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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: | Allocation: Non-Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
|---|---|
|
Experimental: 1
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 | |
| Beatson Oncology Centre | |
| Glasgow, United Kingdom, G11 6NT | |
| Royal Marsden Hospital | |
| Sutton, United Kingdom | |
| Principal Investigator: | JS de Bono, MD | Royal Marsden NHS Foundation Trust |
More Information
| Responsible Party: | Thomas Griffin, MD, Cougar Biotechnology |
| ClinicalTrials.gov Identifier: | NCT00600535 History of Changes |
| Other Study ID Numbers: | COU-AA-BE |
| Study First Received: | January 14, 2008 |
| Last Updated: | January 22, 2009 |
| Health Authority: | United States: Food and Drug Administration; United Kingdom: Medicines and Healthcare Products Regulatory Agency |
|
Abiraterone Acetate CB7630 Prostate Cancer |
|
Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site Neoplasms Genital Diseases, Male Prostatic Diseases Methylprednisolone acetate Prednisolone acetate Prednisolone Methylprednisolone Methylprednisolone Hemisuccinate Prednisone Prednisolone phosphate Anti-Inflammatory Agents |
Therapeutic Uses Pharmacologic Actions Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Antineoplastic Agents, Hormonal Antineoplastic Agents Antiemetics Autonomic Agents Peripheral Nervous System Agents Central Nervous System Agents Gastrointestinal Agents Neuroprotective Agents Protective Agents |