Post-marketing Surveillance of Lenvatinib Mesylate (Lenvi... | NCT02430714

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

NCT02430714

Sponsor

Eisai Co., Ltd.

Status

Completed

Last Update Posted

Jan 9, 2020Actual

Enrollment

629Actual

Phase

Not provided

Conditions

Thyroid Neoplasms

Interventions

Lenvatinib

Countries

Japan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 20, 2015Actual

Primary Completion Date

Nov 6, 2016Actual

Completion Date

Nov 6, 2016Actual

First Submitted Date

Apr 27, 2015

First Submission Date that Met QC Criteria

Apr 27, 2015

First Posted Date

Apr 30, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 7, 2020

Last Update Posted Date

Jan 9, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

629Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Lenvatinib	Drug	24mg once daily oral dosing to Unresectable thyroid cancer patients	Arm 1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of participants with adverse events (AEs)/adverse drug reactions (ADRs)		up to 1 year

Secondary Outcomes

Measure	Description	Time Frame
Overall survival (OS)		up to 1 year

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

All participants with unresectable thyroid cancer and administrated Lenvatinib in Japan

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Yasunori Megumi	Drug Fostering and Evolution Coordination Department, Corporate Medical Affairs Headquarters, Eisai Co., Ltd.	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
		Osaka			Japan

Condition Browse Module

MeSH Terms

ID	Term
D013964	Thyroid Neoplasms

Ancestor Terms

ID	Term
D004701	Endocrine Gland Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D006258	Head and Neck Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C531958	lenvatinib

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided