Study of SU11248 in Men With Advanced Prostate Cancer

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Dror Michaelson, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00299741
First received: March 3, 2006
Last updated: December 14, 2012
Last verified: December 2012
Results First Received: May 9, 2012  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Prostate Cancer
Intervention: Drug: Sunitinib

  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
Patients identified from routine care in oncology clinic

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Metastatic Prostate Cancer Treated With Sunitinib Sunitinib administered orally at a dosage of 37.5 mg once daily

Participant Flow:   Overall Study
    Metastatic Prostate Cancer Treated With Sunitinib  
STARTED     36  
COMPLETED     36  
NOT COMPLETED     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Metastatic Prostate Cancer Treated With Sunitinib Sunitinib

Baseline Measures
    Metastatic Prostate Cancer Treated With Sunitinib  
Number of Participants  
[units: participants]
  36  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     16  
>=65 years     20  
Age  
[units: years]
Mean ± Standard Deviation
  68  ± 10  
Gender  
[units: participants]
 
Female     0  
Male     36  
Region of Enrollment  
[units: participants]
 
United States     36  



  Outcome Measures
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1.  Primary:   The Number of Men With Advanced Prostate Cancer Treated With Sunitinib Who Have a Prostate Specific Antigen (PSA) Response   [ Time Frame: were followed until disease progression, an average of 12 weeks ]

2.  Secondary:   Objective Responses, Defined as the Number of Participants With Complete or Partial Response   [ Time Frame: Participants were followed until the time of disease progression, an average of 12 weeks ]


  Serious Adverse Events


  Other Adverse Events


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.


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
No text entered.  


Results Point of Contact:  
Name/Title: Dr. Dror Michaelson
Organization: Massachusetts General Hospital
phone: 617-726-1594
e-mail: dmichaelson1@partners.org


Publications of Results:
Publications automatically indexed to this study:

Responsible Party: Dror Michaelson, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00299741     History of Changes
Other Study ID Numbers: W81XWH-05-1-0439
Study First Received: March 3, 2006
Results First Received: May 9, 2012
Last Updated: December 14, 2012
Health Authority: United States: Food and Drug Administration