CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,195 enrolled
Drug / intervention
Placebo +2 moredrug
Likely dose
Prednisone/prednisolone 5 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/NCT00638690
NCT00638690Phase 3Completed
CompareCT.gov

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

Cougar Biotechnology, Inc.·interventional·Posted Mar 19, 2008·Updated Apr 30, 2014

In Brief

A Phase 3 clinical trial evaluating Placebo, Abiraterone acetate, and 1 other intervention for Prostatic Neoplasms. Completed, enrolled 1,195 participants across 127 sites in 12 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsProstatic Neoplasms
CountriesAustralia, Austria, Belgium, Canada, France, Germany, Hungary, Ireland, Netherlands, Spain, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMar 19, 2008
Enrollment StartMay 1, 2008
Primary CompletionAug 1, 2010
Study CompletionOct 1, 2012
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 18.3 years ago

Interventions

Placebodrug

Four tablets once daily until disease progression

Abiraterone acetatedrug

Four 250-mg tablets once daily until disease progression

Prednisone/prednisolonedrug

5 mg twice daily until disease progression