A Phase 1-2 Pharmacokinetic Guided Dose-Escalation and Dose-Confirmation Study of ASTX727, a Combination of the Oral Cytidine Deaminase Inhibitor (CDAi) E7727 With Oral Decitabine in Subjects With Myelodysplastic Syndromes (MDS)

Trial Profile

A Phase 1-2 Pharmacokinetic Guided Dose-Escalation and Dose-Confirmation Study of ASTX727, a Combination of the Oral Cytidine Deaminase Inhibitor (CDAi) E7727 With Oral Decitabine in Subjects With Myelodysplastic Syndromes (MDS)

Recruiting
Phase of Trial: Phase I/II

Latest Information Update: 05 Apr 2017

At a glance

  • Drugs Decitabine/E-7727 (Primary) ; Decitabine/E-7727 (Primary) ; Decitabine
  • Indications Chronic myelomonocytic leukaemia; Myelodysplastic syndromes
  • Focus Adverse reactions; Pharmacodynamics; Pharmacokinetics; Therapeutic Use
  • Sponsors Astex Pharmaceuticals
  • Most Recent Events

    • 05 Apr 2017 Results (n=28) analysing genetic correlations with clinical response to ASTX727 in patients with myelodysplastic syndromes, presented at the 108th Annual Meeting of the American Association for Cancer Research.
    • 18 Mar 2017 Results of a PK/PD model developed from data using this study, presented at the 118th Annual Meeting of the American Society for Clinical Pharmacology and Therapeutics.
    • 06 Dec 2016 Final data of phase I portion results (n=43) presented at the 58th Annual Meeting and Exposition of the American Society of Hematology
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