{"database":"biostudies-literature","file_versions":[],"scores":null,"additional":{"omics_type":["Unknown"],"volume":["42(3)"],"submitter":["Piscitelli J"],"funding":["Pfizer"],"pubmed_abstract":["<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 v"],"journal":["Clinical drug investigation"],"pagination":["221-235"],"full_dataset_link":["https://www.ebi.ac.uk/biostudies/studies/S-EPMC8930943"],"repository":["biostudies-literature"],"pubmed_title":["The Effect of Hepatic Impairment on the Pharmacokinetics of Dacomitinib."],"pmcid":["PMC8930943"],"pubmed_authors":["Piscitelli J","Salageanu J","LaBadie RR","Chen J","Tan W","Chung CH"],"additional_accession":[]},"is_claimable":false,"name":"The Effect of Hepatic Impairment on the Pharmacokinetics of Dacomitinib.","description":"<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 v","dates":{"release":"2022-01-01T00:00:00Z","publication":"2022 Mar","modification":"2026-07-14T14:50:11.418Z","creation":"2025-04-06T19:37:48.939Z"},"accession":"S-EPMC8930943","cross_references":{"pubmed":["35195881"],"doi":["10.1007/s40261-022-01125-x"]}}