Hormone refractory prostate cancer MedDRA version: 14.1 Level: LLT Classification code 10062904 Term: Hormone-refractory prostate cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Sponsors
Janssen Oncology, Inc.
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Willing and able to provide written informed consent 2. Written Authorization for Data Protection Consent has been obtained 3. Age = 18 years and male 4. Completed 12 cycles of CB7630 under the main study of COU-AA-001. Last dose of CB7630 is within 14 days prior to study treatment in COU-AA-001-EXT 5. Demonstrating the potential to gain clinical benefit if abiraterone acetate treatment continues. 6. Serum potassium = 3.5 mmol/L 7.Eastern Cooperative Oncology Group (ECOG) Performance Status of =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Serious or uncontrolled co-existent non-malignant disease, including active and uncontrolled infection 2. Uncontrolled hypertension 3. 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 4. Clinically significant heart disease as evidenced by a myocardial infarction in the past twelve months, severe or unstable angina, or New York Heart Association (NYHA) Class III or IV heart disease. Patients with a history of atherosclerotic vascular disease requiring coronary or peripheral artery bypass surgery may be enrolled provided the surgery occurred at least two years prior to enrollment and after consultation with a cardiologist to insure that the disease is stable. 5. 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: To provide access to CB7630 for patients who have completed 12 cycles of abiraterone acetate treatment and continue to receive clinical benefit from such a treatment.; Secondary Objective: To evaluate safety of abiraterone acetate To evaluate efficacy of abiraterone acetate ; Primary end point(s): Criteria for effectiveness (PSA progression and objective progression) are described below. PSA measurements: PSA measurements will be analyzed by the PSAWG (PCWG1) criteria. PSA measurements will be taken at Day 1, cycle one of study COU-AA-001-EXT or end of study COU-AA-001 and subsequently at time points as indicated in the schedule of visits. Any unscheduled PSA measurement may be utilized in the periodic assessment of PSA progression. Survival: Death data will be collected according to the visit schedule Adverse events related to study drug will be collected and graded acording to NCI CTCAE v 3.0 | — |
Countries
United Kingdom
Contacts
Public ContactClinical Trials Manager
Janssen Oncology, Inc.
Outcome results
None listed