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

Cougar Biotechnology, Inc0 sites33 target enrollmentOctober 16, 2006

Overview

No summary available.

Registry

who.int

Start Date

October 16, 2006

End Date

TBD

Last Updated

8 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

Male

Sponsor

•1\. Willing and able to provide written informed consent
•2\. Written Authorization for Use and Release of Health and Research Study Information (USA sites only) or Data Protection Consent (European sites only) has been obtained
•3\. Age \= 18 years and male
•4\. Histologically or cytologically confirmed adenocarcinoma of the prostate, but not with neuroendocrine differentiation or of small cell histology.
•5\. Prior chemotherapy for prostate cancer with regimen(s) containing paclitaxel or docetaxel.
•6\. Documented PSA progression according to PSAWG eligibility criteria with a PSA\> 5 ng/mL.
•7\. On\-going androgen deprivation with serum testosterone \< 50 ng/dL (\< 2\.0nM)
•8\. Serum potassium \= 3\.5 mmol/L
•9\. Eastern Cooperative Oncology Group (ECOG) Performance Status of \= 2 (Karnofsky Performance Status \= 50%)
•10\. No history of adrenal insufficiency or hyperaldosteronism

•1\. Active or uncontrolled autoimmune disease that may require corticosteroid therapy
•2\. Serious or uncontrolled co\-existent non\-malignant disease, including active and uncontrolled infection.
•3\. Uncontrolled hypertension
•4\. Hemoglobin \= 9\.0 g/dL
•5\. Abnormal liver function tests consisting of any of the following:
•Serum bilirubin \> 1\.5 x ULN
•ALT \> 2\.5 x ULN
•AST \> 2\.5 x ULN
•6\. Serum creatinine \> 2\.0 x UNL or a calculated creatinine clearance \< 50 mL/min
•7\. Clinically significant heart disease as evidenced by a myocardial infarction in the past twelve months, severe or unstable angina, or New York Heart Association (NYHA) Class III or IV heart disease. Patients with a history of atherosclerotic vascular disease requiring coronary or peripheral artery bypass surgery may be enrolled provided the surgery occurred at least two years prior to enrollment and after consultation with a cardiologist to insure that the disease is stable.