A Phase 3, Randomized, Double-blind, Placebo-Controlled Study of Abiraterone Acetate (CB7630) Plus Prednisone in Patients with Metastatic Castration-Resistant Prostate Cancer Who Have Failed Docetaxel-Based Chemotherapy

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Study Title: A Phase 3, Randomized, Double-blind, Placebo-Controlled Study of Abiraterone Acetate (CB7630) Plus Prednisone in Patients with Metastatic Castration-Resistant Prostate Cancer Who Have Failed Docetaxel-Based Chemotherapy

What is Abiraterone Acetate?
Abiraterone acetate is an investigational oral medication made by Cougar Biotechnology that is being studied for the treatment of metastatic prostate cancer in patients who have failed previous hormone therapy. It has not received marketing approval anywhere and is only available for testing in clinical trials. Abiraterone acetate is converted by the body to abiraterone, which blocks the production of testosterone in several parts of the body. Testosterone may be helping your prostate cancer to grow.

Trial Details

Study Description: This large Phase 3 international study will compare the clinical benefit of abiraterone acetate plus prednisone with placebo plus prednisone in patients with metastatic castration-resistant prostate cancer (CRPC) who have failed one or two chemotherapy regimens. At least one of the previous chemotherapies must have contained docetaxel.

Study Design: 2:1 Randomization (Abiraterone acetate:Placebo), Double Blind, Placebo Control, Safety/Efficacy Study. All patients will receive prednisone.

Primary Outcome Measures: Overall Survival

Estimated Enrollment: 1158
Study Start Date: April 2008
Estimated Study Completion Date: June 2011

Study Arms Assigned Interventions
1: Experimental abiraterone acetate plus prednisone/prednisolone Drug: abiraterone acetate plus prednisone/prednisolone
1000mg Daily/5mg Twice Daily
2: Placebo Comparator
placebo plus prednisone/prednisolone Drug: placebo plus prednisone/prednisolone
1000mg Daily/5mg Twice Daily
Major Inclusion Criteria:

Metastatic Castration-Resistant Prostate Cancer
Progression after one or two prior cytotoxic chemotherapies. At least one chemotherapy must have contained docetaxel
ECOG Performance Status less than/ equal to 2
Medical or surgical castration with testosterone less than/equal to 50 ng/dL
Adequate bone marrow, hepatic and renal function
Potassium greater than/ equal to 3.5 mmol/L
Able to swallow the study drug whole as a tablet
Informed Consent
Major Exclusion Criteria:

More than two prior cytotoxic chemotherapy regimens
Prior Ketoconazole for prostate cancer
Prior Abiraterone acetate or other CYP17 inhibitor or investigational agents targeting the androgen receptor for prostate cancer
Uncontrolled hypertension
Active or symptomatic viral hepatitis or chronic liver disease
History of pituitary or adrenal dysfunction
Clinically significant heart disease
Other malignancy
Known brain metastasis
GI disorder affecting absorption
For the most up-to-date information, including study locations, go to:

http://clinicaltrials.gov/ct2/show/NCT00638690?term=abiraterone&rank=3