Exposure-response analysis of efficacy and safety for pexidartinib in patients with tenosynovial giant cell tumor.


Journal

CPT: pharmacometrics & systems pharmacology
ISSN: 2163-8306
Titre abrégé: CPT Pharmacometrics Syst Pharmacol
Pays: United States
ID NLM: 101580011

Informations de publication

Date de publication:
11 2021
Historique:
revised: 30 08 2021
received: 14 06 2021
accepted: 01 09 2021
pubmed: 30 9 2021
medline: 5 4 2022
entrez: 29 9 2021
Statut: ppublish

Résumé

This analysis was conducted to assess exposure-response relationships for efficacy and safety of pexidartinib in patients with tenosynovial giant cell tumor. Efficacy was assessed categorically by overall response rate (ORR) with Response Evaluation Criteria in Solid Tumors version 1.1 and longitudinally (changes in tumor size and volume). Safety included hepatic parameters (i.e., alanine aminotransferase [ALT], aspartate aminotransferase [AST], and total bilirubin). Average pexidartinib concentration (C

Identifiants

pubmed: 34585528
doi: 10.1002/psp4.12712
pmc: PMC8592513
doi:

Substances chimiques

Aminopyridines 0
Pyrroles 0
pexidartinib 6783M2LV5X

Types de publication

Journal Article Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

IM

Pagination

1422-1432

Subventions

Organisme : NCI NIH HHS
ID : P30 CA008748
Pays : United States
Organisme : Daiichi Sankyo, Inc.

Informations de copyright

© 2021 Daiichi Sankyo, Inc. CPT: Pharmacometrics & Systems Pharmacology published by Wiley Periodicals LLC on behalf of American Society for Clinical Pharmacology and Therapeutics.

Références

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pubmed: 33043474
Lancet. 2019 Aug 10;394(10197):478-487
pubmed: 31229240
CPT Pharmacometrics Syst Pharmacol. 2014 May 07;3:e113
pubmed: 24806032
Br J Clin Pharmacol. 2015 Jan;79(1):56-71
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Cancer Chemother Pharmacol. 2016 Mar;77(3):459-76
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CPT Pharmacometrics Syst Pharmacol. 2015 Jan;4(1):e00016
pubmed: 26225225
CPT Pharmacometrics Syst Pharmacol. 2021 Nov;10(11):1422-1432
pubmed: 34585528

Auteurs

Ophelia Yin (O)

Quantitative Clinical Pharmacology and Translational Sciences, Daiichi Sankyo, Inc., Basking Ridge, New Jersey, USA.

Hamim Zahir (H)

Quantitative Clinical Pharmacology and Translational Sciences, Daiichi Sankyo, Inc., Basking Ridge, New Jersey, USA.

Jonathan French (J)

Metrum Research Group, Tariffville, Connecticut, USA.

Daniel Polhamus (D)

Metrum Research Group, Tariffville, Connecticut, USA.

Xiaoning Wang (X)

Metrum Research Group, Tariffville, Connecticut, USA.

Michiel van de Sande (M)

Department of Orthopedics, Leiden University Medical Center, Leiden, Netherlands.

William D Tap (WD)

Sarcoma Medical Oncology Service, Memorial Sloan Kettering Cancer Center, New York, New York, USA.

Hans Gelderblom (H)

Medical Oncology, Leiden University Medical Center, Leiden, Netherlands.

Andrew J Wagner (AJ)

Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, Massachusetts, USA.

John H Healey (JH)

Orthopaedic Service, Memorial Sloan Kettering Cancer Center, New York, New York, USA.

Jonathan Greenberg (J)

Global Oncology R&D, Daiichi Sankyo, Inc., Basking Ridge, New Jersey, USA.

Dale Shuster (D)

Global Oncology R&D, Daiichi Sankyo, Inc., Basking Ridge, New Jersey, USA.

Silvia Stacchiotti (S)

Department of Medical Oncology, Fondazione IRCCS Instituto Nazionale dei Tumori, Milan, Italy.

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Classifications MeSH