CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 392 enrolled
Drug / intervention
Lenvatinib +2 moredrug
Likely dose
Lenvatinib 24 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01321554
NCT01321554Phase 3Completed
CompareCT.gov

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Trial of Lenvatinib (E7080) in 131I-Refractory Differentiated Thyroid Cancer

Eisai Inc.·interventional·Posted Mar 23, 2011·Updated Jun 22, 2023

In Brief

A Phase 3 clinical trial evaluating Lenvatinib and Placebo for Thyroid Cancer. Completed, enrolled 392 participants across 155 sites in 23 countries.

Detailed Summary

This is a multicenter, randomized, double-blind, placebo-controlled Phase 3 study to compare the progression free survival, overall response rate (ORR) and safety of participants treated with lenvatinib 24 mg by continuous once daily oral dosing versus placebo. The study is conducted in 3 phases: a Prerandomization Phase (screening and baseline period), a Randomization Phase (double-blind treatment period), and an Extension Phase (Optional Open Label (OOL) Lenvatinib Treatment Period and a follow-up period).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsThyroid Cancer
CountriesArgentina, Australia, Austria, Belgium, Brazil, Canada, Chile, Czechia, Denmark, France, Germany, Italy, Japan, Poland, Portugal, Romania, Russia, South Korea, Spain, Sweden, Thailand, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedMar 23, 2011
Enrollment StartMar 17, 2011
Primary CompletionNov 15, 2013
Study CompletionMar 19, 2019
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 15.3 years ago

Interventions

Lenvatinibdrug

Lenvatinib 24 mg (two 10-mg and one 4-mg lenvatinib matched capsules) taken orally once daily, continuously. Dose interruptions or reductions were allowed for subjects who experienced treatment-related toxicity.

Placebodrug

Matching placebo (two 10-mg and one 4-mg lenvatinib matched capsules) taken orally once daily, continuously.

Lenvatinibdrug

Lenvatinib 20 mg (two 10-mg capsules) taken orally once daily, continuously. Dose interruptions or reductions were allowed for subjects who experienced treatment-related toxicity. The dose of lenvatinib during the OOL Lenvatinib Treatment Period was 24 mg once daily from 03 Oct 2011 until 15 Feb 2013. The dose was lowered at the request of the Data Monitoring Committee to 20 mg on 16 Feb 2013. Thus, more subjects were treated with 24 mg starting dose and the treatment duration was longer for these participants than those whose starting dose was 20 mg.