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

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ClinicalTrials.gov Identifier: NCT02430714
Recruitment Status : Recruiting
First Posted : April 30, 2015
Last Update Posted : February 5, 2019
Sponsor:
Information provided by (Responsible Party):
Eisai Inc. ( Eisai Co., Ltd. )

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.

Condition or disease Intervention/treatment
Thyroid Neoplasms Drug: Lenvatinib

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Study Type : Observational
Estimated Enrollment : 400 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Post-marketing Surveillance of Lenvatinib Mesylate (Lenvima Capsule) in Patients With Unresectable Thyroid Cancer (Study LEN01T)
Actual Study Start Date : May 20, 2015
Estimated Primary Completion Date : March 1, 2025
Estimated Study Completion Date : March 1, 2025

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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
24mg once daily oral dosing to Unresectable thyroid cancer patients
Other Name: E7080, Lenvima




Primary Outcome Measures :
  1. Number of participants with adverse events (AEs)/adverse drug reactions (ADRs) [ Time Frame: up to 1 year ]

Secondary Outcome Measures :
  1. Overall survival (OS) [ Time Frame: up to 1 year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All participants with unresectable thyroid cancer and administrated Lenvatinib in Japan
Criteria

Inclusion Criteria:

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02430714


Contacts
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Contact: Inquiry Service eisai-chiken_hotline@hhc.eisai.co.jp

Locations
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Japan
Recruiting
Osaka, Japan
Recruiting
Tokyo, Japan
Sponsors and Collaborators
Eisai Co., Ltd.
Investigators
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Study Director: Yasunori Megumi Drug Fostering and Evolution Coordination Department, Corporate Medical Affairs Headquarters, Eisai Co., Ltd.

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Responsible Party: Eisai Co., Ltd.
ClinicalTrials.gov Identifier: NCT02430714     History of Changes
Other Study ID Numbers: LEN01T
First Posted: April 30, 2015    Key Record Dates
Last Update Posted: February 5, 2019
Last Verified: July 2018

Keywords provided by Eisai Inc. ( Eisai Co., Ltd. ):
Thyroid Cancer
Lenvima
Post-marketing surveillance
LEN01T
All-Patient Investigation
Lenvatinib Mesylate

Additional relevant MeSH terms:
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Thyroid Diseases
Thyroid Neoplasms
Endocrine System Diseases
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms
Lenvatinib
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action