A Multicentre, Observational, Phase 4 Study to Evaluate the Safety and Tolerability of Lenvatinib in Patients With Advanced or Unresectable Hepatocellular Carcinoma (STELLAR)

Eisai Clinical Trials

Protocol # E7080-M000-508

Study Overview

Study Compound: E7080

Drug Name: lenvatinib

Registry #: NCT04763408, EUPAS36854

Trial Period: Apr 2021 - Dec 2023

Indication: Hepatocellular Carcinoma (HCC)

Primary Endpoint: 1. Number of Participants With Hepatotoxicity Treatment-emergent Adverse Events (TEAEs) With Lenvatinib [Time Frame: Up to 7 years]

2. Number of Participants With SAEs With Lenvatinib [Time Frame: Up to 7 years]

3. Number of Participants With Grade 3 to 5 AEs With Lenvatinib [Time Frame: Up to 7 years]

Population
Males and females 18 Years and older (Adult, Older Adult)
Study Status
Completed
Study Phase
Phase 4
Countries
Australia, Austria, Germany, Italy, Portugal, Russian Federation, Spain, Sweden, United Kingdom, United States See moreSee less

Results

CSR Synopsis

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Lay Summary

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Data Sharing

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CSDR Sharing is available for this study.

CSDR	Availability
Clinical Trial Data

Redacted documents may be available upon request for this study.

Document type	Availability
Protocol
SAP
Sample CRF
Full CSR