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A Study to Evaluate the Safety and Tolerability of Lenvatinib in Participants With Advanced or Unresectable Hepatocellular Carcinoma

NCT04763408 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 335

Last updated 2024-07-18

No results posted yet for this study

Summary

The primary purpose of this study is to further characterise the hepatotoxicity in participants with advanced or unresectable hepatocellular carcinoma (HCC) treated with lenvatinib, and to further characterise the overall safety profile (serious adverse events \[SAEs\], grade 3 to 5 adverse events \[AEs\], dose modifications and discontinuations due to AEs) in participants with advanced or unresectable HCC treated with lenvatinib.

Conditions

  • Carcinoma, Hepatocellular

Interventions

DRUG

Lenvatinib

Oral capsules.

DRUG

Sorafenib

Oral tablets.

Sponsors & Collaborators

  • Eisai Inc.

    lead INDUSTRY

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-09
Primary Completion
2023-12-13
Completion
2023-12-13
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Austria
  • Germany
  • Italy
  • Portugal
  • Russia
  • Spain
  • Sweden
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

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 NCT04763408 on ClinicalTrials.gov