The Effect of Hepatic Impairment on the Pharmacokinetics of Dacomitinib.

ABSTRACT:

Background and objective

Dacomitinib is a kinase inhibitor indicated for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR)-activating mutations. To evaluate the effect of hepatic impairment on the pharmacokinetics of dacomitinib, two dedicated studies were conducted to inform optimal dosing.

Methods

Study 1 (NCT01571388) evaluated the effect of mild and moderate hepatic impairment on the plasma pharmacokinetics, safety, and tolerability after a single oral dose of dacomitinib 30 mg, and Study 2 (NCT03865446) evaluated the same endpoints in a severe hepatic impairment population. Both studies were phase I, open-label, parallel-group studies. A one-way analysis of variance (ANOVA) with unequal v

SUBMITTER: Piscitelli J 

PROVIDER: S-EPMC8930943 | biostudies-literature | 2022 Mar

REPOSITORIES: biostudies-literature