A Phase 3, Randomized, Double-blind, Placebo-Controlled Study of Abiraterone Acetate (CB7630) Plus Prednisone in Patients with Metastatic Castration-Resistant Prostate Cancer Who Have Failed Docetaxel-Based Chemotherapy
- Conditions
- Metastatic prostate cancer10038597
- Registration Number
- NL-OMON32133
- Lead Sponsor
- Cougar Biotechnology, Inc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 18
4. Histologically or cytologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation or small cell histology
5. At least one but not more than 2 cytotoxic chemotherapy regimens for metastatic castration-resistant prostate cancer. At least one regimen must have contained docetaxel.
6. Documented prostate cancer progression by at least the following:
* PSA progression according to the PSA WG eligibility criteria (protocol appendix 3)
* Soft tissue disease progression by modified RECIST criteria (protocol appendix 4)
* Metastatic bone disease on bone scan with >= 2 new lesions and a concurrent PSA >= 5 ng/mL
7. Ongoing androgen deprivation with serum testosterone < 50 ng/dL
8. (ECOG) Performance Status of <= 2
9. Hemoglobin >= 9.0 g/dL independent of transfusion
10. Platelet count >= 100,000/µL
11. Serum albumin >= 3.0 g/dL
12. Serum creatinine < 1.5 x ULN or a calculated creatinine clearance of 60 mL/min
13. Serum potassium >= 3.5 mmol/L
1. Serious or uncontrolled co-existing non-malignant disease, including active and uncontrolled infection
2. Abnormal liver functions consisting of any of the following:
* Serum bilirubin >= 1.5 x ULN
* AST or ALT >= 2.5 x ULN (for patients with known liver metastatis, AST or ALT <= 5 x ULN is allowed)
3. Uncontrolled hypertension (systolic BP >= 160 mmHg, or diastolic BP >= 95 mmHg). Patients with a history of hypertension are allowed provided blood pressure is controlled by anti-hypertensive therapy.
4. Active or symptomatic viral hepatic or chronic liver disease
5. History of pituitary or adrenal dysfunction
6. Clinically significant heart disease
7. Other malignancy, except non-melanoma skin cancer, with a >= 30% probability of recurrence within 12 months.
8. Known brain metastatis
9. History of gastrointestinal disorders which may interfere with the absorption of the study drug.
11. Prior therapy with ketoconazole for prostate cancer
12. Surgery or local prostatic intervention within 30 days of first dose.
13. Radiotherapy, chemotherapy or immunotherapy within 30 days or single fraction of palliative radiotherapy within 14 days of administration of Cycle 1 day 1.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary efficacy endpoint is:<br /><br>Overall survival</p><br>
- Secondary Outcome Measures
Name Time Method