- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01321554
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Trial of Lenvatinib (E7080) in 131I-Refractory Differentiated Thyroid Cancer (DTC) (SELECT)
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Trial of Lenvatinib (E7080) in 131I-Refractory Differentiated Thyroid Cancer
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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Rosario, Argentina
- Facility 1
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San Salvador de Jujuy, Argentina
- Facility 1
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Tucuman, Argentina
- Facility 1
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Heidelberg, Australia
- Facility 1
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New South Wales
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Saint Leonards, New South Wales, Australia
- Facility 1
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Queensland
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Herston, Queensland, Australia
- Facility 1
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Tasmania
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Hobart, Tasmania, Australia
- Facility 1
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Victoria
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Melbourne, Victoria, Australia
- Facility 1
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Wien, Austria
- Facility 1
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Bruxelles, Belgium
- Facility 1
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Edegem, Belgium
- Facility 1
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Namur, Belgium
- Facility 1
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Brasilia, Brazil
- Facility 1
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Joinville, Brazil
- Facility 1
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Novo Hamburgo, Brazil
- Facility 1
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Rio de Janeiro, Brazil
- Facility 1
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Salvador, Brazil
- Facility 1
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Sao Paulo, Brazil
- Facility 1
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Sao Paulo, Brazil
- Facility 2
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Quebec, Canada
- Facility 1
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Ontario
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London, Ontario, Canada
- Facility 1
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Toronto, Ontario, Canada
- Facility 1
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Quebec
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Montreal, Quebec, Canada
- Facility 1
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Santiago, Chile
- Facility 1
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Santiago, Chile
- Facility 2
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Santiago, Chile
- Facility 3
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Temuco, Chile
- Facility 1
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Vina del Mar, Chile
- Facility 1
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Olomouc, Czechia
- Facility 1
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Odense, Denmark
- Facility 1
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Angers, France
- Facility 1
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Bordeaux, France
- Facility 1
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Caen, France
- Facility 1
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Clermont-Ferrand, France
- Facility 1
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Dijon, France
- Facility 1
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Lille, France
- Facility 1
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Lyon, France
- Facility 1
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Marseille, France
- Facility 1
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Nice, France
- Facility 1
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Paris, France
- Facility 1
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Paris, France
- Facility 2
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Strasbourg, France
- Facility 1
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Vandoeuvre Les Nancy, France
- Facility 1
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Villejuif, France
- Facility 1
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Essen, Germany
- Facility 1
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Hannover, Germany
- Facility 1
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Leipzig, Germany
- Facility 1
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Mainz, Germany
- Facility 1
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Munchen, Germany
- Facility 1
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Tubingen, Germany
- Facility 1
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Wurzburg, Germany
- Facility 1
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Catania, Italy
- Facility 1
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Livorno, Italy
- Facility 1
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Milano, Italy
- Facility 1
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Milano, Italy
- Facility 2
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Milano, Italy
- Facility 3
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Milano, Italy
- Facility 4
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Milano, Italy
- Facility 5
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Monserrato, Italy
- Facility 1
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Napoli, Italy
- Facility 1
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Padova, Italy
- Facility 1
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Pisa, Italy
- Facility 1
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Roma, Italy
- Facility 1
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Roma, Italy
- Facility 2
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Rozzano, Italy
- Facility 1
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Torino, Italy
- Facility 1
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Viagrande, Italy
- Facility 1
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Aichi
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Nagoya, Aichi, Japan
- Eisai trial site 1
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Nagoya, Aichi, Japan
- Eisai trial site 2
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Chiba
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Kashiwa, Chiba, Japan
- Eisai trial site 1
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Fukui
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Fukui-city, Fukui, Japan
- Eisai trial site 1
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Hyogo
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Kobe-city, Hyogo, Japan
- Eisai trial site 1
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Tokyo
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Koto-ku, Tokyo, Japan
- Eisai trial site 1
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Daejeon, Korea, Republic of
- Facility 1
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Gyeonggi-do, Korea, Republic of
- Facility 1
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Seoul, Korea, Republic of
- Facility 1
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Seoul, Korea, Republic of
- Facility 2
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Seoul, Korea, Republic of
- Facility 3
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Uijeongbu, Korea, Republic of
- Facility 1
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Gliwice, Poland
- Facility 1
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Kielce, Poland
- Facility 1
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Poznan, Poland
- Facility 1
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Lisbon, Portugal
- Facility 1
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Porto, Portugal
- Facility 1
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Bucharest, Romania
- Facility 1
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Bucharest, Romania
- Facility 2
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Cluj-Napoca, Romania
- Facility 1
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Krasnodar, Russian Federation
- Facility 1
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Kursk, Russian Federation
- Facility 1
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Obninsk, Russian Federation
- Facility 1
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Ufa, Russian Federation
- Facility 1
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Barcelona, Spain
- Facility 2
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L'Hospitalet de Llobregat, Spain
- Facility 1
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Madrid, Spain
- Facility 1
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Madrid, Spain
- Facility 2
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Madrid, Spain
- Facility 3
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Madrid, Spain
- Facility 4
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Madrid, Spain
- Facility 5
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Andalucia
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Malaga, Andalucia, Spain
- Facility 2
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Cataluna
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Barcelona, Cataluna, Spain
- Facility 1
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Galicia
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La Coruna, Galicia, Spain
- Facility 1
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Goteborg, Sweden
- Facility 1
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Lund, Sweden
- Facility 1
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Stockholm, Sweden
- Facility 1
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Bangkok, Thailand
- Facility 1
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Bangkok, Thailand
- Facility 2
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Chiang Mai, Thailand
- Facility 1
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Khon Kaen, Thailand
- Facility 1
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Pathumwan, Thailand
- Facility 1
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Aberdeen, United Kingdom
- Facility 1
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Glasgow, United Kingdom
- Facility 1
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London, United Kingdom
- Facility 2
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London, United Kingdom
- Facility 3
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Manchester, United Kingdom
- Facility 1
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Manchester, United Kingdom
- Facility 2
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Sheffield, United Kingdom
- Facility 1
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Sutton, United Kingdom
- Facility 1
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Arkansas
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Little Rock, Arkansas, United States
- Facility 1
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California
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La Jolla, California, United States
- Facility 1
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Los Gatos, California, United States
- Facility 1
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Mission Viejo, California, United States
- Facility 1
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Orange, California, United States
- Facility 1
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Orange, California, United States
- Facility 2
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Sacramento, California, United States
- Facility 1
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Torrance, California, United States
- Facility 1
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Colorado
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Aurora, Colorado, United States
- Facility 1
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District of Columbia
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Washington, District of Columbia, United States
- Facility 1
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Florida
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Orlando, Florida, United States
- Facility 1
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Weston, Florida, United States
- Facility 1
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Illinois
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Chicago, Illinois, United States
- Facility 1
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Chicago, Illinois, United States
- Facility 2
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Indiana
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Indianapolis, Indiana, United States
- Facility 1
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Kentucky
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Lexington, Kentucky, United States
- Facility 1
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Maryland
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Baltimore, Maryland, United States
- Facility 1
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Michigan
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Boston, Michigan, United States
- Facility 1
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Boston, Michigan, United States
- Facility 2
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Detroit, Michigan, United States
- Facility 1
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Lansing, Michigan, United States
- Facility 1
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Minnesota
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Minneapolis, Minnesota, United States
- Facility 1
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Missouri
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Columbia, Missouri, United States
- Facility 1
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Nebraska
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Omaha, Nebraska, United States
- Facility 1
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New Hampshire
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Lebanon, New Hampshire, United States
- Facility 1
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New Jersey
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Morristown, New Jersey, United States
- Facility 1
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Neptune, New Jersey, United States
- Facility 1
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New York
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Bronx, New York, United States
- Facility 1
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New York, New York, United States
- Facility 1
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New York, New York, United States
- Facility 2
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Ohio
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Columbus, Ohio, United States
- Facility 1
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Oregon
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Portland, Oregon, United States
- Facility 1
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Pennsylvania
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Philadelphia, Pennsylvania, United States
- Facility 1
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Philadelphia, Pennsylvania, United States
- Facility 2
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Texas
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Houston, Texas, United States
- Facility 1
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Washington
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Seattle, Washington, United States
- Facility 1
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West Virginia
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Morgantown, West Virginia, United States
- Facility 1
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Wisconsin
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Milwaukee, Wisconsin, United States
- Facility 1
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion criteria:
- Histologically or cytologically confirmed diagnosis of one of the following DTC subtypes: Papillary thyroid cancer (PTC) or follicular thyroid cancer (FTC).
- Measurable disease according to (RECIST 1.1) and confirmed by central radiographic review.
- 131 I-refractory/resistant disease.
- Evidence of disease progression within 12 months prior to signing informed consent (+1 month screening window).
- Prior treatment with 0 or 1 vascular endothelial growth-factor (VEGF) or vascular endothelial growth-factor receptors (VEGFR) targeted therapy.
- Adequate renal, liver, bone marrow, and blood coagulation function, as defined in the protocol.
Exclusion criteria:
- Anaplastic or medullary carcinoma of the thyroid
- 2 or more prior VEGF/ VEGFR-targeted therapies
- Received any anticancer treatment within 21 days or any investigational agent within 30 days prior to the first dose of study drug.
Inclusion criteria for OOL Lenvatinib Treatment Period :
Participants were eligible for lenvatinib treatment in the OOL Lenvatinib Treatment Period if the met the following criteria:
- Placebo-treated participants in the Randomization Phase who had progressive disease (PD) confirmed by IIR, and who requested treatment with lenvatinib.
- Participants who continued to satisfy specified inclusion and exclusion criteria as presented in the study protocol.
- Participants with maximum interval between the day of confirmation of PD by IIR and Cycle 1/Day 1 of the OOL Lenvatinib Treatment Period of less than or equal to 3 months.
- No systemic anticancer treatment during the interval between the day of confirmation of PD by the IIR and Cycle 1/Day 1 of the OOL Lenvatinib Treatment Period.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Lenvatinib (Randomization Phase)
Participants randomly assigned in a 2:1 ratio to receive blinded study drug (lenvatinib or matching placebo) until documentation of disease progression (confirmed by IIR), development of unacceptable toxicity, or withdrawal of consent.
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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.
Other Names:
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.
Other Names:
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Placebo Comparator: Placebo (Randomization Phase)
Participants randomly assigned in a 2:1 ratio to receive blinded study drug (lenvatinib or matching placebo) until documentation of disease progression (confirmed by IIR), development of unacceptable toxicity, or withdrawal of consent.
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Matching placebo (two 10-mg and one 4-mg lenvatinib matched capsules) taken orally once daily, continuously.
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Experimental: Lenvatinib 24 mg (OOL Lenvatinib Treatment Period)
Participants will receive lenvatinib 24 mg, orally once daily until documentation of disease progression (confirmed by investigator's assessment), development of unacceptable toxicity, or withdrawal of consent.
Placebo treated participants in the Randomization Phase who have progressive disease confirmed by IIR could request to receive lenvatinib treatment in the OOL Treatment Period.
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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.
Other Names:
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.
Other Names:
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Experimental: Lenvatinib 20 mg (OOL Lenvatinib Treatment Period)
Participants will receive lenvatinib 20 mg, orally once daily until documentation of disease progression (confirmed by investigator's assessment), development of unacceptable toxicity, or withdrawal of consent.
Placebo treated participants in the Randomization Phase who have progressive disease confirmed by IIR could request to receive lenvatinib treatment in the OOL Treatment Period.
|
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.
Other Names:
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Progression Free Survival (PFS)
Time Frame: Date of randomization to the date of disease progression or death (whichever occurred first), assessed up to data cutoff date (15 Nov 2013) or up to approximately 2.5 years
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PFS was defined as the time from the date of randomization to the date of first documentation of disease progression or death (whichever occurred first), as determined by blinded IIR using Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 for the double-blind treatment period (Randomization Phase).
Disease progression per RECIST v1.1 was defined as at least a 20 percent (%) relative increase and 5 millimeter (mm) absolute increase in the sum of diameters of target lesions (taking as reference the smallest sum on study), recorded since the treatment started or the appearance of 1 or more new lesions.
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Date of randomization to the date of disease progression or death (whichever occurred first), assessed up to data cutoff date (15 Nov 2013) or up to approximately 2.5 years
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall Response Rate (ORR)
Time Frame: Date of randomization to the date of disease progression or death (whichever occurred first), assessed up to data cutoff date (15 Nov 2013) or up to approximately 2.5 years
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ORR, defined as the percentage of participants who had best overall response (BOR) of complete response (CR) or partial response (PR) as determined by blinded IIR using RECIST 1.1 for target lesions and assessed by magnetic resonance imaging/computed tomography (MRI/CT) scans (for double blind treatment period i.e.
Randomization Phase).
CR was defined as disappearance of all target lesions.
Any pathological lymph nodes (whether target or non-target) had to have reduction in short axis to less than 10 mm.
PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
ORR = CR + PR.
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Date of randomization to the date of disease progression or death (whichever occurred first), assessed up to data cutoff date (15 Nov 2013) or up to approximately 2.5 years
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Overall Survival (OS)
Time Frame: Date of randomization until date of death from any cause, assessed up to data cutoff date (15 Nov 2013) or up to approximately 2.5 years
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Overall survival measured from the date of randomization until date of death from any cause.
Overall survival is adjusted with rank preserving structural failure time.
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Date of randomization until date of death from any cause, assessed up to data cutoff date (15 Nov 2013) or up to approximately 2.5 years
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Pharmacokinetic (PK) Profile of Lenvatinib: Area Under the Plasma Concentration Curve
Time Frame: Cycle 1 Days 1 and 15: 0-10 hours postdose; Cycle 2 Day 1: 0-12 hour postdose
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Cycle 1 Days 1 and 15: 0-10 hours postdose; Cycle 2 Day 1: 0-12 hour postdose
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Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Taylor MH, Takahashi S, Capdevila J, Tahara M, Leboulleux S, Kiyota N, Dutcus CE, Xie R, Robinson B, Sherman S, Habra MA, Elisei R, Wirth LJ. Correlation of Performance Status and Neutrophil-Lymphocyte Ratio with Efficacy in Radioiodine-Refractory Differentiated Thyroid Cancer Treated with Lenvatinib. Thyroid. 2021 Aug;31(8):1226-1234. doi: 10.1089/thy.2020.0779. Epub 2021 Apr 29.
- Tahara M, Kiyota N, Hoff AO, Badiu C, Owonikoko TK, Dutcus CE, Suzuki T, Ren M, Wirth LJ. Impact of lung metastases on overall survival in the phase 3 SELECT study of lenvatinib in patients with radioiodine-refractory differentiated thyroid cancer. Eur J Cancer. 2021 Apr;147:51-57. doi: 10.1016/j.ejca.2020.12.032. Epub 2021 Feb 19.
- Tahara M, Brose MS, Wirth LJ, Suzuki T, Miyagishi H, Fujino K, Dutcus CE, Gianoukakis A. Impact of dose interruption on the efficacy of lenvatinib in a phase 3 study in patients with radioiodine-refractory differentiated thyroid cancer. Eur J Cancer. 2019 Jan;106:61-68. doi: 10.1016/j.ejca.2018.10.002. Epub 2018 Nov 22.
- Tahara M, Schlumberger M, Elisei R, Habra MA, Kiyota N, Paschke R, Dutcus CE, Hihara T, McGrath S, Matijevic M, Kadowaki T, Funahashi Y, Sherman SI. Exploratory analysis of biomarkers associated with clinical outcomes from the study of lenvatinib in differentiated cancer of the thyroid. Eur J Cancer. 2017 Apr;75:213-221. doi: 10.1016/j.ejca.2017.01.013. Epub 2017 Feb 24.
- Robinson B, Schlumberger M, Wirth LJ, Dutcus CE, Song J, Taylor MH, Kim SB, Krzyzanowska MK, Capdevila J, Sherman SI, Tahara M. Characterization of Tumor Size Changes Over Time From the Phase 3 Study of Lenvatinib in Thyroid Cancer. J Clin Endocrinol Metab. 2016 Nov;101(11):4103-4109. doi: 10.1210/jc.2015-3989. Epub 2016 Aug 22.
- Kiyota N, Schlumberger M, Muro K, Ando Y, Takahashi S, Kawai Y, Wirth L, Robinson B, Sherman S, Suzuki T, Fujino K, Gupta A, Hayato S, Tahara M. Subgroup analysis of Japanese patients in a phase 3 study of lenvatinib in radioiodine-refractory differentiated thyroid cancer. Cancer Sci. 2015 Dec;106(12):1714-21. doi: 10.1111/cas.12826. Epub 2015 Nov 2.
- Schlumberger M, Tahara M, Wirth LJ, Robinson B, Brose MS, Elisei R, Habra MA, Newbold K, Shah MH, Hoff AO, Gianoukakis AG, Kiyota N, Taylor MH, Kim SB, Krzyzanowska MK, Dutcus CE, de las Heras B, Zhu J, Sherman SI. Lenvatinib versus placebo in radioiodine-refractory thyroid cancer. N Engl J Med. 2015 Feb 12;372(7):621-30. doi: 10.1056/NEJMoa1406470.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- E7080-G000-303
- 2010-023783-41 (EudraCT Number)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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National Cancer Institute (NCI)TerminatedInsular Thyroid Cancer | Recurrent Thyroid Cancer | Stage IV Follicular Thyroid Cancer | Stage IV Papillary Thyroid Cancer | Anaplastic Thyroid Cancer | Stage III Follicular Thyroid Cancer | Stage III Papillary Thyroid CancerUnited States
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