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NCT02430714 Clinical Trial

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

Thyroid Neoplasms Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02430714
Other study ID # LEN01T
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 20, 2015
Est. completion date November 6, 2016

Study information
Verified date July 2018
Source Eisai Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 629
Est. completion date November 6, 2016
Est. primary completion date November 6, 2016
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria:

1. All participants with unresectable thyroid cancer and administrated Lenvatinib.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Lenvatinib
24mg once daily oral dosing to Unresectable thyroid cancer patients

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Eisai Co., Ltd.

Country where clinical trial is conducted

Japan, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number of participants with adverse events (AEs)/adverse drug reactions (ADRs) up to 1 year
Secondary Overall survival (OS) up to 1 year
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