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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

Phase 1
18 Years
Not Enrolling
Prostate Neoplasms

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Trial Information

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

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.

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

- 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

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Number of participants with serum prostate specific antigen (PSA) decline according to PSA Working Group criteria

Outcome Time Frame:

Screening, Cycle 1 Day 1 Pre-dose, every 3 months up to 3 years after study entry

Safety Issue:


Principal Investigator

Janssen Research & Development, LLC Clinical Trial

Investigator Role:

Study Director

Investigator Affiliation:

Janssen Research & Development, LLC


United States: Food and Drug Administration

Study ID:




Start Date:

April 2007

Completion Date:

September 2012

Related Keywords:

  • Prostate Neoplasms
  • Prostate neoplasms
  • Hormone refractory prostate cancer
  • Castration resistant prostate cancer
  • Castration refractory prostate cancer
  • Abiraterone acetate
  • CB7630
  • Neoplasms
  • Prostatic Neoplasms