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

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

This study will assess time-to-disease progression in patients with advanced gastrointestinal stromal tumor (GIST) previously treated with imatinib ≥600 mg.

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