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)

Trial Profile

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)

Completed
Phase of Trial: Phase I/II

Latest Information Update: 24 Aug 2017

At a glance

  • Drugs Guadecitabine (Primary)
  • Indications Acute myeloid leukaemia; Chronic myelomonocytic leukaemia; Myelodysplastic syndromes
  • Focus Adverse reactions; First in man; Therapeutic Use
  • Sponsors Astex Pharmaceuticals
  • Most Recent Events

    • 24 Aug 2017 Additional group of patients with 10 day schedule was added as per protocol amendment.
    • 24 Aug 2017 Results (n=107, data cut off June 13, 2016) of final analysis of phase II study published in the Lancet Oncology
    • 20 Apr 2016 Results of preliminary analysis (n=23) presented at the 107th Annual Meeting of the American Association for Cancer Research
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