Clinical trial NCT01664728: An Expanded Access Study of Abiraterone Acetate in Patients With Advanced Prostate Cancer Who Have Completed Clinical Study COU-AA-001
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Prostate Neoplasms
Keywords: Prostate neoplasms
Hormone refractory prostate cancer
Castration resistant prostate cancer
Castration refractory prostate cancer
Abiraterone acetate
CB7630
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2012-08-14
Enrollment: 54
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of participants with serum prostate specific antigen (PSA) decline according to PSA Working Group criteria
timeFrame: Screening, Cycle 1 Day 1 Pre-dose, every 3 months up to 3 years after study entry
measure: Overall survival
timeFrame: every 3 months up to 3 years after study entry
Secondary outcomes:
measure: Number of participants with adverse events
timeFrame: up to 30 days after the last dose of study medication
measure: Time to disease progression
timeFrame: every 3 months up to 3 years after study entry
measure: Time to prostate specific antigen progression
timeFrame: every 3 months up to 3 years after study entry
measure: Objective tumor response by Response Evaluation Criteria in Solid Tumors (RECIST)
timeFrame: every 3 months up to 3 years after study entry
Other outcomes:
Locations:
city: Sutton
country: United Kingdom
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References: