in HR-NBL2 trial with parents'/patient's consent within 3 weeks from the beginning of chemotherapy. Patients will be treated with the standard induction regimen per country (rapid COJEC or GPOH) and will be potentially eligible for subsequent randomizations.

    Randomization for HDC strategy will be performed at the end of induction after the disease evaluation and after surgery of the primary tumor for those patients who will receive surgery before HDC.

    R-HDC eligibility criteria:

    - Stage M neuroblastoma above 365 days of age at diagnosis, any MYCN status, EXCEPT patients with stage M or Ms 12-18 months old with numerical chromosomal alterations only, and in complete metastatic response at the end of induction: in this case, patients will have surgery but will not be eligible for R-HDC and will not be able to pursue the trial.

    OR

    - L2, M or Ms neuroblastoma any age with MYCN amplification or focal high level MYC or MYCL amplification

    Age < 21 years
    Complete response (CR) or partial response (PR) at metastatic sites:

    Bone disease: MIBG uptake (or FDG-PET uptake for MIBG-nonavid tumors) completely resolved or SIOPEN score ≤ 3 and at least 50% reduction in mIBG score (or ≤ 3 bone lesions and at least 50% reduction in number of FDG-PET-avid bone lesions for MIBG-nonavid tumors).
    Bone marrow disease: CR and/or minimal disease (MD) according to International Neuroblastoma Response Criteria [Park JR, JCO 2017; Burchill S, Cancer 2017].
    Other metastatic sites: complete response after induction chemotherapy +/- surgery.
    Acceptable organ function and performance status

    Performance status ≥ 50%.
    Hematological status: ANC > 0.5x10^9/L, platelets > 20x 10^9/L
    Cardiac function (< grade 2)
    Normal chest X-ray and oxygen saturation.
    Absence of any toxicity ≥ grade 3.
    Sufficient collected stem cells available; minimum required: 6 x 10^6 CD34+ cells/kg body weight stored in 3 separate fractions.
    Written informed consent, including agreement of patient or parents/legal guardian for minors, to enter the R-HDC randomization.
    Patient affiliated to a social security regimen or beneficiary of the same according to local requirements.
    Patients should be able and willing to comply with study visits and procedures as per protocol.
    In case of parents'/patient's refusal, or insufficient stem cells, collection for tandem HDC but with a minimum of 3 x 10^6 CD34+ cells/kg body weight, or in case of patients older than 21 years, or organ toxicity, HDC will consist on the standard HD Bu-Mel and will be eligible for subsequent randomization.

    An evaluation of the local disease will be performed after HDC/ASCR and surgery:

    In case of no local macroscopic disease, all patients will receive 21-Gy radiotherapy to the pre-operative tumor bed
    In case of local macroscopic residual disease, patients will be eligible to R-RTx if the following criteria are met:

    No evidence of disease progression after HDC/ASCR.
    Interval between the last ASCR and radiotherapy start between 60 and 90 days.
    Performance status greater or equal 50%.
    Hematological status: ANC > 0.5x10^9/L, platelets > 20x10^9/L.
    Written informed consent, including agreement of patient or parents/legal guardian for minors, to enter the R-RTx randomization.
    Patient affiliated to a social security regimen or beneficiary of the same according to local requirements.
    Patients should be able and willing to comply with study visits and procedures as per protocol.
    In case of parents'/patient's refusal of the randomization, the patient will receive 21.6 Gy radiotherapy to the pre-operative tumor bed

    Exclusion Criteria:

    Non-inclusion criteria specific to the R-I randomization (RAPID COJEC/GPOH) :

    Urinary tract obstruction ≥ grade 3
    Heart failure or myocarditis ≥ grade 2, any arrhythmia or myocardial infection
    Peripheral motor or sensory neuropathy ≥ grade 3
    demyelinating form of Charcot-Marie-Tooth syndrome
    hearing impairment ≥ grade 2
    Concurrent prophylactic use of phenytoin
    cardiorespiratory disease that contraindicates hyperhydration
    Non-inclusion criteria common to all randomizations (R-I, R-HDC and R-RTx) :

    Any negative answer concerning the inclusion criteria of R-I or R-HDC or R-RTx will render the patient ineligible for the corresponding therapy phase randomization. However, these patients may remain on study and be considered to receive standard treatment of the respective therapy phase, and may be potentially eligible for subsequent randomizations.
    Liver function: Alanine aminotransferase (ALT) > 3.0 x ULN and blood bilirubin > 1.5 x ULN (toxicity ≥ grade 2). In case of toxicity ≥ grade 2, call national principal investigator study coordinator to discuss the feasibility.
    Renal function: Creatinine clearance and/or GFR < 60 ml/min/1.73m^2 (toxicity ≥ grade 2). If GFR < 60 ml/min/1.73m^2, call national principal investigator to discuss about the treatment
    Dyspnea at rest and/or pulse oximetry < 95% in air.
    Any uncontrolled intercurrent illness or infection that in the investigator opinion would impair study participation.
    Patient under guardianship or deprived of his liberty by a judicial or administrative decision or incapable of giving his consent.
    Participating in another clinical study with an IMP while on study treatment.
    Concomitant use with yellow fever vaccine and with live virus or bacterial vaccines.
    Patient allergic to peanut or soya.
    Chronic inflammatory bowel disease and/or bowel obstruction.
    Pregnant or breastfeeding women.
    Known hypersensitivity to the active substance or to any of the excipients of study drugs known
    Concomitant use with St John's Wort (Hypericum Perforatum).
    Non-inclusion criteria to R-HDC:

    Patients with insufficient metastatic response at the end of induction SIOPEN score > 3 or less than 50% reduction in mIBG score or > 3 bone lesions or less 50% reduction in number of FDG-PET-avid bone lesions for mIBG-non avid tumours, will not be eligible for RHDC


    Otvorené pre nábor: 2023-05-22
    Uzatvorené pre nábor:
    Uzatvorené:

    Pracoviská klinického skúšania:
    1. Názov: Detská fakultná nemocnica Košice, Oddelenie detskej onkológie a hematológie, Trieda SNP 1, Košice
      Mesto: Košice
      Zodpovedný skúšajúci: MUDr. Viktória Halušková
    2. Názov: Detská fakultná nemocnica s poliklinikou Banská Bystrica, Klinika pediatrickej onkológie a hematológie SZU, Námestie L. Svobodu 4, Banská Bystrica
      Mesto: Banská Bystrica
      Zodpovedný skúšajúci: MUDr. Pavel Bician
    3. Názov: Národný ústav detských chorôb, Klinika detskej hematológie a onkológie LF UK a NÚDCH, Limbová 1, Bratislava
      Mesto: Bratislava
      Zodpovedný skúšajúci: MUDr. Monika Achbergerová
  • Randomizované, odslepené skúšanie 3. fázy porovnávajuce MK-5684 s alternatívnou liečbou abiraterón acetátom alebo enzalutamidom u účastníkov s metastatickým kastračne rezistentným karcinómom prostaty (mCRPC), u ktorého došlo k progresii počas predchádzajúcej liečby jedným druhom nového hormonálneho lieku (NHA) alebo po nej
    Liečivo: MK-5684
    Diagnóza: Karcinóm prostaty
    Kód skúšania: 2023-504957-11, MK-5684-004
    Sponzor: MSD Sharp & Dohme GmbH, Germany
    Kritéria:

    Inclusion Criteria:

    The main inclusion criteria include but are not limited to the following:

    Have histologically or cytologically confirmed adenocarcinoma of the prostate without small cell histology
    Has current evidence of metastatic disease documented by either bone lesions on bone scan and/or soft tissue disease shown by computed tomography scan (CT)/magnetic resonance imaging (MRI)
    Has prostate cancer progression while receiving androgen deprivation therapy (ADT) (or post bilateral orchiectomy) within 6 months before Screening
    Has disease that progressed during or after treatment with one next-generation hormonal agent (NHA) for hormone sensitive prostate cancer (HSPC) metastatic hormone sensitive prostate cancer (mHSPC) or non metastatic hormone sensitive prostate cancer (nmHSPC), for at least 8 weeks (at least 14 weeks for participants with bone progression) Note: Participants may have received abiraterone acetate and docetaxel or darolutamide and docetaxel for HSPC. However, participants must have received no more than six cycles of docetaxel and had no radiographic disease progression while receiving docetaxel
    Has an eastern clinical oncology group (ECOG) performance status of 0 or 1 assessed within 7 days before randomization
    Has ongoing androgen deprivation with serum testosterone <50 ng/dL (<1.7 nM)
    Has had prior treatment with Poly polymerase inhibitors (PARPi) or were deemed ineligible to receive treatment by the investigator or have refused PARPi treatment
    Has adequate organ function
    Has provided tumor tissue from a fresh core or excisional biopsy from soft tissue not previously irradiated. Samples from tumors progressing at a prior site of radiation are allowed
    Participants who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks and have undetectable HBV viral load before randomization.
    Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at Screening
    Participants who have adverse event (AEs) due to previous anticancer therapies must have recovered to ≤Grade 1 or baseline. Participants with endocrine-related AEs who are adequately treated with hormone replacement therapy (HRT) or participants who have ≤Grade 2 neuropathy are eligible
    Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy (ART)
    Exclusion Criteria:

    The main exclusion criteria include but are not limited to the following:

    Has presence of gastrointestinal condition
    Is unable to swallow capsules/tablets
    Has history of pituitary dysfunction
    Has poorly controlled diabetes mellitus
    Has active or unstable cardio/cerebro-vascular disease, including thromboembolic events
    Has clinically significant abnormal serum potassium or sodium level. Has any of the following at Screening Visit: Hypotension: systolic BP <110 mmHg, or Uncontrolled hypertension: systolic BP ≥160mmHg or diastolic BP ≥90 mmHg, in 2 out of 3 recordings with optimized antihypertensive therapy
    History or family history of long QTc syndrome
    Has a history of seizure(s) within 6 months prior to signing the IC or has any condition that may predispose to seizure within 12 months prior to the date of enrollment
    Has a history of clinically significant ventricular arrhythmias or Mobitz II second degree or third-degree heart block without a permanent pacemaker in place
    Has received a taxane-based chemotherapy and or NHA for metastatic castration-resistant prostate cancer (mCRPC)
    Has not adequately recovered from major surgery or have ongoing surgical complications
    Has received prior treatment with radium for prostate cancer
    Is currently being treated with Cytochrome P450 (CYP450)-inducing antiepileptic drugs for seizures
    Participants on an unstable dose of thyroid hormone therapy within 6 months before the start of the study intervention
    Receives prior radiotherapy within 2 weeks before the first dose of study intervention, or radiation-related toxicities, requiring corticosteroids
    Receives prior systemic anticancer therapy including investigational agents within 4 weeks before the first dose of study intervention
    Has systemic use of strong Cytochrome P450 3A4 (CYP3A4) inducers and P-glycoprotein (P-gp) inhibitors within 2 weeks before the first dose of study intervention
    Has received prior targeted small molecule therapy or NHA treatment within 4 weeks before the first dose of study intervention
    Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention
    Has received an investigational agent or has used an investigational device within 4 weeks prior to study intervention administration
    Has known hypersensitivity to the components or excipients in abiraterone acetate, prednisone or prednisolone, or enzalutamide
    Has a "superscan" bone scan defined as an intense symmetric activity in the bones and diminished renal parenchymal activity on baseline bone scan such that the presence of additional metastases in the future could not be evaluated
    Has known additional malignancy that is progressing or has required active treatment within the past 3 years
    Diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior the first dose of study medication
    Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are radiologically stable, (ie, without evidence of progression) for at least 4 weeks as confirmed by repeat imaging performed during study screening, are clinically stable and have not required steroid treatment for at least 14 days prior to the first dose of study intervention
    Has active autoimmune disease that has required systemic treatment in the past 2 years. Replacement therapy is allowed
    Active infection requiring systemic therapy
    Has concurrent active Hepatitis B virus and Hepatitis C virus infection


    Otvorené pre nábor:
    Uzatvorené pre nábor:
    Uzatvorené:

    Pracoviská klinického skúšania:
    1. Názov: Národný onkologický ústav, II. Onkologická klinika LFUK a NOÚ, Klinika klinickej onkológie SZU a NOÚ, Klenová 1, 833 10 Bratislava
      Mesto: Bratislava
      Zodpovedný skúšajúci: prof. MUDr. Michal Mego, DrSc.
      Referovať pacienta do klinického skúšania
    2. Názov: Privátna Urologická Ambulancia s.r.o., Piaristická ul č. 8, 911 01 Trenčín
      Mesto: Trenčín
      Zodpovedný skúšajúci: MUDr. MPH Roman Sokol
    3. Názov: UROEXAM, spol. s.r.o., Urologická ambulancia, Špitálska 13, 949 01 Nitra
      Mesto: Nitra
      Zodpovedný skúšajúci: MUDr. Marek Brezovský
  • Randomizované, dvojito zaslepené, placebom a aktívnym komparátorom kontrolované klinické skúšanie fázy 3,skúmajúce V940 (mRNA-4157) s pembrolizumabom v adjuvancii oproti placebu s pemprolizumabom v adjuvancii u pacientov s resekovaným nemalobunkovým pľúcnym karcinómom v štádiu II, IIIA a IIIB
    Liečivo: V940 (mRNA-4157), Pembrolizumab
    Diagnóza: Karcinóm pľúc
    Kód skúšania: 2023-504923-20-00,V940-002
    Sponzor: MSD Sharp & Dohme GmbH, Germany
    Kritéria:

    Inclusion Criteria:

    The main inclusion criteria include but are not limited to the following:

    Has surgically resected and histologically confirmed diagnosis of Stage II, IIIA, IIIB (N2) squamous or nonsquamous NSCLC as per American Joint Committee on Cancer (AJCC) Eighth Edition guidelines.
    Has no evidence of disease at the time of providing documented consent for the main study.
    Has received at least one dose of adjuvant treatment with standard of care platinum doublet chemotherapy.
    No more than 24 weeks have elapsed between surgical resection of curative intent and the first dose of pembrolizumab.
    Participants who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks and have undetectable HBV viral load prior to randomization.
    Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at screening.
    Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on anti-retroviral therapy (ART).
    Exclusion Criteria:

    The main exclusion criteria include but are not limited to the following:

    Diagnosis of small cell lung cancer (SCLC) or, for mixed tumors, presence of small cell elements, or has a neuroendocrine tumor with large cell components or a sarcomatoid carcinoma.
    HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease.
    Received prior neoadjuvant therapy for their current NSCLC diagnosis.
    Received or is a candidate to receive radiotherapy for their current NSCLC diagnosis.
    Received prior therapy with an anti-programmed cell death 1 protein (PD-1), anti-PD-ligand 1 (L1), or anti-PD-L2 agent, or with an agent directed to another stimulatory or coinhibitory T-cell receptor.
    Received prior systemic anticancer therapy including investigational agents within 4 weeks before randomization.
    Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines are allowed.
    Has received an investigational agent or has used an investigational device within 4 weeks prior to study intervention administration.
    Diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study medication.
    Known additional malignancy that is progressing or has required active treatment within the past 5 years.
    Active autoimmune disease that has required systemic treatment in the past 2 years. Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid) is allowed.
    History of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease.
    Active infection requiring systemic therapy.


    Otvorené pre nábor:
    Uzatvorené pre nábor:
    Uzatvorené:

    Pracoviská klinického skúšania:
    1. Názov: Fakultná nemocnica s poliklinikou F.D.Roosevelta, Oddelenie pneumológie a ftizeológie, Nám. L.Svobodu 1, 97401 Banská Bystrica
      Mesto: Banská Bystrica
      Zodpovedný skúšajúci: MUDr. Michal Urda
    2. Názov: Špecializovaná nemocnica sv. Svorada Zobor, n,o., Oddelenie klinickej onkológie, Kláštorská 134, 949 88 Nitra
      Mesto: Nitra
      Zodpovedný skúšajúci: MUDr. Gabriela Chowaniecová
    3. Názov: Východoslovenský onkologický ústav, a.s., Oddelenie klinickej onkológie, Rastislavova 43, 041 91 Košice
      Mesto: Košice
      Zodpovedný skúšajúci: MUDr. Jana Jankurová
    4. Názov: Univerzitná nemocnica Bratislava – Nemocnica Ružinov, Klinika pneumológie, ftizeológie a funkčnej diagnostiky SZU a UNB, Ružinovská 6
      Mesto: Bratislava
      Zodpovedný skúšajúci: MUDr. Zuzana Švihelová Lišková
      Referovať pacienta do klinického skúšania
  • RANDOMIZOVANÉ, DVOJITO ZASLEPENÉ SKÚŠANIE III. FÁZY S TIRAGOLUMABOM PLUS ATEZOLIZUMABOM V POROVNANÍ S PLACEBOM PLUS ATEZOLIZUMABOM U PACIENTOV S KOMPLETNE RESEKOVANÝM PD-L1 POZITÍVNYM NEMALOBUNKOVÝM KARCINÓMOM PĽÚC V ŠTÁDIU IIB, IIIA ALEBO VO VYBRANÝCH PRÍPADOCH IIIB, KTORÍ UŽÍVALI ADJUVANTNÚ CHEMOTERAPIU NA BÁZE PLATINY
    Liečivo: Atezolizumab, Tiragolumab
    Diagnóza: Karcinóm pľúc
    Kód skúšania: 2023-506696-10-00, GO45006, SKYSCRAPER-15
    Sponzor: F. Hoffmann-La Roche Ltd
    Kritéria:

    Inclusion Criteria:

    Eastern Cooperative Oncology Group performance status of 0 or 1
    Histological or cytological diagnosis of Stage IIB, IIIA, and select IIIB NSCLC of either non-squamous or squamous histology
    Participants must have had complete resection of NSCLC
    Participants must have received between one to four cycles of adjuvant histology-based platinum doublet chemotherapy
    Participants must have recovered adequately from surgery and from adjuvant chemotherapy
    Tumor cell PD-L1 expression at >/= 1%
    Adequate hematologic and end-organ function.
    Exclusion Criteria:

    Any history of prior NSCLC within the last 5 years
    Any evidence of residual disease or disease recurrence following surgical resection of NSCLC, or during or following adjuvant chemotherapy
    NSCLC known to have mutation in the EGFR gene or an ALK fusion oncogene


    Otvorené pre nábor: 2024-05-23
    Uzatvorené pre nábor:
    Uzatvorené:

    Pracoviská klinického skúšania:
    1. Názov: FNsP J.A. Reimana Prešov, Ambulancia klinickej onkológie, J. Hollého 14, 081 81 Prešov
      Mesto: Prešov
      Zodpovedný skúšajúci: MUDr. Jaroslava Lešková, PhD.
      Referovať pacienta do klinického skúšania
    2. Názov: Nemocnica na okraji mesta n.o., Ambulancia klinickej onkológie, Nová Nemocnica 511, 958 01 Partizánske
      Mesto: Partizánske
      Zodpovedný skúšajúci: MUDr. Alexandra Szabová
      Referovať pacienta do klinického skúšania
    3. Názov: NsP Štefana Kukuru Michalovce, a.s., Ambulancia klinickej onkológie, Špitálska 2, 071 01 Michalovce
      Mesto: Michalovce
      Zodpovedný skúšajúci: MUDr. Lenka Rušinová
      Referovať pacienta do klinického skúšania
    4. Názov: POKO Poprad s.r.o., Mnoheľova 2, 058 01 Poprad
      Mesto: Poprad
      Zodpovedný skúšajúci: MUDr. Juraj Beniak
      Referovať pacienta do klinického skúšania
    5. Názov: Špecializovaná nemocnica sv. Svorada Zobor, n,o., Oddelenie klinickej onkológie, Kláštorská 134, 949 88 Nitra
      Mesto: Nitra
      Zodpovedný skúšajúci: MUDr. Gabriela Chowaniecová
    6. Názov: Východoslovenský onkologický ústav, a.s., Oddelenie klinickej onkológie, Rastislavova 43, 041 91 Košice
      Mesto: Košice
      Zodpovedný skúšajúci: MUDr. Jana Jankurová
    7. Názov: Univerzitná nemocnica Bratislava – Nemocnica Ružinov, Klinika pneumológie, ftizeológie a funkčnej diagnostiky SZU a UNB, Ružinovská 6
      Mesto: Bratislava
      Zodpovedný skúšajúci: MUDr. Zuzana Šviheľová Lišková
      Referovať pacienta do klinického skúšania
    8. Názov: Všeobecná nemocnica Rimavská Sobota Oddelenie klinickej onkológie Šrobárova 1, 979 01 Rimavská Sobota
      Mesto: Rimavská Sobota
      Zodpovedný skúšajúci: MUDr. Iveta Pálkovácsová
    9. Názov: Univerzitná nemocnica Martin, Onkologické centrum, Kollárova 2, 036 59 Martin
      Mesto: Martin
      Zodpovedný skúšajúci: MUDr. Ivan Kecskés MBA
  • Paralelné, randomizované, multicentrické, nezaslepené globálne klinické skúšanie s dvoma ramenami liečby vo fáze III na vyhodnotenie účinnosti volrustomigu (MEDI5752) + chemoterapie oproti pembrolizumabu + chemoterapii v prvej línii liečby u pacientov s metastatickým nemalobunkovým karcinómom pľúc (mNSCLC) (eVOLVELung02)
    Liečivo: Volrustomig, Pembrolizumab, Carboplatin, Paclitaxel, Pemetrexed
    Diagnóza: Karcinóm pľúc
    Kód skúšania: 2023-503298-39-00 , D798AC00001, eVOLVE-Lung02
    Sponzor: ASTRAZENECA AB
    Kritéria:

    Key Inclusion Criteria:

    Histologically or cytologically documented squamous or non-squamous NSCLC.
    Stage IV NSCLC (according to Version 8 of the IASLC Staging Manual in Thoracic Oncology 2016), not amenable to curative surgery or radiation.
    Absence of sensitizing EGFR mutations and ALK and ROS1 rearrangements.
    Absence of documented tumor genomic alteration results from tests conducted as part of standard local practice in any other actionable driver oncogenes for which there are locally approved targeted first-line therapies.
    Key Exclusion Criteria:

    Mixed small-cell lung cancer and NSCLC histology or sarcomatoid variant. Rare subtypes are excluded.
    Spinal cord compression.
    Brain metastases unless asymptomatic, stable, and not requiring steroids for at least 14 days prior to start of study intervention. A minimum of 2 weeks must have elapsed between the end of whole brain radiotherapy and study enrollment.
    History of another primary malignancy except for:

    Malignancy treated with curative intent with no known active disease ≥ 2 years before the first dose of study intervention and of low potential risk for recurrence.
    Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease.
    Adequately treated carcinoma in situ without evidence of disease.
    As judged by the investigator, any condition that would interfere with evaluation of the study intervention or interpretation of participant safety or study results.


    Otvorené pre nábor: 2024-01-25
    Uzatvorené pre nábor:
    Uzatvorené:

    Pracoviská klinického skúšania:
  • Liečba karcinómu prostaty s použitím stereotaktickej rádioterapie na abláciu oligometastáz u hormonálne senzitívnych pacientov - GETUG-AFU randomizované, kontrolované klinické skúšanie fázy III
    Liečivo:
    Diagnóza: Karcinóm prostaty
    Kód skúšania: UC-0160/1716, Presto
    Sponzor: UNICANCER
    Kritéria:

    DIAGNOSIS AND INCLUSION CRITERIA:

    Histologically proven adenocarcinoma of the prostate (any T stage, Gleason score or prostate-specific antigen (PSA) level);
    Defined as M1 based on the presence of at least one bone or lung metastasis;
    Diagnostic workup including functional imaging (F or C-Choline-PET/CT or Prostate Specific Membrane Antigen (PSMA) PET/CT or whole body MRI) - done prior to the start of hormonal therapy;
    With up to 5 asymptomatic or paucisymptomatic metastatic sites including at least one bone or pulmonary lesion +/- nodal mestastases. Are counted as a "separate" metastatic site :

    each bone lesion, whatever the location (including pelvic localization), except if two lesions show hyperfixation in the same bone and are located < 1cm from each other they can be counted as one lesion
    each node or nodal area located outside the true pelvis with a small diameter of 1cm or greater or with univoqual abnormal function imaging (PET Scan hyperfixation or hypersignal in whole body MRI); if multiple nodes are in close vicinity (<1cm distance between them and <4cm in total distance including the nodes, amenable to one SBRT treatment) they can be counted as one lesion
    and patients with lung metastasis can be included
    Patients with a previous prostatectomy or radiotherapy to the prostate and/or pelvic lymph nodes are eligible provided they have no active disease within the irradiated areas, based on functional imaging findings;
    Age ≥18 years;
    Eastern Cooperative Oncology Group (ECOG) ≤2;
    Suitable for long term anti androgen therapy;
    Patient not suitable for docetaxel or abiraterone can be included;
    Patient that have started long term hormonal therapy are eligible if hormonal therapy has been initiated less than 2 months before randomization;
    Patients must agree to use adequate contraception methods for the duration of study treatment and for 6 months after completing treatment;
    Patient must have received the information sheet and signed the consent form;
    Patients must be willing and able to comply with the protocol for the duration of the study including scheduled visits, treatment plan, laboratory tests and other study procedures;
    Patient must be affiliated to the social security system.
    NON-INCLUSION CRITERIA:

    Patient with more than 5 metastatic sites;
    Patient with metastatic sites other than bone, lymph nodes or lung;
    Metastases not amenable to radiotherapy treatment with high/curative doses by multidisciplinary meeting [i.e. SBRT as per protocol or curative doses using moderate hypofractionation (55-60Gy/20) or conventional fractionation (≥74 Gy)] (e.g. gross epidural involvement, involvement of three contiguous vertebral bodies, major soft tissue involvement, and previous radiation treatment);
    Metastases requiring immediate treatment due to significant pain (use of opioid medication), or at risk of fracture or neurological deficit;
    Prior radiotherapy or focal ablative treatment (cryotherapy, radiofrequency ablation,…) to metastatic lesions;
    Castrate testosterone level <50 ng/dL or ≤0.50 ng/mL or 1.73 nmol/L prior use of ADT;
    Prior invasive (except non-melanoma skin cancer) malignancy unless disease-free for ≥5 years;
    Contra-indication to MRI (needed for spinal SBRT);
    Persons deprived of their liberty or under protective custody or guardianship;
    Patients unwilling or unable to comply with the medical follow-up required by the trial because of geographic, familial, social, or psychological reasons;
    Participation in another therapeutic trial within 30 days prior to randomization.


    Otvorené pre nábor: 2022-09-19
    Uzatvorené pre nábor:
    Uzatvorené:

    Pracoviská klinického skúšania:
    1. Názov: Národný onkologický ústav, II. Onkologická klinika LFUK a NOÚ, Klinika klinickej onkológie SZU a NOÚ, Klenová 1, 833 10 Bratislava
      Mesto: Bratislava
      Zodpovedný skúšajúci: Prof. MUDr.Michal Mego,DrSc.
      Referovať pacienta do klinického skúšania
  • Multicentrické randomizované otvorené skúšanie fázy 3 na vyhodnotenie bezpečnosti a účinnosti epkoritamabu + rituximabu a lenalidomidu (R2) v porovnaní s chemoimunoterapiou pri doteraz neliečenom folikulárnom lymfóme (EPCORE™FL-2)
    Liečivo: Epcoritamab - ABBV-GMAB-3013
    Diagnóza: Lymfómy
    Kód skúšania: 2023-506906-38-00 / M22-003
    Sponzor: AbbVie Deutschland GmbH & Co. KG
    Kritéria:

    Inclusion Criteria:

    Diagnosis of follicular lymphoma (FL).
    Have CD20+, histologically confirmed classic FL (previously Grade 1 to 3a FL) at most recent representative tumor biopsy based on the local pathology report, according to the 5th edition of World Health Organization (WHO) Classification of Haematolymphoid Tumours.
    Are willing and able to comply with procedures required in this protocol.
    Must have stage, III or IV disease, or stage II with bulky disease (tumor diameter of >=7 cm).
    Must be in need of systemic treatment per investigator, as evidenced by meeting at least one of the Groupe d'Etude des Lymphomes Folliculaire (GELF) criteria.
    Has one or more target lesions:

    A positron emission tomography (PET)/computerized tomography (CT) scan demonstrating PET-positive lesion(s), and
    >=1 measurable nodal lesion (long axis >1.5cm) or >=1 measurable extra-nodal lesion (long axis >1.0 cm) on CT scan or MRI
    Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
    Eligible to receive one of the standard of care regimens: chemoimmunotherapy (CIT) [Arm B] or rituximab and lenalidomide (R2) [Arm C].
    Have laboratory values meeting the criteria in the protocol.
    Exclusion Criteria:

    Had major surgery within 4 weeks prior to randomization.
    Have active cytomegalovirus (CMV) disease.


    Otvorené pre nábor: 2024-04-08
    Uzatvorené pre nábor:
    Uzatvorené:

    Pracoviská klinického skúšania:
  • Randomizované, dvojito zaslepené, kontrolované klinické skúšanie fázy 2/3 zanzalintinibu (XL092) v kombinácii s pembrolizumabom oproti pembrolizumabu v prvej línii liečby účastníkov s PD-L1 pozitívnym rekurentným alebo metastatickým skvamocelulárnym karcinómom hlavy a krku
    Liečivo: Zanzalintinib- XL092
    Diagnóza: Nádory hlavy a krku
    Kód skúšania: 2023-506308-24-00 / XL092-305
    Sponzor: Iqvia Rds Ireland Limited
    Kritéria:

    Inclusion Criteria:

    Histologically or cytologically-confirmed R/M HNSCC that is considered incurable by local therapy.

    Subjects should not have had prior systemic therapy administered in the recurrent or metastatic setting. Systemic therapy which was completed more than 6 months prior to randomization if given as part of multimodal treatment for locally advanced disease is allowed.
    The eligible primary tumor locations are the oropharynx, oral cavity, hypopharynx, and larynx.
    PD-L1 expression level Combined Positive Score (CPS) ≥ 1 by immunohistochemistry (IHC) testing.
    Have human papilloma virus (HPV) testing result for oropharyngeal cancer defined as p16 IHC testing.
    Measurable disease according to RECIST 1.1 determined by the Investigator.
    Tumor samples (archival or fresh tumor biopsy) are required. If archival tissue is unavailable, must provide fresh tumor tissue biopsy prior to randomization.
    Recovery to baseline or ≤ Grade 1 severity (CTCAE v5) from adverse events (AEs) related to any prior treatments, unless AE(s) are clinically nonsignificant and/or stable on supportive therapy.
    Age 18 years or older on the day of consent.
    Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
    Adequate organ and marrow function.
    Exclusion Criteria:

    Nasopharynx, salivary gland or occult primary site (regardless of p16 status).
    Has disease that is suitable for local therapy administered with curative intent.
    Has received prior therapy with zanzalintinib, any anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX-40, CD137).
    Life expectancy < 3 months.
    Had progressive disease within 6 months of completion of curatively intended systemic treatment for locoregionally advanced HNSCC.
    Radiation therapy for bone metastases within 2 weeks, any other radiation therapy within 4 weeks prior to randomization.
    Known brain metastases or cranial epidural disease unless adequately treated with radiotherapy and/or surgery (including radiosurgery) and stable for at least 4 weeks prior to randomization.
    Positive hepatitis B surface antigen (HBsAg) test.
    Positive hepatitis C virus (HCV) antibody test.
    Major surgery (eg, GI surgery, removal or biopsy of brain metastasis) within 8 weeks prior to randomization. Complete wound healing from major or minor surgery must have occurred at least prior to randomization.
    Corrected QT interval calculated by the Fridericia formula (QTcF) > 480 ms per electrocardiogram (ECG) within 28 days before randomization.
    Pregnant or lactating females.
    Administration of a live, attenuated vaccine within 30 days before randomization.


    Otvorené pre nábor: 2024-04-16
    Uzatvorené pre nábor:
    Uzatvorené:

    Pracoviská klinického skúšania:
  • Globálna multicentrická, otvorená, randomizovaná, registračná štúdia vo fáze 3 Lisaftoclaxu (APG-2575) u predtým liečených pacientov s chronickou lymfocytovou leukémiou/s lymfómom z malých lymfocytov (Štúdia GLORA)
    Liečivo: Lisaftoclax (APG-2575)
    Diagnóza: Leukémia
    Kód skúšania: 2023-508005-24-00/ APG2575CG301, GLORA
    Sponzor: Ascentage Pharma Group Inc.
    Kritéria:

    Inclusion Criteria:

    - Age ≥ 18 years.
    . Patients that have documented CLL/SLL who meet iwCLL 2018 criteria for CLL treatment guidelines are eligible for treatment and must be receiving BTKi monotherapy for at least 12 months
    ECOG Performance Status grade 0-2
    Adequate bone marrow function independent of growth factor or transfusion support within 2 weeks of screening initiation as follows:

    Absolute neutrophil count ≥ 1.0 × 109/L
    Platelet counts ≥ 75 × 109/L; in cases of thrombocytopenia
    Total hemoglobin ≥ 9 g/dL,
    Adequate renal function

    Creatinine clearance must be > 50 ml/min directly measured with 24hr urine collection or calculated according to the modified formula of Cockcroft and Gault (for men: GFR ≈ ((140 - age) x actual body weight)/(72 x creatinine), for women x 0.85) or an equally accurate method.
    For patients with creatinine values within the normal range, the calculation of clearance is not necessary. Dehydrated patients with an estimated creatinine clearance less than 50 ml/min may be eligible if a repeat estimate after adequate hydration is > 50 ml/min.
    Adequate liver function as indicated by:

    Total bilirubin ≤ 1.5 x ULN, except patients with known Gilbert's Syndrome
    Aspartate aminotransferase (AST) ≤ 2.5 x the institutional ULN value
    Alanine aminotransferase (ALT) ≤ 2.5 x the institutional ULN value,
    International normalized Ratio (INR), Prothrombin Time (PT) or Activated Partial Thromboplastin time (APTT) ≤ 1.5×ULN.
    Ability and willingness to provide written informed consent and to adhere to the study visit schedule and other protocol requirements


    Otvorené pre nábor: 2024-05-13
    Uzatvorené pre nábor:
    Uzatvorené:

    Pracoviská klinického skúšania:
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