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

• Sponsor: Eisai Co., Ltd. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02430714
• Collaborator: (none)
• Enrollment: 629
• Locations: 2
• Actual Duration (Months): 17.6
• Patients Per Site: 314.5
• Patients Per Site Per Month: 17.9

Study Details

Study Description

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	Phase
Thyroid Neoplasms	Drug: Lenvatinib

Study Design

• Study Type: Observational
• Actual Enrollment: 629 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
• Actual Primary Completion Date: Nov 6, 2016
• Actual Study Completion Date: Nov 6, 2016

Arms and Interventions

Arm	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 Names: E7080, Lenvima

Outcome Measures

Primary Outcome Measures

1. Number of participants with adverse events (AEs)/adverse drug reactions (ADRs) [up to 1 year]

Secondary Outcome Measures

1. Overall survival (OS) [up to 1 year]

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Osaka		Japan
2		Tokyo		Japan

Sponsors and Collaborators

• Eisai Co., Ltd.

Investigators

• Study Director: Yasunori Megumi, Drug Fostering and Evolution Coordination Department, Corporate Medical Affairs Headquarters, Eisai Co., Ltd.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Eisai Co., Ltd.
• ClinicalTrials.gov Identifier: NCT02430714
• Other Study ID Numbers: LEN01T
• First Posted: Apr 30, 2015
• Last Update Posted: Jan 9, 2020
• Last Verified: Jul 1, 2018

• Keywords provided by Eisai Co., Ltd.: Thyroid Cancer; Lenvima; Post-marketing surveillance; LEN01T; All-Patient Investigation; Lenvatinib Mesylate
• Additional relevant MeSH terms: Thyroid Neoplasms; Thyroid Diseases; Lenvatinib

Study Results

No Results Posted as of Jan 9, 2020