Study of Dose Escalation Versus no Dose Escalation of Imatinib in Metastatic Gastrointestinal Stromal Tumors (GIST) Patients

This study has been terminated.
(Lack of feasibility secondary to slow accrual)
Sponsor:
Collaborator:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Sarcoma Alliance for Research through Collaboration
ClinicalTrials.gov Identifier:
NCT01031628
First received: December 11, 2009
Last updated: August 22, 2013
Last verified: August 2013
Results First Received: June 12, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Gastrointestinal Stromal Tumors
Intervention: Drug: Imatinib mesylate

  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
400 mg for Patients With Imatinib Blood Levels < 1100

Patients with imatinib trough blood levels less than 1100 will continue imatinib 400 mg daily

Imatinib mesylate : 400 mg daily. Number of cycles: until disease progression or unacceptable toxicity develops

600 or 800 mg for Patients With Imatinib Blood Levels < 1100

Patients with imatinib trough blood levels less than 1100 dose adjust imatinib mesylate to goal blood level ≥1100 ng/mL

Imatinib mesylate : 600 or 800 mg daily. Number of cycles: until disease progression or unacceptable toxicity develops

400 mg for Patients With Imatinib Blood Levels ≥ 1100

Patients with imatinib trough blood levels ≥1100 will continue imatinib 400 mg daily

Imatinib mesylate : 400 mg daily. Number of cycles: until disease progression or unacceptable toxicity develops

400, 600 or 800 mg for Patients With Exon 9 Mutation Tumors

Patients with tumors that harbor exon 9 mutations will continue imatinib mesylate at 400 mg or dose escalate up to 800 mg daily

Imatinib mesylate : 400, 600 or 800 mg daily. Number of cycles: until disease progression or unacceptable toxicity develops


Participant Flow:   Overall Study
    400 mg for Patients With Imatinib Blood Levels < 1100     600 or 800 mg for Patients With Imatinib Blood Levels < 1100     400 mg for Patients With Imatinib Blood Levels ≥ 1100     400, 600 or 800 mg for Patients With Exon 9 Mutation Tumors  
STARTED     0     1     3     0  
COMPLETED     0     0     0     0  
NOT COMPLETED     0     1     3     0  
Study terminated early                 0                 1                 3                 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
Arm A

Patients with blood level less than 1100 will continue imatinib 400 mg daily

Imatinib mesylate : 400 mg daily. Number of cycles: until disease progression or unacceptable toxicity develops

Arm B

Patients with blood level less than 1100 dose adjust imatinib mesylate to goal blood level ≥1100 ng/mL

Imatinib mesylate : 600 or 800 mg daily. Number of cycles: until disease progression or unacceptable toxicity develops

Arm C

Patients with blood level ≥1100 will continue imatinib 400 mg daily

Imatinib mesylate : 400 mg daily. Number of cycles: until disease progression or unacceptable toxicity develops

Arm D

Patients with tumors that harbor exon 9 mutations will continue imatinib mesylate at 400 mg or dose escalate up to 800 mg daily

Imatinib mesylate : 400, 600 or 800 mg daily. Number of cycles: until disease progression or unacceptable toxicity develops

Total Total of all reporting groups

Baseline Measures
    Arm A     Arm B     Arm C     Arm D     Total  
Number of Participants  
[units: participants]
  0     1     3     0     4  
Age  
[units: participants]
         
<=18 years         0     0         0  
Between 18 and 65 years         0     3         3  
>=65 years         1     0         1  
Age  
[units: years]
Mean ± Standard Deviation
      71     56.7  ± 8.39         60.25  ± 7.68  
Gender  
[units: participants]
         
Female         1     1         2  
Male         0     2         2  
Region of Enrollment  
[units: participants]
         
United States         1     3         4  



  Outcome Measures

1.  Primary:   Evaluation of Lesions for Progression or Response Via RECIST Criteria   [ Time Frame: Every 3 months ]


  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
A decision was made to discontinue the SARC019 trial effective March 3, 2011, due to lack of feasibility secondary to slow accrual. Due to early termination of the study, no patients were analyzed.  


Results Point of Contact:  
Name/Title: Research Project Manager
Organization: SARC
phone: (734) 930-7600
e-mail: sarc@sarctrials.org


No publications provided


Responsible Party: Sarcoma Alliance for Research through Collaboration
ClinicalTrials.gov Identifier: NCT01031628     History of Changes
Other Study ID Numbers: SARC019, STI571BUS286T
Study First Received: December 11, 2009
Results First Received: June 12, 2013
Last Updated: August 22, 2013
Health Authority: United States: Institutional Review Board