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

• Status: Completed
• Trial end date: 2013-07-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Imatinib Mesylate; Sunitinib

Criteria

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.