drugset / Trial / NCT01664728

An Expanded Access Study of Abiraterone Acetate in Patients With Advanced Prostate Cancer Who Have Completed Clinical Study COU-AA-001

NCT01664728

Phase 1 Completed 54 enrolled Janssen Research & Development, LLC
NaSingle-groupOpen-labelTreatment

Summary

The purpose of this study is to provide access to abiraterone acetate for patients who have completed 12 cycles of abiraterone acetate treatment in Clinical Study COU-AA-001 and continue to receive clinical benefit from this treatment.

Timeline

Start
2007-04
Primary completion
2009-02
Completion
2012-09

Drugs

EvaluationDrugModalityDoseRoute
Subject Abiraterone acetate Small molecule Oral
Background Dexamethasone Small molecule 0.5 mg Oral
Background Prednisolone Other / unclassified 5 mg Oral
Background Prednisone Other / unclassified 5 mg Oral

Indications