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Completed Phase 3 Interventional Results available

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

ClinicalTrials.gov ID: NCT01321554

Public ClinicalTrials.gov record NCT01321554. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 5, 2026, 10:06 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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 identification

NCT ID
NCT01321554
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Eisai Inc.
Industry
Enrollment
392 participants

Conditions and interventions

Conditions

Interventions

Drug

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Mar 16, 2011
Primary completion
Nov 14, 2013
Completion
Mar 18, 2019
Last update posted
Jun 21, 2023

2011 – 2019

United States locations

U.S. sites
38
U.S. states
23
U.S. cities
33
Facility City State ZIP Site status
Facility 1 Little Rock Arkansas
Facility 1 La Jolla California
Facility 1 Los Gatos California
Facility 1 Mission Viejo California
Facility 1 Orange California
Facility 2 Orange California
Facility 1 Sacramento California
Facility 1 Torrance California
Facility 1 Aurora Colorado
Facility 1 Washington D.C. District of Columbia
Facility 1 Orlando Florida
Facility 1 Weston Florida
Facility 1 Chicago Illinois
Facility 2 Chicago Illinois
Facility 1 Indianapolis Indiana
Facility 1 Lexington Kentucky
Facility 1 Baltimore Maryland
Facility 1 Boston Michigan
Facility 2 Boston Michigan
Facility 1 Detroit Michigan
Facility 1 Lansing Michigan
Facility 1 Minneapolis Minnesota
Facility 1 Columbia Missouri
Facility 1 Omaha Nebraska
Facility 1 Lebanon New Hampshire
Facility 1 Morristown New Jersey
Facility 1 Neptune City New Jersey
Facility 1 New York New York
Facility 2 New York New York
Facility 1 The Bronx New York
Facility 1 Columbus Ohio
Facility 1 Portland Oregon
Facility 1 Philadelphia Pennsylvania
Facility 2 Philadelphia Pennsylvania
Facility 1 Houston Texas
Facility 1 Seattle Washington
Facility 1 Morgantown West Virginia
Facility 1 Milwaukee Wisconsin

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 117 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01321554, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jun 21, 2023 · Synced Sep 5, 2026

Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.

Open the official record

The complete protocol, eligibility criteria, and contact information for NCT01321554 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →