An Extended Study of CB7630 (Abiraterone Acetate) in Patients with Advanced Prostate Cancer Who Have Failed Androgen Deprivation and Docetaxel-Based Chemotherapy and Completed Clinical Study COU-AA-003

Phase 1

• Conditions: 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)

• Registration Number: EUCTR2008-002210-22-GB
• Lead Sponsor: Janssen Oncology, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-06-27
• Study Completion: 2010-01-22
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

Willing and able to provide written informed consent.

Written Authorization for Use and Release of Health and Research Study Information (US) or Data Protection Consent (EU) has been obtained .

Completed 12 cycles of abiraterone acetate under study COU-AA-003.

Last dose of abiraterone acetate is within 14 days of the anticipated commencement of study treatment should the patient meet all other eligibility criteria.

Serum potassium = 3.5 mmol/L.

Eastern Cooperative Oncology Group (ECOG) Performance Status of = 3. (Karnofsky Performance Status = 30%).

Able to swallow the abiraterone acetate capsules whole.

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

Serious or uncontrolled co-existent non-malignant disease, including active and uncontrolled infection,

Uncontrolled hypertension.

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

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 enrolment and after consultation with a cardiologist to insure that the disease is stable.

Current enrolment in an investigational drug or device study or participation in such a study within 30 days of Cycle 13 Day 1 other than abiraterone acetate study COU-AA-003.

Patients who have partners of childbearing potential who are not willing to use a method of birth control determined to be acceptable by the principal investigator and sponsor during the study and for 13 weeks after last study drug administration.

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified