HRPC (Hormone refractory prostate cancer) refractory to androgen deprivation and Docetaxel based chemotherapy MedDRA version: 9.1 Level: LLT Classification code 10062904 Term: Hormone-refractory prostate cancer
Conditions
Interventions
Product Name: Abiraterone acetate
Product Code: CB7630
Pharmaceutical Form: Tablet
Current Sponsor code: CB7630
Other descriptive name:
Sponsors
Cougar Biotechnology, Inc
Eligibility
Sex/Gender
Male
Inclusion 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 12 weeks 11. Able to swallow the CB7630 whole as a tablet 12. 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 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 30% probability of recurrence within 12 months 11. History of adrenal insufficiency or hyperaldosteronism 12. History of gastrointestinal disorders (medical disorders or extensive surgery) which may interfere with the absorption of the study medication 13. Radiotherapy, chemotherapy or immunotherapy within 30 days of administration of the Cycle 1 Day 1. Supportive care with glucocorticoid is not considered as an immunotherapy; however, PSA progression must be documented under current dose/regimen 14. 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 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. Initiate bisphosphonate therapy or adjust bisphosphonate dose/regimen within 30 days of Cycle 1 Day 1 17. 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The proportion of patients achieving a PSA decline of >50% (PSA response) according to Prostate-Specific Antigen Working Group (PSAWG) criteria ; Secondary Objective: The safety and tolerability of CB7630, with concurrent prednisone, in the study population PSA-based progression-free survival (PSA-PFS) Radiographic progression-free survival (RAD-PFS) Overall survival Objective radiographic response rate (RAD-ORR) in patients with measurable lesions using RECIST Duration of PSA decline >50% and objective response (PSA-ORR), if applicable Clinical benefit, as determined by disease stabilization and change in patient ECOG performance status ; Primary end point(s): To evaluate anti-tumor effects and safety of CB7630 in patients with advanced prostate cancer who have failed androgen deprivation and docetaxel-based chemotherapy The proportion of patients achieving a PSA decline >50% (PSA response) according to Prostate-Specific Antigen Working Group (PSAWG) criteria Efficacy measures: • Serum PSA decline evaluation according to PSAWG criteria. (Attachment 1) • Tumor measurements and response evaluation (RAD-ORR) using RECIST Criteria for patients with measurable disease (Attachment 2) • PSA based progression free survival (PSA-PFS) • Radiographic progression free survival (RAD-PFS) • Overall survival Safety measures: • Adverse events including laboratory adverse events will be graded and summarized according to the National Cancer Institute Common Terminology Cri | — |
Countries
United Kingdom
Outcome results
None listed