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A Phase 1, Multicenter, Single-Arm Study Evaluating Pharmacokinetic, Pharmacodynamic, Safety, and Clinical Efficacy of Orally Administered Ivosidenib in Chinese Subjects With Relapsed or Refractory Acute Myeloid Leukemia With an IDH1 Mutation

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Trial Profile

A Phase 1, Multicenter, Single-Arm Study Evaluating Pharmacokinetic, Pharmacodynamic, Safety, and Clinical Efficacy of Orally Administered Ivosidenib in Chinese Subjects With Relapsed or Refractory Acute Myeloid Leukemia With an IDH1 Mutation

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 06 Nov 2023

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At a glance

  • Drugs Ivosidenib (Primary)
  • Indications Acute myeloid leukaemia
  • Focus Pharmacokinetics; Registrational; Therapeutic Use
  • Sponsors Cornerstone Pharmaceuticals Inc; CStone Pharmaceuticals

Most Recent Events

  • 02 Nov 2023 Results assessing the pharmacokinetics (PK) and pharmacodynamics (PD) of ivosidenib in Chinese patients with relapsed or refractory acute myeloid leukemia , published in the European Journal of Clinical Pharmacology.
  • 15 Mar 2023 According to Cstone Pharmaceuticals media release, in October 2022 company received Pediatric and Minority Serious Disease Designation from TFDA for IDH1-mutated R/R AML in adults.
  • 10 Feb 2023 Status changed from active, no longer recruiting to completed.

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