NCT02430714

Brief Summary

This study is a post-marketing surveillance of lenvatinib in participants with unresectable thyroid cancer. The objectives of this study are to capture unknown adverse reactions, incidences of adverse drug reaction, efficacy, factors considered to have effect to safety and effectiveness, and incidences of hypertension, hemorrhagic events and thromboembolic event, and liver disorder.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
629

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2015

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

April 27, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 30, 2015

Completed
20 days until next milestone

Study Start

First participant enrolled

May 20, 2015

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 6, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 6, 2016

Completed
Last Updated

January 9, 2020

Status Verified

July 1, 2018

Enrollment Period

1.5 years

First QC Date

April 27, 2015

Last Update Submit

January 7, 2020

Conditions

Thyroid Neoplasms

Keywords

Thyroid CancerLenvimaPost-marketing surveillanceLEN01TAll-Patient InvestigationLenvatinib Mesylate

Outcome Measures

Primary Outcomes (1)

  • Number of participants with adverse events (AEs)/adverse drug reactions (ADRs)

    up to 1 year

Secondary Outcomes (1)

  • Overall survival (OS)

    up to 1 year

Study Arms (1)

Arm 1

A prospective, centrally registered investigation will be conducted. The new administering participants are to be registered at the time of administration.

Drug: Lenvatinib

Interventions

LenvatinibDRUG

24mg once daily oral dosing to Unresectable thyroid cancer patients

Also known as: E7080, Lenvima
Arm 1

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All participants with unresectable thyroid cancer and administrated Lenvatinib in Japan

You may qualify if:

  • \. All participants with unresectable thyroid cancer and administrated Lenvatinib.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Unknown Facility

Osaka, Japan

Location

Unknown Facility

Tokyo, Japan

Location

MeSH Terms

Conditions

Thyroid Neoplasms

Interventions

lenvatinib

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsEndocrine System DiseasesThyroid Diseases

Study Officials

  • Yasunori Megumi

    Drug Fostering and Evolution Coordination Department, Corporate Medical Affairs Headquarters, Eisai Co., Ltd.

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

April 27, 2015

First Posted

April 30, 2015

Study Start

May 20, 2015

Primary Completion

November 6, 2016

Study Completion

November 6, 2016

Last Updated

January 9, 2020

Record last verified: 2018-07

Locations

JP(2)