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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 Severe Renal Impairment and Cancer Patients With Normal Renal Function

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Trial Profile

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 Severe Renal Impairment and Cancer Patients With Normal Renal Function

Status: Recruiting
Phase of Trial: Phase I

Latest Information Update: 27 Sep 2024

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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

    • 29 Jun 2023 Planned End Date changed from 15 Dec 2023 to 15 Dec 2024.
    • 29 Jun 2023 Planned primary completion date changed from 15 Dec 2023 to 15 Dec 2024.
    • 16 Feb 2023 Planned End Date changed from 1 Jan 2023 to 15 Dec 2023.

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