Phase I, Open-Label, Dose-Escalation Study to Evaluate the Safety, PK & PD of Oral Azacitidine in Subjects With Myelodysplastic Syndromes (MDS), Chronic Myelomonocytic Leukemia (CMML) or Acute Myelogenous Leukemia (AML)

Inclusion Criteria:

- 18 years or older.

- Diagnosis of low or Int-1 risk MDS

- Low platelet count, and/or low hemoglobin, and/or RBC transfusion-dependent and/or
platelet transfusion-dependent

- ECOG Performance status 0-2

- Standard safety inclusion for serum creatinine, AST, ALT, bilirubin.

- Serum bicarbonate greater than or equal to 20 mEq/L.

- Use of acceptable birth control.

- Signed, written informed consent.

Exclusion Criteria:

- Diagnosis of acute PML.

- Previous or concurrent malignancy.

- Prior treatment with azacitidine or other demethylating agents.

- Treatment with any anticancer therapy or investigational drugs within 21 days.

- Hypersensitivity to azacitidine or mannitol.

- Presence of GI disease.

- Active, uncontrolled infection.

- Known Human Immunodeficiency Virus (HIV) or Hepatitis C, or known active viral
Hepatitis B.

- Breastfeeding or Pregnant females;

- Presence of serious illness, medical condition, or other medical history which would
be likely to interfere with a subject's participation in the study or with the
interpretation of the results.

- Current congestive heart failure (NY Heart Association Class III-IV), unstable angina
or angina requiring surgical or medical intervention within 6 months, myocardial
infarct within 6 months, or uncontrolled cardiac arrhythmia.