CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 66 enrolled
Drug / intervention
Lenvatinibdrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00946153
NCT00946153Phase 2Completed
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Phase I/II Study of E7080 in Patients With Advanced Hepatocellular Carcinoma (HCC)

Eisai Co., Ltd.·interventional·Posted Jul 24, 2009·Updated Feb 1, 2019

In Brief

A Phase 2 clinical trial evaluating Lenvatinib for Hepatocellular Carcinoma. Completed, enrolled 66 participants across 12 sites in 2 countries.

Detailed Summary

The purpose of this study is to determine maximum tolerated dose (MTD), efficacy, safety and tolerability, pharmacokinetics, pharmacodynamics, and anti-tumor effect of E7080 when is administered continually once daily in participants with advanced hepatocellular carcinoma.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHepatocellular Carcinoma
CountriesJapan, South Korea
Collaborators--

Timeline

Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedJul 24, 2009
Enrollment StartJul 24, 2009
Primary CompletionJun 15, 2014
Study CompletionAug 13, 2015
TodayJul 2, 2026
Enrollment to primary: 4.9 yearsPosted 16.9 years ago

Interventions

Lenvatinibdrug

In the Dose-Escalation Component of the study, lenvatinib will be administered as continuous once-daily oral dosing. Dose-escalation will occur based on safety information obtained during Cycle 1. The recommended dose for the Expansion Component of the study will use the MTD in Cycle 1.