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

Completed · Phase 1/Phase 2

Conditions studied: MDS, CMML, AML

In brief

Phase 1-2 dose-escalation randomized study in participants with intermediate or high risk myelodysplastic syndromes (MDS) or acute myelogenous leukemia (AML). The Dose Escalation Segment will evaluate the biological activity, preliminary safety and efficacy of SGI-110 with two dosing schedules in MDS and AML participants while the Dose Expansion Segment will further evaluate safety and efficacy at the biological effective dose (BED) or maximum tolerated dose (MTD) as defined in the Dose Escalation Segment.

Key facts

Study ID: NCT01261312
Run by: Astex Pharmaceuticals, Inc.
People needed: 414
Starts: 2011-01-04
Expected to finish: 2016-07-22
Last updated by the study team: 2025-01-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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
Eastern ECOG performance status of 0 to 2.
Adequate organ function.
Prior allogeneic stem cell transplant, no evidence of active graft-versus host disease (GVHD) and must be ≥ 2 weeks off immunosuppressive therapy.
No major surgery within 4 weeks of first dose of SGI-110.
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.
Sign an approved informed consent form for this study.

You may not qualify if…

In the Dose Expansion Segment, which includes the 10-day regimen, participants 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 participant (including CMML) relapsed or refractory to prior HMA treatment).
Acute promyelocytic leukemia (M3 classification).
Prior malignancy, except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer from which the participant has been disease free for at least 3 years.
Life-threatening illnesses other than AML or MDS, uncontrolled medical conditions or organ system dysfunction which, in the investigator's opinion, could compromise the participant's safety, or put the study outcomes at risk.
Known history of human immunodeficiency virus (HIV) or active infection with hepatitis C virus (HCV) or hepatitis B virus (HBV).
Hypersensitivity to decitabine, SGI-110, or SGI-110 excipients.
With the exception of treatment-naïve elderly AML participants, participants 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.

Where it is running

Mayo Clinic — Scottsdale, Arizona, United States
University of Southern California — Los Angeles, California, United States
Yale University — New Haven, Connecticut, United States
Florida Cancer Specialists - South — Fort Myers, Florida, United States
Florida Cancer Specialists - North — St. Petersburg, Florida, United States
University of Chicago Cancer Center — Chicago, Illinois, United States
Roswell Park Cancer Institute — Buffalo, New York, United States
Cornell University — New York, New York, United States
Columbia University Medical Center — New York, New York, United States
Duke University — Durham, North Carolina, United States
Ohio State University — Columbus, Ohio, United States
Temple University — Philadelphia, Pennsylvania, United States
Sarah Cannon Research Institute — Nashville, Tennessee, United States
Tennessee Oncology — Nashville, Tennessee, United States
MD Anderson Cancer Center — Houston, Texas, United States
Princess Margaret Hospital — Toronto, Ontario, Canada

Full record on ClinicalTrials.gov

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