An Expanded Access Study of Abiraterone Acetate in Patients With Advanced Prostate Cancer Who Have Completed Clinical Study COU-AA-001

Janssen (J&J Innovative Medicine)

Status and phase

Completed

Phase 1

Conditions

Prostate Neoplasms

Treatments

Drug: Glucocorticoid

Drug: Abiraterone acetate

Study type

Interventional

Funder types

Industry

Identifiers

NCT01664728

COU-AA-001EXT (Other Identifier)

2006-006755-12 (EudraCT Number)

CR016912

Details and patient eligibility

About

The purpose of this study is to provide access to abiraterone acetate for patients who have completed 12 cycles of abiraterone acetate treatment in Clinical Study COU-AA-001 and continue to receive clinical benefit from this treatment.

Full description

This is an open-label (identity of study drug will be known) extended access study to evaluate the safety and efficacy of continued administration of abiraterone acetate in patients who have completed 12 cycles of abiraterone acetate treatment in Clinical Study COU-AA-001 and continue to receive clinical benefit from this treatment. Patients will continue with the same dose regimen administered at the end of Study COU-AA-001 and will receive a low-dose glucocorticoid daily. Patients will be followed every 3 months for disease progression and survival for up to 3 years following study entry. Safety will be monitored throughout the study up to 30 days after the last dose of study medication.

Enrollment

54 patients

Sex

Male

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Completed 12 cycles of abiraterone acetate under study COU-AA-001
Last dose of abiraterone acetate within 14 days prior to treatment in this study
Demonstrates potential to gain clinical benefit with continued abiraterone acetate treatment
Serum potassium level >=3.5 mmol/L
Eastern Cooperative Oncology Group Performance Status of <3 (Karnofsky Performance Status >=30%)
Agrees to protocol-defined use of effective contraception

Exclusion criteria

Serious or uncontrolled co-existent non-malignant disease, including active and uncontrolled infection
Uncontrolled hypertension
Abnormal liver function
Clinically significant heart disease as evidenced by a myocardial infarction in the past 12 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 2 years prior to enrollment and after consultation with a cardiologist to insure that the disease is stable)
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