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A Multicenter, Open-Label, Phase 3 Trial to Compare the Efficacy and Safety of Lenvatinib (E7080) Versus Sorafenib in First-line Treatment of Participants With Unresectable Hepatocellular Carcinoma

NCT01761266 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 954

Last updated 2022-04-05

Study results available
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Summary

E7080-G000-304 is a multicenter, randomized, open-label, noninferiority Phase 3 study to compare the efficacy and safety of lenvatinib versus sorafenib as a first-line systemic treatment in participants with unresectable Hepatocellular Carcinoma (HCC).

Conditions

  • Hepatocellular Carcinoma (HCC)

Interventions

DRUG

Lenvatinib

12 mg (or 8 mg) once daily (QD) oral dosing.

DRUG

Sorafenib

400 mg twice daily (BID) oral dosing.

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-03-01
Primary Completion
2016-11-13
Completion
2021-03-10
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Belgium
  • Canada
  • China
  • France
  • Germany
  • Hong Kong
  • Israel
  • Italy
  • Japan
  • Malaysia
  • Philippines
  • Poland
  • Russia
  • Singapore
  • South Korea
  • Spain
  • Taiwan
  • Thailand
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01761266 on ClinicalTrials.gov