Evaluation of hepatic impairment on pharmacokinetics and safety of crizotinib in patients with advanced cancer.

ABSTRACT:

Purpose

This phase 1 study evaluated the effect of hepatic impairment on pharmacokinetics and safety of crizotinib in patients with advanced cancer.

Methods

Patients were dosed according to hepatic function classified by modified National Cancer Institute Organ Dysfunction Working Group criteria and group assignment [normal (A1 and A2), mild (B), moderate (C1 and C2), or severe (D)]. Primary pharmacokinetic endpoints included area under the concentration-time curve as daily exposure (AUC_daily) and maximum plasma concentration (C_max) at steady state. Safety endpoints included types, incidence, seriousness, and relationship to crizotinib of adverse events.

Results

The AUC_daily and C_max in patients with normal liver function we

SUBMITTER: El-Khoueiry AB 

PROVIDER: S-EPMC7539325 | biostudies-literature | 2018 Apr

REPOSITORIES: biostudies-literature