Efficacy and Safety Study of CC-4047 (Pomalidomide) to Treat Advanced Soft Tissue Sarcoma

This study has been terminated.
(Study enrollment was terminated due to a corporate strategic decision unrelated to patient safety.)
Sponsor:
Information provided by (Responsible Party):
Celgene Corporation
ClinicalTrials.gov Identifier:
NCT00717522
First received: July 16, 2008
Last updated: March 6, 2013
Last verified: March 2013
Results First Received: March 6, 2013  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Soft Tissue Sarcoma
Intervention: Drug: Pomalidomide

  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
No text entered.

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
Pomalidomide 7 mg pomalidomide taken orally once daily (QD) on days 1 through 21 of each 28-day cycle

Participant Flow:   Overall Study
    Pomalidomide  
STARTED     7  
COMPLETED     0  
NOT COMPLETED     7  
Disease Progression                 5  
Adverse Event                 1  
Death                 1  



  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
Pomalidomide 7 mg pomalidomide taken orally once daily (QD) on days 1 through 21 of each 28-day cycle

Baseline Measures
    Pomalidomide  
Number of Participants  
[units: participants]
  7  
Age  
[units: years]
Mean ± Standard Deviation
  58.9  ± 13.52  
Gender  
[units: participants]
 
Female     3  
Male     4  
Race/Ethnicity, Customized  
[units: participants]
 
White     7  
Non-white     0  



  Outcome Measures
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1.  Primary:   Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths, or Discontinuations Due to AEs   [ Time Frame: AEs/SAEs were recorded from informed consent to 30 days post treatment discontinuation visit. Median treatment duration was 49 days (range: 3 to 102 days). ]

2.  Secondary:   Tumor Response as Assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee Guidelines   [ Time Frame: Assessed every 8 weeks for the first 8 months and then every 12 weeks thereafter, and at treatment discontinuation. Median treatment duration was 49 days (range: 3 to 102 days). ]


  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 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
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Results Point of Contact:  
Name/Title: Associate Director, Clinical Trial Disclosure
Organization: Celgene Corporation
phone: 1-888-260-1599
e-mail: clinicaltrialdisclosure@celgene.com


No publications provided


Responsible Party: Celgene Corporation
ClinicalTrials.gov Identifier: NCT00717522     History of Changes
Other Study ID Numbers: CC-4047-STSAR-001
Study First Received: July 16, 2008
Results First Received: March 6, 2013
Last Updated: March 6, 2013
Health Authority: United States: Food and Drug Administration