Concentration-QTc analysis of quizartinib in patients with relapsed/refractory acute myeloid leukemia.

ABSTRACT:

Purpose

This analysis evaluated the relationship between concentrations of quizartinib and its active metabolite AC886 and QT interval corrected using Fridericia's formula (QTcF) in patients with relapsed/refractory acute myeloid leukemia (AML) treated in the phase 3 QuANTUM-R study (NCT02039726).

Methods

The analysis dataset included 226 patients with AML. Quizartinib dihydrochloride was administered as daily doses of 20, 30, and 60 mg. Nonlinear mixed-effects modeling was performed using observed quizartinib and AC886 concentrations and time-matched mean electrocardiogram measurements.

Results

Observed QTcF increased with quizartinib and AC886 concentrations; the relationship was best described by a nonlinear maximum effect (E_max) model. The predicted mea

SUBMITTER: Kang D 

PROVIDER: S-EPMC7946665 | biostudies-literature | 2021 Apr

REPOSITORIES: biostudies-literature