SGI-110 in Patients With Myelodysplastic Syndromes (MDS) or Acute Myelogenous Leukemia (AML)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01261312|
Recruitment Status : Completed
First Posted : December 16, 2010
Last Update Posted : April 20, 2021
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|Condition or disease||Intervention/treatment||Phase|
|MDS CMML AML||Drug: SGI-110||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||401 participants|
|Intervention Model:||Sequential Assignment|
|Masking:||None (Open Label)|
|Official Title:||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)|
|Study Start Date :||December 2010|
|Actual Primary Completion Date :||July 2016|
|Actual Study Completion Date :||January 2019|
Experimental: Daily Regimen
Experimental: Weekly Regimen
- Dose Escalation Segment (Safety Lead-in): Determine the optimal BED or MTD and the frequency of drug administration. [ Time Frame: Assessed at the end of Course 1 (4 weeks) for each dose cohort. ]
- Number of patients with adverse events.
- Incidence of dose limiting toxicities.
- Degree of hypomethylation as measured by LINE-1.
- Dose Expansion Segment: Assess the activity of SGI-110 as measured by overall remission rate. [ Time Frame: 12 Months ]Overall survival measured in weeks.
- Determine the pharmacokinetic profile of SGI-110 and decitabine. [ Time Frame: Assessed at the end of Course 1 (4 weeks) for each cohort. ]Cmax, Cmin, AUC and other secondary PK parameters of SGI-110 and decitabine in patients during Course 1.
- Remission duration, hematological improvements and transfusion independence rates. [ Time Frame: 12 months ]Assess remission duration, hematological improvement and transfusion independence rates as measured by weeks.
- Determine epigenetic modulation in peripheral blood and bone marrow samples. [ Time Frame: 12 months ]
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
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, patients who are refractory, relapsed, or unresponsive to standard treatment.
In the Dose Expansion Segment, hypomethylating agent (HMA) treatment-naïve MDS subjects (including CMML), and intermediate-2 or high-risk MDS subjects (including CMML) relapsed or refractory to prior HMA treatment are allowed, and treatment-naïve AML subjects who are 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.
- In the Dose Expansion Segment, which includes the 10-day regimen, subjects 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 subjects (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 patient 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 patient'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 patients, patients 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01261312
|United States, Arizona|
|Scottsdale, Arizona, United States, 85259|
|United States, California|
|University of Southern California|
|Los Angeles, California, United States, 90033|
|United States, Connecticut|
|New Haven, Connecticut, United States, 06520|
|United States, Florida|
|Florida Cancer Specialists - South|
|Fort Myers, Florida, United States, 33916|
|Florida Cancer Specialists - North|
|Saint Petersburg, Florida, United States, 33705|
|United States, Illinois|
|University of Chicago Cancer Center|
|Chicago, Illinois, United States, 60637|
|United States, New York|
|Roswell Park Cancer Institute|
|Buffalo, New York, United States, 14263|
|New York, New York, United States, 10021|
|Columbia University Medical Center|
|New York, New York, United States, 10032|
|United States, North Carolina|
|Durham, North Carolina, United States, 27705|
|United States, Ohio|
|Ohio State University|
|Columbus, Ohio, United States, 43210|
|United States, Pennsylvania|
|Philadelphia, Pennsylvania, United States, 19111|
|United States, Tennessee|
|Sarah Cannon Research Institute|
|Nashville, Tennessee, United States, 37203|
|Nashville, Tennessee, United States, 37203|
|United States, Texas|
|MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Princess Margaret Hospital|
|Toronto, Ontario, Canada, M5G 2M9|
|Responsible Party:||Astex Pharmaceuticals, Inc.|
|Other Study ID Numbers:||
|First Posted:||December 16, 2010 Key Record Dates|
|Last Update Posted:||April 20, 2021|
|Last Verified:||April 2021|
DNA Hypomethylating Agent
Intermediate 1, Intermediate 2, CMML or High Risk MDS
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Bone Marrow Diseases
Molecular Mechanisms of Pharmacological Action