To hear about similar clinical trials, please enter your email below

Trial Title: Substudy 01A: Safety and Efficacy of Opevesostat (MK-5684)-Based Treatment Combinations or Opevesostat Alone in Participants With Metastatic Castration-resistant Prostate Cancer (mCRPC) (MK-5684-01A)

NCT ID: NCT06353386

Condition: Prostatic Neoplasms, Castration-Resistant

Conditions: Official terms:
Prostatic Neoplasms
Prostatic Neoplasms, Castration-Resistant
Dexamethasone
Prednisone
Fludrocortisone
Docetaxel
Olaparib

Study type: Interventional

Study phase: Phase 1/Phase 2

Overall status: Recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: Opevesostat
Description: Oral Tablet
Arm group label: Arm A1: Opevesostat
Arm group label: Arm A2: Olaparib + Opevesostat
Arm group label: Arm A3: Docetaxel + Opevesostat
Arm group label: Arm A4: Cabazitaxel + Opevesostat

Other name: MK-5684

Intervention type: Drug
Intervention name: Olaparib
Description: Oral Tablet
Arm group label: Arm A2: Olaparib + Opevesostat

Other name: LYNPARZA®

Intervention type: Drug
Intervention name: Docetaxel
Description: IV Infusion
Arm group label: Arm A3: Docetaxel + Opevesostat

Other name: TAXOTERE®

Intervention type: Drug
Intervention name: Cabazitaxel
Description: IV Infusion
Arm group label: Arm A4: Cabazitaxel + Opevesostat

Other name: JEVTANA®

Intervention type: Drug
Intervention name: Fludrocortisone acetate
Description: Oral Tablet
Arm group label: Arm A1: Opevesostat
Arm group label: Arm A2: Olaparib + Opevesostat
Arm group label: Arm A3: Docetaxel + Opevesostat
Arm group label: Arm A4: Cabazitaxel + Opevesostat

Intervention type: Drug
Intervention name: Dexamethasone
Description: Oral Tablet
Arm group label: Arm A1: Opevesostat
Arm group label: Arm A2: Olaparib + Opevesostat
Arm group label: Arm A3: Docetaxel + Opevesostat
Arm group label: Arm A4: Cabazitaxel + Opevesostat

Intervention type: Drug
Intervention name: Prednisone
Description: Oral Tablet
Arm group label: Arm A3: Docetaxel + Opevesostat
Arm group label: Arm A4: Cabazitaxel + Opevesostat

Summary: 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.

Criteria for eligibility:
Criteria:
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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Macquarie University-MQ Health Clinical Trials Unit ( Site 0108)

Address:
City: Macquarie University
Zip: 2109
Country: Australia

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: 0402856430

Facility:
Name: Gallipoli Medical Research Ltd-GMRF CTU ( Site 0107)

Address:
City: Greenslopes
Zip: 4120
Country: Australia

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: +61 7 33947284

Facility:
Name: Peter MacCallum Cancer Centre-Parkville Cancer Clinical Trials Unit (PCCTU) ( Site 0110)

Address:
City: Melbourne
Zip: 3000
Country: Australia

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: +6138559500

Facility:
Name: Jewish General Hospital ( Site 0206)

Address:
City: Montreal
Zip: H3T 1E2
Country: Canada

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: 5143408110

Facility:
Name: Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésus ( Site 0

Address:
City: Quebec
Zip: G1J 1Z4
Country: Canada

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: 418-691- 5225

Facility:
Name: CIDO SpA-Oncology ( Site 0302)

Address:
City: Temuco
Zip: 4810218
Country: Chile

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: 569 5 798 31 73

Facility:
Name: Clinica Universidad Catolica del Maule-Oncology ( Site 0304)

Address:
City: Talca
Zip: 3465584
Country: Chile

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: 56992992913

Facility:
Name: FALP ( Site 0301)

Address:
City: Santiago
Zip: 7500921
Country: Chile

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: +56956075934

Facility:
Name: Pontificia Universidad Catolica de Chile-Centro del Cáncer ( Site 0303)

Address:
City: Santiago
Zip: 8330032
Country: Chile

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: 56223547919

Facility:
Name: Bradfordhill ( Site 0300)

Address:
City: Santiago
Zip: 8420383
Country: Chile

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: 56954240753

Facility:
Name: Herlev and Gentofte Hospital ( Site 0501)

Address:
City: Copenhagen
Zip: 2730
Country: Denmark

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: 45 3868 9255

Facility:
Name: Aalborg Universitetshospital, Syd ( Site 0503)

Address:
City: Aalborg
Zip: 9000
Country: Denmark

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: 4597661408

Facility:
Name: Vaasan Keskussairaala ( Site 0603)

Address:
City: Vaasa
Zip: 65130
Country: Finland

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: 35862136981

Facility:
Name: Helsinki University Hospital - Comprehensive Cancer Center (HYKS - Syöpäkeskus) ( Site 0604)

Address:
City: Helsinki
Zip: 00029
Country: Finland

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: 0406802708

Facility:
Name: Institut de cancérologie Strasbourg Europe (ICANS) ( Site 0700)

Address:
City: Strasbourg
Zip: 67033
Country: France

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: 33368766767

Facility:
Name: Gustave Roussy ( Site 0701)

Address:
City: Villejuif
Zip: 94800
Country: France

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: 0142114211

Facility:
Name: Hôpital Européen Georges Pompidou-Service d'Oncologie Médicale ( Site 0702)

Address:
City: Paris
Zip: 75015
Country: France

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: 33156093447

Facility:
Name: Universitaetsklinikum Heidelberg ( Site 0805)

Address:
City: Heidelberg
Zip: 69120
Country: Germany

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: +496221565982

Facility:
Name: Universitaetsklinikum Tuebingen-Urologie ( Site 0801)

Address:
City: Tübingen
Zip: 72076
Country: Germany

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: 07071 29-87235

Facility:
Name: Charité Universitaetsmedizin Berlin - Campus Mitte ( Site 0800)

Address:
City: Berlin
Zip: 10117
Country: Germany

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: +4930450615137

Facility:
Name: Universitaetsklinikum Hamburg-Eppendorf-Onkologisches Zentrum ( Site 0804)

Address:
City: Hamburg
Zip: 20246
Country: Germany

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: +4915222815585

Facility:
Name: St. Vincent's University Hospital ( Site 0901)

Address:
City: Dublin 4
Zip: D04 T6F4
Country: Ireland

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: 35314144208

Facility:
Name: Tallaght University Hospital ( Site 0900)

Address:
City: Dublin
Zip: D24 NR0A
Country: Ireland

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: 35314144208

Facility:
Name: Rambam Health Care Campus-Oncology Division ( Site 1002)

Address:
City: Haifa
Zip: 3109601
Country: Israel

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: 97247776750

Facility:
Name: Rabin Medical Center ( Site 1001)

Address:
City: Petah Tikva
Zip: 4941492
Country: Israel

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: +972-39378074

Facility:
Name: Sheba Medical Center ( Site 1000)

Address:
City: Ramat Gan
Zip: 5265601
Country: Israel

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: 0525505090

Facility:
Name: Fondazione Policlinico Universitario Agostino Gemelli IRCCS -Medical Oncology ( Site 1102)

Address:
City: Roma
Zip: 00168
Country: Italy

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: +390630154844

Facility:
Name: Azienda Ospedaliera Universitaria Integrata Verona - Ospedal-Centro Ricerche Cliniche di Verona ( Si

Address:
City: Verona
Zip: 37134
Country: Italy

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: 390458122768

Facility:
Name: Toho University Sakura Medical Center ( Site 1201)

Address:
City: Sakura
Zip: 285-8741
Country: Japan

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: +81-43-462-8811

Facility:
Name: Yokohama City University Medical Center ( Site 1203)

Address:
City: Yokohama
Zip: 232-0024
Country: Japan

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: +81-45-261-5656

Facility:
Name: The Jikei University Hospital ( Site 1202)

Address:
City: Mitato
Zip: 105-8471
Country: Japan

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: +81-3-3433-1111

Facility:
Name: Kyushu University Hospital ( Site 1204)

Address:
City: Fukuoka
Zip: 812-8582
Country: Japan

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: +81-92-641-1151

Facility:
Name: Asan Medical Center-Oncology ( Site 1500)

Address:
City: Songpagu
Zip: 05505
Country: Korea, Republic of

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: 82230105977

Facility:
Name: Severance Hospital, Yonsei University Health System-Medical oncology ( Site 1502)

Address:
City: Seoul
Zip: 03722
Country: Korea, Republic of

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: 82222288138

Facility:
Name: Samsung Medical Center-Division of Hematology/Oncology ( Site 1501)

Address:
City: Seoul
Zip: 06351
Country: Korea, Republic of

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: 82234101767

Facility:
Name: Auckland City Hospital-Cancer & Blood Research ( Site 1333)

Address:
City: Auckland
Zip: 1023
Country: New Zealand

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: 64212407080

Facility:
Name: Centrum Onkologii im. Prof. Franciszka Lukaszczyka-Ambulatorium Chemioterapii ( Site 1402)

Address:
City: Bydgoszcz
Zip: 85-796
Country: Poland

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: +48523743525

Facility:
Name: Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Oddzial Badan Wczesnych Faz ( Site 1400

Address:
City: Warszawa
Zip: 02-781
Country: Poland

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: 48225463381

Facility:
Name: Institut Català d'Oncologia - L'Hospitalet-Medical Oncology ( Site 1603)

Address:
City: L Hospitalet
Zip: 08908
Country: Spain

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: 34932607744

Facility:
Name: Hospital Universitario Ramón y Cajal-Medical Oncology ( Site 1600)

Address:
City: Madrid
Zip: 28034
Country: Spain

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: 34913368263

Facility:
Name: Hospital Universitari Vall d'Hebron-Departamento de Oncologia- VHIO ( Site 1602)

Address:
City: Barcelona
Zip: 08035
Country: Spain

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: 344893846

Facility:
Name: Hospital Clinico San Carlos-Oncology Department ( Site 1604)

Address:
City: Madrid
Zip: 28040
Country: Spain

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: 34913303000x7554

Facility:
Name: The Beatson West of Scotland Cancer Centre ( Site 1904)

Address:
City: Glasgow
Zip: G12 0YN
Country: United Kingdom

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: +447780777067

Start date: May 20, 2024

Completion date: March 31, 2028

Lead sponsor:
Agency: Merck Sharp & Dohme LLC
Agency class: Industry

Collaborator:
Agency: Orion Corporation, Orion Pharma
Agency class: Industry

Source: Merck Sharp & Dohme LLC

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06353386
https://www.merckclinicaltrials.com/
https://msd.trialsummaries.com/Study/StudyDetails?id=26115&tenant=MT_MSD_9011

Login to your account

Did you forget your password?