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)
Sponsor:
Collaborator:
Schering-Plough
Information provided by (Responsible Party):
University of Utah
ClinicalTrials.gov Identifier:
NCT00585221
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,
Cancer,
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
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
All Patients All participants enrolled.

Participant Flow:   Overall Study
    All Patients  
STARTED     8  
COMPLETED     0  
NOT COMPLETED     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.
No text entered.

Reporting Groups
  Description
Group 1 No text entered.

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



  Outcome Measures
  Show All Outcome Measures

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


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


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: Director of Clinical Trials
Organization: Huntsman Cancer Institute
phone: 801-213-4241
e-mail: candace.larson@hci.utah.edu


No publications provided by University of Utah

Publications automatically indexed to this study:

Responsible Party: University of Utah
ClinicalTrials.gov 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