Back to resultsAn Expanded Access Study of Abiraterone Acetate in Patients With Advanced Prostate Cancer Who Have Completed Clinical Study COU-AA-001
Primary Purpose
Prostate Neoplasms
Status
Completed
Phase
Phase 1
Locations
United Kingdom
Study Type
Interventional
Intervention
Abiraterone acetate
Glucocorticoid
Sponsored by
About this trial
This is an interventional treatment trial for Prostate Neoplasms focused on measuring Prostate neoplasms, Hormone refractory prostate cancer, Castration resistant prostate cancer, Castration refractory prostate cancer, Abiraterone acetate, CB7630
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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Abiraterone acetate
Arm Description
Outcomes
Primary Outcome Measures
Number of participants with serum prostate specific antigen (PSA) decline according to PSA Working Group criteria
Overall survival
Secondary Outcome Measures
Number of participants with adverse events
Time to disease progression
Time to prostate specific antigen progression
Objective tumor response by Response Evaluation Criteria in Solid Tumors (RECIST)
Full Information
NCT ID
NCT01664728
First Posted
August 10, 2012
Last Updated
April 18, 2013
Sponsor
Janssen Research & Development, LLC
1. Study Identification
Unique Protocol Identification Number
NCT01664728
Brief Title
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
2. Study Status
Record Verification Date
April 2013
Overall Recruitment Status
Completed
Study Start Date
April 2007 (undefined)
Primary Completion Date
February 2009 (Actual)
Study Completion Date
September 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Janssen Research & Development, LLC
4. Oversight
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Neoplasms
Keywords
Prostate neoplasms, Hormone refractory prostate cancer, Castration resistant prostate cancer, Castration refractory prostate cancer, Abiraterone acetate, CB7630
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
54 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Abiraterone acetate
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Abiraterone acetate
Intervention Description
Phase 2 maximum tolerated dose from Study COU-AA-001 taken orally once daily
Intervention Type
Drug
Intervention Name(s)
Glucocorticoid
Intervention Description
prednisolone/prednisone 5 mg taken orally twice daily or dexamethasone 0.5 mg taken orally once daily
Primary Outcome Measure Information:
Title
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
Title
Overall survival
Time Frame
every 3 months up to 3 years after study entry
Secondary Outcome Measure Information:
Title
Number of participants with adverse events
Time Frame
up to 30 days after the last dose of study medication
Title
Time to disease progression
Time Frame
every 3 months up to 3 years after study entry
Title
Time to prostate specific antigen progression
Time Frame
every 3 months up to 3 years after study entry
Title
Objective tumor response by Response Evaluation Criteria in Solid Tumors (RECIST)
Time Frame
every 3 months up to 3 years after study entry
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janssen Research & Development, LLC Clinical Trial
Organizational Affiliation
Janssen Research & Development, LLC
Official's Role
Study Director
Facility Information:
City
Sutton
Country
United Kingdom
12. IPD Sharing Statement
Links:
URL
http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_JNJ_6051&studyid=2388&filename=CR016912_CSR.pdf
Description
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
Learn more about this trial
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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