A Phase 1, Dose Escalation, Multicenter Study of Two Subcutaneous Regimens of SGI-110, a DNA Hypomethylating Agent, in Subjects With Intermediate-2 or High-Risk Myelodysplastic Syndromes (MDS) or Acute Myelogenous Leukemia (AML)

Study Status

Open to Enrollment

Study Description

The study drug that will be used in this study, SGI-110, is experimental. This means the US Food and Drug Administration (FDA)  has not approved the drug for use by the general public.

The purpose of this study is to evaluate the safety of the study drug and any potential benefits at different doses. Patients will be asked to provide samples of blood and bone marrow. These samples will be used to tell how the patient is responding to the intervention with the study drug. These samples will also be studied to look for special indicators, called biomarkers, which may help researchers learn more about the study drug, Myelodysplastic Syndromes (MDS) or Acute Myelogenous Leukemia (AML).

Patients will be randomly assigned into one of the two study invervention groups. Both groups will receive the study drug. The study drug will be injected in the fat layer just below your skin. This is called a subcutaneous injection.

Disease Status and/or Stage

Intermediate-2 or high-risk Myelodysplastic Syndromes (MDS) or Acute Myelogenous Leukemia (AML)

Sponsor

SuperGen

Key Eligibility

  • Men and women age 18 and older
  • Diagnosis of:
    • Intermediate-2 high-risk Myelodysplastic Syndromes (MDS) or
    • Acute Myelogenous Leukemia (AML)
  • Detailed eligibility discussed when you contact the study team

Principal Investigator

Gail Roboz, MD

Contact

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Contact Us

For general inquiries, or if you need assistance finding a study, please contact:

Robert Hagerty
Subject Recruitment Manager
Tel: (646) 962-9340
[email protected]

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