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An Efficacy and Safety Study of Abiraterone Acetate and Prednisone in Participants With Prostate Cancer Who Failed Androgen Deprivation and Docetaxel-Based Chemotherapy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Cougar Biotechnology, Inc.
ClinicalTrials.gov Identifier:
NCT00485303
First received: June 8, 2007
Last updated: April 23, 2013
Last verified: April 2013
History of Changes
Results First Received: April 23, 2013  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Prostatic Neoplasms
Prostate Cancer
Interventions: Drug: Abiraterone acetate
Drug: Prednisone

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Abiraterone Abiraterone acetate 1000 milligram (mg) (4 oral tablets of 250 mg each) was administered once daily along with 5 mg oral prednisolone or prednisone tablet administered twice daily for 28-days dosing cycle and was continued until disease progression or unacceptable toxicity.

Participant Flow:   Overall Study
    Abiraterone  
STARTED     58  
COMPLETED     2  
NOT COMPLETED     56  
Adverse Event                 5  
Progressive Disease                 44  
Unspecified                 3  
Initiation of new anti-cancer treatment                 2  
Treatment ongoing at cutoff date                 2  



  Baseline Characteristics
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Reporting Groups
  Description
Abiraterone Abiraterone acetate 1000 milligram (mg) (4 oral tablets of 250 mg each) was administered once daily along with 5 mg oral prednisolone or prednisone tablet administered twice daily for 28-days dosing cycle and was continued until disease progression or unacceptable toxicity.

Baseline Measures
    Abiraterone  
Number of Participants  
[units: participants]
 		  58  
Age  
[units: Years]
Mean ± Standard Deviation 		  68.6  ± 9.78  
Gender  
[units: Participants]
 		 
Female     0  
Male     58  
Region of Enrollment  
[units: Participants]
 		 
United Kingdom     4  
United States     54  



  Outcome Measures
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1.  Primary:   Percentage of Participants With Prostate Specific Antigen (PSA) Response   [ Time Frame: Day 1 of each cycle (of 28 days each) up to Cycle 12 ]
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2.  Secondary:   Prostate-Specific Antigen Based Progression-free Survival (PSA-PFS)   [ Time Frame: Baseline and Day 1 of each cycle until first documented disease progression or up to 60 months ]
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3.  Secondary:   Radiographic Progression Free Survival (PFS)   [ Time Frame: Baseline, Day 1 of Cycle 4, 7 and 10, and thereafter every third cycle until first documented disease progression or up to 60 months ]
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4.  Secondary:   Overall Survival (OS)   [ Time Frame: Every 3 months until death or up to 60 months ]
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5.  Secondary:   Percentage of Participants With Objective Radiographic Response   [ Time Frame: Baseline, Day 1 of Cycle 4, 7 and 10, and thereafter every third cycle until first documented disease progression or up to 60 months ]
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6.  Secondary:   Time to PSA Progression   [ Time Frame: Day 8 of Cycle 1, thereafter Day 1 of each cycle up to end of study (60 months) ]
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7.  Secondary:   Time to Radiographic Progression   [ Time Frame: Baseline, Day 1 of Cycle 4, 7 and 10, and thereafter every third cycle until first documented disease progression or up to 60 months ]
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8.  Secondary:   Shift From Baseline in Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Score   [ Time Frame: Baseline and Day 1 of each cycle until first documented disease progression or up to 60 months ]
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9.  Secondary:   Percentage of Participants With Clinical Benefit   [ Time Frame: Baseline, Day 1 of Cycle 4, 7 and 10, and thereafter every third cycle until first documented disease progression or up to 60 months ]
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  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:  
Name/Title: Senior Director, Clinical Research
Organization: Janssen Research & Development, 10990 Wilshire Blvd, Suite 1200, Los Angeles, California 90024
phone: (310) 943-8040 ext 2917


No publications provided by Cougar Biotechnology, Inc.

Publications automatically indexed to this study:


Responsible Party: Cougar Biotechnology, Inc.
ClinicalTrials.gov Identifier: NCT00485303     History of Changes
Other Study ID Numbers: CR016921, COU-AA-004, 2007-002725-74
Study First Received: June 8, 2007
Results First Received: April 23, 2013
Last Updated: April 23, 2013
Health Authority: United States: Food and Drug Administration
United Kingdom: Medicines and Healthcare Products Regulatory Agency