MedTrace Logo

Ph II Study to Evaluate Olaparib With Abiraterone in Treating Metastatic Castration Resistant Prostate Cancer.

NCT01972217 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 158

Last updated 2023-11-14

Study results available
· View outcomes & findings →

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.

Conditions

Interventions

DRUG

Olaparib

Olaparib bid

DRUG

Placebo

Placebo bid

DRUG

Abiraterone

Abiraterone 1000 mg

DRUG

Prednisone or prednisolone

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

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
130 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-04-01
Primary Completion
2017-09-22
Completion
2023-08-24

Countries

  • United States
  • Belgium
  • Canada
  • Czechia
  • France
  • Italy
  • Netherlands
  • Poland
  • Russia
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01972217 on ClinicalTrials.gov