US 12,226,409 B2
Treatment of hepatocellular carcinoma
Toshiyuki Tamai, Tokyo (JP)
Assigned to Eisai R&D Management Co., Ltd., Tokyo (JP)
Filed by Eisai R&D Management Co., Ltd., Tokyo (JP)
Filed on Aug. 20, 2021, as Appl. No. 17/407,742.
Application 17/407,742 is a continuation of application No. 16/609,895, abandoned, previously published as PCT/JP2018/018810, filed on May 15, 2018.
Claims priority of provisional application 62/506,900, filed on May 16, 2017.
Prior Publication US 2022/0040168 A1, Feb. 10, 2022
Int. Cl. A61K 31/47 (2006.01); A61K 9/48 (2006.01); A61P 35/00 (2006.01)
CPC A61K 31/47 (2013.01) [A61K 9/48 (2013.01); A61P 35/00 (2018.01)] 25 Claims
 
1. A method of treating unresectable hepatocellular carcinoma, the method comprising administering to a human subject that has an unresectable hepatocellular carcinoma a first dosage regimen comprising lenvatinib or a pharmaceutically acceptable salt thereof at a dose of (i) 12 mg/day if the body weight of the human subject is equal to or more than 60 kg or (ii) 8 mg/day if the body weight of the human subject is less than 60 kg,
wherein the human subject develops an occurrence of a first Grade 3 nonhematologic toxicity during treatment with the first dosage regimen, and the method further comprises:
(a) terminating administration of the first dosage regimen after the occurrence of the first Grade 3 nonhematologic toxicity until the first Grade 3 nonhematologic toxicity is resolved to Grade 0-1 or baseline, and administering to the human subject a second dosage regimen comprising lenvatinib or a pharmaceutically acceptable salt thereof at a dose of (i) 8 mg/day if the body weight of the human subject is equal to or more than 60 kg or (ii) 4 mg/day if the body weight of the human subject is less than 60 kg, wherein the human subject develops an occurrence of a second Grade 3 nonhematologic toxicity during treatment with the second dosage regimen;
(b) terminating administration of the second dosage regimen after the occurrence of the second Grade 3 nonhematologic toxicity until the second Grade 3 nonhematologic toxicity is resolved to Grade 0-1 or baseline, and administering to the human subject a third dosage regimen comprising lenvatinib or a pharmaceutically acceptable salt thereof at a dose of (i) 4 mg/day if the body weight of the human subject is equal to or more than 60 kg or (ii) 4 mg every other day if the body weight of the human subject is less than 60 kg, wherein the human subject develops an occurrence of a third Grade 3 nonhematologic toxicity during treatment with the third dosage regimen; and
(c) terminating administration of the third dosage regimen after the occurrence of the third Grade 3 nonhematologic toxicity until the third Grade 3 nonhematologic toxicity is resolved to Grade 0-1 or baseline, and, if the body weight of the human subject is equal to or more than 60 kg, administering to the human subject a fourth dosage regimen comprising lenvatinib or a pharmaceutically acceptable salt thereof at a dose of 4 mg every other day.