Hormone refractory prostate cancer MedDRA version: 8.1 Level: LLT Classification code 10062904 Term: Hormone-refractory prostate cancer
Conditions
Interventions
Product Name: abiraterone acetate
Product Code: CB7630
Pharmaceutical Form: Capsule, hard
Current Sponsor code: CB7630
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration numbe
Sponsors
Cougar Biotechnology, Inc
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 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 12 weeks 15. Able to swallow the CB7630 whole as a capsule 16. Able to follow study instructions, accessible for treatment and follow-up, and likely to complete all study requirements. 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
Exclusion criteria
Exclusion criteria: 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 30% probability of recurrence within 12 months. 9. History of gastrointestinal disorders (medical disorders or extensive surgery) which may interfere with the absorption of the study medication. 10. Current enrollment in an investigational drug or device study or participation in such a study within 30 days of Cycle 1 Day 1 11. 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. 12. 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the anti-tumor effects of CB7630 in patients with androgen independent metastatic prostate cancer (AIPC) who have failed docetaxel based chemotherapy, as measured by the proportion of patients achieving a PSA decline of >50% (PSA response) according to Prostate-Specific Antigen Working Group (PSAWG) criteria ;Secondary Objective: • To assess the rate of objective response in patients with measurable lesions by RECIST criteria • To determine the duration of PSA decline, and objective response if applicable • To determine the duration of progression-free survival • To determine the safety and tolerability of CB7630 in study population • To assess clinical benefits as determined by symptomatic relief, disease stabilization, and improvement of performance status • To evaluate the role of circulating tumor cell (CTC) enumeration and isolation in the assessment of prognosis and treatment response in study population.;Primary end point(s): Serum PSA decline according to Prostate-Specific Antigen Working Group (PSAWG) criteria. Other efficacy measures include tumor response in patients with measurable lesions based on RECIST criteria; the duration of PSA decline by > 50% and objective response (if applicable); duration of progression-free survival; and clinical benefit as determined by symptomatic relief, disease stabilization, and improvement of performance status. Safety endpoints include incidence of worst grade adverse events; incidence of deaths and other serious and significant adverse events; and incidence of worst grade laboratory abnormalities. | — |
Countries
United Kingdom
Outcome results
None listed