CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 158 enrolled
Drug / intervention
Olaparib +3 moredrug
Likely dose
Abiraterone 1000 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01972217
NCT01972217Phase 2Completed
CompareCT.gov

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

AstraZeneca·interventional·Posted Oct 30, 2013·Updated Nov 14, 2023

In Brief

A Phase 2 clinical trial evaluating Olaparib, Placebo, and 2 other interventions for Metastatic Castration-resistant Prostate Cancer. Completed, enrolled 158 participants across 41 sites in 11 countries.

Detailed Summary

This is a 2-part study in patients with metastatic CRPC. Part A is an open-label safety run-in study to assess the safety, tolerability and pharmacokinetics (PK) of olaparib when given in addition to abiraterone 1000 mg once daily. Part B is a randomised, double-blind, placebo controlled comparison of the efficacy, safety and tolerability of the dose of olaparib selected from Part A when given in addition to abiraterone, versus placebo given in addition to abiraterone. Abiraterone is indicated in combination with prednisone or prednisolone for the treatment of patients with metastatic CRPC. Prednisone or prednisolone 5 mg twice daily (bid) will be administered with the abiraterone in this study.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMetastatic Castration-resistant Prostate Cancer
CountriesBelgium, Canada, Czechia, France, Italy, Netherlands, Poland, Russia, Spain, United Kingdom, United States
CollaboratorsMerck Sharp & Dohme LLC

Timeline

Phase 2CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedOct 30, 2013
Enrollment StartApr 1, 2014
Primary CompletionSep 22, 2017
Study CompletionAug 24, 2023
TodayJul 2, 2026
Enrollment to primary: 3.5 yearsPosted 12.7 years ago

Interventions

Olaparibdrug

Olaparib bid

Placebodrug

Placebo bid

Abirateronedrug

Abiraterone 1000 mg

Prednisone or prednisolonedrug

Prednisone or prednisolone 5 mg bid will be co-administered with the abiraterone in this study.