Status:
COMPLETED
Efficacy and Safety of Nilotinib (AMN107) Compared With Current Treatment Options in Patients With GIST Who Have Failed Both Imatinib and Sunitinib
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Gastrointestinal Stromal Tumors
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The study evaluated the safety and efficacy of nilotinib versus current treatment in adults with gastrointestinal stromal tumors (GIST) who have either progressed or who were intolerant to the first a...
Eligibility Criteria
Inclusion
- Inclusion criteria (Core Phase):
- Age ≥18 years
- 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
- Inclusion criteria (Extension Phase):
- 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 (Core Phase):
- Previous treatment with nilotinib or any other drug in this class or other targeted therapy
- 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
- Exclusion criteria (Extension Phase):
- 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.
- Other protocol-defined inclusion/exclusion criteria applied
Exclusion
Key Trial Info
Start Date :
March 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2011
Estimated Enrollment :
248 Patients enrolled
Trial Details
Trial ID
NCT00471328
Start Date
March 1 2007
End Date
June 1 2011
Last Update
June 12 2012
Active Locations (35)
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1
UCLA's Jonsson Comprehensive Cancer Center
Los Angeles, California, United States, 90095
2
Washington Hospital Center - Washington Cancer Institute
Washington D.C., District of Columbia, United States, 20010-2965
3
H. Lee Moffitt Cancer Center
Tampa, Florida, United States, 33612
4
University of Chicago Hospital
Chicago, Illinois, United States, 60637