Pharmacokinetic Study of Osimertinib in Cancer Patients with Mild or Moderate Hepatic Impairment.
Journal
The Journal of pharmacology and experimental therapeutics
ISSN: 1521-0103
Titre abrégé: J Pharmacol Exp Ther
Pays: United States
ID NLM: 0376362
Informations de publication
Date de publication:
05 2019
05 2019
Historique:
received:
21
12
2018
accepted:
20
02
2019
pubmed:
16
3
2019
medline:
21
12
2019
entrez:
16
3
2019
Statut:
ppublish
Résumé
Osimertinib, an epidermal growth factor receptor (EGFR)-tyrosine kinase inhibitor (TKI), undergoes significant hepatic elimination. In this phase 1 study, we assessed the effects of mild and moderate hepatic impairment on the pharmacokinetics (PK) of osimertinib in patients with malignant solid tumors. In part A, patients with normal hepatic function, mild hepatic impairment, and moderate hepatic impairment, according to the Child-Pugh classification, received a single 80 mg oral dose of osimertinib. Standard PK measures were assessed. In part B, patients could continue osimertinib treatment if deemed clinically appropriate. We compared these study results with a population PK analysis including other osimertinib clinical studies. Geometric mean osimertinib plasma concentrations were lower in patients with mild (
Identifiants
pubmed: 30872388
pii: jpet.118.255919
doi: 10.1124/jpet.118.255919
doi:
Substances chimiques
Acrylamides
0
Aniline Compounds
0
osimertinib
3C06JJ0Z2O
Banques de données
ClinicalTrials.gov
['NCT02161770']
Types de publication
Clinical Trial, Phase I
Journal Article
Research Support, N.I.H., Extramural
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
291-299Subventions
Organisme : NCI NIH HHS
ID : P30 CA054174
Pays : United States
Informations de copyright
Copyright © 2019 by The American Society for Pharmacology and Experimental Therapeutics.