Ph II Study to evaluate Olaparib with Abiraterone in treating metastatic castration resistant prostate cancer.

Study identifier:D081DC00008

ClinicalTrials.gov identifier:NCT01972217

EudraCT identifier:2013-003520-37

CTIS identifier:N/A

Study Complete

Official Title

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

Medical condition

metastatic castration-resistant prostate cancer

Phase

Phase 2

Healthy volunteers

No

Study drug

Olaparib, Placebo, Abiraterone, Prednisone or prednisolone

Sex

Male

Actual Enrollment

158

Study type

Interventional

Age

18 Years - 130 Years

Date

Study Start Date: 01 Apr 2014
Primary Completion Date: 22 Sept 2017
Study Completion Date: 24 Aug 2023

Study design

Allocation: Randomized
Endpoint Classification: Safety/Efficacy
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment

Verification:

Verified 01 Oct 2023 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.

Inclusion and exclusion criteria