Efficacy and Safety of AMN107 in Patients With GastroIntestinal Stromal Tumors (GIST) Who Have Failed Both Imatinib and Sunitinib

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

This study will evaluate the efficacy and safety of nilotinib in gastrointestinal stromal tumors patients who failed imatinib and sunitinib therapy.

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.