Inclusion Criteria:

1. 18 years or older

2. World Health Organization (WHO) Performance Status Score of: 0- you are fully active
and more or less as you were before your illness, 1 - you cannot carry out heavy
physical work, but can do anything else.

3. Adequate hematological laboratory parameters

4. No major impairment of renal or hepatic function

5. Female patients must have a negative serum pregnancy test at screening.

Exclusion Criteria:

1. Severe and/or uncontrolled medical disease;

2. Severe cardiac insufficiency with uncontrolled and/or unstable cardiac or coronary
artery disease;

3. Known diagnosis of human immunodeficiency virus (HIV) infection;

4. Presence of any other active or suspected acute or chronic uncontrolled infection;

5. Symptomatic brain metastases or leptomeningeal disease.

Other protocol-defined inclusion/exclusion criteria may apply.