Efficacy and Safety of Nilotinib (AMN107) Compared With Current Treatment Options in Patients With GIST Who Have Failed Both Imatinib and Sunitinib
NCT ID: NCT00471328
Last Updated: 2012-06-12
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
248 participants
INTERVENTIONAL
2007-03-31
2011-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Nilotinib
400mg twice daily in core and extension phases of the study.
Nilotinib
Nilotinib 400 mg twice daily (bid)
Control/cross-over to Nilotinib
In core study phase, patients in this arm received Best Supportive Care (BSC) with or without imatinib or sunitinib at the last tolerated dose or at the investigator's choice until documented disease progression followed by cross-over to nilotinib arm.
Patients entering the extension study on this control arm were permitted to cross over to nilotinib arm only upon documented disease progression.
Nilotinib
Nilotinib 400 mg twice daily (bid)
Best Supportive Care (BSC) +/- imatinib or sunitinib
Can include pain medication, localized radiotherapy, nutritional support, and/or oxygen therapy and blood transfusions. Imatinib or sunitinib can be administered at the last tolerated dose and regimen or at the Investigator's choice.
Interventions
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Nilotinib
Nilotinib 400 mg twice daily (bid)
Best Supportive Care (BSC) +/- imatinib or sunitinib
Can include pain medication, localized radiotherapy, nutritional support, and/or oxygen therapy and blood transfusions. Imatinib or sunitinib can be administered at the last tolerated dose and regimen or at the Investigator's choice.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Radiological confirmation of disease progression during imatinib and sunitinib therapy OR intolerance to imatinib and/or sunitinib
* At least one measurable site of disease on CT/MRI scan
* Physically fit even if not able to work
* Normal organ, electrolyte, and bone marrow function
* Patients whose tumors had progressed on the control arm and had crossed over to the nilotinib arm.
* The study was stopped due to meeting the primary efficacy endpoint of PFS at the interim analysis.
* Patients who were still being treated at the close of the Core study on the control arm or nilotinib arm (whose tumors have not progressed at the time of the end of the Core study).
* Patients must have had documented, confirmed stable, partial or complete response as defined by the RECIST criteria at the time of entry into the Extension study with the exception of patients who had progressed on the control arm.
Exclusion Criteria
* Treatment with any cytotoxic and/or investigational cytotoxic drug ≤ 4 weeks prior to study entry
* Impaired cardiac function
* Use of coumarin derivatives (i.e. warfarin, acenocoumarol, phenprocoumon)
* Women who are pregnant or lactating
* Use of other anticancer treatments or investigational drugs (with exception of the study drugs)
* Patients with a history of noncompliance with study drug treatment in the Core study protocol.
18 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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UCLA's Jonsson Comprehensive Cancer Center
Los Angeles, California, United States
Washington Hospital Center - Washington Cancer Institute
Washington D.C., District of Columbia, United States
H. Lee Moffitt Cancer Center
Tampa, Florida, United States
University of Chicago Hospital
Chicago, Illinois, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
Wayne State University/Wertz Clinical Cancer Center
Detroit, Michigan, United States
Washington University School of Medicine - Siteman Cancer Center
St Louis, Missouri, United States
St. Vincent's Comprehensive Cancer Center
New York, New York, United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States
University of Texas/MD Anderson Cancer Center
Houston, Texas, United States
Novartis Investigative Site
Auchenflower, Queensland, Australia
Novartis Investigative Site
East Melbourne, Victoria, Australia
Novartis Investigative Site
Vienna, , Austria
Novartis Investigative Site
Toronto, , Canada
Novartis Investigative Site
Prague, , Czechia
Novartis Investigative Site
Bordeaux, , France
Novartis Investigative Site
Lyon, , France
Novartis Investigative Site
Marseille, , France
Novartis Investigative Site
Berlin, , Germany
Novartis Investigative Site
Cologne, , Germany
Novartis Investigative Site
Düsseldorf, , Germany
Novartis Investigative Site
Essen, , Germany
Novartis Investigative Site
Frankfurt, , Germany
Novartis Investigative Site
Hanover, , Germany
Novartis Investigative Site
Mannheim, , Germany
Novartis Investigative Site
München, , Germany
Novartis Investigative Site
Tübingen, , Germany
Novrtis Investigative Site
Bologna, , Italy
Novartis Investigative Site
Milan, , Italy
Novartis Investigative Site
Leiden, , Netherlands
Novartis Investigative Site
Warsaw, , Poland
Novartis Investigative Site
Seoul, , South Korea
Novartis Investigative Site
Madrid, , Spain
Novartis Investigative Site
Chur, , Switzerland
Countries
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Other Identifiers
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2006-002267-11
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CAMN107A2201
Identifier Type: -
Identifier Source: org_study_id
NCT00488150
Identifier Type: -
Identifier Source: nct_alias
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