A Trial of Lenvatinib (E7080) in Subjects With Iodine-131 Refractory Differentiated Thyroid Cancer to Evaluate Whether an Oral Starting Dose of 18 Milligram (mg) Daily Will Provide Comparable Efficacy to a 24 mg Starting Dose, But Have a Better Safety Profile

PHASE2CompletedINTERVENTIONAL
Enrollment

241

Participants

Timeline

Start Date

June 8, 2017

Primary Completion Date

December 12, 2019

Study Completion Date

September 10, 2020

Conditions
Thyroid Cancer
Interventions
DRUG

Lenvatinib

Lenvatinib capsule.

DRUG

Lenvatinib matching placebo

Lenvatinib matching placebo capsule.

Trial Locations (101)

144

Facility #6, Rome

1200

Facility #1, Brussels

2650

Facility #1, Edegem

4006

Royal Brisbane and Women's Hospital, Brisbane

5000

Facility #2, Namur

8035

Facility #1, Badalona

8036

Facility #2, Barcelona

10461

Facility #1, The Bronx

11863

Facility #1, Bucharest

14076

Facility #1, Caen

19104

Facility #2, Philadelphia

19111

Facility #1, Philadelphia

20010

Facility #1, Washington D.C.

20122

Facility #6, Milan

20149

Facility #7, Milan

21079

Facility #1, Dijon

Facility #1, Dijon

28034

Facility #1, Madrid

29010

Facility #1, Málaga

30625

Facility #1, Hanover

33076

Facility #1, Bordeaux

43210

Facility #1, Columbus

45147

Facility #1, Essen

48109

Facility #1, Ann Arbor

48201

Facility #1, Detroit

49241

Facility#1, Busan

49933

Facility #2, Angers

56124

Facility #2, Pisa

57100

Facility #1, Livorno

69373

Facility #2, Lyon

72076

Facility #1, Tübingen

75013

Facility #1, Paris

90502

Facility #1, Torrance

92093

Facility#1, La Jolla

92307

Facility #1, San Diego

94805

Facility #2, Villejuif

97080

Facility #1, Würzburg

97239

Facility #1, Portland

98109

Facility #1, Seattle

115478

Facility #3, Moscow

117036

Facility #4, Moscow

197758

Facility #4, Saint Petersburg

Facility #3, Saint Petersburg

249036

Facility #1, Obninsk

400058

Facility #1, Cluj-Napoca

02114

Facility #1, Boston

02115

Facility #2, Boston

07962

Facility#2, Morristown

07902

Facility#1, Summit

Unknown

Facility #1, Darlinghurst

Facility #1, Saint Leonards

Facility#2, Chermside

Facility #1, Herston

Facility #1, Melbourne

Facility #1, Nedlands

Facility #1, Melbourne

Facility #1, Saint Leonards

Facility #1, Namur

Facility #1, Calgary

Facility #1, Toronto

Facility #1, Québec

Facility #1, Strasbourg

Facility #1, Bordeaux

Facility #1, Angers

Facility #1, Villejuif

Facility #1, Caen

Facility #1, Essen

Facility #2, Essen

Facility #1, Leipzig

Facility #1, Petah Tikva

Facility #1, Rome

Facility #2, Rome

Facility #3, Rome

Facility #2, Milan

Facility #3, Milan

Facility #4, Milan

Facility #5, Milan

Facility #1, Pisa

Facility #4, Roma

Facility #2, Rozzano

Facility #1, Torino

Facility #1, Viagrande

Facility #2, Kielce

Facility #1, Moscow

Facility #2, Moscow

Facility #1, Saint Petersburg

Facility #2, Saint Petersburg

Facility #1, Goyang-si

Facility #1, Seoul

Facility #2, Seoul

Facility #1, Barcelona

Facility #2, Madrid

Facility #2, Madrid

Facility #3, Madrid

Facility #1, London

Facility #1, Glasgow

DK-5000

Facility #1, Odense

135-710

Facility #3, Seoul

137-701

Facility #4, Seoul

SE-41345

Facility #1, Gothenburg

SE-22185

Facility #1, Lund

All Listed Sponsors
collaborator

Merck Sharp & Dohme LLC

INDUSTRY

lead

Eisai Inc.

INDUSTRY

NCT02702388 - A Trial of Lenvatinib (E7080) in Subjects With Iodine-131 Refractory Differentiated Thyroid Cancer to Evaluate Whether an Oral Starting Dose of 18 Milligram (mg) Daily Will Provide Comparable Efficacy to a 24 mg Starting Dose, But Have a Better Safety Profile | Biotech Hunter | Biotech Hunter