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)
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.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label
Dose Escalation Segment (Safety Lead-in): Determine the optimal BED or MTD and the frequency of drug administration.
Number of patients with adverse events. Incidence of dose limiting toxicities. Degree of hypomethylation as measured by LINE-1.
Assessed at the end of Course 1 (4 weeks) for each dose cohort.
United States: Food and Drug Administration
|MD Anderson Cancer Center||Houston, Texas 77030-4096|
|Roswell Park Cancer Institute||Buffalo, New York 14263|
|Temple University||Philadelphia, Pennsylvania 19140|
|Duke University||Durham, North Carolina 27710|
|Ohio State University||Columbus, Ohio 43210|
|Mayo Clinic||Scottsdale, Arizona|
|University of Southern California||Los Angeles, California 90033|
|Cornell University||New York, New York 10021|
|Tennessee Oncology||Nashville, Tennessee 37203|
|University of Chicago Cancer Center||Chicago, Illinois 60637|