A Study of Nilotinib Versus Imatinib in GIST Patients

Inclusion criteria

• Histologically confirmed diagnosis of GIST which is unresectable and/or metastatic and either:

• have not received any prior anti-neoplastic therapy other than adjuvant imatinib. Note: newly diagnosed patients may have received up to 14 days of treatment with imatinib for disease management while awaiting entry to the study or
• recurrent GIST after stopping adjuvant treatment with imatinib and no subsequent treatment with any other therapies.
• At least one measurable site of disease on CT/MRI scan
• Performance status ≤ 2 (capable of self-care but unable to carry out any work)
• Normal organ, electrolyte and marrow function

Exclusion criteria

• Any prior anti-neoplastic therapy with the exception of patients who have received adjuvant imatinib or patients with newly diagnosed metastatic/ unresectable GIST whose disease requires therapy while awaiting entry to the study.
• Disease progression during adjuvant therapy with imatinib
• History of active malignancy (other than GIST) within 10 years prior to study entry with the exception of previous or concomitant basal cell skin cancer, previous cervical carcinoma in situ.
• Impaired cardiac function

Other protocol-defined inclusion/exclusion criteria may apply