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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: 07 Sep 2025

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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

  • 09 Jul 2025 According to a Taiho Pharmaceutical media release, Company announced today that the U.S. Food and Drug Administration (FDA) has accepted their supplemental new drug application (sNDA) for INQOVI (decitabine and cedazuridine) plus venetoclax as a treatment for adults with newly diagnosed acute myeloid leukemia. The sNDA is supported by results from ASCERTAIN-V, a Phase 2b study.
  • 23 May 2025 Results presented in the Taiho Pharmaceutical Media Release.
  • 22 May 2025 According to a Taiho Pharmaceutical media release, results form this trial will be presented at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting, May 30 through June 3 at McCormick Place in Chicago.

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