4.4 Article

Pharmacokinetic study of lenvatinib in Chinese patients with solid tumors

期刊

FUTURE ONCOLOGY
卷 17, 期 15, 页码 1855-1863

出版社

FUTURE MEDICINE LTD
DOI: 10.2217/fon-2020-0877

关键词

area under the curve; Chinese ethnicity; race; lenvatinib; pharmacokinetics; solid tumors

类别

资金

  1. Eisai Co., Ltd., Tokyo, Japan
  2. Merck Sharp Dohme Corp.
  3. Eisai, Inc.,
  4. Woodcliff Lake, NJ, USA

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This study assessed the pharmacokinetics of once-daily oral lenvatinib in Chinese patients and found that the data were consistent with multinational trials, supporting the usage of the 24-mg dose.
Aim: To assess the pharmacokinetics of once-daily oral lenvatinib 24 mg in Chinese patients. Material & methods: Patients had any solid tumor (except hepatocellular carcinoma) that was resistant to standard antitumor therapies or for which no appropriate treatment was available. Results: Twelve patients were enrolled. Maximum plasma concentrations of lenvatinib were observed at 2 and 4 h (median) after single and multiple doses (day 15), respectively. Steady state was achieved within 8 days. The geometric mean maximum observed concentration at steady state was 258 ng/ml (coefficient of variance: 49.2%); and the geometric mean area under the concentration-time curve from zero to 24 h at steady state was 3090 ng center dot h/ml (coefficient of variance: 44.7%). No accumulation was seen after 15 days. Conclusion: Lenvatinib pharmacokinetic data in Chinese patients are consistent with data in multinational trials, supporting usage of the 24-mg dose.

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