PKC412 in Patients With Acute Myeloid Leukemia and Patients With Myelodysplastic Syndrome With Either Wild Type or Mutated FLT3

Inclusion criteria:

1. Patients:

with AML who are not candidates for myelosuppressive chemotherapy or with AML who
have relapsed disease or are refractory to standard therapy and not likely to require
cytoreductive therapy within one month or with MDS subtypes RAEB, RAEB-T or CMML.

2. Patients with a relevant FLT3-ITD mutation or D835Y point mutation

3. Patients at least 18 years or older

4. Patients with WHO performance status of 0 to 2 with a life expectancy of at least 3
months

5. Patients must not be treated within 4 weeks after any prior therapy

6. Written informed consent obtained according to local guidelines

Exclusion criteria:

Patients meeting any of the following criteria during screening will be excluded from
entry into the study:

1. Patients who had prior allogeneic, syngeneic, or autologous bone marrow transplant or
stem cell transplant less than 2 months previously.

2. Female patients who are pregnant or breast feeding, or adults of childbearing age not
employing an effective method of birth control.

3. Concurrent severe and/or uncontrolled medical or psychiatric condition which may
interfere with the completion of the study.

4. Impairment of gastrointestinal (GI) function or GI disease that may significantly
alter the absorption of PKC412.