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

Sponsor

Janssen Research & Development, LLC (Industry)

Overall Status

Completed

CT.gov ID

NCT01664728

Collaborator

(none)

Enrollment

Location

Arm

65.1

Duration (Months)

0.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Prostate Neoplasms	Drug: Abiraterone acetate Drug: Glucocorticoid	Phase 1

Detailed 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.

Study Design

Study Type:

Interventional

Actual Enrollment :

54 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Apr 1, 2007

Actual Primary Completion Date :

Feb 1, 2009

Actual Study Completion Date :

Sep 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Abiraterone acetate	Drug: Abiraterone acetate Phase 2 maximum tolerated dose from Study COU-AA-001 taken orally once daily Drug: Glucocorticoid prednisolone/prednisone 5 mg taken orally twice daily or dexamethasone 0.5 mg taken orally once daily

Arm

Intervention/Treatment

Experimental: Abiraterone acetate

Drug: Abiraterone acetate

Phase 2 maximum tolerated dose from Study COU-AA-001 taken orally once daily

Drug: Glucocorticoid

prednisolone/prednisone 5 mg taken orally twice daily or dexamethasone 0.5 mg taken orally once daily

Outcome Measures

Primary Outcome Measures

Number of participants with serum prostate specific antigen (PSA) decline according to PSA Working Group criteria [Screening, Cycle 1 Day 1 Pre-dose, every 3 months up to 3 years after study entry]
Overall survival [every 3 months up to 3 years after study entry]

Secondary Outcome Measures

Number of participants with adverse events [up to 30 days after the last dose of study medication]
Time to disease progression [every 3 months up to 3 years after study entry]
Time to prostate specific antigen progression [every 3 months up to 3 years after study entry]
Objective tumor response by Response Evaluation Criteria in Solid Tumors (RECIST) [every 3 months up to 3 years after study entry]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Male

Accepts 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