Inclusion Criteria

Inclusion criteria:

- Age ≥ 18 years at Visit 1

- Radiological confirmation of disease progression (CT scan PET-CT, or MRI) during
imatinib therapy, on 600- 800 mg per day for at least 6 weeks.

- Radiological confirmation of disease progression (CT scan or MRI and PET-CT) during
2nd line TK inhibitor therapy.

- Patients who were intolerant to Imatinib or second line TK inhibitor (like
:sunitinib). Intolerance (at any dose and/or duration), is defined as patients who
did not progress on imatinib or sunitinib and have discontinued imatinib and or
sunitinib therapy due to any ≥ Grade 3 adverse events that persist in spite of
optimal supportive care. Patients with Grade 2 adverse events related to imatinib or
sunitinib therapy, in spite of optimal supportive care measures, that persist for ≥
one month or that recurs for more than 3 times whether the dose is reduced or
discontinued will also qualify patients as intolerant

Exclusion criteria:

- Prior treatment with nilotinib

- Treatment with any investigational drug ≤ 4 weeks prior to Visit 1 with the exception
of imatinib and sunitinib therapy .

Other protocol-defined inclusion/exclusion criteria may apply