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Sponsored by: |
Cougar Biotechnology |
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Information provided by: | Cougar Biotechnology |
ClinicalTrials.gov Identifier: | NCT00474383 |
To evaluate the anti-tumor effects of CB7630 in patients with androgen independent metastatic prostate cancer (AIPC) who have failed docetaxel based chemotherapy, as measured by the proportion of patients achieving a PSA decline of >50% (PSA response) according to Prostate-Specific Antigen Working Group (PSAWG) criteria
Condition | Intervention | Phase |
---|---|---|
Prostate Cancer |
Drug: Abiraterone Acetate |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Phase II Open Label Study of CB7630 (Abiraterone Acetate) in Patients With Advanced Prostate Cancer Who Have Failed Androgen Deprivation and Docetaxel-Based Chemotherapy |
Estimated Enrollment: | 33 |
Study Start Date: | December 2006 |
Estimated Study Completion Date: | June 2008 |
Castrated male patients with androgen independent metastatic prostate cancer who have failed taxane based chemotherapy.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Serum bilirubin > 1.5 x ULN ALT > 2.5 x ULN AST > 2.5 x ULN
United States, California | |
Ucsf Comprehensive Cancer Center | |
SAN FRANCISCO, California, United States, 94143 | |
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: | Johann Sebastian de Bono, MD | Royal Marsden NHS Foundation Trust |
Principal Investigator: | Howard Scher, MD | Memorial Sloan-Kettering Cancer Center |
Study ID Numbers: | COU-AA-003 |
Study First Received: | May 14, 2007 |
Last Updated: | January 14, 2008 |
ClinicalTrials.gov Identifier: | NCT00474383 |
Health Authority: | United States: Food and Drug Administration; United Kingdom: Medicines and Healthcare Products Regulatory Agency |
Post-chemo failed hormone resistant CB7630 Abiraterone Acetate |
Docetaxel Prostatic Diseases Genital Neoplasms, Male Urogenital Neoplasms |
Genital Diseases, Male Taxane Prostatic Neoplasms |
Neoplasms Neoplasms by Site |