drugset / Trial / NCT04176393
A China Bridging Study of Ivosidenib in r/r AML Subjects With an IDH1 Mutation
NaSingle-groupOpen-labelTreatment
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.
Timeline
- Start
- 2019-11-12
- Primary completion
- 2021-02-18
- Completion
- 2023-01-18
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ivosidenib | Small molecule | 500 mg | Oral |