Phase 2 Study of Azacitidine (Vidaza) vs MGCD0103 vs Combination in Elderly Subjects With Newly Diagnosed Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS)

Inclusion Criteria:

• Able to provide written informed consent, and be willing and able to comply with all the study procedures
• Must be 60 years of age or older
• Must have a pathologic confirmation of newly diagnosed (de novo or untreated secondary) AML or newly diagnosed Int-2 or high-risk MDS (IPSS classification) according to WHO criteria
• Must have a Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
• Must have adequate organ function, including total bilirubin ≤ 1.5 x upper limit of normal (ULN); AST & ALT ≤ 2.5 x ULN; and serum creatinine ≤ 2.0 x ULN.

Exclusion Criteria:

• Considered fit for intensive chemotherapy and opt to be treated with intensive chemotherapy
• Prior transplantation or any prior anticancer therapy (standard or investigational, including chemotherapy, treatment with HDAC inhibitors, or combination HDAC and azacitidine) administered to treat AML or MDS.
• Clinical evidence of central nervous system (CNS) involvement by leukemia
• A diagnosis of promyelocytic leukemia
• Previous or concurrent malignancy 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
• Active and uncontrolled clinically significant infection
• Known positive serology for hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV Ab) or human immunodeficiency virus (HIV)
• Less than 4 weeks elapsed since any major surgery
• Any prior or active disease that may interfere with the procedures or evaluations to be conducted in the study