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
Latest Information Update: 06 Nov 2023
At a glance
- Drugs Ivosidenib (Primary)
- Indications Acute myeloid leukaemia
- Focus Pharmacokinetics; Registrational; Therapeutic Use
- Sponsors Cornerstone Pharmaceuticals Inc; CStone Pharmaceuticals
- 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.