A Trial of Lenvatinib (E7080) in Radioiodine (131 I)-Refractory Differentiated Thyroid Cancer in China

Differentiated Thyroid Cancer (DTC) Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Differentiated Thyroid Cancer (DTC)
Thyroid Diseases
Thyroid Neoplasms

Clinical Trial Details

NCT number	NCT02966093
Study type	Interventional
Source	Eisai Inc.
Contact
Status	Completed
Phase	Phase 3
Start date	January 11, 2017
Completion date	December 29, 2021

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT01788982` - Nintedanib(BIBF1120) in Thyroid Cancer	Phase 2
Active, not recruiting	`NCT02041260` - A Phase II Trial of Cabozantinib for the Treatment of Radioiodine (RAI)-Refractory Differentiated Thyroid Carcinoma (DTC) in the First-line Setting	Phase 2
Completed	`NCT02432274` - Study of Lenvatinib in Children and Adolescents With Refractory or Relapsed Solid Malignancies and Young Adults With Osteosarcoma	Phase 1/Phase 2