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

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

54

Participants

Timeline

Start Date

November 30, 2005

Primary Completion Date

November 30, 2008

Study Completion Date

November 30, 2008

Conditions
Prostatic Neoplasms
Interventions
DRUG

Abiraterone acetate

Abiraterone 250 mg (1 capsule) up to 2000 mg (8 capsules) once daily, each dose will be tested in sequential order for 28 days to determine the MTD.

DRUG

Abiraterone acetate MTD

Abiraterone acetate MTD orally for 12 cycles (28 day each).

DRUG

Dexamethasone

Dexamethasone 0.5 mg orally will be given (If participants have disease progression) daily up to 12 cycles.

Trial Locations (1)

Unknown

Sutton

Sponsors
All Listed Sponsors
lead

Cougar Biotechnology, Inc.

INDUSTRY