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A Single-Arm, Open-Label Pharmacokinetic, Safety, and Efficacy Study of ASTX727 in Combination With Venetoclax in Adult Patients With Acute Myeloid Leukemia

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Trial Profile

A Single-Arm, Open-Label Pharmacokinetic, Safety, and Efficacy Study of ASTX727 in Combination With Venetoclax in Adult Patients With Acute Myeloid Leukemia

Status: Active, no longer recruiting
Phase of Trial: Phase I/II

Latest Information Update: 28 May 2026

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At a glance

  • Drugs Cedazuridine/decitabine (Primary) ; Venetoclax (Primary)
  • Indications Acute myeloid leukaemia
  • Focus Pharmacokinetics; Therapeutic Use
  • Acronyms ASCERTAIN-V
  • Sponsors Astex Pharmaceuticals; Taiho Oncology

Most Recent Events

  • 13 May 2026 Results presented in the Taiho Oncology media release.
  • 13 May 2026 Primary endpoint has been met. (Complete Response (CR))
  • 13 May 2026 According to a Taiho Oncology media release, based on the results from the trial, the U.S. FDA has approved INQOVI (decitabine and cedazuridine) plus venetoclax as a treatment for adults with newly diagnosed acute myeloid leukemia (AML) who are 75 years or older or who are ineligible for intensive induction chemotherapy.

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