30
Participants
Start Date
November 12, 2019
Primary Completion Date
February 18, 2021
Study Completion Date
January 18, 2023
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).
Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences, Tianjin
Lead Sponsor
CStone Pharmaceuticals
INDUSTRY