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)

Conditions

Leukemia, not otherwise specified | Myeloid and Monocytic Leukemia

What is the purpose of this trial?

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.

Participation Guidelines

Age:
Gender:

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Sponsor:
Astex Pharmaceuticals, Inc.
Dates:
05/21/2013
Last Updated:
Study HIC#:
1302011505