| Exclusion Criteria: | 1) A diagnosis of acute promyelocytic leukemia.
2) Previous or concurrent malignancy (other than MDS, CMML or AML) except adequately treated basal cell or squamous cell skin cancer; in situ carcinoma of the cervix, or other solid tumor treated curatively, and without evidence of recurrence for at least 3 years prior to study entry.
3) Prior treatment with azacitidine or other demethylating agents.
4) Active, uncontrolled clinically significant infections.
5) Presence of serious illness, medical condition, or other medical history, including abnormal laboratory parameters, which, in the opinion of the Investigator, would be likely to interfere with a subject's participation in the study or with the interpretation of the results.
6) Any known or suspected hypersensitivity to azacitidine or mannitol or any other ingredient used in the manufacture of azacitidine drug product.
7) Presence of gastrointestinal disease or other conditions known to interfere with the absorption, distribution, metabolism, or excretion of drugs.
8) Known Human Immunodeficiency Virus (HIV) or Hepatitis C, or known active viral Hepatitis B.
9) Breastfeeding or pregnant females.
10) Treatment with any anticancer therapy (standard or investigational) within the previous 21 days prior to the first dose of study drug or less than full recovery (CTCAE grade 1) from the clinically significant toxic effects of that treatment. The use of hydroxyurea in subjects with rapidly proliferating disease is allowed only during Cycle 1 after SC administration of azacitidine for 7 days for subjects in Part 1 only. Hydroxyurea may be used for two weeks after dosing in Cycle 1 (eg, Days 8-21 dosed with hydroxyurea) for subjects in Part 1 only.
11) Treatment with any investigational drugs within the previous 21 days prior to Cycle 1, Day 1, or ongoing adverse events from previous treatment with investigational drugs, regardless of the time period.
12) Current congestive heart failure (NY Heart Association Class III-IV), unstable angina or angina requiring surgical or medical intervention within 6 months prior to Cycle 1, Day 1, myocardial infarct within 6 months prior to Cycle 1, Day 1, or uncontrolled cardiac arrhythmia (defined as arrhythmia that is symptomatic or requires treatment or asymptomatic sustained ventricular tachycardia). Subjects with controlled atrial fibrillation that is asymptomatic are eligible. |