Inclusion Criteria:

1. Male or female patients with diagnosis of CP-CML with cytogenetic confirmation of
Philadelphia (Ph) chromosome

2. Ph negative cases or patients with variant translocations who are BCR-ABL positive in
multiplex PCR are also eligible

3. WHO performance status 0-2

4. Laboratory assessments within normal limits

5. Written informed consent prior to any study procedures being performed

Exclusion Criteria:

1. Known impaired cardiac function

2. History of acute or chronic pancreatitis

3. Impaired gastrointestinal function or disease that may alter the absorption of study
drug

4. Concomitant medications with potential QT prolongation, or known to interact with
CYP450 isoenzymes (CYP3A4, CYP2C9, and CYP2C8)

5. Patients who have undergone major surgery ≤ 2 weeks prior to starting study drug or
who have not recovered from side effects of such therapy

6. Patients who are pregnant or breast feeding, or females of reproductive potential not
employing an effective method of birth control. Female patients must agree to employ
an effective barrier method of birth control throughout the study and for up to 3
months following discontinuation of study drug

Other protocol-defined inclusion/exclusion criteria may apply