NCT04008082

Brief Summary

The primary purpose of this study to continue follow-up of participants enrolled in the study E7080-M081-504 (NCT03663114) of lenvima capsules and to evaluate the overall survival of participants with hepatocellular carcinoma.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
412

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2019

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 13, 2019

Completed
1 day until next milestone

Study Start

First participant enrolled

May 14, 2019

Completed
2 months until next milestone

First Posted

Study publicly available on registry

July 5, 2019

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 28, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 28, 2022

Completed
Last Updated

March 8, 2022

Status Verified

June 1, 2021

Enrollment Period

2.7 years

First QC Date

May 13, 2019

Last Update Submit

March 7, 2022

Conditions

Carcinoma, HepatocellularCarcinomaNeoplasms, Glandular and EpithelialNeoplasms

Keywords

Hepatocellular CarcinomaLenvatinib MesilateLenvimaLEN03T

Outcome Measures

Primary Outcomes (2)

  • Overall Survival (OS)

    OS is calculated as the period from the day of starting administration to the day of death from any cause.

    From date of study drug administration until date of death from any cause (approximately 2.8 years)

  • Presence or absence of factors with a possible influence on OS

    Factor analysis is performed according to the category of participant background (aetiology of chronic liver disease, baseline alpha-fetoprotein concentration etc), lenvima administration status and treatment situation before and after administration of lenvima, and factors affecting OS are examined. Appropriate statistical methods (Cox regression analysis, etc.) will be used to examine the relationship of OS with various factors in order to identify the factors affecting survival.

    From date of study drug administration until date of death from any cause (approximately 2.8 years)

Study Arms (1)

Lenvatinib

Lenvatinib capsules 12 milligram (mg) for participants with body weight greater than or equal to (\>=) 60 kilograms (kg) or 8 mg for participants with body weight less than (\<) 60 kg, orally, once daily as per routine clinical practice.

Drug: Lenvatinib

Interventions

LenvatinibDRUG

Lenvatinib capsule.

Also known as: Lenvima, E7080
Lenvatinib

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Participants with unresectable hepatocellular carcinoma will be observed for specific use results survey of lenvima 4 mg capsules.

You may qualify if:

  • \- All participants enrolled in the study E7080-M081-504 with informed consent to participate in this study.

You may not qualify if:

  • Participants who do not have unresectable hepatocellular carcinoma
  • Participants who have not given informed consent or have withdrawn consent to participation
  • Participants with a history of hypersensitivity to any ingredient of lenvima
  • Pregnant or possibly pregnant women
  • Participants previously treated with lenvima (excluding those previously enrolled in the Study E7080-M081-504 \[NCT03663114\] at another clinical site).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Eisai Trial Site #1

Osaka, Japan

Location

Eisai Trial Site #2

Tokyo, Japan

Location

Related Publications (1)

  • Furuse J, Izumi N, Motomura K, Inaba Y, Katamura Y, Kondo Y, Yabushita K, Matsuoka T, Motoyoshi K, Kudo M. Long-Term Survival of Patients with Unresectable Hepatocellular Carcinoma Treated with Lenvatinib in Real-World Clinical Practice. Cancers (Basel). 2025 Feb 1;17(3):479. doi: 10.3390/cancers17030479.

    PMID: 39941845DERIVED

MeSH Terms

Conditions

Carcinoma, HepatocellularCarcinomaNeoplasms, Glandular and EpithelialNeoplasms

Interventions

lenvatinib

Condition Hierarchy (Ancestors)

AdenocarcinomaNeoplasms by Histologic TypeLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver Diseases

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 13, 2019

First Posted

July 5, 2019

Study Start

May 14, 2019

Primary Completion

January 28, 2022

Study Completion

January 28, 2022

Last Updated

March 8, 2022

Record last verified: 2021-06

Data Sharing

IPD Sharing
Will share

Eisai's data sharing commitment and further information on how to request data can be found on our website http://eisaiclinicaltrials.com/.

Locations

JP(2)