drugset / Trial / NCT01424930

A Study to Determine the Short-Term Safety of Continuous Dosing of Abiraterone Acetate and Prednisone in Modified Fasting and Fed States to Patients With Metastatic Castration-Resistant Prostate Cancer

NCT01424930 ↗

Phase 2 Completed 25 enrolled Janssen-Ortho Inc., Canada
Non-randomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study is to establish the safety profile of oral (by mouth) abiraterone acetate and oral prednisone following short-term administration after standardized low-fat or high-fat meals to patients with metastatic (spreading) castration-resistant prostate cancer (mCRPC).

Timeline

Start
2011-10
Primary completion
2013-04
Completion
2013-05

Drugs

EvaluationDrugModalityDoseRoute
Subject Abiraterone acetate Small molecule 1000 mg Oral
Background Prednisone Other / unclassified 5 mg Oral

Indications