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