Status:
COMPLETED
SGI-110 in Participants With Myelodysplastic Syndromes (MDS) or Acute Myelogenous Leukemia (AML)
Lead Sponsor:
Astex Pharmaceuticals, Inc.
Conditions:
MDS
CMML
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
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...
Detailed Description
Once the biologically effective dose (BED) and maximum tolerated dose (MTD) is determined in the Dose Escalation Segment, the Dose Expansion Segment will randomize participants with MDS, treatment naï...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
January 4 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 22 2016
Estimated Enrollment :
414 Patients enrolled
Trial Details
Trial ID
NCT01261312
Start Date
January 4 2011
End Date
July 22 2016
Last Update
January 23 2025
Active Locations (16)
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1
Mayo Clinic
Scottsdale, Arizona, United States, 85259
2
University of Southern California
Los Angeles, California, United States, 90033
3
Yale University
New Haven, Connecticut, United States, 06520
4
Florida Cancer Specialists - South
Fort Myers, Florida, United States, 33916