Who is sponsoring NCT00638690?

NCT00638690 is sponsored by Cougar Biotechnology, Inc..

What condition does NCT00638690 study?

NCT00638690 studies Prostatic Neoplasms.

What drugs are being tested in NCT00638690?

Interventions: Placebo, Abiraterone acetate, Prednisone/prednisolone.

What is the status of NCT00638690?

NCT00638690 is currently COMPLETED.

Last reviewed 2014-04-10 · How we verify

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

NCT00638690 Phase 3 COMPLETED Results posted

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.

Details

Lead sponsor	Cougar Biotechnology, Inc.
Phase	Phase 3
Status	COMPLETED
Enrolment	1195
Start date	2008-05
Completion	2012-10

Conditions

Prostatic Neoplasms

Interventions

Placebo
Abiraterone acetate
Prednisone/prednisolone

Primary outcomes

Overall Survival — Up to 60 months
Overall survival is defined as the time interval from the date of randomization to the date of death from any cause.

Countries

United States, Australia, Austria, Belgium, Canada, France, Germany, Hungary, Ireland, Netherlands, Spain, United Kingdom