A Multi-center Phase II Study to Evaluate the Efficacy and Safety of AMN107 (Nilotinib) in Patients With Gastrointestinal Stromal Tumors Who Have Progressed on or Are Intolerant to Both Imatinib and Sunitinib
Phase 2
20 Years
N/A
20 Years
N/A
Open (Enrolling)
Both
Gastrointestinal Stromal Tumors
Both
Gastrointestinal Stromal Tumors
Trial Information
A Multi-center Phase II Study to Evaluate the Efficacy and Safety of AMN107 (Nilotinib) in Patients With Gastrointestinal Stromal Tumors Who Have Progressed on or Are Intolerant to Both Imatinib and Sunitinib
Inclusion Criteria:
- Documented 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
- PS≤2
- Normal organ, electrolyte, and bone marrow function
Exclusion Criteria:
- Previous treatment with nilotinib or any other drug in this class or other targeted
therapy
- Treatment with any cytotoxic and/or investigational drug ≤ 4 weeks prior to study
entry
- Impaired cardiac function
- Use of coumarin derivatives (i.e. warfarin)
- Women who are pregnant or lactating
Other protocol-defined inclusion/exclusion criteria may apply.
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Disease Control Rate (DCR) in all patients with either sunitinib-resistant GIST or in patients with GIST who are intolerant of sunitinib
Outcome Time Frame:
24 weeks
Safety Issue:
No
Principal Investigator
Novartis Pharmaceuticals
Investigator Role:
Study Director
Investigator Affiliation:
Novartis Pharmaceuticals
Authority:
Japan: Pharmaceuticals and Medical Devices Agency
Study ID:
CAMN107D1201
NCT ID:
NCT00718562
Start Date:
September 2008
Completion Date:
June 2013
Related Keywords:
- Gastrointestinal Stromal Tumors
- nilotinib
- AMN107
- Sunitinib
- Sunitinib malate
- Imatinib
- Imatinib mesylate
- Tyrosine
- Gastrointestinal Stromal Tumors
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