Post-marketing Surveillance of Lenvatinib Mesylate (Lenvima Capsule) in Patients With Unresectable Thyroid Cancer (Study LEN01T)

NCT ID: NCT02430714

Last Updated: 2020-01-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

629 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-05-20

Study Completion Date

2016-11-06

Brief Summary

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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.

Detailed Description

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Conditions

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Thyroid Neoplasms

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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Arm 1

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

Lenvatinib

Intervention Type DRUG

24mg once daily oral dosing to Unresectable thyroid cancer patients

Interventions

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Lenvatinib

24mg once daily oral dosing to Unresectable thyroid cancer patients

Intervention Type DRUG

Other Intervention Names

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E7080, Lenvima

Eligibility Criteria

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Inclusion Criteria

1\. All participants with unresectable thyroid cancer and administrated Lenvatinib.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Eisai Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Yasunori Megumi

Role: STUDY_DIRECTOR

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

Locations

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Osaka, , Japan

Site Status

Tokyo, , Japan

Site Status

Countries

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Japan

Other Identifiers

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LEN01T

Identifier Type: -

Identifier Source: org_study_id

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