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

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, participants who are refractory, relapsed, or unresponsive to standard treatment.
• •* In the Dose Expansion Segment, hypomethylating agent (HMA) treatment-naïve MDS participants (including CMML), and intermediate-2 or high-risk MDS participant (including CMML) relapsed or refractory to prior HMA treatment are allowed, and treatment-naïve AML participants who is 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.