Evaluation of Nilotinib In Patients With Advanced Gastrointestinal Stromal Tumor (GIST)

Inclusion Criteria: * Histologically confirmed diagnosis of GIST that is unresectable and/or metastatic * Radiological confirmation of disease progression or intolerance to imatinib therapy at a any dose * At least one measurable site of disease on CT scan at Visit-2 * WHO Performance Status of 0, 1 or 2 at Visit-2 * Patients must have normal organ, electrolyte, and marrow function at Visit-1 and Visit-2 Exclusion Criteria: * Prior treatment with nilotinib or any other tyrosine kinase inhibitors except imatinib. * Treatment with any cytotoxic and/or investigational cytotoxic drug ≤ 4 weeks * Prior or concomitant malignancies other than GIST * Impaired cardiac function at Visit-1 or 2 * Patients with severe and/or uncontrolled concurrent medical disease * Use of therapeutic coumarin derivatives * Use of any medications that prolong the QT interval * Use of CYP3A4 inhibitors * Patients who have undergone major surgery ≤ 2 weeks prior to Visit-1 or who have not recovered from side effects of such surgery * Patients who have received wide field radiotherapy ≤ 4 weeks or limited field radiation for palliation \< 2 weeks prior to Visit-1 or who have not recovered from side effects of such therapy Other protocol-defined inclusion/exclusion criteria may apply