31
Participants
Start Date
July 31, 2007
Primary Completion Date
March 31, 2012
Study Completion Date
March 31, 2012
Stage 1 Group 1: abiraterone acetate
1000 mg capsules/day orally on Day 1. On Day 8, patients will crossover and receive tablet formulation at the same dose.
Stage 1 Group 2: abiraterone acetate
1000 mg tablets/day orally on Day 1. On Day 8, patients will crossover and receive capsule formulation at the same dose.
Stage 2: abiraterone acetate
1000 mg tablets/day orally for 12 cycles (28 days/cycle) according to assigned group from Stage 1.
Stage 3: abiraterone acetate
1000 mg tablets/day orally for 12 cycles (28 days/cycle).
Stage 3: glucocorticoid
prednisone/prednisolone 5 mg twice daily orally or dexamethasone 0.5 mg once daily for 12 cycles (28 days/cycle).
Stage 4: abiraterone acetate
1000 mg tablets/day orally for up to 24 cycles (28 days/cycle).
Stage 4: glucocorticoid
prednisone/prednisolone 5 mg twice daily orally or dexamethasone 0.5 mg once daily for up to 24 cycles (28 days/cycle).
Los Angeles
Glasgow
Sutton
Lead Sponsor
Cougar Biotechnology, Inc.
INDUSTRY