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A Phase 1b, Open-label, Parallel Group, Multiple-dose Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Oral Decitabine and Cedazuridine (ASTX727) in Cancer Patients With Moderate and Severe Hepatic Impairment

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A Phase 1b, Open-label, Parallel Group, Multiple-dose Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Oral Decitabine and Cedazuridine (ASTX727) in Cancer Patients With Moderate and Severe Hepatic Impairment

Status: Recruiting
Phase of Trial: Phase I

Latest Information Update: 13 Jan 2025

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At a glance

  • Drugs Cedazuridine/decitabine (Primary)
  • Indications Acute myeloid leukaemia; Haematological malignancies; Myelodysplastic syndromes; Solid tumours
  • Focus Pharmacokinetics
  • Sponsors Astex Pharmaceuticals; Taiho Oncology

    • Most Recent Events

    • 08 Jan 2025 Planned End Date changed from 1 Dec 2024 to 1 Dec 2026.
    • 08 Jan 2025 Planned primary completion date changed from 1 Dec 2024 to 1 Dec 2026.
    • 21 Jan 2022 Planned initiation date (estimated date for recruitment of the first subject) changed from 1 Sep 2021 to 1 Feb 2022.

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