Sorafenib in Treating Patients With Malignant Gastrointestinal Stromal Tumor That Progressed During or After Previous Treatment With Imatinib Mesylate and Sunitinib Malate

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00265798
First received: December 14, 2005
Last updated: December 6, 2013
Last verified: December 2013
Results First Received: December 6, 2013  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Gastrointestinal Stromal Tumor
Intervention: Drug: sorafenib tosylate

  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 were enrolled from 6 centers between 2006 and 2009

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
Sorafenib Patients receive oral Sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Participant Flow:   Overall Study
    Sorafenib  
STARTED     38  
COMPLETED     38  
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
Sorafenib Patients receive oral Sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Baseline Measures
    Sorafenib  
Number of Participants  
[units: participants]
  38  
Age  
[units: years]
Median ( Full Range )
  57  
  ( 42 to 85 )  
Gender  
[units: participants]
 
Female     17  
Male     21  
Region of Enrollment  
[units: participants]
 
United States     38  
Study Cohort [1]
[units: participants]
 
Imatinib-resistant     6  
Imatinib- and sunitinib-resistant     32  
Performance Status [2]
[units: participants]
 
0     18  
1     18  
2     2  
[1] Participants were classified as having either imatinib-resistant disease or imatinib- and sunitinib-resistant disease
[2] ECOG performance status scores on a scale of 0-5, higher is worse



  Outcome Measures
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1.  Primary:   Objective Response Rate   [ Time Frame: Up to 5 years ]

2.  Secondary:   Progression-free Survival   [ Time Frame: Up to 5 years ]

3.  Secondary:   Overall Survival   [ Time Frame: Up to 5 years ]


  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. Hedy L. Kindler
Organization: University of Chicago
phone: 773-702-0360
e-mail: hkindler@medicine.bsd.uchicago.edu


No publications provided


Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00265798     History of Changes
Other Study ID Numbers: NCI-2009-00116, NCI-2009-00116, NCI-7028, CDR0000739566, 13780A, 7028, N01CM62201, N01CM62206, N01CM62207, N01CM62209
Study First Received: December 14, 2005
Results First Received: December 6, 2013
Last Updated: December 6, 2013
Health Authority: United States: Food and Drug Administration