Study identifier:D081DC00008
ClinicalTrials.gov identifier:NCT01972217
EudraCT identifier:2013-003520-37
CTIS identifier:N/A
A Randomised, Double-Blind, Placebo-Controlled, Multicentre Phase II Study to Compare the Efficacy, Safety and Tolerability of Olaparib Versus Placebo When Given in Addition to Abiraterone Treatment in Patients With Metastatic Castrate-Resistant Prostate Cancer Who Have Received Prior Chemotherapy Containing Docetaxel
metastatic castration-resistant prostate cancer
Phase 2
No
Olaparib, Placebo, Abiraterone, Prednisone or prednisolone
Male
158
Interventional
18 Years - 130 Years
Allocation: Randomized
Endpoint Classification: Safety/Efficacy
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment
Verified 01 Oct 2023 by AstraZeneca
AstraZeneca
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
No locations available
Arms | Assigned Interventions |
---|---|
Active Comparator: Olaparib 200 mg or 300 mg bid | Drug: Olaparib Olaparib bid Other Name: PARP inhibition Drug: Abiraterone Abiraterone 1000 mg Other Name: Abiraterone Drug: Prednisone or prednisolone Prednisone or prednisolone 5 mg bid will be co-administered with the abiraterone in this study. |
Placebo Comparator: Placebo placebo to match olaparib bid | Drug: Placebo Placebo bid Other Name: Placebo to PARP inhibition Drug: Abiraterone Abiraterone 1000 mg Other Name: Abiraterone Drug: Prednisone or prednisolone Prednisone or prednisolone 5 mg bid will be co-administered with the abiraterone in this study. |