NCT01424930View on ClinicalTrials.gov

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

PHASE2CompletedINTERVENTIONAL
Enrollment

25

Participants

Timeline

Start Date

October 31, 2011

Primary Completion Date

April 30, 2013

Study Completion Date

May 31, 2013

Conditions
Prostate NeoplasmsProstate Cancer
Interventions
DRUG

Abiraterone

Participants will receive abiraterone acetate at a starting dose of 1,000 mg once daily for 7 days post 30-minutes of a standardized low-fat meal and high-fat meal from Cycle 1 Day 8 to Cycle 1 Day 14.

DRUG

Prednisone

Prednisone will be administered as 5 mg oral tablet twice daily during Cycle 1 Day 8 to Cycle 1 Day 14.

Trial Locations (2)

Unknown

Edmonton

Vancouver

All Listed Sponsors
lead

Janssen-Ortho Inc., Canada

INDUSTRY

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 | Biotech Hunter | Biotech Hunter