Pharmacokinetics of oral vinorelbine in French children with recurrent or progressive primary low-grade glioma.
between-subject variability
exposure matching
low-grade glioma
non-compartmental analysis
paediatrics
pharmacokinetics
vinorelbine
Journal
British journal of clinical pharmacology
ISSN: 1365-2125
Titre abrégé: Br J Clin Pharmacol
Pays: England
ID NLM: 7503323
Informations de publication
Date de publication:
05 2022
05 2022
Historique:
revised:
29
09
2021
received:
21
06
2021
accepted:
21
10
2021
pubmed:
29
10
2021
medline:
13
4
2022
entrez:
28
10
2021
Statut:
ppublish
Résumé
There is a crucial need for pharmacokinetic (PK) data on oral vinorelbine (VNR) in the paediatric population. The aim of this work was to assess the PK profile of orally administered VNR in children with recurrent/progressive primary low-grade glioma (LGG). A multicentre, open-label, single-arm intervention phase II study was conducted. Patients, aged between 6 and 18 years, with histologically confirmed recurrent or progressive primary LGG or non-documented typical optic pathway tumours, were included. PK parameters were estimated by non-compartmental analysis using Phoenix WinNonlin® software (version 8.0, Certara, Inc.). The influence of demographic and biological covariates on VNR PK parameters was investigated using a multivariate linear regression analysis. PK analysis included 36 patients with a median age (range) of 11 (6-17) years. Estimates of apparent oral clearance (CL/F), apparent volume of distribution (V/F), half-life (t Higher doses may be necessary for children with LGG. BSA showed a significant impact on VNR systemic exposure. We believe that our findings will serve as a basis for further studies to better characterize the concentration-response relationships of VNR among paediatric patients.
Substances chimiques
Vinorelbine
Q6C979R91Y
Types de publication
Clinical Trial, Phase II
Journal Article
Multicenter Study
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
2096-2117Informations de copyright
© 2021 British Pharmacological Society.
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