An Expanded Access Open Label Study of CB7630 (Abiraterone Acetate) in Patients with Advanced Prostate Cancer Who Have Completed CB7630 Clinical Study COU-AA-001

Janssen Oncology, Inc.0 个研究点目标入组 0 人开始时间: 2007年1月4日最近更新: 2019年11月25日

适应症

试验速览

暂无简介。

•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 < 3. (Karnofsky Performance Status = 30%) (Attachment 13.4)
•8. Able to swallow the CB7630 whole as a capsule or tablet
•9. Able to follow study instructions, accessible for treatment and follow-up, and likely to complete all study requirements
•10. Agree to use effective contraception precautions throughout the study and for 13 weeks after the last dose if sexually active with partners of child bearing potential
•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

•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

发起方