EUCTR2007-002725-74-GB
Active, not recruiting
Phase 1
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
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Cougar Biotechnology, Inc
- Status
- Active, not recruiting
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Willing and able to provide written informed consent
- •2\. Written Data Protection Consent 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 docetaxel.
- •Patients may have had up to two previous chemotherapy regimens
- •6\. Documented PSA progression according to PSAWG eligibility criteria
- •(Attachment 1\) with a PSA\> 5 ng/mL
- •7\. On\-going androgen deprivation with serum testosterone \< 50 ng/dL (\<
Exclusion Criteria
- •1\. Active or uncontrolled autoimmune disease that may require corticosteroid
- •2\. Serious or uncontrolled co\-existent non\-malignant disease, including active and
- •uncontrolled infection
- •3\. Uncontrolled hypertension
- •4\. Hemoglobin \= 9\.0 g/dL without growth factor or transfusion support
- •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
Outcomes
Primary Outcomes
Not specified
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