サブ研究 01A: 転移性去勢抵抗性前立腺がん (mCRPC) の参加者における MK-5684 ベースの治療併用療法または MK-5684 単独の安全性と有効性 (MK-5684-01A)
MK-5684-01Aサブ研究：転移性去勢抵抗性前立腺がんの参加者におけるMK-5684ベースの治療併用療法またはMK-5684単独の安全性と有効性を評価するためのMK-5684-U01マスタープロトコルの第1/2相包括サブ研究(mCRPC)
Substudy 01A is part of a larger research study that is testing experimental treatments for metastatic castration-resistant prostate cancer (mCRPC). The larger study is the umbrella study (U01).
The goal of substudy 01A is to evaluate the safety and efficacy of opevesostat-based treatment combinations, or as a single agent, in participants with mCRPC.
This substudy will have two phases: a safety lead-in phase and an efficacy phase. The safety lead-in phase will be used to evaluate the safety and tolerability, and to establish a recommended Phase 2 dose (RP2D) for the opevesostat-based treatment combinations. There will be no hypothesis testing in this study.
調査の概要
状態
状態
条件
条件
介入・治療
介入・治療
研究の種類
研究の種類
入学 (推定)
入学
段階
段階
- フェーズ2
- フェーズ 1
連絡先と場所
研究場所
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-
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Cork、アイルランド、T12 DC4A
- Cork University Hospital ( Site 0902)
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Dublin、アイルランド、D24 NR0A
- Tallaght University Hospital ( Site 0900)
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Dublin
-
Dublin、Dublin、アイルランド、D04 T6F4
- St. Vincent's University Hospital ( Site 0901)
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-
-
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California
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La Jolla、California、アメリカ、92037
- UCSD Moores Cancer Center ( Site 0039)
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Los Angeles、California、アメリカ、90404
- UCLA Hematology/Oncology - Santa Monica ( Site 0044)
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Florida
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Miami、Florida、アメリカ、33136
- University of Miami Hospital and Clinics, Sylvester Cancer Center-Cancer Research Services ( Site 0051)
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Maryland
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Baltimore、Maryland、アメリカ、21201
- University of Maryland-Greenebaum Comprehensive Cancer Center ( Site 0049)
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New Jersey
-
New Brunswick、New Jersey、アメリカ、08903-2681
- Rutgers Cancer Institute of New Jersey ( Site 0033)
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Ohio
-
Cleveland、Ohio、アメリカ、44106
- University Hospitals Cleveland Medical Center ( Site 0043)
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Wisconsin
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Milwaukee、Wisconsin、アメリカ、53226
- MEDICAL COLLEGE OF WISCONSIN-Cancer Center Clinical Trials Office ( Site 0020)
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-
-
-
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Birmingham、イギリス、B15 2TH
- Queen Elizabeth Hospital Birmingham ( Site 1903)
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Cambridgeshire
-
Cambridge、Cambridgeshire、イギリス、CB2 2QQ
- Addenbrooke's Hospital ( Site 1902)
-
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Glasgow City
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Glasgow、Glasgow City、イギリス、G12 0YN
- The Beatson West of Scotland Cancer Centre ( Site 1904)
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Lancashire
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Preston、Lancashire、イギリス、PR2 9HT
- Royal Preston Hospital-Lancashire Clinical Research Facility ( Site 1900)
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London, City of
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London、London, City of、イギリス、NW1 2PG
- University College London Hospital ( Site 1905)
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-
-
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Haifa、イスラエル、3109601
- Rambam Health Care Campus-Oncology Division ( Site 1002)
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Petah Tikva、イスラエル、4941492
- Rabin Medical Center ( Site 1001)
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Ramat Gan、イスラエル、5265601
- Sheba Medical Center ( Site 1000)
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-
-
-
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Verona、イタリア、37134
- Azienda Ospedaliera Universitaria Integrata Verona - Ospedal-Centro Ricerche Cliniche di Verona ( Site 1100)
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Lazio
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Rome、Lazio、イタリア、00168
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS -Medical Oncology ( Site 1102)
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Lombardy
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Milan、Lombardy、イタリア、20133
- Fondazione IRCCS Istituto Nazionale dei Tumori-Struttura Complessa Oncologia Medica 1 ( Site 1103)
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Milano
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Rozzano、Milano、イタリア、20089
- Istituto Clinico Humanitas-U.O di Oncologia medica ed Ematologia ( Site 1101)
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-
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New South Wales
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Macquarie University、New South Wales、オーストラリア、2109
- Macquarie University-MQ Health Clinical Trials Unit ( Site 0108)
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Queensland
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Greenslopes、Queensland、オーストラリア、4120
- Gallipoli Medical Research Ltd-GMRF CTU ( Site 0107)
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Victoria
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Melbourne、Victoria、オーストラリア、3000
- Peter MacCallum Cancer Centre-Parkville Cancer Clinical Trials Unit (PCCTU) ( Site 0110)
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-
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Quebec
-
Montreal、Quebec、カナダ、H2X 3E4
- Centre Hospitalier de l'Université de Montréal ( Site 0200)
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Montreal、Quebec、カナダ、H3T 1E2
- Jewish General Hospital ( Site 0206)
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Québec、Quebec、カナダ、G1J 1Z4
- Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésus ( Site 0207)
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-
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Bogota D.C.
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Bogotá、Bogota D.C.、コロンビア、110131
- FUNDACION CTIC CENTRO DE TRATAMIENTO E INVESTIGACION SOBRE CANCER LUIS CARLOS SARMIENTO ANGULO ( Site 0406)
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Bogotá、Bogota D.C.、コロンビア、111321
- Clinica Colsanitas S.A, Sede Clínica Universitaria Colombia ( Site 0402)
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Cesar Department
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Valledupar、Cesar Department、コロンビア、200001
- Sociedad De Oncología y Hematología Del Cesar SAS-Oncology ( Site 0400)
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Departamento de Córdoba
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Montería、Departamento de Córdoba、コロンビア、230002
- IMAT S.A.S ( Site 0404)
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Valle del Cauca Department
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Cali、Valle del Cauca Department、コロンビア、760032
- Fundación Valle del Lili-Oncology CIC ( Site 0403)
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Barcelona、スペイン、08035
- Hospital Universitari Vall d'Hebron-Departamento de Oncologia- VHIO ( Site 1602)
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Madrid、スペイン、28007
- Hospital General Universitario Gregorio Marañón ( Site 1601)
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Madrid、スペイン、28040
- Hospital Clinico San Carlos-Oncology Department ( Site 1604)
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Barcelona
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L'Hospitalet de Llobregat、Barcelona、スペイン、08908
- Institut Català d'Oncologia - L'Hospitalet-Medical Oncology ( Site 1603)
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Madrid, Comunidad de
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Madrid、Madrid, Comunidad de、スペイン、28034
- Hospital Universitario Ramón y Cajal-Medical Oncology ( Site 1600)
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Biobio
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Temuco、Biobio、チリ、4810218
- CIDO SpA-Oncology ( Site 0302)
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Maule Region
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Talca、Maule Region、チリ、3465584
- Clinica Universidad Catolica del Maule-Oncology ( Site 0304)
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Region M. de Santiago
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Santiago、Region M. de Santiago、チリ、7500921
- Fundación Arturo López Pérez ( Site 0301)
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Santiago、Region M. de Santiago、チリ、832000
- Pontificia Universidad Catolica de Chile ( Site 0303)
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Santiago、Region M. de Santiago、チリ、8420383
- Bradfordhill ( Site 0300)
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Capital Region
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Copenhagen、Capital Region、デンマーク、2730
- Herlev and Gentofte Hospital ( Site 0501)
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North Denmark
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Aalborg、North Denmark、デンマーク、9000
- Aalborg Universitetshospital, Syd ( Site 0503)
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Adana、トルコ（Türkiye）、01250
- Baskent University Dr. Turgut Noyan Research and Training Center-ONCOLOGY ( Site 1802)
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Ankara、トルコ（Türkiye）、06230
- Hacettepe Universite Hastaneleri-oncology hospital ( Site 1800)
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Ankara、トルコ（Türkiye）、06800
- Ankara Bilkent Şehir Hastanesi ( Site 1801)
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Istanbul、トルコ（Türkiye）、34668
- Istanbul Universitesi Cerrahpasa-Medical Oncology ( Site 1804)
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Istanbul、トルコ（Türkiye）、34722
- TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 1803)
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Berlin、ドイツ、10117
- Charité Universitaetsmedizin Berlin - Campus Mitte ( Site 0800)
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Hamburg、ドイツ、20246
- Universitaetsklinikum Hamburg-Eppendorf-Onkologisches Zentrum ( Site 0804)
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Baden-Wurttemberg
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Heidelberg、Baden-Wurttemberg、ドイツ、69120
- Universitaetsklinikum Heidelberg ( Site 0805)
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Tübingen、Baden-Wurttemberg、ドイツ、72076
- Universitaetsklinikum Tuebingen-Urologie ( Site 0801)
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Bavaria
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Munich、Bavaria、ドイツ、81675
- klinikum rechts der isar der technischen universität münchen-Urologische Klinik und Poliklinik ( Site 0802)
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Auckland、ニュージーランド、1023
- Auckland City Hospital ( Site 1333)
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Pohjanmaa
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Vaasa、Pohjanmaa、フィンランド、65130
- Vaasan Keskussairaala ( Site 0603)
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Uusimaa
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Helsinki、Uusimaa、フィンランド、00029
- Helsinki University Hospital - Comprehensive Cancer Center (HYKS - Syöpäkeskus) ( Site 0604)
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Helsinki、Uusimaa、フィンランド、00180
- Docrates Syöpäsairaala ( Site 0602)
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Paris、フランス、75015
- Hôpital Européen Georges Pompidou-Service d'Oncologie Médicale ( Site 0702)
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Aquitaine
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Bordeaux、Aquitaine、フランス、33076
- Institut Bergonié - Centre Régional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest ( Site 0703)
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Bas-Rhin
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Strasbourg、Bas-Rhin、フランス、67200
- Hopitaux Universitaires de Strasbourg ( Site 0700)
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Île-de-France Region
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Villejuif、Île-de-France Region、フランス、94805
- Gustave Roussy ( Site 0701)
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Kuyavian-Pomeranian Voivodeship
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Bydgoszcz、Kuyavian-Pomeranian Voivodeship、ポーランド、85-796
- Centrum Onkologii im. Prof. Franciszka Lukaszczyka ( Site 1402)
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Masovian Voivodeship
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Warsaw、Masovian Voivodeship、ポーランド、02-781
- Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Oddzial Badan Wczesnych Faz ( Site 1400)
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Pomeranian Voivodeship
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Gdansk、Pomeranian Voivodeship、ポーランド、80-952
- Uniwersyteckie Centrum Kliniczne ( Site 1405)
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-
-
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Taichung、台湾、404332
- China Medical University Hospital ( Site 1703)
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Taipei、台湾、112
- Taipei Veterans General Hospital ( Site 1701)
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Taoyuan、台湾、333
- Chang Gung Medical Foundation-Linkou Branch-Medical Oncology ( Site 1702)
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Kaohsiung
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Kaohsiung Niao Sung Dist、Kaohsiung、台湾、83301
- Chang Gung Memorial Hospital at Kaohsiung-Oncology and Hematology ( Site 1704)
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Fukuoka、日本、812-8582
- Kyushu University Hospital ( Site 1204)
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Chiba
-
Sakura、Chiba、日本、285-8741
- Toho University Sakura Medical Center ( Site 1201)
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Kanagawa
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Yokohama、Kanagawa、日本、232-0024
- Yokohama City University Medical Center ( Site 1203)
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Tokyo
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Mitato、Tokyo、日本、105-8471
- The Jikei University Hospital ( Site 1202)
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-
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Seoul、韓国、03722
- Severance Hospital, Yonsei University Health System-Medical oncology ( Site 1502)
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Seoul、韓国、06351
- Samsung Medical Center-Division of Hematology/Oncology ( Site 1501)
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Seoul
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Songpagu、Seoul、韓国、05505
- Asan Medical Center-Oncology ( Site 1500)
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参加基準
適格基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
The main inclusion criteria include but are not limited to the following:
- Histologically or cytologically confirmed diagnosis of adenocarcinoma of the prostate without small cell histology.
- Prostate cancer progression and received androgen deprivation therapy (ADT) or post bilateral orchiectomy within 6 months before screening.
- Evidence of disease progression from either, >4 weeks from last flutamide treatment, or >6 weeks from last bicalutamide or nilutamide treatment, if receiving first generation anti-androgen therapy as last treatment therapy.
- Current evidence of metastatic disease.
- Prior treatment with 1 to 2 novel hormonal agent(s) (NHA) for non-metastatic, or metastatic, hormone-sensitive prostate cancer or castration-resistant prostate cancer and have disease progression during or after treatment.
- Treatment with bone resorptive therapy (including, but not limited to, bisphosphonate or denosumab) must have been on stable doses for >4 weeks before randomization.
- Participants who experienced adverse events (AEs) due to previous anticancer therapies must have recovered to <Grade 1 or baseline.
- Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy.
- 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.
- Participants with a history of Hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable.
Exclusion Criteria:
The main exclusion criteria include but are not limited to the following:
- History of pituitary dysfunction.
- Poorly controlled diabetes mellitus.
- Active or unstable cardio/cerebro-vascular disease, including thromboembolic events and history of stroke or transient ischemic attack within 6 months before the first dose of study intervention, history of myocardial infarction within 6 months before the first dose of study intervention, New York Heart Association Class III or IV cardiac disease or congestive heart failure, coronary heart disease that is symptomatic, or unstable angina
- History or family history of long corrected QT interval (QTc) syndrome.
- Myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML) or features suggestive of MDS/AML.
- History or current condition of adrenal insufficiency.
- History of (noninfectious) pneumonitis requiring steroids, or current pneumonitis.
- HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease.
- Undergone major surgery, including local prostate intervention (except prostate biopsy) within 28 days before randomization, and has not recovered from the toxicities and/or complications.
- Is on an unstable dose of thyroid hormone therapy within 6 months prior to first dose of study intervention.
- Received a whole blood transfusion in the last 120 days before randomization (packed red blood cells and platelet transfusions are acceptable if not given within 28 days before randomization).
- Received prior systemic anticancer therapy including investigational agents within 4 weeks before randomization.
- 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 does of study intervention. Administration of killed vaccines is allowed.
- 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 study intervention.
- Known additional malignancy that is progressing or has required active treatment within the past 3 years.
- Known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
- Active autoimmune disease that has required systemic treatment in the past 2 years.
- Active infection requiring systemic therapy.
- Concurrent active HBV or HCV infections.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
アーム数
武器と介入
参加者グループ / アーム参加者グループ / アーム |
介入・治療介入・治療 |
|---|---|
|
実験的：Arm A1: Opevesostat
Participants receive 5 mg of opevesostat twice daily (BID) via oral tablet plus dexamethasone 1.5 mg by oral tablets once daily (QD) and 0.1 mg fludrocortisone acetate by oral tablet QD until progression or discontinuation. |
Oral Tablet
他の名前：
Oral Tablet Oral Tablet |
|
実験的：Arm A2: Olaparib + Opevesostat
Participants receive 5 mg of opevesostat BID via oral tablet plus dexamethasone 1.5 mg by oral tablets QD and 0.1 mg fludrocortisone acetate by oral tablet QD, PLUS 300 mg of olaparib BID via oral tablet until progressive disease or discontinuation. |
Oral Tablet
他の名前：
Oral Tablet Oral Tablet Oral Tablet
他の名前：
|
|
実験的：Arm A3: Docetaxel + Opevesostat
Participants receive 5 mg of opevesostat BID via oral tablet plus dexamethasone 1.5 mg by oral tablets QD and 0.1 mg fludrocortisone acetate by oral tablet QD, PLUS 75 mg/m^2 of docetaxel once every 3 weeks (Q3W) via IV infusion, plus prednisone per approved product label BID by oral tablets until progressive disease or discontinuation. |
IV Infusion
他の名前：
Oral Tablet
他の名前：
Oral Tablet Oral Tablet Oral Tablet |
|
実験的：Arm A4: Cabazitaxel + Opevesostat
Participants receive 5 mg of opevesostat BID via oral tablet plus dexamethasone 1.5 mg by oral tablets QD and 0.1 mg fludrocortisone acetate by oral tablet QD, PLUS 20 mg/m^2 of cabazitaxel Q3W via IV infusion, plus prednisone per approved product label BID by oral tablets until progressive disease or discontinuation. |
Oral Tablet
他の名前：
Oral Tablet Oral Tablet Oral Tablet IV Infusion
他の名前：
|
この研究は何を測定していますか？
主要な結果の測定
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Number of participants who experience one or more dose-limiting toxicities (DLTs)
時間枠：Up to approximately 28 days
|
The following events, if considered drug related by the investigator, will be considered a DLT: Grade 4 nonhematologic toxicity (not laboratory value); Grade 4 hematologic toxicity lasting >7 days, except thrombocytopenia (Grade 4 thrombocytopenia of any duration, Grade 3 thrombocytopenia associated with clinically significant bleeding); Any nonhematologic adverse event (AE) >Grade 3 in severity should be considered a DLT (with exceptions); Any Grade 3 or Grade 4 nonhematologic laboratory value (if certain criteria are met); Febrile neutropenia Grade 3 or Grade 4; Prolonged delay (>2 weeks) in initiating treatment after the first 28 days due to study intervention-related toxicity; Missing >25% of study intervention doses as a result of drug-related AE(s) during the first 28 days; Grade 5 toxicity. |
Up to approximately 28 days
|
|
Number of participants who experience one or more adverse events (AEs)
時間枠：Up to approximately 46 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 approximately 46 months
|
|
Number of participants who discontinue study intervention due to an AE
時間枠：Up to approximately 46 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 approximately 46 months
|
|
Prostate-specific antigen (PSA) response rate
時間枠：Up to approximately 46 months
|
The Prostate-specific Antigen (PSA) response rate is the percentage of participants who had PSA response defined as a reduction in the PSA level from baseline by ≥50%. The reduction in PSA level will be confirmed by an additional PSA evaluation performed ≥3 weeks from the original response per Prostate Cancer Working Group (PCWG) criteria. |
Up to approximately 46 months
|
二次結果の測定
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Objective response rate (ORR)
時間枠：Up to approximately 46 months
|
The ORR is defined as the percentage of participants with complete response (CR: disappearance of all target lesions per Response Criteria in Solid Tumors version 1.1 (RECIST 1.1); and no evidence of disease (NED) on base scan per Prostate Cancer Working Group (PCWG) or partial response (PR: at least a 30% decrease in the sum of diameters of target lesions per RECIST 1.1; and non-progressive disease, non-evaluable [NE], or NED on bone scan or CR with non-progressive disease or NE bone scan per PCWG). ORR will be assessed by Blinded Independent Central Review (BICR). |
Up to approximately 46 months
|
|
Radiographic progression-free survival (rPFS)
時間枠：Up to approximately 46 months
|
rPFS is defined as the time from randomization to occurrence of: radiological tumor progression using RECIST 1.1 as assessed by BICR; progression of bone lesions using PCWG criteria; or death due to any cause. Progression as per modified RECIST 1.1 is ≥20% increase in the sum of diameters of target lesions and progression of existing non-target lesions. Progression of bone lesions by PCWG criteria is the appearance of ≥2 new bone lesions on bone scan, that have been confirmed to not represent tumor flare, and are persistent for ≥6 weeks. rPFS will be assessed by BICR. |
Up to approximately 46 months
|
|
Overall survival (OS)
時間枠：Up to approximately 46 months
|
OS is defined as the time from randomization to death due to any cause. |
Up to approximately 46 months
|
|
Duration of response (DOR)
時間枠：Up to approximately 46 months
|
DOR is defined as the time from first documented evidence of complete response (CR) or partial response (PR) per PCWG and RECIST 1.1 criteria until progressive disease (PD) or death. PD per RECIST 1.1 is defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of a least 5 mm. PD per PCWG is the appearance of >2 new bone lesions on bone scan, that have been confirmed to not represent tumor flare, and are persistent for >6 weeks. DOR will be assessed by BICR. |
Up to approximately 46 months
|
|
Time to first subsequent anticancer therapy (TFST)
時間枠：Up to approximately 46 months
|
TFST is defined as the time from randomization to initiation of the first subsequent anticancer therapy or death, whichever occurs first. |
Up to approximately 46 months
|
|
Time to pain progression (TTPP)
時間枠：Up to approximately 46 months
|
TTPP is defined as the time from randomization to pain progression based on the Brief Pain Inventory-Short Form (BPI-SF) Item 3 "worst pain in 24 hours" and by opiate analgesic use. |
Up to approximately 46 months
|
協力者と研究者
協力者
協力者
捜査官
捜査官
- スタディディレクター：Medical Director、Merck Sharp & Dohme LLC
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始 (実際)
研究開始
一次修了 (推定)
一次修了
研究の完了 (推定)
研究の完了
試験登録日
最初に提出
最初に提出
QC基準を満たした最初の提出物
QC基準を満たした最初の提出物
最初の投稿 (実際)
最初の投稿
学習記録の更新
投稿された最後の更新 (実際)
投稿された最後の更新
QC基準を満たした最後の更新が送信されました
QC基準を満たした最後の更新が送信されました
最終確認日
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
その他の研究ID番号
- 5684-01A
- MK-5684-01A (その他の識別子：MSD)
- U1111-1292-6912 (レジストリ識別子：UTN)
- jRCT2031240224 (レジストリ識別子：Japan Registry of Clinical Trials (jRCT))
- 2023-506288-33-00 (レジストリ識別子：EU CT)
- 2023 (米国 NIH グラント/契約)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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