A Phase 1-2, Dose Escalation, Multicenter Study of Two Subcutaneous Regimens of SGI-110, a DNA Hypomethylating Agent, in Subjects with Intermediate or High-Risk Myelodysplastic Syndromes (MDS) or Acute Myelogenous Leukemia (AML)
The goal of this clinical research study is to find the highest tolerable dose of SGI-110 when given on different schedules in patients with MDS or AML. The safety of this drug will also be studied. The objectives for this study have been met, and the main results have been analyzed, so we do not need to collect as much information as before: If you are continuing to receive study treatment, we want to allow you to keep receiving treatment. (If we stopped the study, you would not be able to keep receiving treatment.) We still need to collect some information, but we do not need to collect as much. Collecting less information will save time for your study doctor. We also hope this will make your study visits shorter and more convenient for you. If you are in long-term follow-up, we will not continue to collect information, and you will no longer receive follow-up calls from your study doctor’s office.
Treatment Location: N/A
Primary Objective Dose Escalation Segment: Determine the overall safety profile, including dose limiting toxicities (DLTs) and determine the recommended Dose Expansion Segment regimen(s) by identifying the optimal biologically effective dose (BED) for each regimen, based on maximum global DNA hypomethylation and gene expression, OR based on the maximum tolerated dose (MTD) whichever occurs first during dose escalation. Dose Expansion Segment: Evaluate the activity of SGI-110 as measured by overall remission rate. Secondary Objectives Determine the pharmacokinetic (PK) profile of SGI-110 and decitabine. Remission duration, hematological improvement and transfusion independence rates. Determine epigenetic modulation in peripheral blood and bone marrow samples and whether any putative biomarkers (eg, cytogenetic or molecular) for SGI-110 response exists.
IRB Review and Approval Date: 12/01/2010
Recruitment Status: Closed
Projected Accrual: N/A