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| Sponsor: | Cougar Biotechnology, Inc. |
|---|---|
| Information provided by: | Cougar Biotechnology, Inc. |
| ClinicalTrials.gov Identifier: | NCT00485303 |
Purpose
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/prednisolone |
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) and Prednisone in Patients With Advanced Prostate Cancer Who Have Failed Androgen Deprivation and Docetaxel-Based Chemotherapy |
| Enrollment: | 58 |
| Study Start Date: | June 2007 |
| Estimated Study Completion Date: | March 2010 |
| Estimated Primary Completion Date: | January 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
abiraterone acetate and prednisone
|
Drug: Abiraterone acetate (CB7630)
1000mg PO daily
Drug: Prednisone/prednisolone
5mg PO BID
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| 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 |
More Information
| Responsible Party: | Cougar Biotechnology, Inc. ( Christopher Haqq, MD, PhD ) |
| Study ID Numbers: | COU-AA-004 |
| Study First Received: | June 8, 2007 |
| Last Updated: | January 22, 2009 |
| ClinicalTrials.gov Identifier: | NCT00485303 History of Changes |
| 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 |
|
Anti-Inflammatory Agents Prednisone Antineoplastic Agents, Hormonal Genital Neoplasms, Male Prostatic Diseases Antineoplastic Agents Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Urogenital Neoplasms Genital Diseases, Male |
Glucocorticoids Hormones Pharmacologic Actions Docetaxel Neoplasms Neoplasms by Site Therapeutic Uses Prednisolone Prostatic Neoplasms Androgens |