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A Phase 3, Randomized, Open-Label, Crossover Study of ASTX727 (Cedazuridine and Decitabine Fixed-Dose Combination) Versus IV Decitabine in Subjects With Myelodysplastic Syndromes (MDS), Chronic Myelomonocytic Leukemia (CMML), and Acute Myeloid Leukemia (AML)

Trial Profile

A Phase 3, Randomized, Open-Label, Crossover Study of ASTX727 (Cedazuridine and Decitabine Fixed-Dose Combination) Versus IV Decitabine in Subjects With Myelodysplastic Syndromes (MDS), Chronic Myelomonocytic Leukemia (CMML), and Acute Myeloid Leukemia (AML)

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 09 Dec 2024

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At a glance

  • Drugs Cedazuridine/decitabine (Primary) ; Decitabine
  • Indications Acute myeloid leukaemia; Chronic myelomonocytic leukaemia; Myelodysplastic syndromes; Refractory anaemia; Refractory anaemia with excess of blasts; Sideroblastic anaemia
  • Focus Pharmacokinetics; Registrational
  • Acronyms ASCERTAIN
  • Sponsors Astex Pharmaceuticals

Most Recent Events

  • 01 Nov 2024 Results evaluating Oral decitabine/cedazuridine versus intravenous decitabine, published in the British Journal of Haematology
  • 23 Jan 2024 Results published in the Taiho Oncology Media Release
  • 02 Jan 2024 According to a Taiho Oncology media release, data from this trial published in Lancet Haematology

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