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

PHASE1CompletedINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

November 12, 2019

Primary Completion Date

February 18, 2021

Study Completion Date

January 18, 2023

Conditions
Relapsed or Refractory Acute Myeloid Leukemia
Interventions
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).

Trial Locations (1)

Unknown

Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences, Tianjin

Sponsors
All Listed Sponsors
lead

CStone Pharmaceuticals

INDUSTRY