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: June 2, 2014
Last verified: January 2014
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 400mg 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 400mg 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]

Eastern Cooperative Oncology Group (ECOG) performance status scores on a scale of 0-5, higher is worse 0= Fully active, able to carry on all pre-disease performance without restriction

  1. Restricted in physically strenuous activity but ambulatory and able to carry out work of a light/sedentary nature
  2. Ambulatory and capable of all selfcare, unable to carry out any work activities. Up and about > 50% of waking hours
  3. Capable of only limited selfcare, confined to bed/chair > 50% of waking hours
  4. Completely disabled. Cannot carry on any selfcare. Totally confined to bed/chair
  5. Dead



  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


  Limitations and Caveats
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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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  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.


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: June 2, 2014
Health Authority: United States: Food and Drug Administration