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

Part of paid clinical trials in San Diego, California.

Sponsor
AstraZeneca
Study ID
NCT01972217
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
MALE
Age
18 Years - 130 Years
Healthy Volunteers
Not accepted

Interventions

  • Olaparib — DRUG
    Olaparib bid
  • Placebo — DRUG
    Placebo bid
  • Abiraterone — DRUG
    Abiraterone 1000 mg
  • Prednisone or prednisolone — DRUG
    Prednisone or prednisolone 5 mg bid will be co-administered with the abiraterone in this study.

Study Details

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.

Key Dates

Start date
Apr 1, 2014
Status verified
Oct 2023
Primary completion
Sep 22, 2017
Completion
Aug 24, 2023

Study Design

Enrollment
158 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Olaparib
    200 mg or 300 mg bid
  • Placebo Comparator: Placebo
    placebo to match olaparib bid

Primary Outcome Measure

Part A: Percentage of Patients Experiencing Adverse Events (AEs) [ Time Frame: Cohort 1 and 2: From baseline in Part A (Day 1 for each cohort) up to 30 days following last dose of study treatment. ]

Locations (2)

FacilityCityStateZIPSite coordinators
Research SiteSan DiegoCalifornia92123-
Research SiteLake SuccessNew York11041-

Find similar trials in San Diego, CA

By condition
Prostate cancer
By specialty
OncologyProstate oncologyMen's healthUrology
By research site
Research Site· San Diego, CAResearch Site· Lake Success, NY

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