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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)

Status: Completed
Phase of Trial: Phase I/II

Latest Information Update: 28 Jan 2025

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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

  • 22 Jan 2025 Protocol has been amended to include new arms , changed from 2 to 13.
  • 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

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