drugset / Trial / NCT00473512

A Safety and Efficacy Study of Abiraterone Acetate in Participants With Prostate Cancer Who Have Failed Hormone Therapy

NCT00473512

Phase 1/2 Completed 54 enrolled Cougar Biotechnology, Inc.
NaSingle-groupOpen-labelTreatment

Summary

The purpose of this study is to determine the maximum tolerated dose and evaluate the safety, tolerability, and activity at the recommended dose (maximum tolerated dose \[MTD\]) of abiraterone acetate (also known as CB7630) in participants with hormone refractory prostate (gland that makes fluid that aids movement of sperm) cancer (HRPC).

Timeline

Start
2005-11
Primary completion
2008-11
Completion
2008-11

Drugs

EvaluationDrugModalityDoseRoute
Subject Abiraterone acetate Small molecule 250 mg Oral
Subject Abiraterone acetate Small molecule 2000 mg Oral
Background Dexamethasone Small molecule 0.5 mg Oral

Indications