SGI-110 in Patients With Myelodysplastic Syndromes (MDS) or Acute Myelogenous Leukemia (AML)

Once the BED and MTD is determined in the Dose Escalation Segment, the Dose Expansion Segment
will randomize patients with MDS, treatment naïve elderly AML, and relapsed/refractory AML
patients to receive the BED or MTD dose. Relapsed/refractory AML patients may also receive
SGI-110 on a daily x 10 schedule based on the total dose per cycle evaluated in the Dose
Escalation Segment using the 5-daily regimen.

Inclusion Criteria:

1. Men or women, 18 years of age or older, with a confirmed diagnosis of international
prognostic scoring system (IPSS) intermediate-1, intermediate-2 or high-risk MDS
including Chronic Myelomonocytic Leukemia (CMML) or AML.

- In the Dose Escalation Segment, patients who are refractory, relapsed, or
unresponsive to standard treatment.

- In the Dose Expansion Segment, hypomethylating agent (HMA) treatment-naïve MDS
subjects (including CMML), and intermediate-2 or high-risk MDS subjects
(including CMML) relapsed or refractory to prior HMA treatment are allowed, and
treatment-naïve AML subjects who are at least 65 years of age will be allowed if
they also have at least one of the following criteria

- AML secondary to MDS, chemotherapy, or radiation therapy

- poor cytogenetics

- pre-existing clinically significant dysfunction of the heart or Chronic
Obstructive Pulmonary Disease (COPD)

- poor performance status, Eastern Cooperative Oncology Group (ECOG), of 2

2. Eastern ECOG performance status of 0 to 2.

3. Adequate organ function.

4. Prior allogeneic stem cell transplant, no evidence of active graft-versus host disease
(GVHD) and must be ≥ 2 weeks off immunosuppressive therapy.

5. No major surgery within 4 weeks of first dose of SGI-110.

6. No chemotherapy within 2 weeks of first dose of SGI-110 (minimum of 6 weeks for
nitrosoureas and 8 weeks for bone marrow transplantation) with the exception of
hydroxyurea which will be allowed during course 1 of treatment.

7. Sign an approved informed consent form for this study.

Exclusion Criteria:

1. In the Dose Expansion Segment, which includes the 10-day regimen, subjects who have
received 2 complete full dose cycles or more of a hypomethylating agent (HMA)
decitabine or azacitidine (except for intermediate-2 or high-risk MDS subjects
(including CMML) relapsed or refractory to prior HMA treatment).

2. Acute promyelocytic leukemia (M3 classification).

3. Prior malignancy, except for adequately treated basal cell or squamous cell skin
cancer, in situ cervical cancer, or other cancer from which the patient has been
disease free for at least 3 years.

4. Life-threatening illnesses other than AML or MDS, uncontrolled medical conditions or
organ system dysfunction which, in the investigator's opinion, could compromise the
patient's safety, or put the study outcomes at risk.

5. Known history of human immunodeficiency virus (HIV) or active infection with hepatitis
C virus (HCV) or hepatitis B virus (HBV).

6. Hypersensitivity to decitabine, SGI-110, or SGI-110 excipients.

7. With the exception of treatment-naïve elderly AML patients, patients with uncontrolled
congestive heart failure (CHF), coronary heart disease (CAD), chronic obstructive
pulmonary disease (COPD), or left ventricular ejection fraction (LVEF) of ≤ 50% are
excluded, symptomatic or uncontrolled arrhythmias or on continuous corticosteroids.