- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02430714
Post-marketing Surveillance of Lenvatinib Mesylate (Lenvima Capsule) in Patients With Unresectable Thyroid Cancer (Study LEN01T)
January 7, 2020 updated by: Eisai Co., Ltd.
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.
Study Overview
Study Type
Observational
Enrollment (Actual)
629
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Osaka, Japan
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Tokyo, Japan
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
All participants with unresectable thyroid cancer and administrated Lenvatinib in Japan
Description
Inclusion Criteria:
1. All participants with unresectable thyroid cancer and administrated Lenvatinib.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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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.
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24mg once daily oral dosing to Unresectable thyroid cancer patients
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of participants with adverse events (AEs)/adverse drug reactions (ADRs)
Time Frame: up to 1 year
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up to 1 year
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
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Overall survival (OS)
Time Frame: up to 1 year
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up to 1 year
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Yasunori Megumi, Drug Fostering and Evolution Coordination Department, Corporate Medical Affairs Headquarters, Eisai Co., Ltd.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 20, 2015
Primary Completion (Actual)
November 6, 2016
Study Completion (Actual)
November 6, 2016
Study Registration Dates
First Submitted
April 27, 2015
First Submitted That Met QC Criteria
April 27, 2015
First Posted (Estimate)
April 30, 2015
Study Record Updates
Last Update Posted (Actual)
January 9, 2020
Last Update Submitted That Met QC Criteria
January 7, 2020
Last Verified
July 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- LEN01T
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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