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 Castration-Resistant Prostate Cancer in Patients who have Failed Docetaxel-Based Chemotherapy.MedDRA version: 9.1Level: LLTClassification code 10062904Term: Hormone-refractory prostate cancer
- Registration Number
- EUCTR2007-005837-13-HU
- Lead Sponsor
- Cougar Biotechnology, Inc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Male
- Target Recruitment
- 1158
Each patient must meet the following criteria to be enrolled in this study.
1. Willing and able to provide written informed consent
2. Written Authorization for Use and Release of Health and Research Study Information (US 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 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. If docetaxel-containing chemotherapy is used more than once, this will be considered as one regimen.
6. Documented prostate cancer progression as assessed by the investigator with one of the following:
a. PSA progression according to PSAWG criteria.
(Patients on systemic glucocorticoids for the treatment of prostate cancer or control of symptoms must have documented PSA progression by PSAWG criteria prior to Cycle 1 Day 1. Patients with confirmed PSA progression while on systemic glucocorticoids other than prednisone or prednisolone are required to switch to prednisone or prednisolone 5 mg twice daily prior to Cycle 1 Day 1, but PSA progression does not have to be reconfirmed.)
b. Radiographic progression in soft tissue or bone with or without PSA progression.
7. Ongoing androgen deprivation with serum testosterone < 50 ng/dL (< 2.0nM)
8. Eastern Cooperative Oncology Group (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 = 60 mL/min
13. Serum potassium = 3.5 mmol/L
14. Able to swallow the study drug whole as a tablet
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Patients who meet any of the following criteria will be excluded from the study:
1. Serious or uncontrolled co-existent non-malignant disease, including active and uncontrolled infection.
2. Abnormal liver functions consisting of any of the following:
• Serum bilirubin = 1.5 x ULN (except for patients with documented Gilbert’s disease)
• AST or ALT = 2.5 x ULN, (for patients with known liver metastasis, 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 hepatitis or chronic liver disease
5. History of pituitary or adrenal dysfunction
6. Clinically significant heart disease as evidenced by myocardial infarction, or arterial thrombotic events in the past 6 months, severe or unstable angina, or New York Heart Association (NYHA) Class III or IV heart disease or cardiac ejection fraction measurement of < 50 % at baseline
7. Other malignancy, except non-melanoma skin cancer, with a = 30% probability of recurrence within 12 months
8. Known brain metastasis
9. History of gastrointestinal disorders (medical disorders or extensive surgery) which may interfere with the absorption of the study drug
10. Prior therapy with abiraterone acetate or other CYP17 inhibitor(s), or investigational agent(s) targeting the androgen receptor for metastatic prostate cancer.
11. Prior therapy with ketoconazole for prostate cancer
12. Surgery or local prostatic intervention within 30 days of the first dose. In addition, any clinically relevant sequelae from the surgery must have resolved prior to Cycle 1 Day 1
13. Radiotherapy, chemotherapy or immunotherapy within 30 days, or single fraction of palliative radiotherapy within 14 days of administration of Cycle 1 Day 1
14. Any acute toxicities due to prior chemotherapy and/or radiotherapy that have not resolved to a NCI CTCAE (version 3) grade of = 1. Chemotherapy induced alopecia and grade 2 peripheral neuropathy is allowed.
15. Current enrollment in an investigational drug or device study or participation in such a study within 30 days of Cycle 1 Day 1.
16. Condition or situation which, in the investigator’s opinion, may put the patient at significant risk, may confound the study results, or may interfere significantly with patient’s participation in the study
17. Not willing to comply with the procedural requirements of this protocol
18. Patients who have partners of childbearing potential who are not willing to use a method of birth control with adequate barrier protection as determined to be acceptable by the principal investigator and sponsor during the study and for 13 weeks after last study drug administration.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To compare the clinical benefit of abiraterone acetate plus prednisone with placebo plus prednisone in patients with metastatic castration-resistant prostate cancer (CRPC) who have failed one or two chemotherapy regimens, one of which contains docetaxel;Secondary Objective: • To further evaluate the safety profile of abiraterone acetate plus prednisone<br>• To further characterize the pharmacokinetics (PK) of abiraterone acetate when<br>administered concurrently with prednisone<br>• To further explore the potential utility of circulating tumor cells (CTCs) as a surrogate for clinical benefit<br>• To evaluate the impact of abiraterone acetate plus prednisone on health-related quality of life (QOL);Primary end point(s): The primary endpoint is overall survival defined as the time from date of randomization to death from any cause.
- Secondary Outcome Measures
Name Time Method