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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:
ClinicalTrials.gov Identifier:
NCT00585221
First Posted: January 3, 2008
Last Update Posted: February 10, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Schering-Plough
Information provided by (Responsible Party):
University of Utah
Results First Submitted: June 15, 2012  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Gastrointestinal Stromal Tumors
Cancer Brain
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
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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 
Overall Participants Analyzed 
[Units: Participants]
 8 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      0   0.0% 
Between 18 and 65 years      4  50.0% 
>=65 years      4  50.0% 
Age 
[Units: Years]
Mean (Standard Deviation)
 64.875  (17.97) 
Gender 
[Units: Participants]
Count of Participants
 
Female      3  37.5% 
Male      5  62.5% 
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
e-mail: candace.larson@hci.utah.edu


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

Responsible Party: University of Utah
ClinicalTrials.gov Identifier: NCT00585221     History of Changes
Other Study ID Numbers: IRB_00022172
First Submitted: December 21, 2007
First Posted: January 3, 2008
Results First Submitted: June 15, 2012
Results First Posted: November 21, 2012
Last Update Posted: February 10, 2017