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| Sponsor: | Cougar Biotechnology, Inc. |
|---|---|
| Information provided by: | Cougar Biotechnology, Inc. |
| ClinicalTrials.gov Identifier: | NCT00600535 |
Purpose
To compare the total exposure of CB7630 administered in capsule formulation with that in tablet formulation in patients with prostate cancer under fasted and fed conditions
| Condition | Intervention | Phase |
|---|---|---|
|
Prostate Cancer |
Drug: abiraterone acetate plus prednisone/prednisolone |
Phase I |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment, Pharmacokinetics Study |
| Official Title: | A Pharmacokinetics Study to Assess the Oral Administration of CB7630 (Abiraterone Acetate) Capsule Formulation and Tablet Formulation in Patients With Prostate Cancer |
| Enrollment: | 31 |
| Study Start Date: | July 2007 |
| Estimated Study Completion Date: | March 2010 |
| Estimated Primary Completion Date: | December 2009 (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
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Abnormal liver function tests consisting of any of the following:
Contacts and Locations| United States, California | |
| UCLA | |
| Los Angeles, California, United States, 90024 | |
| United Kingdom | |
| Royal Marsden Hospital | |
| Sutton, United Kingdom | |
| Beatson Oncology Centre | |
| Glasgow, United Kingdom, G11 6NT | |
| Principal Investigator: | JS de Bono, MD | Royal Marsden NHS Foundation Trust |
More Information
| Responsible Party: | Cougar Biotechnology ( Thomas Griffin, MD ) |
| Study ID Numbers: | COU-AA-BE |
| Study First Received: | January 14, 2008 |
| Last Updated: | January 22, 2009 |
| ClinicalTrials.gov Identifier: | NCT00600535 History of Changes |
| Health Authority: | United States: Food and Drug Administration; United Kingdom: Medicines and Healthcare Products Regulatory Agency |
|
Abiraterone Acetate CB7630 Prostate Cancer |
|
Anti-Inflammatory Agents 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 Neoplasms Neoplasms by Site Therapeutic Uses Prednisolone Prostatic Neoplasms |