biostudies-literatureUnknown42(3)Piscitelli JPfizer<h4>Background and objective</h4>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.<h4>Methods</h4>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 vClinical drug investigation221-235https://www.ebi.ac.uk/biostudies/studies/S-EPMC8930943biostudies-literatureThe Effect of Hepatic Impairment on the Pharmacokinetics of Dacomitinib.PMC8930943Piscitelli JSalageanu JLaBadie RRChen JTan WChung CHfalseThe Effect of Hepatic Impairment on the Pharmacokinetics of Dacomitinib.<h4>Background and objective</h4>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.<h4>Methods</h4>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 v2022-01-01T00:00:00Z2022 Mar2026-07-14T14:50:11.418Z2025-04-06T19:37:48.939ZS-EPMC89309433519588110.1007/s40261-022-01125-x