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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)

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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)

Status: Completed
Phase of Trial: Phase I/II

Latest Information Update: 29 Aug 2024

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At a glance

  • Drugs Cedazuridine/decitabine (Primary) ; Cedazuridine; Decitabine; Decitabine
  • Indications Chronic myelomonocytic leukaemia; Myelodysplastic syndromes
  • Focus Adverse reactions; First in man; Pharmacodynamics; Pharmacokinetics; Therapeutic Use
  • Sponsors Astex Pharmaceuticals

    • Most Recent Events

    • 15 Jun 2023 Results assessing combined clinical experience of patients with CMML in the critical studies leading to FDAapproval of oral DEC/CED (ClinicalTrilas.gov NCT02103478 and NCT03306264, respectively) with additional analysis of genetic profiles for the subset, presented at the 28th Congress of the European Haematology Association.
    • 02 Dec 2020 According to a Taiho Oncology media release, data from this study have been published in Lancet Haematology in April 2019.
    • 13 Apr 2020 Results published in the Blood

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