CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 117 enrolled
Drug / intervention
Lenvatinib (DTC Cohort) +1 moredrug
Likely dose
Lenvatinib (DTC Cohort) 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/NCT00784303
NCT00784303Phase 2Completed
CompareCT.gov

Phase II, Multicenter, Open-label, Single Arm Trial to Evaluate the Safety and Efficacy of Oral E7080 in Medullary and Iodine-131 Refractory, Unresectable Differentiated Thyroid Cancers, Stratified by Histology

Eisai Inc.·interventional·Posted Nov 3, 2008·Updated Apr 22, 2020

In Brief

A Phase 2 clinical trial evaluating Lenvatinib (DTC Cohort) and Lenvatinib (MTC Cohort) for Thyroid Cancer. Completed, enrolled 117 participants across 42 sites in 6 countries.

Detailed Summary

The purpose of this study is to determine the safety and efficacy of oral lenvatinib in participants with medullary thyroid cancer (MTC) or radioiodine (131 I)-refractory/resistant differentiated thyroid cancer (DTC), unresectable differentiated thyroid cancers, stratified by Histology.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsThyroid Cancer
CountriesAustralia, France, Italy, Poland, United Kingdom, United States
Collaborators--

Timeline

Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedNov 3, 2008
Enrollment StartNov 6, 2008
Primary CompletionApr 11, 2011
Study CompletionMar 29, 2019
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 17.7 years ago

Interventions

Lenvatinib (DTC Cohort)drug

24 mg lenvatinib (two 10 mg tablets and one 4 mg tablet) given orally, once daily, or 10 mg lenvatinib orally twice daily (20 mg total). Out of 58 participants in the DTC cohort, 56 participants received 24 mg lenvatinib once daily and 2 participants received 10 mg lenvatinib twice daily (total 20 mg daily), given continuously in 28-day treatment cycles.

Lenvatinib (MTC Cohort)drug

24 mg lenvatinib (two 10 mg tablets and one 4 mg tablet) given orally, once daily given continuously in 28-day treatment cycles.