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Sunitinib Plus Prednisone In Patients With Metastatic Castration-Resistant Prostate Cancer After Failure Of Docetaxel Chemotherapy (SUN 1120)

This study has been terminated.
(Study A6181120 was prematurely discontinued due to futility on 27 September 2010. No new or unexpected safety issues were identified.)
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00676650
First received: May 8, 2008
Last updated: February 5, 2013
Last verified: February 2013
History of Changes
Results First Received: December 20, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Prostatic Neoplasms
Interventions: Drug: Prednisone
Drug: sunitinib
Drug: Placebo

  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
Sunitinib and Prednisone Sunitinib capsules administered orally as a continuous daily dose in a continuous regimen, expressed as 4-week cycles; starting dose of 37.5 milligrams (mg) with option to increase dose to 50 mg at Cycle 3. Prednisone administered continuously at 5 mg orally twice a day (BID) as either a tablet, solution or concentrated solution.
Placebo and Prednisone Matched placebo administered orally as a continuous daily dose expressed as 4-week cycles; with a starting dose of 37.5 milligrams (mg) with option to increase dose to 50 mg at Cycle 3 plus prednisone administered continuously at 5 mg orally BID as either a tablet, solution or concentrated solution.

Participant Flow:   Overall Study
    Sunitinib and Prednisone     Placebo and Prednisone  
STARTED     584     289  
Treated     581     285  
COMPLETED     0     0  
NOT COMPLETED     584     289  
Death                 45                 14  
Adverse Event                 159                 21  
Global deterioration of health status                 66                 31  
Lost to Follow-up                 0                 1  
Objective progression or relapse                 189                 140  
Unspecified                 14                 10  
Protocol Violation                 3                 1  
Study terminated by sponsor                 57                 43  
Withdrawal by Subject                 48                 24  
Randomized but not treated                 3                 4  



  Baseline Characteristics
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Reporting Groups
  Description
Sunitinib and Prednisone Sunitinib capsules administered orally as a continuous daily dose in a continuous regimen, expressed as 4-week cycles; starting dose of 37.5 milligrams (mg) with option to increase dose to 50 mg at Cycle 3. Prednisone administered continuously at 5 mg orally twice a day (BID) as either a tablet, solution or concentrated solution.
Placebo and Prednisone Matched placebo administered orally as a continuous daily dose expressed as 4-week cycles; with a starting dose of 37.5 milligrams (mg) with option to increase dose to 50 mg at Cycle 3 plus prednisone administered continuously at 5 mg orally BID as either a tablet, solution or concentrated solution.
Total Total of all reporting groups

Baseline Measures
    Sunitinib and Prednisone     Placebo and Prednisone     Total  
Number of Participants  
[units: participants]
 		  584     289     873  
Age, Customized  
[units: participants]
 		     
18 - 44 years     3     0     3  
45 - 64 years     177     97     274  
greater than or equal to (>=) 65 years     404     192     596  
Gender  
[units: participants]
 		     
Female     0     0     0  
Male     584     289     873  



  Outcome Measures
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1.  Primary:   Overall Survival (OS)   [ Time Frame: Baseline up to 32 months ]
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2.  Secondary:   Progression-Free Survival (PFS)   [ Time Frame: Baseline, every 8 weeks up to 123 weeks ]
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3.  Secondary:   Percent of Participants With Objective Response (OR)   [ Time Frame: Baseline, every 8 weeks up to 123 weeks ]
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4.  Secondary:   Duration of Response (DR)   [ Time Frame: Baseline, every 8 weeks up to 123 weeks ]
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5.  Secondary:   Change From Baseline in Pain Severity   [ Time Frame: Day 1 through Day 7 every 28 days (every cycle) up to 29 months ]
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6.  Secondary:   Change From Baseline in Functional Assessment of Cancer Therapy-Prostate (FACT-P)   [ Time Frame: Baseline, every 4 weeks up to 123 weeks ]
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7.  Secondary:   Change From Baseline in Euro Quality of Life (EQ-5D)- Health State Profile Utility Score   [ Time Frame: Baseline, every 4 weeks up to 123 weeks ]
  Show Outcome Measure 7


  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 less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
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.


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
A complete analysis was not performed due to the sponsors early termination of the clinical trial.  


Results Point of Contact:  
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
phone: 1-800-718-1021
e-mail: ClinicalTrials.gov_Inquiries@pfizer.com


No publications provided


Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00676650     History of Changes
Other Study ID Numbers: A6181120
Study First Received: May 8, 2008
Results First Received: December 20, 2012
Last Updated: February 5, 2013
Health Authority: United States: Food and Drug Administration