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Studie van MK-5684 versus alternatief NHA in mCRPC (MK-5684-003) (OMAHA-003)

4 november 2026 bijgewerkt door: Merck Sharp & Dohme LLC

Een gerandomiseerde, open-label fase 3-studie van MK-5684 versus alternatief abirateronacetaat of enzalutamide bij deelnemers met gemetastaseerde castratieresistente prostaatkanker (mCRPC) die eerder zijn behandeld met hormoontherapie van de volgende generatie (NHA) en op taxaan gebaseerde chemotherapie

This is a phase 3, randomized, open-label study of opevesostat compared to alternative abiraterone acetate or enzalutamide in participants with metastatic castration-resistant prostate cancer (mCRPC) with respect to overall survival (OS) in participants with mCRPC previously treated with next-generation hormonal agent (NHA) and taxane-based chemotherapy. It is hypothesized that opevesostat is superior with respect to OS in androgen receptor ligand binding domain (AR LBD) mutation-negative and -positive participants.

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Geschat)

1310

Fase

  • Fase 3

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Locaties

  • Argentinië
      • Buenos Aires, Argentinië, C1118AAT
        • Actief, niet wervend
        • Hospital Aleman-Oncology ( Site 0207)
      • Mendoza, Argentinië, M5500AYB
        • Werving
        • Fundacion Centro Oncologico de Integración Regional-Medical Oncology ( Site 0204)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +5492615449901
    • Buenos Aires
      • Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentinië, C1280AEB
        • Actief, niet wervend
        • Hospital Británico de Buenos Aires-Oncology ( Site 0202)
      • Mar del Plata, Buenos Aires, Argentinië, B7600FZO
        • Actief, niet wervend
        • Instituto de Investigaciones Clínicas Mar del Plata ( Site 0201)
    • Buenos Aires F.D.
      • Buenos Aires, Buenos Aires F.D., Argentinië, C1419AHN
        • Werving
        • Asociación de Beneficencia Hospital Sirio Libanés ( Site 0205)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +5491145744343
      • Buenos Aires, Buenos Aires F.D., Argentinië, C1426ANZ
        • Werving
        • Instituto Alexander Fleming-Alexander Fleming ( Site 0206)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +5491132218900
    • Santa Fe Province
      • Rosario, Santa Fe Province, Argentinië, S2000DSV
        • Werving
        • Sanatorio Parque ( Site 0208)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +5493414200222
  • Australië
    • New South Wales
      • Dubbo, New South Wales, Australië, 2830
        • Werving
        • Dubbo Hospital ( Site 0235)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: 0268096200
      • Macquarie University, New South Wales, Australië, 2109
        • Werving
        • Macquarie University-MQ Health Clinical Trials Unit ( Site 0234)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: 0298122979
      • Westmead, New South Wales, Australië, 2145
        • Werving
        • Westmead Hospital ( Site 0232)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +61288905555
    • Queensland
      • Brisbane, Queensland, Australië, 4102
        • Werving
        • Princess Alexandra Hospital-Cancer Care Serices ( Site 0237)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +6173176 9289
    • Victoria
      • Melbourne, Victoria, Australië, 3000
        • Werving
        • Peter MacCallum Cancer Centre-Parkville Cancer Clinical Trials Unit (PCCTU) ( Site 0230)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: 03 8559 5000
  • Brazilië
    • Espírito Santo
      • Vitória, Espírito Santo, Brazilië, 29041-295
        • Werving
        • Hospital Santa Rita de Cassia-Centro de Pesquisa Clínica ( Site 0320)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +55 27 3334-8346
    • Estado de Bahia
      • Salvador, Estado de Bahia, Brazilië, 41680-430
        • Werving
        • Obras Sociais Irma Dulce ( Site 0302)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +55 71 3310-1978
    • Minas Gerais
      • Belo Horizonte, Minas Gerais, Brazilië, 30110-934
        • Werving
        • Hospital Felicio Rocho ( Site 0317)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +55 31 35147195
      • Belo Horizonte, Minas Gerais, Brazilië, 30380-472
        • Werving
        • Hospital Mario Penna ( Site 0309)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +551 31 3299-9543
    • Paraná
      • Curitiba, Paraná, Brazilië, 80440-220
        • Werving
        • Hospital Universitário Evangélico Mackenzie-Centro de Oncologia Mackenzie ( Site 0314)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: 5541991681411
    • Santa Catarina
      • Itajaí, Santa Catarina, Brazilië, 88301-220
        • Werving
        • Clínica de Neoplasias Litoral ( Site 0305)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +5547984046243
    • São Paulo
      • Bragança Paulista, São Paulo, Brazilië, 12916-542
        • Werving
        • Hospital Universitário São Francisco de Assis - Bragança Paulista ( Site 0308)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +55 11 98337-1381
      • São Paulo, São Paulo, Brazilië, 01509-010
        • Actief, niet wervend
        • A. C. Camargo Cancer Center ( Site 0310)
  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 1Z2
        • Werving
        • Cross Cancer Institute ( Site 0332)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: 7804328762
    • Ontario
      • Ottawa, Ontario, Canada, K1H 8L6
        • Werving
        • The Ottawa Hospital - General Campus-The Ottawa Hospital Cancer Centre ( Site 0336)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: 613-737-7700
      • Toronto, Ontario, Canada, M4N 3M5
        • Werving
        • Sunnybrook Research Institute ( Site 0331)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: 647-533-1023
      • Toronto, Ontario, Canada, M5G 2M9
        • Werving
        • Princess Margaret Cancer Centre ( Site 0330)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: (416) 946-4501
    • Quebec
      • Greenfield Park, Quebec, Canada, J4V 2H1
        • Werving
        • Centre Intégré de Santé et de Services Sociaux de la Montérégie-Centre ( Site 0328)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: 4504665000 ext 3226
      • Montreal, Quebec, Canada, H2X 3E4
        • Actief, niet wervend
        • Centre Hospitalier de l'Université de Montréal ( Site 0326)
      • Québec, Quebec, Canada, G1J 1Z4
        • Werving
        • Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésus ( Site 0327)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: 418 525-4444
      • Sherbrooke, Quebec, Canada, J1H 5H4
        • Actief, niet wervend
        • Centre intégré universitaire de santé et de services sociaux de l'Estrie - Centre Hospitalier Univer ( Site 0329)
  • Chili
      • Antofagasta, Chili, 1240000
        • Werving
        • Bradford Hill Norte ( Site 0357)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: 56442023631
    • Coquimbo Region
      • La Serena, Coquimbo Region, Chili, 1720430
        • Voltooid
        • IC La Serena Research ( Site 0356)
    • Los Ríos Region
      • Valdivia, Los Ríos Region, Chili, 5110683
        • Actief, niet wervend
        • Clinical Research Chile SpA ( Site 0358)
    • Maule Region
      • Talca, Maule Region, Chili, 3465584
        • Werving
        • Clinica Universidad Catolica del Maule-Oncology ( Site 0355)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +56947532700
    • Region M. de Santiago
      • Santiago, Region M. de Santiago, Chili, 8330024
        • Werving
        • Pontificia Universidad Catolica de Chile-Hemato-Oncology ( Site 0354)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +56934331806
      • Santiago, Region M. de Santiago, Chili, 8420383
        • Werving
        • Bradfordhill-Clinical Area ( Site 0351)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +56229490970
      • Santiago, Region M. de Santiago, Chili, 7500921
        • Actief, niet wervend
        • Fundación Arturo López Pérez ( Site 0353)
  • China
    • Anhui
      • Hefei, Anhui, China, 230000
        • Werving
        • Second Affiliated hospital of Anhui Medical University-Urology ( Site 0408)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +86 02782201756
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100034
        • Werving
        • Peking University First Hospital-Urology ( Site 0390)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +86 (010) 64008229
      • Beijing, Beijing Municipality, China, 100050
        • Werving
        • Beijing Friendship Hospital Affiliate of Capital University ( Site 0396)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +86(010)63138375
      • Beijing, Beijing Municipality, China, 100142
        • Werving
        • Beijing Cancer hospital-Urinary Surgery ( Site 0395)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: 86 010 8812 1122
    • Chongqing Municipality
      • Chongqing, Chongqing Municipality, China, 400030
        • Werving
        • Chongqing University Cancer Hospital ( Site 0416)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: 02365075629
      • Chongqing, Chongqing Municipality, China, 400038
        • Werving
        • Southwest Hospital of Third Military Medical University ( Site 0420)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: 023 68765878
      • Chongqing, Chongqing Municipality, China, 404100
        • Werving
        • Chongqing Three Gorges Central Hospital's ( Site 0426)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: 023 58103150
      • Chongqing, Chongqing Municipality, China, 400010
        • Werving
        • The First Affiliated Hospital of Chongqing Medical University ( Site 0427)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: 023 89012012
    • Fujian
      • Fuzhou, Fujian, China, 350005
        • Werving
        • The First Affiliated Hospital Of Fujian Medical University-Urology ( Site 0414)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +86059187983333
      • Xiamen, Fujian, China, 361003
        • Werving
        • The First Affiliated hospital of Xiamen University-Urology ( Site 0415)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: 0592-2132222
    • Guangdong
      • Guangzhou, Guangdong, China, 511400
        • Werving
        • Sun Yat-sen University Cancer Center-Internal medicine ( Site 0413)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +8602087343533
      • Guangzhou, Guangdong, China, 510230
        • Werving
        • The First Affiliated Hospital of Guangzhou Medical University ( Site 0412)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +8602034294311
    • Hubei
      • Wuhan, Hubei, China, 430079
        • Werving
        • Hubei Cancer Hospital-Urinary surgery ( Site 0406)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: 8613907110640
      • Wuhan, Hubei, China, 430000
        • Werving
        • Tongji Hospital Tongji Medical,Science & Technology ( Site 0407)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: 027-83665555
    • Hunan
      • Changsha, Hunan, China, 410013
        • Werving
        • Hunan Cancer Hospital ( Site 0405)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: 073189762270
    • Jiangsu
      • Huaian, Jiangsu, China, 223300
        • Werving
        • First Huai'an Hospital Affiliated to Nanjing Medical University ( Site 0436)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: 0517-80872519
      • Nanjing, Jiangsu, China, 210008
        • Werving
        • Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School-Urology ( Site 0377)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: 025-83105910
      • Wuxi, Jiangsu, China, 214122
        • Werving
        • Affiliated hospital of Jiangnan university ( Site 0434)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: 0510-88682957
    • Jiangxi
      • Nanchang, Jiangxi, China, 330029
        • Werving
        • Jiangxi Cancer Hospital ( Site 0386)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: 86079188317256
    • Shaanxi
      • Xi'an, Shaanxi, China, 710061
        • Werving
        • The First Affiliated Hospital of Xi'an Jiaotong University-Oncology ( Site 0393)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: 029-85323112
      • Xi'an, Shaanxi, China, 710004
        • Werving
        • The Second Affiliated Hospital of Xi'an Jiaotong University ( Site 0394)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: 029-87679000
    • Shandong
      • Yantai, Shandong, China, 264099
        • Werving
        • Yantai Yuhuangding Hospital ( Site 0397)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: 86 0535 6691999
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200000
        • Werving
        • Fudan University Shanghai Cancer Center-Urology department ( Site 0376)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: 021-38196379
      • Shanghai, Shanghai Municipality, China, 200041
        • Werving
        • Huadong Hospital Affiliated to Fudan University-Urology ( Site 0388)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: 021-62483180
      • Shanghai, Shanghai Municipality, China, 200032
        • Werving
        • Zhongshan Hospital Fudan University ( Site 0430)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: 021-31587858
    • Sichuan
      • Chengdu, Sichuan, China, 500643
        • Werving
        • The Third People's Hospital of Chengdu (CDTPH) ( Site 0428)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: 67566947
      • Chengdu, Sichuan, China, 610041
        • Werving
        • West China Hospital, Sichuan University-Urology Surgery ( Site 0417)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +86028-85422114
      • Nanchong, Sichuan, China, 500643
        • Werving
        • Nanchong Central Hospital-urology ( Site 0422)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: 08172606822
      • Suining, Sichuan, China, 629000
        • Werving
        • Suining Central Hospital ( Site 0437)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: 08252292093
    • Tianjin Municipality
      • Tianjin, Tianjin Municipality, China, 300060
        • Werving
        • Tianjin Medical University Cancer Institute & Hospital ( Site 0392)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +862223340123
      • Tianjin, Tianjin Municipality, China, 300211
        • Werving
        • The Second Hospital of Tianjin Medical University ( Site 0391)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +8602288326748
    • Xinjiang
      • Ürümqi, Xinjiang, China, 830000
        • Werving
        • Xinjiang Medical University Cancer Hospital - Urumqi-Urology ( Site 0419)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: 86 09917819156
    • Yunnan
      • Kunming, Yunnan, China, 650033
        • Werving
        • The Second Affiliated Hospital Of Kunming Medical University ( Site 0429)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: 087165351281
      • Kunming, Yunnan, China, 650107
        • Werving
        • Yunnan Province Cancer Hospital ( Site 0418)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: 0871-68179210
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310014
        • Werving
        • Zhejiang Provincial People's Hospital-Urology ( Site 0378)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +86 13858019285
      • Hangzhou, Zhejiang, China, 310022
        • Werving
        • Zhejiang Cancer Hospital ( Site 0435)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: 0571-88122261
      • Jiaxing, Zhejiang, China, 314001
        • Werving
        • The First Hospital of Jiaxing-urology ( Site 0380)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +86 13957391616
      • Ningbo, Zhejiang, China, 315010
        • Werving
        • The First Affiliated Hospital of Ningbo University ( Site 0383)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: 86057487085588
      • Wenzhou, Zhejiang, China, 325000
        • Werving
        • The First Affiliated Hospital of Wenzhou Medical University-Urology Surgery ( Site 0379)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +8618267857001
  • Colombia
    • Bogota D.C.
      • Bogotá, Bogota D.C., Colombia, 111321
        • Werving
        • Clinica Colsanitas S.A, Sede Clínica Universitaria Colombia-Center Investigator ( Site 0501)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: 6017058333
    • Cesar Department
      • Valledupar, Cesar Department, Colombia, 200001
        • Werving
        • Sociedad De Oncología y Hematología Del Cesar SAS-Oncology ( Site 0502)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +57 3158505190
    • Departamento de Córdoba
      • Montería, Departamento de Córdoba, Colombia, 230002
        • Werving
        • IMAT S.A.S ( Site 0504)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +573135342052
    • Santander Department
      • Piedecuesta, Santander Department, Colombia, 681017
        • Werving
        • Fundación Cardiovascular de Colombia ( Site 0503)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +573203400438
    • Valle del Cauca Department
      • Cali, Valle del Cauca Department, Colombia, 760032
        • Werving
        • Fundación Valle del Lili ( Site 0505)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +573133288646
      • Cali, Valle del Cauca Department, Colombia, 760042
        • Voltooid
        • Clínica Imbanaco S.A.S ( Site 0509)
  • Denemarken
    • Capital Region
      • Copenhagen, Capital Region, Denemarken, 2100
        • Werving
        • Rigshospitalet ( Site 0576)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +45 35453545
    • Region Syddanmark
      • Odense, Region Syddanmark, Denemarken, 5000
        • Actief, niet wervend
        • Odense Universitetshospital-Department of oncology ( Site 0579)
      • Vejle, Region Syddanmark, Denemarken, 7100
        • Werving
        • Vejle Sygehus ( Site 0578)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +45 79405000
  • Duitsland
      • Berlin, Duitsland, 10117
        • Werving
        • Charité Universitaetsmedizin Berlin - Campus Mitte ( Site 0679)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: 0049 30 450615285
      • Hamburg, Duitsland, 20246
        • Werving
        • Universitaetsklinikum Hamburg-Eppendorf-Onkologisches Zentrum ( Site 0705)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +4915222815585
    • Bavaria
      • Munich, Bavaria, Duitsland, 81675
        • Actief, niet wervend
        • klinikum rechts der isar der technischen universität münchen-Urologische Klinik und Poliklinik ( Site 0696)
    • Mecklenburg-Vorpommern
      • Schwerin, Mecklenburg-Vorpommern, Duitsland, 19055
        • Werving
        • HELIOS Kliniken Schwerin ( Site 0694)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +493855202120
    • North Rhine-Westphalia
      • Bonn, North Rhine-Westphalia, Duitsland, 53127
        • Werving
        • Universitätsklinikum Bonn-Klinik und Poliklinik für Urologie und Kinderurologie ( Site 0680)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +4922828714249
      • Münster, North Rhine-Westphalia, Duitsland, 48149
        • Werving
        • Universitätsklinikum Münster - Albert Schweitzer Campus-Klinik für Urologie ( Site 0678)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: 0049251-8344658
    • Schleswig-Holstein
      • Lübeck, Schleswig-Holstein, Duitsland, 23538
        • Werving
        • Universitätsklinikum Schleswig-Holstein-Klinik für Urologie ( Site 0691)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +4945150043699
    • Thuringia
      • Jena, Thuringia, Duitsland, 07747
        • Werving
        • Universitätsklinikum Jena-Klinik und Poliklinik für Urologie ( Site 0682)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +49 3641 9 32 9947
  • Finland
    • Northern Savonia
      • Kuopio, Northern Savonia, Finland, 70200
        • Actief, niet wervend
        • Kuopion Yliopistollinen Sairaala ( Site 0603)
    • Pirkanmaa
      • Tampere, Pirkanmaa, Finland, 33520
        • Werving
        • Tampereen yliopistollinen sairaala ( Site 0604)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: 358331166811
    • Southwest Finland
      • Turku, Southwest Finland, Finland, 20520
        • Werving
        • Turku University Hospital-Department of Oncology ( Site 0601)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: 35823130729
  • Frankrijk
      • Paris, Frankrijk, 75015
        • Actief, niet wervend
        • Hôpital Européen Georges Pompidou ( Site 0628)
    • Ain
      • Lille, Ain, Frankrijk, 59020
        • Werving
        • Centre Oscar Lambret ( Site 0634)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +33320295959
    • Bas-Rhin
      • Strasbourg, Bas-Rhin, Frankrijk, 67200
        • Werving
        • Hopitaux Universitaires de Strasbourg ( Site 0627)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +33368767207
    • Gard
      • Nîmes, Gard, Frankrijk, 30029
        • Werving
        • Centre Hospitalier Universitaire de Nîmes - Institut de Cancérologie du Gard - Hôpital Universitaire ( Site 0630)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +33466683301
    • Ille-et-Vilaine
      • Rennes, Ille-et-Vilaine, Frankrijk, 35042
        • Werving
        • Centre Eugène Marquis Rennes - Centre de Lutte Contre le Cancer ( Site 0632)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +33299253182
    • Puy-de-Dome
      • Clermont-Ferrand, Puy-de-Dome, Frankrijk, 63003
        • Werving
        • Centre Jean Perrin - Centre Régional de Lutte contre le Cancer d'Auvergne ( Site 0629)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +33473278005
    • Pyrenees-Atlantiques
      • Bayonne, Pyrenees-Atlantiques, Frankrijk, 64109
        • Werving
        • Centre Hospitalier de la Cote Basque ( Site 0633)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: 33559443535
    • Val-de-Marne
      • Villejuif, Val-de-Marne, Frankrijk, 94800
        • Werving
        • Gustave Roussy ( Site 0626)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +33 1 42 11 42 11
  • Hongarije
      • Debrecen, Hongarije, 4032
        • Werving
        • Debreceni Egyetem Klinikai Kozpont-Onkológiai Klinika ( Site 0758)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +3652411717
    • Bács-Kiskun county
      • Kecskemét, Bács-Kiskun county, Hongarije, 6000
        • Werving
        • Bacs-Kiskun Varmegyei Oktatokorhaz-Onkoradiologiai Kozpont ( Site 0752)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +3676516719
    • Nógrád megye
      • Salgótarján, Nógrád megye, Hongarije, 3100
        • Werving
        • Nograd Varmegyei Szent Lazar Korhaz-Onkologia es Sugarterapias Osztaly ( Site 0761)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +3632522000
    • Pest County
      • Budapest, Pest County, Hongarije, 1122
        • Werving
        • Országos Onkológiai Intézet-Urogenitális Tumorok és Klinikai Farmakológiai Osztály ( Site 0756)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +36122486001171
  • Hongkong
      • Hong Kong, Hongkong
        • Actief, niet wervend
        • Queen Mary Hospital ( Site 0727)
      • Shatin, Hongkong
        • Actief, niet wervend
        • Prince of Wales Hospital ( Site 0730)
  • Ierland
      • Dublin, Ierland, D24 NR0A
        • Werving
        • Tallaght University Hospital ( Site 0801)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +35314144299
    • Dublin
      • Dublin, Dublin, Ierland, D04 T6F4
        • Werving
        • St. Vincent's University Hospital ( Site 0802)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +35312214000
  • Israël
      • Afula, Israël, 1834111
        • Werving
        • Emek Medical Center ( Site 0830)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: 0546708579
      • Haifa, Israël, 3109601
        • Werving
        • Rambam Health Care Campus-Oncology Division ( Site 0826)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: 04-7776234
      • Jerusalem, Israël, 9112001
        • Werving
        • Hadassah Medical Center ( Site 0833)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: 02-6777111
      • Kfar Saba, Israël, 4428164
        • Werving
        • Meir Medical Center. ( Site 0832)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: 0503745684
      • Petah Tikva, Israël, 4941492
        • Werving
        • Rabin Medical Center ( Site 0828)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: 972-50-3745684
      • Ramat Gan, Israël, 5265601
        • Werving
        • Sheba Medical Center ( Site 0827)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: : +972-35302191
  • Italië
      • Milan, Italië, 20132
        • Werving
        • Ospedale San Raffaele-Oncologia Medica ( Site 0876)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +390226435668
    • Emilia-Romagna
      • Meldola, Emilia-Romagna, Italië, 47014
        • Werving
        • IRCCS - Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori"-Oncologia Medica ( Site 0879)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +390543739100
    • Lombardy
      • Milan, Lombardy, Italië, 20133
        • Werving
        • Fondazione IRCCS Istituto Nazionale dei Tumori-Struttura Complessa Oncologia Medica 1 ( Site 0877)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: 00390223903033
  • Japan
      • Akita, Japan, 010-8543
        • Werving
        • Akita University Hospital ( Site 0904)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +81188341111
      • Fukuoka, Japan, 812-8582
        • Werving
        • Kyushu University Hospital ( Site 0919)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +81926411151
      • Fukushima, Japan, 960-1295
        • Werving
        • Fukushima Medical University Hospital ( Site 0933)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +81245471111
      • Gifu, Japan, 501-1112
        • Werving
        • Gifu University Hospital ( Site 0910)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +81-58-230-6000
      • Hiroshima, Japan, 734-8551
        • Werving
        • Hiroshima University Hospital ( Site 0916)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +81-82-257-5555
      • Kagoshima, Japan, 890-8520
        • Werving
        • Kagoshima University Hospital ( Site 0929)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +81-99-275-5111
      • Kumamoto, Japan, 860-0008
        • Werving
        • National Hospital Organization Kumamoto Medical Center ( Site 0924)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +81963536501
      • Miyazaki, Japan, 880-8510
        • Werving
        • Miyazaki Prefectural Miyazaki Hospital ( Site 0927)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +81985244181
      • Miyazaki, Japan, 889-1692
        • Werving
        • University of Miyazaki Hospital ( Site 0926)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +81-98-585-1510
      • Nagano, Japan, 381-8551
        • Werving
        • Nagano Municipal Hospital ( Site 0932)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +81-26-295-1199
      • Ōita, Japan, 870-0263
        • Werving
        • National Hospital Organization Oita Medical Center ( Site 0925)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +81-97-593-1111
    • Chiba
      • Sakura, Chiba, Japan, 285-8741
        • Werving
        • Toho University Sakura Medical Center ( Site 0906)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +81434628811
    • Ehime
      • Tōon, Ehime, Japan, 791-0295
        • Werving
        • Ehime University Hospital ( Site 0918)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +81-89-964-5111
    • Fukuoka
      • Kitakyushu, Fukuoka, Japan, 807-8556
        • Voltooid
        • Hospital of the University of Occupational and Environmental Health, Japan ( Site 0921)
      • Kurume, Fukuoka, Japan, 830-0011
        • Werving
        • Kurume University Hospital ( Site 0920)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +81-942-35-3311
    • Hokkaido
      • Asahikawa, Hokkaido, Japan, 078-8510
        • Werving
        • Asahikawa Medical University Hospital ( Site 0901)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +81-166-65-2111
      • Sapporo, Hokkaido, Japan, 060-8543
        • Werving
        • Sapporo Medical University Hospital ( Site 0902)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +81-11-611-2111
      • Sapporo, Hokkaido, Japan, 060-8648
        • Werving
        • Hokkaido University Hospital ( Site 0931)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +81117161161
    • Hyōgo
      • Kobe, Hyōgo, Japan, 650-0017
        • Werving
        • Kobe University Hospital ( Site 0914)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +81783825111
    • Ishikawa-ken
      • Mukai-awagasaki, Ishikawa-ken, Japan, 920-0265
        • Werving
        • Kanazawa Medical University Hospital ( Site 0909)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +81-76-286-3511
    • Kagawa-ken
      • Kita, Kagawa-ken, Japan, 761-0701
        • Werving
        • Kagawa University Hospital ( Site 0917)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +81878985111
    • Kanagawa
      • Yokohama, Kanagawa, Japan, 232-0024
        • Werving
        • Yokohama City University Medical Center ( Site 0908)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +81452615656
    • Nagasaki
      • Ōmura, Nagasaki, Japan, 856-8562
        • Werving
        • National Hospital Organization Nagasaki Medical Center ( Site 0923)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +81-957-52-3121
    • Nara
      • Kashihara, Nara, Japan, 634-8522
        • Voltooid
        • Nara Medical University Hospital ( Site 0915)
    • Okinawa
      • Shimajiri, Okinawa, Japan, 901-0417
        • Werving
        • Nanbu Tokushukai Hospital ( Site 0930)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +81-98-998-3221
    • Osaka
      • Hirakata, Osaka, Japan, 573-1191
        • Werving
        • Kansai Medical University Hospital ( Site 0912)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +81-72-804-0101
      • Sakai, Osaka, Japan, 599-8247
        • Werving
        • Bell Land General Hospital ( Site 0913)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +81722342001
      • Suita, Osaka, Japan, 565-0871
        • Werving
        • The University of Osaka Hospital ( Site 0911)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +81668795111
    • Saga-ken
      • Saga, Saga-ken, Japan, 840-8571
        • Werving
        • Saga-Ken Medical Centre Koseikan ( Site 0922)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +81952242171
    • Tokyo
      • Minato, Tokyo, Japan, 105-8471
        • Voltooid
        • The Jikei University Hospital ( Site 0907)
  • Maleisië
      • Kuala Lumpur, Maleisië, 50586
        • Werving
        • Hospital Kuala Lumpur-Radiotherapy and Oncology ( Site 1078)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +60326155810
    • Johor
      • Johor Bahru, Johor, Maleisië, 81100
        • Werving
        • Hospital Sultan Ismail ( Site 1081)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +6073565155
    • Kuala Lumpur
      • Lembah Pantai, Kuala Lumpur, Maleisië, 59100
        • Voltooid
        • University Malaya Medical Centre ( Site 1077)
    • Putrajaya
      • Putrajaya, Putrajaya, Maleisië, 62250
        • Werving
        • National Cancer Institute ( Site 1079)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +60388925418
    • Sarawak
      • Kuching, Sarawak, Maleisië, 93586
        • Werving
        • Sarawak General Hospital-Radiotherapy Unit ( Site 1076)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +6082276820
  • Mexico
    • Jalisco
      • Guadalajara, Jalisco, Mexico, 44630
        • Werving
        • CIO - Centro de Inmuno-Oncología de Occidente ( Site 1103)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +52 3313587270
    • Mexico City
      • Mexico City, Mexico City, Mexico, 14308
        • Werving
        • Quemex Medical and Research ( Site 1112)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +52555673461
      • Mexico City, Mexico City, Mexico, 68020
        • Werving
        • Centro de Investigacion Clinica de Oaxaca ( Site 1109)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +529515473137
    • Nuevo León
      • Monterrey, Nuevo León, Mexico, 64460
        • Werving
        • Filios Alta Medicina ( Site 1106)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +528110623583
      • Monterrey, Nuevo León, Mexico, 64460
        • Werving
        • Hospital Universitario "Dr. Jose Eleuterio Gonzalez"-Servicio de Oncología ( Site 1107)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +528183338111 Ext.9
    • Yucatán
      • Mérida, Yucatán, Mexico, 97070
        • Voltooid
        • Medical Care and Research SA de CV ( Site 1108)
  • Nederland
    • Gelderland
      • Nijmegen, Gelderland, Nederland, 6525 GA
        • Werving
        • Radboudumc-Medical Oncology ( Site 1152)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +31 (0)24 361 0353
    • Limburg
      • Sittard-Geleen, Limburg, Nederland, 6162 BG
        • Werving
        • Zuyderland Medical Centre-Trialbureau Interne Geneeskunde ( Site 1163)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +31884599740
      • Venlo, Limburg, Nederland, 5912 BL
        • Voltooid
        • VieCuri Medisch Centrum ( Site 1173)
    • North Brabant
      • Tilburg, North Brabant, Nederland, 5022 GC
        • Werving
        • ETZ Elisabeth-Internal Medicine ( Site 1160)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +3113221 0210
    • North Holland
      • Amsterdam, North Holland, Nederland, 1066 CX
        • Werving
        • Nederlands Kanker Instituut - Antoni van Leeuwenhoek - NKI-AVL ( Site 1153)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +31205122569
      • Amsterdam, North Holland, Nederland, 1081 HV
        • Voltooid
        • Amsterdam UMC, locatie VUmc ( Site 1156)
      • Hoofddorp, North Holland, Nederland, 2134 TM
        • Actief, niet wervend
        • Spaarne Gasthuis - Hoofddorp-Oncology ( Site 1170)
    • Provincie Friesland
      • Leeuwarden, Provincie Friesland, Nederland, 8934 AD
        • Actief, niet wervend
        • Medische Centrum Leeuwarden ( Site 1172)
    • South Holland
      • Schiedam, South Holland, Nederland, 3118 JH
        • Werving
        • Franciscus Gasthuis & Vlietland, Locatie Vlietland ( Site 1151)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: 003110- 4617590
      • The Hague, South Holland, Nederland, 2545 AA
        • Werving
        • Haga Ziekenhuis locatie Leyweg-Oncology ( Site 1164)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +31702102143
    • Utrecht
      • Amersfoort, Utrecht, Nederland, 3813 TZ
        • Werving
        • Meander Medisch Centrum ( Site 1157)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +003133 - 850 1189
  • Nieuw-Zeeland
    • Bay of Plenty
      • Tauranga, Bay of Plenty, Nieuw-Zeeland, 3112
        • Werving
        • Tauranga Hospital-Bay of Plenty Clinical Trials Unit ( Site 1201)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +64277033845
    • Otago
      • Dunedin, Otago, Nieuw-Zeeland, 9016
        • Werving
        • Dunedin Hospital-Southern Blood and Cancers Service ( Site 1203)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +64 3 470 9692
  • Noorwegen
    • Akershus
      • Lørenskog, Akershus, Noorwegen, 1474
        • Werving
        • Akershus Universitetssykehus-Onkologisk avdeling ( Site 1227)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +4767963800
    • Sor-Trondelag
      • Trondheim, Sor-Trondelag, Noorwegen, 7030
        • Actief, niet wervend
        • St. Olavs Hospital-Kreftklinikken ( Site 1231)
    • Østfold fylke
      • Sarpsborg, Østfold fylke, Noorwegen, 1714
        • Voltooid
        • Sykehuset Østfold Kalnes ( Site 1228)
  • Oostenrijk
    • Styria
      • Graz, Styria, Oostenrijk, 8036
        • Werving
        • Medizinische Universität Graz-Innere Medizin Klin. Abt. Onkologie ( Site 0280)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +4331638581307
    • Upper Austria
      • Linz, Upper Austria, Oostenrijk, 4020
        • Werving
        • Ordensklinikum Linz GmbH Elisabethinen-Urologie ( Site 0276)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +4373276774724
      • Wels, Upper Austria, Oostenrijk, 4600
        • Werving
        • Klinikum Wels-Grieskirchen GmbH ( Site 0279)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +4372424152328
  • Peru
      • Lima, Peru, 15038
        • Werving
        • INSTITUTO NACIONAL DE ENFERMEDADES NEOPLASICAS-Medical Oncology ( Site 1256)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +511 2016500
      • Lima, Peru, 15036
        • Actief, niet wervend
        • Aliada-Oncologìa ( Site 1257)
      • Lima, Peru, 15036
        • Actief, niet wervend
        • IPOR Instituto Peruano de Oncología & Radioterapia-Centro de Investigación ( Site 1254)
      • Lima, Peru, 15036
        • Actief, niet wervend
        • Oncosalud-Clinical Research ( Site 1260)
    • Departamento de Junín
      • Concepción, Departamento de Junín, Peru, 12125
        • Werving
        • Instituto Regional de Enfermedades Neoplasicas del Centro (IREN CENTRO) ( Site 1258)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +51 958864658
    • La Libertad
      • Trujillo, La Libertad, Peru, 13009
        • Werving
        • Clínica Sánchez Ferrer ( Site 1261)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: 948319999
  • Polen
    • Kuyavian-Pomeranian Voivodeship
      • Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Polen, 85-796
        • Actief, niet wervend
        • Centrum Onkologii im. Prof. Franciszka Lukaszczyka ( Site 1302)
      • Grudziądz, Kuyavian-Pomeranian Voivodeship, Polen, 86-300
        • Voltooid
        • Regionalny Szpital Specjalistyczny im. dr. Władyslawa Biegańskiego ( Site 1316)
      • Torun, Kuyavian-Pomeranian Voivodeship, Polen, 87-100
        • Voltooid
        • Wojewodzki Szpital Zespolony im Ludwika Rydygiera w Toruniu ( Site 1304)
    • Masovian Voivodeship
      • Siedlce, Masovian Voivodeship, Polen, 08-110
        • Werving
        • Mazowiecki Szpital Wojewódzki w Siedlcach-Siedleckie Centrum Onkologii ( Site 1310)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +48256403301
    • West Pomeranian Voivodeship
      • Koszalin, West Pomeranian Voivodeship, Polen, 75-581
        • Werving
        • Szpital Wojewódzki im. Mikoaja Kopernika w Koszalinie-Oddzial Dzienny Chemioterapii ( Site 1303)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +48943488930
      • Szczecin, West Pomeranian Voivodeship, Polen, 71-730
        • Werving
        • Zachodniopomorskie Centrum Onkologii ( Site 1311)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +48914251502
    • Świętokrzyskie Voivodeship
      • Kielce, Świętokrzyskie Voivodeship, Polen, 25-734
        • Werving
        • Swietokrzyskie Centrum Onkologii, Samodzielny Publiczny Zakl-Klinika Onkologii Klinicznej, Dzial Ch ( Site 1318)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +48413674811
  • Puerto Rico
      • Hato Rey, Puerto Rico, 00917
        • Voltooid
        • Puerto Rico Medical Research Center LLC ( Site 1354)
      • Ponce, Puerto Rico, 00717
        • Actief, niet wervend
        • Ad-Vance Medical Research-Research ( Site 1353)
      • San Juan, Puerto Rico, 00909
        • Voltooid
        • Pan American Center for Oncology Trials - Ciudadela ( Site 1351)
  • Singapore
    • Central Singapore
      • Singapore, Central Singapore, Singapore, 168583
        • Werving
        • National Cancer Centre Singapore ( Site 1377)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +65-64368000
      • Singapore, Central Singapore, Singapore, 308433
        • Werving
        • Tan Tock Seng Hospital-Medical Oncology ( Site 1378)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +65-62566011
      • Singapore, Central Singapore, Singapore, 119074
        • Werving
        • National University Hospital ( Site 1376)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: 6569082222
  • Spanje
      • Lugo, Spanje, 27003
        • Werving
        • Hospital Lucus Augusti-Oncology ( Site 1432)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +34982296459
      • Seville, Spanje, 41013
        • Werving
        • HOSPITAL UNIVERSITARIO VIRGEN DEL ROCIO-Medical Oncology ( Site 1428)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: 34955013068
    • Cadiz
      • Jerez de la Frontera, Cadiz, Spanje, 11407
        • Werving
        • Hospital Jerez de la Frontera ( Site 1427)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +34661753582
    • Madrid, Comunidad de
      • Madrid, Madrid, Comunidad de, Spanje, 28034
        • Werving
        • Hospital Universitario Ramón y Cajal-Medical Oncology ( Site 1431)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: 34913368263
      • Madrid, Madrid, Comunidad de, Spanje, 28041
        • Werving
        • Hospital Universitario 12 de Octubre-Medical Oncology ( Site 1433)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: 608464547
    • Orense
      • Ourense, Orense, Spanje, 32005
        • Werving
        • Complexo Hospitalario Universitario de Ourense ( Site 1426)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +34988385471
    • Valenciana, Comunitat
      • Valencia, Valenciana, Comunitat, Spanje, 46009
        • Werving
        • Fundación Instituto Valenciano de Oncología-Oncologico ( Site 1430)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +34 961114229
  • Taiwan
      • Taichung, Taiwan, 40447
        • Werving
        • China Medical University Hospital-Department of Urology ( Site 1503)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +886-4-2205-2121
      • Tainan, Taiwan, 704
        • Werving
        • National Cheng Kung University Hospital-Urology ( Site 1502)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +886-6-2353535
      • Taipei, Taiwan, 112
        • Werving
        • Taipei Veterans General Hospital ( Site 1505)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +886-2-28712121
      • Taipei, Taiwan, 10002
        • Werving
        • National Taiwan University Hospital-Urology ( Site 1506)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +886-2-2312-3456
      • Taoyuan, Taiwan, 333
        • Werving
        • Chang Gung Medical Foundation-Linkou Branch-Medical Oncology ( Site 1504)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +886-3-3281200
  • Thailand
    • Bangkok
      • Bangkok, Bangkok, Thailand, 10330
        • Werving
        • Chulalongkorn University ( Site 1530)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +6622564533
      • Bangkoknoi, Bangkok, Thailand, 10700
        • Werving
        • Faculty of Medicine Siriraj Hospital ( Site 1531)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +6624194489
    • Changwat Khon Kaen
      • Muang, Changwat Khon Kaen, Thailand, 40002
        • Werving
        • Faculty of Medicine - Khon Kaen University ( Site 1526)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +66 43 366568-9
    • Changwat Songkhla
      • Hat Yai, Changwat Songkhla, Thailand, 90110
        • Werving
        • Songklanagarind hospital ( Site 1527)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +6674451469
  • Tsjechië
      • Prague, Tsjechië, 150 06
        • Actief, niet wervend
        • Fakultní nemocnice Motol a Homolka ( Site 0551)
    • Brno-mesto
      • Brno, Brno-mesto, Tsjechië, 656 53
        • Werving
        • Masarykuv onkologicky ustav-Klinika komplexni onkologicke pece ( Site 0553)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +420 543 136 216
    • Moravian-Silesian Region
      • Ostrava, Moravian-Silesian Region, Tsjechië, 708 52
        • Werving
        • Fakultni nemocnice Ostrava-Klinika onkologicka ( Site 0554)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +420597372264
    • Olomouc Region
      • Olomouc, Olomouc Region, Tsjechië, 779 00
        • Werving
        • Fakultni nemocnice Olomouc-Onkologicka klinika ( Site 0555)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +420 588 444 699
  • Turkije (Türkiye)
      • Adana, Turkije (Türkiye), 01250
        • Werving
        • Baskent University Dr. Turgut Noyan Research and Training Center-ONCOLOGY ( Site 1554)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +903223444444
      • Ankara, Turkije (Türkiye), 06010
        • Werving
        • Gulhane Egitim Arastirma Hastanesi ( Site 1558)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: 00903123042020
      • Ankara, Turkije (Türkiye), 06230
        • Werving
        • Hacettepe Universite Hastaneleri-oncology hospital ( Site 1551)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +90 (312) 305 29 41
      • Ankara, Turkije (Türkiye), 06520
        • Werving
        • Memorial Ankara Hastanesi-Medical Oncology ( Site 1557)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: 903122536666
      • Ankara, Turkije (Türkiye), 06800
        • Werving
        • Ankara Bilkent Şehir Hastanesi-Medical Oncology ( Site 1552)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: 00903125526060
      • Istanbul, Turkije (Türkiye), 34668
        • Werving
        • Istanbul Universitesi Cerrahpasa-Medical Oncology ( Site 1555)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: 0090212 414 30 00
      • Istanbul, Turkije (Türkiye), 34722
        • Werving
        • TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 1553)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +902166065200
      • Istanbul, Turkije (Türkiye), 34010
        • Werving
        • Koc Universitesi Hastanesi ( Site 1561)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +908502508250
      • Samsun, Turkije (Türkiye), 55200
        • Werving
        • Samsun Medical Park Hastanesi-medical oncology ( Site 1560)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +90 (539) 780 90 07
  • Verenigd Koninkrijk
      • Manchester, Verenigd Koninkrijk, m20 4bx
        • Werving
        • The Christie NHS Foundation Trust ( Site 1608)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +441614463000
    • Cambridgeshire
      • Cambridge, Cambridgeshire, Verenigd Koninkrijk, CB2 2QQ
        • Werving
        • Addenbrooke's Hospital ( Site 1605)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: 01223216083
    • England
      • Truro, England, Verenigd Koninkrijk, TR1 3LJ
        • Werving
        • The Royal Cornwall Hospital ( Site 1610)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: 01872258345
    • Glasgow City
      • Glasgow, Glasgow City, Verenigd Koninkrijk, G12 0YN
        • Werving
        • The Beatson West of Scotland Cancer Centre ( Site 1603)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +441413017000
    • Hammersmith and Fulham
      • London, Hammersmith and Fulham, Verenigd Koninkrijk, W6 8RF
        • Werving
        • Charing Cross Hospital-Oncology Research ( Site 1606)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: 0208 331 10277
    • London, City of
      • London, London, City of, Verenigd Koninkrijk, NW1 2PG
        • Werving
        • University College London Hospital ( Site 1612)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: 0203 447 3042
  • Verenigde Staten
    • California
      • Orange, California, Verenigde Staten, 92868
        • Voltooid
        • University of California, Irvine (UCI) Health - UC Irvine Medical Center ( Site 0040)
      • Palo Alto, California, Verenigde Staten, 94304
        • Werving
        • Stanford Cancer Center ( Site 0036)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: 650-725-2078
      • Riverside, California, Verenigde Staten, 92505
        • Werving
        • Kaiser Permanente Riverside Medical Center ( Site 0099)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: 951-809-8361
    • Colorado
      • Aurora, Colorado, Verenigde Staten, 80045
        • Werving
        • Anschutz Cancer Pavilion ( Site 0046)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: 302-290-3598
      • Highlands Ranch, Colorado, Verenigde Staten, 80129
        • Werving
        • University of Colorado Health - Highlands Ranch Hospital ( Site 0111)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: 302-290-3598
      • Lakewood, Colorado, Verenigde Staten, 80228
        • Voltooid
        • Colorado Clinical Research ( Site 0067)
      • Lone Tree, Colorado, Verenigde Staten, 80124
        • Werving
        • University of Colorado Health - Lone Tree Medical Center ( Site 0112)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: 720-848-5146
    • Connecticut
      • New Haven, Connecticut, Verenigde Staten, 06510
        • Werving
        • Yale-New Haven Hospital-Yale Cancer Center ( Site 0064)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: 203-737-8076
    • Florida
      • Fort Myers, Florida, Verenigde Staten, 33901
        • Voltooid
        • Florida Cancer Specialists - South ( Site 7003)
      • Miami, Florida, Verenigde Staten, 33136
        • Werving
        • University of Miami Hospital and Clinics, Sylvester Cancer Center ( Site 0051)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: 305-243-1543
      • Miami, Florida, Verenigde Staten, 33125
        • Voltooid
        • Bruce W. Carter Veterans Affairs Medical Center ( Site 0082)
    • Illinois
      • Chicago, Illinois, Verenigde Staten, 60637
        • Werving
        • University of Chicago Medical Center ( Site 0045)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: 773-702-7609
      • Chicago, Illinois, Verenigde Staten, 60612
        • Werving
        • University of Illinois at Chicago ( Site 0105)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: 973-330-2391
    • Iowa
      • Iowa City, Iowa, Verenigde Staten, 52242
        • Voltooid
        • University of Iowa ( Site 0047)
    • Kentucky
      • Lexington, Kentucky, Verenigde Staten, 40536
        • Voltooid
        • University of Kentucky Chandler Medical Center ( Site 0048)
    • Louisiana
      • New Orleans, Louisiana, Verenigde Staten, 70121
        • Voltooid
        • Ochsner Clinic Foundation ( Site 0108)
    • Maryland
      • Baltimore, Maryland, Verenigde Staten, 21201
        • Werving
        • Baltimore Veterans Affairs Medical Center ( Site 0069)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: 410-707-4011
      • Baltimore, Maryland, Verenigde Staten, 21201
        • Werving
        • Greenebaum Comprehensive Cancer Center ( Site 0049)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: 410-707-4011
    • Michigan
      • Detroit, Michigan, Verenigde Staten, 48202
        • Voltooid
        • Henry Ford Hospital ( Site 0015)
    • Minnesota
      • Marshall, Minnesota, Verenigde Staten, 56258
        • Werving
        • Avera Cancer Institute - Marshall ( Site 0122)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: 605-601-1830
      • Minneapolis, Minnesota, Verenigde Staten, 55455
        • Werving
        • M Health Fairview Clinics and Surgery Center ( Site 0019)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: 612-626-1422
      • Saint Louis Park, Minnesota, Verenigde Staten, 55416
        • Actief, niet wervend
        • Metro-Minnesota Community Clinical Oncology ( Site 0014)
    • Mississippi
      • Hattiesburg, Mississippi, Verenigde Staten, 39401
        • Werving
        • Hattiesburg Clinic Hematology/Oncology ( Site 0120)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: 601-261-1700
    • Missouri
      • St Louis, Missouri, Verenigde Staten, 63110
        • Werving
        • Washington University School of Medicine-Internal Medicine/Oncology ( Site 0062)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: 314-286-2341
    • Nebraska
      • Omaha, Nebraska, Verenigde Staten, 68105
        • Werving
        • University Of Nebraska Medical Center-Oncology/Hematology ( Site 0095)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: 402-559-8500
    • Nevada
      • Las Vegas, Nevada, Verenigde Staten, 89148
        • Werving
        • Comprehensive Cancer Centers of Nevada ( Site 0010)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: 702-952-1251
    • New Jersey
      • Morristown, New Jersey, Verenigde Staten, 07960
        • Werving
        • Atlantic Health System Morristown Medical Center ( Site 0115)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: 973-971-7960
      • New Brunswick, New Jersey, Verenigde Staten, 08903
        • Voltooid
        • Rutgers Cancer Institute of New Jersey ( Site 0033)
    • New York
      • The Bronx, New York, Verenigde Staten, 10468
        • Werving
        • James J. Peters VA Medical Center ( Site 0088)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: 718-584-9000
    • Ohio
      • Cleveland, Ohio, Verenigde Staten, 44106
        • Werving
        • University Hospitals Cleveland Medical Center ( Site 0043)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: 216-844-3951
    • Oregon
      • Portland, Oregon, Verenigde Staten, 97239
        • Werving
        • VA Portland Health Care System ( Site 0058)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: 503-220-8262
      • Portland, Oregon, Verenigde Staten, 97239
        • Voltooid
        • Oregon Health and Science University ( Site 0028)
    • Pennsylvania
      • Pittsburgh, Pennsylvania, Verenigde Staten, 15212
        • Voltooid
        • AHN Allegheny General Hospital ( Site 0001)
    • South Carolina
      • Charleston, South Carolina, Verenigde Staten, 29401
        • Voltooid
        • Ralph H. Johnson VA Health Care System (RHJVAHCS)-Urology ( Site 0083)
    • South Dakota
      • Aberdeen, South Dakota, Verenigde Staten, 57401
        • Werving
        • Avera Cancer Institute - Aberdeen ( Site 0123)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: 605-601-1830
      • Mitchell, South Dakota, Verenigde Staten, 57301
        • Werving
        • Avera Cancer Institute - Mitchell ( Site 0121)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: 605-601-1830
      • Pierre, South Dakota, Verenigde Staten, 57501
        • Werving
        • Avera Cancer Institute - Pierre ( Site 0118)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: 605-224-3370
      • Sioux Falls, South Dakota, Verenigde Staten, 57105
        • Werving
        • Avera Cancer Institute- Research ( Site 0094)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: 605-322-6900
      • Yankton, South Dakota, Verenigde Staten, 57078
        • Werving
        • Avera Cancer Institute - Yankton ( Site 0117)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: 605-655-1800
    • Tennessee
      • Nashville, Tennessee, Verenigde Staten, 37203
        • Werving
        • SCRI Oncology Partners ( Site 7000)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: 615-218-4647
    • Texas
      • Austin, Texas, Verenigde Staten, 78731
        • Werving
        • Texas Oncology - Central/South Texas ( Site 8003)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: 512-427-9400
      • Dallas, Texas, Verenigde Staten, 75246
        • Voltooid
        • Texas Oncology - DFW ( Site 8001)
      • Houston, Texas, Verenigde Staten, 77024
        • Werving
        • Texas Oncology - Gulf Coast ( Site 8002)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: 713-467-1722
    • Virginia
      • Charlottesville, Virginia, Verenigde Staten, 22908
        • Werving
        • University of Virginia Health System ( Site 0054)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: 434-327-3029
      • Richmond, Virginia, Verenigde Staten, 23219
        • Voltooid
        • VCU Health Adult Outpatient Pavillion ( Site 0061)
      • Roanoke, Virginia, Verenigde Staten, 24014
        • Werving
        • Blue Ridge Cancer Care ( Site 0004)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: 540-982-0237
    • Washington
      • Seattle, Washington, Verenigde Staten, 98109
        • Werving
        • Fred Hutchinson Cancer Center ( Site 0013)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: 617-413-9079
    • Wisconsin
      • Milwaukee, Wisconsin, Verenigde Staten, 53226
        • Werving
        • Medical College of Wisconsin ( Site 0020)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: 414-805-4600
  • Zuid -Korea
      • Seoul, Zuid -Korea, 06351
        • Werving
        • Samsung Medical Center ( Site 1405)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +82234101767
      • Seoul, Zuid -Korea, 03080
        • Werving
        • Seoul National University Hospital-Oncology ( Site 1401)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +82220721672
      • Seoul, Zuid -Korea, 03722
        • Werving
        • Severance Hospital, Yonsei University Health System-Medical oncology ( Site 1404)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +82222288138
    • Seoul
      • Songpagu, Seoul, Zuid -Korea, 05505
        • Werving
        • Asan Medical Center-Oncology ( Site 1402)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +82230106095
  • Zweden
    • Stockholm County
      • Stockholm, Stockholm County, Zweden, 171 64
        • Actief, niet wervend
        • Karolinska Universitetssjukhuset Solna ( Site 1478)
    • Uppsala County
      • Uppsala, Uppsala County, Zweden, 751 85
        • Werving
        • Akademiska sjukhuset-Blod- och tumörsjukdomar ( Site 1477)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: 0046186110000
    • Västra Götaland County
      • Gothenburg, Västra Götaland County, Zweden, 413 45
        • Werving
        • Sahlgrenska Universitetssjukhuset ( Site 1479)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: 0046313421000

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

Inclusion Criteria:

  • Has histologically- or cytologically-confirmed adenocarcinoma of the prostate without small cell histology.
  • Has prostate cancer progression while on androgen deprivation therapy (or post bilateral orchiectomy) within 6 months before Screening
  • Has current evidence of distant metastatic disease (M1 disease) documented by either bone lesions on bone scan and/or soft tissue disease by computed tomography/magnetic resonance imaging (CT/MRI).
  • Has disease that progressed during or after treatment with 1 novel hormonal agent (NHA)
  • Has received 1 but no more than 2 taxane-based chemotherapy regimens for metastatic castration-resistant prostate cancer (mCRPC) and has had progressive disease (PD) during or after treatment
  • Has ongoing androgen deprivation with serum testosterone <50 ng/dL (<1.7 nM)
  • Has provided tumor tissue from a fresh core or excisional biopsy from soft tissue not previously irradiated
  • Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 assessed within 7 days of randomization
  • Has had prior treatment with PARPi or were deemed ineligible to receive treatment by the investigator or have refused PARPi treatment
  • Has received prior 177Lu-PSMA-617 or were deemed ineligible to receive 177Lu-PSMA-617 treatment by the investigator or refused 177Lu-PSMA-617 treatment
  • Participants who have not received cabazitaxel can be enrolled if they are ineligible for cabazitaxel treatment as determined by the investigator or have refused treatment
  • If participant received first generation anti-androgen therapy before screening, the participant has evidence of disease progression >4 weeks since the last flutamide treatment and >6 weeks since the last bicalutamide or nilutamide treatment
  • Participants receiving bone resorptive therapy (including, but not limited to, bisphosphonate or denosumab) must have been on stable doses for ≥ 4 weeks before the date of randomization
  • Participants with human immunodeficiency virus (HIV) infection must have well controlled HIV on antiretroviral therapy (ART)
  • 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 can produce sperm must agree to the following during the study treatment period and for at least 7 days after the last dose of opevesostat, for at least 30 days after the last dose of abiraterone acetate, and for at least 3 months after the last dose of enzalutamide: EITHER be abstinent OR must agree to use male condom

Exclusion Criteria:

  • Has a gastrointestinal disorder that might affect absorption
  • Has a history of pituitary dysfunction
  • Has poorly controlled diabetes mellitus
  • Has clinically significant abnormal serum potassium or sodium level
  • Has a history of active or unstable cardio/cerebro-vascular disease, including thromboembolic events
  • Has a history of seizure within 6 months of providing documented informed consent or any condition that may predispose to seizures within 12 months before the date of randomization
  • Has a history of clinically significant ventricular arrhythmias
  • Has received an anticancer monoclonal antibody (mAb) within 4 weeks before the date of randomization, or has not recovered from adverse events (AEs) due to mAbs administered more than 4 weeks before the date of randomization
  • Has undergone major surgery, including local prostate intervention (except prostate biopsy), within 28 days before the date of randomization, and has not recovered from the toxicities and/or complications
  • Participants who have not adequately recovered from major surgery or have ongoing surgical complications
  • Has used herbal or medicinal products that may have hormonal anti-prostate cancer activity and/or are known to decrease prostate-specific Antigen (PSA) (eg, saw palmetto, megesterol acetate, citrus pectin polysaccharide) within 4 weeks before the date of randomization
  • Has received radium-223 or Lutetium-177 within 4 weeks before the date of randomization, or has not recovered to Grade ≤1 or baseline from AEs due to radium-223 or Lutetium-177 administered more than 4 weeks before the date of randomization
  • Has received treatment with 5-αreductase inhibitors (eg, finasteride or dutasteride), estrogens, or cyproterone within 4 weeks before the date of randomization
  • Has received colony-stimulating factors within 28 days before the date of randomization
  • Has received a whole blood transfusion in the last 120 days before the date of randomization. Packed red blood cells and platelet transfusions are acceptable if not given within 28 days of the date of randomization
  • Has received prior targeted small molecule therapy or NHA treatment within 4 weeks before the first dose of study intervention as follows: enzalutamide or apalutamide within 3 weeks or abiraterone acetate + prednisone or darolutamide within 2 weeks
  • Has a "superscan" bone scan
  • Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior the first dose of study medication
  • Has a known additional malignancy that is progressing or has required active treatment within the past 3 years
  • Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis
  • Has an active autoimmune disease that has required systemic treatment in past 2 years
  • Has an active infection requiring systemic therapy
  • Has concurrent active HBV or known active HCV infection
  • Has a history of long QTc syndrome
  • Has any of the following at Screening Visit: hypotension (systolic BP <110 mm Hg) or uncontrolled hypertension (systolic BP ≥160 mm Hg or diastolic BP ≥90 mm Hg, in 2 out of 3 recordings with optimized antihypertensive therapy)
  • Is unable to swallow capsules/tablets
  • Is currently being treated with cytochrome 450-inducing antiepileptic drugs for seizures
  • Participants on an unstable dose of thyroid hormone therapy within 6 months before the start of the study intervention
  • Received prior systemic anticancer therapy including investigational agents within 4 weeks before the first dose of study intervention
  • Received prior radiotherapy within 2 weeks of start of study intervention, or radiation-related toxicities, requiring corticosteroids
  • Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention
  • Systemic use of the following medications within 2 weeks before the first dose of study intervention: strong CYP3A4 inducers (eg, avasimibe, carbamazepine, lumacaftor, phenobarbital, rifampicin, rifapentine, or St John's Wort); P-gp inhibitors (eg, erythromycin, clarithromycin, rifampicin, ketoconazole, itraconazole, posaconazole, artesunate-pyronaridine, ritonavir, indinavir, nelfinavir, atazanavir, glecaprevir-pibrentasvir, simeprevir, ledipasvir-sofosbuvir, verapamil, diltiazem, dronedarone, propafenone, quinidine, cyclosporine, valspodar, or milk thistle [Silybum marianum])
  • Use of aldosterone antagonist (eg, spironolactone, eplerenone) and phenytoin within 4 weeks before the start of the study intervention

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Opevesostat

Participants receive opevesostat 5 mg by oral tablets twice daily (bid) plus dexamethasone 1.5 mg by oral tablets once daily (qd) and 0.1 mg fludrocortisone acetate by oral tablet qd until progression. Hydrocortisone 100 mg (oral or intramuscular [IM]) dose will also be provided to participants for use as rescue medication. Prior to study protocol amendment 9, prednisone was provided as a rescue medication during adrenal recovery, titrated at 5mg daily maintenance dose and then titrated to discontinuation.
Geneesmiddel: Opevesostat

Administered orally

Andere namen:
  • MK-5684
Geneesmiddel: Hydrocortisone

Administered orally or IM as a rescue medication

Geneesmiddel: Fludrocortisone acetate

Administered orally

Geneesmiddel: Prednisone

Administered orally as a rescue medication

Geneesmiddel: Dexamethasone

Administered orally as rescue medication
Actieve vergelijker: Abiraterone Acetate or Enzalutamide

Participants receive abiraterone 1000 mg qd by oral tablets plus prednisone 5 mg bid by oral tablets or enzalutamide 160 mg qd by oral tablets.
Geneesmiddel: Prednisone

Administered orally as a rescue medication

Geneesmiddel: Abiraterone acetate

Administered orally

Andere namen:
  • ZYTIGA
  • YONSA
Geneesmiddel: Enzalutamide

Administered orally

Andere namen:
  • XTANDI

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Overall Survival (OS) in Androgen Receptor Ligand Binding Domain (AR LBD) Mutation-Positive Participants
Tijdsspanne: Up to ~54 months

OS is defined as time from randomization to death due to any cause. OS in AR LBD mutation-positive participants will be reported for each study arm.
Up to ~54 months
OS in AR LBD Mutation-Negative Participants
Tijdsspanne: Up to ~54 months

OS is defined as time from randomization to death due to any cause. OS in AR LBD mutation-negative participants will be reported for each study arm.
Up to ~54 months

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Radiographic Progression-free Survival (rPFS) Per Prostate Cancer Working Group-modified Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review in AR LBD Mutation-Positive Participants
Tijdsspanne: Up to ~36 months

rPFS is defined as the time from randomization to the first documented disease progression per Prostate Cancer Working Group (PCWG)-modified Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as assessed by Blinded Independent Central Review (BICR) or death due to any cause, whichever occurs first. rPFS in AR LBD mutation-positive participants will be reported for each study arm.
Up to ~36 months
rPFS Per Prostate Cancer Working Group-modifiedRECIST 1.1 as Assessed by Blinded Independent Central Review in AR LBD Mutation-Negative Participants
Tijdsspanne: Up to ~36 months

rPFS is defined as the time from randomization to the first documented disease progression per Prostate Cancer Working Group (PCWG)-modified Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as assessed by Blinded Independent Central Review (BICR) or death due to any cause, whichever occurs first. rPFS in AR LBD mutation-positive participants will be reported for each study arm.
Up to ~36 months
Time to Initiation of the First Subsequent Anti-Cancer Therapy or Death (TFST)
Tijdsspanne: Up to ~54 months

TFST is defined as the time from randomization to initiation of the first subsequent anticancer therapy or death, whichever occurs first.
Up to ~54 months
Objective Response (OR)
Tijdsspanne: Up to ~54 months

OR is determined by PCWG-modified RECIST 1.1 as assessed by BICR.
Up to ~54 months
Duration of Response (DOR)
Tijdsspanne: Up to ~54 months

DOR is determined by PCWG-modified RECIST 1.1 as assessed by BICR.
Up to ~54 months
Time to Pain Progression (TTPP)
Tijdsspanne: Up to ~54 months

TTPP is assessed by Brief Pain Inventory-Short Form (BPI-SF) Item 3 ("Worst Pain in 24 Hours") and opiate analgesic use (Analgesic Quantification Algorithm [AQA] Score).
Up to ~54 months
Time to Prostate-specific Antigen (PSA) Progression
Tijdsspanne: Up to ~54 months

The time from randomization to PSA progression. The PSA progression date is defined as the date of either: 1) ≥25% increase and ≥2 ng/mL above the nadir, confirmed by a second value ≥3 weeks later if there is PSA decline from baseline 2) ≥25% increase and ≥2 ng/mL increase from baseline beyond 12 weeks if there is no PSA decline from baseline.
Up to ~54 months
Time to First Symptomatic Skeletal-related Event (SSRE)
Tijdsspanne: Up to ~54 months

The time from randomization to the first occurrence of any of the following symptomatic skeletal-related events: 1) Use of EBRT to prevent or relieve skeletal symptoms; 2) new symptomatic pathologic bone fracture (vertebral or non-vertebral); 3) spinal cord compression; or 4) tumor-related orthopedic surgical intervention.
Up to ~54 months
Number of Participants Who Experience an Adverse Event
Tijdsspanne: Up to ~54 months

An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Up to ~54 months
Number of Participants Who Discontinue Study Treatment Due to an Adverse Event
Tijdsspanne: Up to ~54 months

An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Up to ~54 months

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Merck Sharp & Dohme LLC

Onderzoekers

  • Studie directeur: Medical Director, Merck Sharp & Dohme LLC

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Nuttige links

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

31 december 2023

Primaire voltooiing (Geschat)

30 november 2028

Studie voltooiing (Geschat)

29 maart 2030

Studieregistratiedata

Eerst ingediend

13 november 2023

Eerst ingediend dat voldeed aan de QC-criteria

13 november 2023

Eerst geplaatst (Werkelijk)

18 november 2023

Updates van studierecords

Laatste update geplaatst (Werkelijk)

5 november 2026

Laatste update ingediend die voldeed aan QC-criteria

4 november 2026

Laatst geverifieerd

1 november 2026

Meer informatie

Termen gerelateerd aan deze studie

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 5684-003
  • MK-5684-003 (Andere identificatie: MSD)
  • jRCT2031240029 (Register-ID: Japan Registry of Clinical Trials (jRCT))
  • U1111-1287-5304 (Register-ID: UTN)
  • 2023-504899-25-00 (Andere identificatie: EU CT)
  • 2023 (Subsidie/contract van de Amerikaanse NIH)

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

JA

Beschrijving IPD-plan

https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Ja

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

Abonneren