Dose Finding of Lenvatinib in Subjects With Advanced Hepatocellular Carcinoma Based on Population Pharmacokinetic and Exposure–Response Analyses

• Published in: Journal of clinical pharmacology Vol. 57; no. 9; pp. 1138 - 1147
• Main Authors: Tamai, Toshiyuki, Hayato, Seiichi, Hojo, Seiichiro, Suzuki, Takuya, Okusaka, Takuji, Ikeda, Kenji, Kumada, Hiromitsu
• Format: Journal Article
• Language: English
• Published: England 01.09.2017
• Subjects: Adolescent; Adult; Aged; Aged, 80 and over; Antineoplastic Agents - administration & dosage; Antineoplastic Agents - adverse effects; Antineoplastic Agents - pharmacokinetics; Antineoplastic Agents - therapeutic use; Carcinoma, Hepatocellular - drug therapy; Carcinoma, Hepatocellular - metabolism; dose finding; Dose-Response Relationship, Drug; Female; HCC; hepatocellular carcinoma; Humans; lenvatinib; Liver Neoplasms - drug therapy; Liver Neoplasms - metabolism; Male; Middle Aged; Models, Biological; pharmacokinetics; Phenylurea Compounds - administration & dosage; Phenylurea Compounds - adverse effects; Phenylurea Compounds - pharmacokinetics; Phenylurea Compounds - therapeutic use; Protein Kinase Inhibitors - administration & dosage; Protein Kinase Inhibitors - adverse effects; Protein Kinase Inhibitors - pharmacokinetics; Protein Kinase Inhibitors - therapeutic use; Quinolines - administration & dosage; Quinolines - adverse effects; Quinolines - pharmacokinetics; Quinolines - therapeutic use; Young Adult; dose finding; pharmacokinetics; HCC; lenvatinib; hepatocellular carcinoma

Hepatocellular carcinoma (HCC) accounts for up to 90% of primary liver cancer occurrences worldwide. Lenvatinib, a multikinase inhibitor, was approved in radioiodine‐refractory differentiated thyroid cancer. In this phase 2 study (study 202), we aimed to identify the lenvatinib optimal dose for subj...