Ignite Creation Date:
2025-12-25 @ 1:14 AM
Ignite Modification Date:
2025-12-27 @ 1:33 AM
Study NCT ID:
NCT02966093
Status:
COMPLETED
Last Update Posted:
2022-01-26
First Post:
2016-11-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Trial of Lenvatinib (E7080) in Radioiodine (131 I)-Refractory Differentiated Thyroid Cancer in China
Sponsor:
Eisai Co., Ltd.
Organization:
Study Overview
Official Title:
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Trial of Lenvatinib (E7080) in 131 I-Refractory Differentiated Thyroid Cancer in China
Status:
COMPLETED
Status Verified Date:
2022-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The primary purpose of this study is to compare the progression-free survival (PFS) of participants with radioiodine (131 I)-refractory differentiated thyroid cancer (DTC) and radiographic evidence of disease progression within the prior 12 months treated with lenvatinib 24 mg by continuous once daily (QD) oral dosing versus placebo.
Detailed Description:
This study will be conducted in 3 phases: a Prerandomization Phase, a Randomization Phase, and an Extension Phase. The Extension Phase will consist of the Optional Open Label (OOL) Lenvatinib Treatment Period and the Follow-up Period.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: