RT Journal Article T1 A multicenter, phase I, pharmacokinetic study of osimertinib in cancer patients with normal renal function or severe renal impairment. A1 Vishwanathan, Karthick A1 Sanchez-Simon, Inmaculada A1 Keam, Bhumsuk A1 Penel, Nicolas A1 de Miguel-Luken, Maria A1 Weilert, Doris A1 Mills, Andrew A1 Marotti, Marcelo A1 Johnson, Martin A1 Ravaud, Alain K1 epidermal growth factor receptors K1 kidney K1 non-small cell lung cancer K1 osimertinib K1 pharmacokinetics K1 renal disposition K1 tyrosine kinase inhibitors AB 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 YR 2020 FD 2020 LK http://hdl.handle.net/10668/15791 UL http://hdl.handle.net/10668/15791 LA en DS RISalud RD Apr 5, 2025