MGCD0103 in Elderly Patients With Previously Untreated AML/High Risk MDS or Adults With Relapsed/Refractory Disease

Inclusion Criteria:

Pathologic confirmation of AML or high risk MDS.
Elderly cohort (70 years of age or more): no prior chemotherapy treatment for AML/high risk MDS and not currently candidates for intensive chemotherapy.
Relapsed/refractory cohort (18 years of age or more): relapsed or refractory to prior treatment.
ECOG performance status of 0 or 1.
Total bilirubin < 1.5 x upper limit of normal (ULN).
AST/SGOT and ALT/SGPT < 2.5 x ULN.
Serum creatinine < 1.5 x ULN.
Patients must read, understand, and sign a written informed consent form (ICF).
Women of childbearing potential and male patients' female partners must use an acceptable method of contraception while on study, and for 3 months after study drug treatment.

Exclusion Criteria:

Pregnant or lactating women.
Patients with uncontrolled, intercurrent illness, active or uncontrolled infections, or a fever > 38.5C (not due to tumor fever) on the day of scheduled dosing.
Patients with serious illnesses or medical conditions, including laboratory results, which, in the investigator's opinion, would interfere with a patient's participation, or with the interpretation of the results.
Patients treated with an investigational drug within 30 days prior to study initiation.
Known hypersensitivity to HDAC inhibitors or to any of the components of MG-0103.
Known HIV or active hepatitis B or C.
Any condition that may affect the patient's ability to sign the ICF and undergo study procedures.
Any conditions that will put the patient at undue risk or discomfort as a result of adherence to study procedures.