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A multicenter, phase I, pharmacokinetic study of osimertinib in cancer patients with normal renal function or severe renal impairment.

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Date

2020

Authors

Vishwanathan, Karthick
Sanchez-Simon, Inmaculada
Keam, Bhumsuk
Penel, Nicolas
de Miguel-Luken, Maria
Weilert, Doris
Mills, Andrew
Marotti, Marcelo
Johnson, Martin
Ravaud, Alain

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Abstract

Osimertinib is a third-generation, irreversible, oral epidermal growth factor receptor (EGFR)-tyrosine kinase inhibitor (TKI) that potently and selectively inhibits both EGFR-TKI sensitizing and EGFR T790M and has demonstrated efficacy in non-small cell lung cancer (NSCLC) central nervous system metastases. In this phase I study, we assessed the effects of normal renal function (NRF) and severe renal impairment (SRI) on the pharmacokinetics (PK) of osimertinib in patients with solid tumors. Part A: patients with NRF (creatinine clearance [CrCL] ≥90 mL/min), and SRI, (CrCL

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Acrylamides
Administration, Oral
Aged
Aged, 80 and over
Aniline Compounds
Antineoplastic Agents
Area Under Curve
Female
Hepatic Insufficiency
Humans
Kidney Function Tests
Male
Middle Aged
Neoplasms
Protein Kinase Inhibitors
Severity of Illness Index

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Keywords

epidermal growth factor receptors, kidney, non-small cell lung cancer, osimertinib, pharmacokinetics, renal disposition, tyrosine kinase inhibitors

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