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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 2
18 Years
Not Enrolling
Prostate Neoplasms

Thank you

Trial Information

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

This is an open-label study (identity of study drug will be known) to provide additional
treatment of abiraterone acetate (CB7630) to patients with advanced prostate cancer who have
completed 12 cycles of abiraterone acetate treatment in Clinical Study COU-AA-003 and
continue to receive clinical benefit from such treatment. Patients will continue taking
abiraterone acetate at the dose they were receiving at the end of Study COU-AA-003
concurrently with a glucocorticoid (such as prednisone/prednisolone 5 mg oral twice daily,
or dexamethasone 0.5 mg once daily). Efficacy and safety will be monitored throughout the
study. Study treatment will end when the patient dies, is lost to follow-up, withdraws
informed consent, experiences sustained side-effects, has disease progression, or the
sponsor discontinues the study. After the end of study visit is completed, patients' status
will be followed every 12 weeks for survival for up to 3 years following study entry.

Inclusion Criteria:

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

- Last dose of abiraterone acetate is within 14 days of the anticipated start of study
treatment and the patient meets all other eligibility criteria

- Serum potassium >=3.5 mmol/L

- Eastern Cooperative Oncology Group (ECOG) 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
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)

- Current enrollment 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

- 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:

Prostate specific antigen (PSA) response

Outcome Description:

PSA decline >=50% according to Prostate Specific Antigen Working Group criteria

Outcome Time Frame:

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:

December 2008

Completion Date:

July 2012

Related Keywords:

  • Prostate Neoplasms
  • Prostate neoplasms
  • Prostate cancer
  • Hormone refractory prostate cancer
  • Advanced prostate cancer
  • Failed androgen deprivation
  • CB7630
  • Abiraterone acetate
  • Docetaxel-based chemotherapy
  • Taxane-based chemotherapy
  • Neoplasms
  • Prostatic Neoplasms