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

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ClinicalTrials.gov Identifier: NCT01664728
Recruitment Status : Completed
First Posted : August 14, 2012
Last Update Posted : April 19, 2013
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC

August 10, 2012
August 14, 2012
April 19, 2013
April 2007
February 2009   (Final data collection date for primary outcome measure)
  • Number of participants with serum prostate specific antigen (PSA) decline according to PSA Working Group criteria [ Time Frame: Screening, Cycle 1 Day 1 Pre-dose, every 3 months up to 3 years after study entry ]
  • Overall survival [ Time Frame: every 3 months up to 3 years after study entry ]
Same as current
Complete list of historical versions of study NCT01664728 on ClinicalTrials.gov Archive Site
  • Number of participants with adverse events [ Time Frame: up to 30 days after the last dose of study medication ]
  • Time to disease progression [ Time Frame: every 3 months up to 3 years after study entry ]
  • Time to prostate specific antigen progression [ Time Frame: every 3 months up to 3 years after study entry ]
  • Objective tumor response by Response Evaluation Criteria in Solid Tumors (RECIST) [ Time Frame: every 3 months up to 3 years after study entry ]
Same as current
Not Provided
Not Provided
 
An Expanded Access Study of Abiraterone Acetate in Patients With Advanced Prostate Cancer Who Have Completed Clinical Study COU-AA-001
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
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.
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.
Interventional
Phase 1
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Prostate Neoplasms
  • 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
Experimental: Abiraterone acetate
Interventions:
  • Drug: Abiraterone acetate
  • Drug: Glucocorticoid
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
54
27
September 2012
February 2009   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Male
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
 
NCT01664728
CR016912
COU-AA-001EXT ( Other Identifier: Janssen Research & Development, LLC )
2006-006755-12 ( EudraCT Number )
No
Not Provided
Not Provided
Janssen Research & Development, LLC
Janssen Research & Development, LLC
Not Provided
Study Director: Janssen Research & Development, LLC Clinical Trial Janssen Research & Development, LLC
Janssen Research & Development, LLC
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP