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Sponsored by: |
Cougar Biotechnology, Inc. |
---|---|
Information provided by: | Cougar Biotechnology, Inc. |
ClinicalTrials.gov Identifier: | NCT00638690 |
This is a phase 3 study to 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
Condition | Intervention | Phase |
---|---|---|
Metastatic Castration-Resistant Prostate Cancer |
Drug: placebo plus prednisone/prednisolone Drug: abiraterone acetate plus prednisone/prednisolone |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official 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 |
Estimated Enrollment: | 1158 |
Study Start Date: | April 2008 |
Estimated Study Completion Date: | June 2011 |
Estimated Primary Completion Date: | June 2011 (Final data collection date for primary outcome measure) |
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
|
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Major Inclusion Criteria:
Major Exclusion Criteria:
Study Chair: | Howard I Scher, MD | Memorial Sloan-Kettering Cancer Center |
Study Chair: | JS de Bono, MD FRCP PhD | ICR/Royal Marsden Hospital |
Responsible Party: | Cougar Biotechnology, Inc. ( Christopher M. Haqq MD PhD ) |
Study ID Numbers: | COU-AA-301 |
Study First Received: | March 13, 2008 |
Last Updated: | April 10, 2009 |
ClinicalTrials.gov Identifier: | NCT00638690 History of Changes |
Health Authority: | United States: Food and Drug Administration; European Union: European Medicines Agency; Australia: National Health and Medical Research Council; Canada: Health Canada |
Metastatic Castration Resistant Prostate Cancer CRPC Abiraterone Acetate CB7630 |
Anti-Inflammatory Agents Prednisone Antineoplastic Agents, Hormonal Genital Neoplasms, Male Prostatic Diseases Methylprednisolone Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Antiemetics Methylprednisolone acetate Urogenital Neoplasms |
Prednisolone acetate Genital Diseases, Male Neuroprotective Agents Hormones Glucocorticoids Docetaxel Prednisolone Peripheral Nervous System Agents Prostatic Neoplasms Methylprednisolone Hemisuccinate |
Anti-Inflammatory Agents Prednisone Prostatic Diseases Genital Neoplasms, Male Methylprednisolone Antineoplastic Agents Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Antiemetics Prednisolone acetate Urogenital Neoplasms Neuroprotective Agents Hormones Neoplasms by Site Therapeutic Uses |
Methylprednisolone Hemisuccinate Antineoplastic Agents, Hormonal Gastrointestinal Agents Methylprednisolone acetate Genital Diseases, Male Protective Agents Glucocorticoids Pharmacologic Actions Neoplasms Autonomic Agents Prednisolone Peripheral Nervous System Agents Central Nervous System Agents Prostatic Neoplasms |