Study of Dose Escalation Versus no Dose Escalation of Imatinib in Metastatic Gastrointestinal Stromal Tumors (GIST) Patients
NCT ID: NCT01031628
Last Updated: 2013-09-09
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE3
5 participants
INTERVENTIONAL
2010-01-31
2011-06-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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
Interventions
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Imatinib mesylate
400 mg daily. Number of cycles: until disease progression or unacceptable toxicity develops
Imatinib mesylate
600 or 800 mg daily. Number of cycles: until disease progression or unacceptable toxicity develops
Imatinib mesylate
400, 600 or 800 mg daily. Number of cycles: until disease progression or unacceptable toxicity develops
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Unresectable and/or metastatic GIST
* Currently receiving imatinib 400 mg per day for a minimum of 4 weeks prior to registration, and for no more than 6 months prior to registration. This must be the first time that the patient has been treated for metastatic and/or unresectable GIST
* For patients who received imatinib following surgery at the time of an initial diagnosis of GIST, there must be a 6 month interval between completion of imatinib and the diagnosis of metastatic GIST
* Good physical functioning (ECOG Performance Status of 0 or 1)
* Generally, good function of organ such as liver and kidneys
Exclusion Criteria
* Known intolerance of imatinib at a dose of 400 mg/day or higher
* Prior systemic therapy for advanced GIST with imatinib or those who have been on imatinib for longer than 6 months for unresectable and/or metastatic disease
* Major surgery within 2 weeks prior to Day 1 of study or who have not yet recovered from prior surgery
* Use of coumadin derivatives (i.e. warfarin, acenocoumarol, phenprocoumon)
* Patients who have received wide field radiotherapy ≤ 4 weeks or limited field radiation for palliation \< 2 weeks or who have not recovered from side effects of this therapy
18 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Sarcoma Alliance for Research through Collaboration
OTHER
Responsible Party
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Principal Investigators
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Suzanne George, MD
Role: PRINCIPAL_INVESTIGATOR
Dana-Farber Cancer Institute
Locations
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Cedars-Sinai Outpatient Cancer Center
Los Angeles, California, United States
Sarcoma Oncology Center
Santa Monica, California, United States
Washington Cancer Institute
Washington D.C., District of Columbia, United States
Northwestern University
Chicago, Illinois, United States
Indiana University Cancer Center
Indianapolis, Indiana, United States
University of Iowa
Iowa City, Iowa, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
Carolinas Hematology Oncology Associates
Charlotte, North Carolina, United States
Duke University Medical Center
Durham, North Carolina, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States
University of Pittsburgh Cancer Institute
Pittsburgh, Pennsylvania, United States
MD Anderson Cancer Center
Houston, Texas, United States
Countries
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References
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George S, Trent JC. The role of imatinib plasma level testing in gastrointestinal stromal tumor. Cancer Chemother Pharmacol. 2011 Jan;67 Suppl 1:S45-50. doi: 10.1007/s00280-010-1527-2. Epub 2010 Dec 8.
Marrari A, Trent JC, George S. Personalized cancer therapy for gastrointestinal stromal tumor: synergizing tumor genotyping with imatinib plasma levels. Curr Opin Oncol. 2010 Jul;22(4):336-41. doi: 10.1097/CCO.0b013e32833a6b8e.
Related Links
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SARC Website
Other Identifiers
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STI571BUS286T
Identifier Type: -
Identifier Source: secondary_id
SARC019
Identifier Type: -
Identifier Source: org_study_id