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

Novartis

Status and phase: Completed; Phase 2

Conditions: Gastrointestinal Stromal Tumors

Treatments: Drug: AMN107

Study type: Interventional

Funder types: Industry

Identifiers

NCT00718562

CAMN107D1201

Details and patient eligibility

About

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

Enrollment: 35 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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35 participants in 1 patient group

Nilotinib

Experimental group

Treatment:

Drug: AMN107