OncRef

Clinical Trial: NCT00638690

Abiraterone Acetate in Castration-Resistant Prostate Cancer Previously Treated With Docetaxel-Based Chemotherapy

Status:

COMPLETED

Phase:

Phase 3

Lead Sponsor:Cougar Biotechnology, Inc.
Information Provided By:Cougar Biotechnology, Inc.
Last Update Posted:2014-04-30

Study Overview

Brief Summary

This is a phase 3 study to compare the clinical benefit of abiraterone acetate plus prednisone with placebo plus prednisone in patients with metastatic castration-resistant prostate cancer (CRPC) who have failed one or two chemotherapy regimens. At least one of the previous chemotherapies must have contained docetaxel.

Official Title

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Abiraterone Acetate (CB7630) Plus Prednisone in Patients With Metastatic Castration-Resistant Prostate Cancer Who Have Failed Docetaxel-Based Chemotherapy

Conditions

Prostatic Neoplasms

Intervention / Treatment

  • Drug: Placebo
  • Drug: Abiraterone acetate
  • Drug: Prednisone/prednisolone

Other Study ID Numbers

  • CR016924
  • COU-AA-301

Start Date

2008-05

Primary Completion Date (Actual)

2010-08

Study Completion Date (Actual)

2012-10

Enrollment (Actual)

1195

Study Type

Interventional

Phase

Phase 3