NCT04176393

A China Bridging Study of Ivosidenib in r/r AML Subjects With an IDH1 Mutation

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: Phase 1
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: CStone Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a phase 1, multi-center, single-arm study to evaluate the pharmacokinetics(PK)/ pharmacodynamics(PD), safety, and clinical efficacy of orally administered Ivosidenib in Chinese subjects with R/R AML with an IDH1 mutation.

Conditions

• Relapsed or Refractory Acute Myeloid Leukemia

Interventions

Type	Name	Description
DRUG	ivosidenib	subjects will receive a single dose of ivosidenib 500 mg on Day -3 (i.e., 3 days prior to the start of daily dosing) and undergo PK/PD assessments over 72 hours to evaluate drug concentrations and 2-HG levels. Following that, subjects will be treated with ivosidenib 500 mg once a day (QD) PO continuously (28-day cycles, there are no inter-cycle rest periods).

Timeline

• Start date: 2019-11-12
• Primary completion: 2021-02-18
• Completion: 2023-01-18
• First posted: 2019-11-25
• Last updated: 2023-02-13

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated drug study