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Sponsored by: |
Cougar Biotechnology |
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Information provided by: | Cougar Biotechnology |
ClinicalTrials.gov Identifier: | NCT00485303 |
To evaluate anti-tumor effects and safety of CB7630 in patients with advanced prostate cancer who have failed androgen deprivation and docetaxel-based chemotherapy
Condition | Intervention | Phase |
---|---|---|
Hormone Refractory Prostate Cancer |
Drug: Abiraterone acetate (CB7630) Drug: Prednisone |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Phase II Open Label Study of CB7630 (Abiraterone Acetate) and Prednisone in Patients With Advanced Prostate Cancer Who Have Failed Androgen Deprivation and Docetaxel-Based Chemotherapy |
Estimated Enrollment: | 50 |
Study Start Date: | June 2007 |
Estimated Study Completion Date: | January 2009 |
Estimated Primary Completion Date: | January 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
abiraterone acetate and prednisone
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Drug: Abiraterone acetate (CB7630)
1000mg PO daily
Drug: Prednisone
5mg PO BID
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In order to fully assess the efficacy of abiraterone acetate (CB7630) in patients who have been treated with docetaxel-based chemotherapy, this study is designed to assess anti-tumor activity of CB7630 given with prednisone in prostate cancer patients who have progressive disease after docetaxel-based chemotherapy.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, California | |
UCLA | |
Los Angeles, California, United States, 90024 | |
UCSF Comprehensive Cancer Center | |
San Francisco, California, United States, 94115 | |
United States, Maryland | |
John Hopkins | |
Baltimore, Maryland, United States, 21205 | |
United States, Massachusetts | |
Dana-Farber Cancer Institute | |
BOSTON, Massachusetts, United States, 02115 | |
Masachussetts General Hospital Cancer Center | |
BOSTON, Massachusetts, United States, 02114 | |
Beth Israel Hospital | |
Boston, Massachusetts, United States, 02215 | |
United States, New York | |
Memorial Sloan-Kettering Cancer Center | |
NEW YORK, New York, United States, 10021 | |
United Kingdom | |
Royal Marsden Hospital | |
Sutton, United Kingdom |
Principal Investigator: | Howard Scher, MD | Memorial Sloan-Kettering Cancer Center |
Principal Investigator: | JS deBono, MD PhD | Royal Marsden NHS Foundation Trust |
Responsible Party: | Cougar Biotechnology, Inc. ( Christopher Haqq, MD, PhD ) |
Study ID Numbers: | COU-AA-004 |
Study First Received: | June 8, 2007 |
Last Updated: | August 5, 2008 |
ClinicalTrials.gov Identifier: | NCT00485303 |
Health Authority: | United States: Food and Drug Administration; United Kingdom: Medicines and Healthcare Products Regulatory Agency |
Abiraterone acetate Abiraterone CB7630 HPRC |
Prednisone Hormone Refractory Prostate Cancer Docetaxel-based Chemotherapy failure |
Docetaxel Prednisone Prostatic Diseases Genital Neoplasms, Male |
Urogenital Neoplasms Genital Diseases, Male Prostatic Neoplasms |
Anti-Inflammatory Agents Neoplasms Neoplasms by Site Antineoplastic Agents, Hormonal Antineoplastic Agents Therapeutic Uses |
Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Hormones Glucocorticoids Pharmacologic Actions |