Study of Imatinib and Peginterferon α-2b in Gastrointestinal Stromal Tumor (GIST) Patients

This study has been terminated.
(PI terminated at the recommendation of DSMC & IRB)
Information provided by (Responsible Party):
University of Utah Identifier:
First received: December 21, 2007
Last updated: July 23, 2013
Last verified: July 2013
Results First Received: June 15, 2012  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Gastrointestinal Stromal Tumors,
Solid Tumors
Interventions: Drug: Peginterferon-alpha 2b (PegIFNa2b);
Drug: Imatinib

  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
All Patients All participants enrolled.

Participant Flow:   Overall Study
    All Patients  
STARTED     8  
Protocol Violation                 8  

  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.
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Reporting Groups
Group 1 No text entered.

Baseline Measures
    Group 1  
Number of Participants  
[units: participants]
[units: participants]
<=18 years     0  
Between 18 and 65 years     4  
>=65 years     4  
[units: years]
Mean (Standard Deviation)
  64.875  (17.97)  
[units: participants]
Female     3  
Male     5  
Region of Enrollment  
[units: participants]
United States     8  

  Outcome Measures
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1.  Primary:   Decrease in Tumor Size.   [ Time Frame: 18 months ]

2.  Primary:   Time to Progression (TTP).   [ Time Frame: two 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:  
All Principal Investigators ARE employed by the organization sponsoring the study.

Results Point of Contact:  
Name/Title: Director of Clinical Trials
Organization: Huntsman Cancer Institute
phone: 801-213-4241

Publications automatically indexed to this study by Identifier (NCT Number):

Responsible Party: University of Utah Identifier: NCT00585221     History of Changes
Other Study ID Numbers: IRB_00022172
Study First Received: December 21, 2007
Results First Received: June 15, 2012
Last Updated: July 23, 2013
Health Authority: United States: Institutional Review Board