Pharmacokinetic Study of E7080/Lenvatinib in Chinese Patients With Unresectable Hepatocellular Carcinoma (HCC)

Phase 1

Completed

• Conditions: Unresectable Hepatocellular Carcinoma (HCC)
• Interventions: Drug: Lenvatinib

• Registration Number: NCT02953743
• Lead Sponsor: Eisai Co., Ltd.

Brief Summary

The primary purpose of this study is to assess the single- and multiple-dose pharmacokinetic (PK) profile of lenvatinib in Chinese participants with unresectable Hepatocellular Carcinoma (HCC).

Detailed Description

Not available

Study Timeline

• Study Start: 2016-09-01
• Study First Submitted: 2016-11-01
• Study First Submitted QC: 2016-11-02
• Study First Posted: 2016-11-03
• Primary Completion: 2017-06-28
• Study Completion: 2020-12-28
• Status Verified: 2021-02
• Last Update Submitted: 2021-03-30
• Last Update Posted: 2021-04-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lenvatinib 8 mg	Lenvatinib	Participants weighing \< 60 kg will be enrolled in this arm.
Lenvatinib 12 mg	Lenvatinib	Participants weighing ≥ 60 kg will be enrolled in this arm.

Primary Outcome Measures

Name	Time	Method
Mean maximum observed concentration (Cmax)	Day 1 at pre-dose, 0.5, 1, 2, 4, 6, and 8 hours; Day 2 at pre-dose; Day 8 at pre-dose; Day 15 at pre-dose, 0.5, 1, 2, 4, 6, and 8 hours; Day 16 at pre-dose; and Day 22 at pre-dose
Mean time at which the highest drug concentration occurs (tmax)	Day 1 at pre-dose, 0.5, 1, 2, 4, 6, and 8 hours; Day 2 at pre-dose; Day 8 at pre-dose; Day 15 at pre-dose, 0.5, 1, 2, 4, 6, and 8 hours; Day 16 at pre-dose; and Day 22 at pre-dose
Mean maximum observed concentration at steady-state (Css,max )	Day 1 at pre-dose, 0.5, 1, 2, 4, 6, and 8 hours; Day 2 at pre-dose; Day 8 at pre-dose; Day 15 at pre-dose, 0.5, 1, 2, 4, 6, and 8 hours; Day 16 at pre-dose; and Day 22 at pre-dose
Mean minimum observed concentration at steady-state (Css,min)	Day 1 at pre-dose, 0.5, 1, 2, 4, 6, and 8 hours; Day 2 at pre-dose; Day 8 at pre-dose; Day 15 at pre-dose, 0.5, 1, 2, 4, 6, and 8 hours; Day 16 at pre-dose; and Day 22 at pre-dose
Mean time at which the highest drug concentration occurs at steady-state (tss,max)	Day 1 at pre-dose, 0.5, 1, 2, 4, 6, and 8 hours; Day 2 at pre-dose; Day 8 at pre-dose; Day 15 at pre-dose, 0.5, 1, 2, 4, 6, and 8 hours; Day 16 at pre-dose; and Day 22 at pre-dose
Mean area under the concentration-time curve over the dosing interval on multiple dosing (AUC(0-τ))	Day 1 at pre-dose, 0.5, 1, 2, 4, 6, and 8 hours; Day 2 at pre-dose; Day 8 at pre-dose; Day 15 at pre-dose, 0.5, 1, 2, 4, 6, and 8 hours; Day 16 at pre-dose; and Day 22 at pre-dose
Mean area under the concentration-time curve from zero time to time of last quantifiable concentration (AUC(0-t))	Day 1 at pre-dose, 0.5, 1, 2, 4, 6, and 8 hours; Day 2 at pre-dose; Day 8 at pre-dose; Day 15 at pre-dose, 0.5, 1, 2, 4, 6, and 8 hours; Day 16 at pre-dose; and Day 22 at pre-dose
Average steady-state concentration (Css,av)	Day 1 at pre-dose, 0.5, 1, 2, 4, 6, and 8 hours; Day 2 at pre-dose; Day 8 at pre-dose; Day 15 at pre-dose, 0.5, 1, 2, 4, 6, and 8 hours; Day 16 at pre-dose; and Day 22 at pre-dose

Secondary Outcome Measures

Name	Time	Method
Number of participants with treatment emergent adverse events (TEAEs) and serious adverse events (SAEs)	Up to 30 days after the administration of the last dose of study drug or up to approximately 1 year

Trial Locations

Locations (3)

Harbin Medical University Cancer Hospital; 🇨🇳 Harbin, Heilongjiang, China

Shanghai Cancer Hospital, Fudan University; 🇨🇳 Shanghai, Shanghai, China

Zhongshan Hospital Fudan University; 🇨🇳 Shanghai, Shanghai, China