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A Study of Cabozantinib Compared With Placebo in Subjects With Radioiodine-refractory Differentiated Thyroid Cancer Who Have Progressed After Prior Vascular Endothelial Growth Factor Receptor (VEGFR) -Targeted Therapy

Primary Purpose

Differentiated Thyroid Cancer

Status

Active

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Cabozantinib

Placebo

About this trial

This is an interventional treatment trial for Differentiated Thyroid Cancer focused on measuring Thyroid cancer, papillary, Papillary thyroid carcinoma, Nonmedullary thyroid carcinoma, Cancer of the thyroid, Thyroid cancer, Follicular thyroid cancer, Thyroid cancer, follicular, Hürthle cell cancer

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Histologically or cytologically confirmed diagnosis of Differentiated Thyroid Cancer (DTC)
Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
Previously treated with or deemed ineligible for treatment with Iodine- 131 for differentiated thyroid cancer (DTC)
Previously treated with at least one of the following vascular endothelial growth factor receptor (VEGFR)-targeting tyrosine kinase inhibitor (TKI) agents for DTC: lenvatinib or sorafenib. Note: Up to two prior VEGFR-targeting TKI agents are allowed
Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1

Exclusion Criteria:

Prior treatment with any of the following: Cabozantinib; Selective small-molecule v-raf murine sarcoma viral oncogene homolog B1 (BRAF) kinase inhibitor; More than 2 VEGFR-targeting TKI agents; More than 1 immune checkpoint inhibitor therapy; 1 systemic chemotherapy regimen (given as single agent or in combination with another chemotherapy agent)
Receipt of any type of small molecule kinase inhibitor (including investigational kinase inhibitor) within 2 weeks or 5 half-lives of the agent, whichever is longer, before randomization
Receipt of any type of anticancer antibody (including investigational antibody) or systemic chemotherapy within 4 weeks before randomization
Receipt of radiation therapy for bone metastasis within 2 weeks or any other radiation therapy within 4 weeks before randomization.
Known brain metastases or cranial epidural disease unless adequately treated

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Cabozantinib

Placebo

Arm Description

cabozantinib (60 mg) once daily orally (qd)

placebo once daily orally (qd)

Outcomes

Primary Outcome Measures

Progression Free Survival (PFS)

Time to the earlier of either radiographic progressive disease (PD) or death from any cause.

Objective Response Rate (ORR)

Proportion of subjects with the best overall response of complete response (CR) or partial response (PR).

Secondary Outcome Measures

Full Information

NCT ID

NCT03690388

First Posted

September 26, 2018

Last Updated

July 7, 2023

Sponsor

Exelixis

Collaborators

Ipsen

1. Study Identification

Unique Protocol Identification Number

NCT03690388

Brief Title

A Study of Cabozantinib Compared With Placebo in Subjects With Radioiodine-refractory Differentiated Thyroid Cancer Who Have Progressed After Prior Vascular Endothelial Growth Factor Receptor (VEGFR) -Targeted Therapy

Official Title

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Cabozantinib (XL184) in Subjects With Radioiodine-Refractory Differentiated Thyroid Cancer Who Have Progressed After Prior Vascular Endothelial Growth Factor Receptor (VEGFR) -Targeted Therapy

Study Type

Interventional

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

October 5, 2018 (Actual)

Primary Completion Date

August 19, 2020 (Actual)

Study Completion Date

December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Exelixis

Collaborators

Ipsen

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The objective of this study is to evaluate the effect of cabozantinib compared with placebo on progression free survival (PFS) and objective response rate (ORR) in subjects with Radioiodine-Refractory Differentiated Thyroid Cancer (DTC) who have progressed after prior vascular endothelial growth factor receptor (VEGFR)-Targeted therapy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Differentiated Thyroid Cancer

Keywords

Thyroid cancer, papillary, Papillary thyroid carcinoma, Nonmedullary thyroid carcinoma, Cancer of the thyroid, Thyroid cancer, Follicular thyroid cancer, Thyroid cancer, follicular, Hürthle cell cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Model Description

This is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study of cabozantinib in subjects with radioactive iodine (RAI)-refractory differentiated thyroid cancer (DTC) after prior vascular endothelial growth factor receptor (VEGFR)-tyrosine kinase inhibitor (TKI) therapy. Cabozantinib-matched placebo will be given in the control arm to blind (mask) study treatment. Approximately 300 eligible subjects will be randomized in a 2:1 ratio to receive either cabozantinib or placebo. After the primary efficacy endpoints have been analyzed and sufficient data have been collected to adequately evaluate all study endpoints to establish, for regulatory purposes, the safety and efficacy profile of the experimental drug within this study, the study will transition to an open label Maintenance Phase.

Masking

ParticipantCare ProviderInvestigator

Masking Description

Study treatment assignment will be unknown to the subjects, investigators, study centers, Sponsor, and any Contract Research Organization affiliated with the study other than those authorized to access treatment assignment for regulatory safety reporting and submission processes, interactive response technology (IRT) system administration, and drug supply management. Cabozantinib-matched placebo will be packaged and color-, size-, and shape-matched to be indistinguishable from cabozantinib. Individual study treatment assignment will be unblinded and information provided to the Investigators upon request for subjects with radiographic progressive disease (PD) per Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 confirmed by the blinded independent radiology committee (BIRC).

Allocation

Randomized

Enrollment

187 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Cabozantinib

Arm Type

Experimental

Arm Description

cabozantinib (60 mg) once daily orally (qd)

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

placebo once daily orally (qd)

Intervention Type

Drug

Intervention Name(s)

Cabozantinib

Other Intervention Name(s)

XL184, Cabometyx®

Intervention Description

Tablets containing 60-mg or 20-mg cabozantinib once daily orally.

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Tablets containing placebo equivalent of 60-mg or 20-mg cabozantinib once daily orally.

Primary Outcome Measure Information:

Title

Progression Free Survival (PFS)

Description

Time to the earlier of either radiographic progressive disease (PD) or death from any cause.

Time Frame

Up to approximately twenty months after the first subject is randomized. Time from randomization to the earlier of the following events: radiographic PD as determined by the blinded independent central review (BIRC) or death due to any cause.

Title

Objective Response Rate (ORR)

Description

Proportion of subjects with the best overall response of complete response (CR) or partial response (PR).

Time Frame

Six months after 100 subjects are randomized. Time from randomization to best overall response of confirmed complete response (CR) or confirmed partial response (PR) per BIRC per RECIST 1.1.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

16 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Histologically or cytologically confirmed diagnosis of Differentiated Thyroid Cancer (DTC) Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 Previously treated with or deemed ineligible for treatment with Iodine- 131 for differentiated thyroid cancer (DTC) Previously treated with at least one of the following vascular endothelial growth factor receptor (VEGFR)-targeting tyrosine kinase inhibitor (TKI) agents for DTC: lenvatinib or sorafenib. Note: Up to two prior VEGFR-targeting TKI agents are allowed Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1 Exclusion Criteria: Prior treatment with any of the following: Cabozantinib; Selective small-molecule v-raf murine sarcoma viral oncogene homolog B1 (BRAF) kinase inhibitor; More than 2 VEGFR-targeting TKI agents; More than 1 immune checkpoint inhibitor therapy; 1 systemic chemotherapy regimen (given as single agent or in combination with another chemotherapy agent) Receipt of any type of small molecule kinase inhibitor (including investigational kinase inhibitor) within 2 weeks or 5 half-lives of the agent, whichever is longer, before randomization Receipt of any type of anticancer antibody (including investigational antibody) or systemic chemotherapy within 4 weeks before randomization Receipt of radiation therapy for bone metastasis within 2 weeks or any other radiation therapy within 4 weeks before randomization. Known brain metastases or cranial epidural disease unless adequately treated

Facility Information:

Facility Name

Exelixis Clinical Site #2

City

Newport Beach

State/Province

California

ZIP/Postal Code

92658

Country

United States

Facility Name

Exelixis Clinical Site #98

City

Sacramento

State/Province

California

ZIP/Postal Code

95817

Country

United States

Facility Name

Exelixis Clinical Site #69

City

San Francisco

State/Province

California

ZIP/Postal Code

94115

Country

United States

Facility Name

Exelixis Clinical Site #10

City

Stanford

State/Province

California

ZIP/Postal Code

94305

Country

United States

Facility Name

Exelixis Clinical Site #3

City

Torrance

State/Province

California

ZIP/Postal Code

90502

Country

United States

Facility Name

Exelixis Clinical Site #9

City

Aurora

State/Province

Colorado

ZIP/Postal Code

80045

Country

United States

Facility Name

Exelixis Clinical Site #21

City

New Haven

State/Province

Connecticut

ZIP/Postal Code

06510

Country

United States

Facility Name

Exelixis Clinical Site #4

City

Washington

State/Province

District of Columbia

ZIP/Postal Code

20010

Country

United States

Facility Name

Exelixis Clinical Site #94

City

Miami

State/Province

Florida

ZIP/Postal Code

33136

Country

United States

Facility Name

Exelixis Clinical Site #93

City

Orlando

State/Province

Florida

ZIP/Postal Code

32804

Country

United States

Facility Name

Exelixis Clinical Site #6

City

Tampa

State/Province

Florida

ZIP/Postal Code

33612

Country

United States

Facility Name

Exelixis Clinical Site #164

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60637

Country

United States

Facility Name

Exelixis Clinical Site #54

City

Lexington

State/Province

Kentucky

ZIP/Postal Code

40536

Country

United States

Facility Name

Exelixis Clinical Site #153

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02114

Country

United States

Facility Name

Exelixis Clinical Site #80

City

Ann Arbor

State/Province

Michigan

ZIP/Postal Code

48109

Country

United States

Facility Name

Exelixis Clinical Site #78

City

Detroit

State/Province

Michigan

ZIP/Postal Code

48201

Country

United States

Facility Name

Exelixis Clinical Site #22

City

Detroit

State/Province

Michigan

ZIP/Postal Code

48202

Country

United States

Facility Name

Exelixis Clinical Site #63

City

Columbia

State/Province

Missouri

ZIP/Postal Code

65212

Country

United States

Facility Name

Exelixis Clinical Site #42

City

Saint Louis

State/Province

Missouri

ZIP/Postal Code

63110

Country

United States

Facility Name

Exelixis Clinical Site #11

City

Omaha

State/Province

Nebraska

ZIP/Postal Code

68114

Country

United States

Facility Name

Exelixis Clinical Site #118

City

Morristown

State/Province

New Jersey

ZIP/Postal Code

07962

Country

United States

Facility Name

Exelixis Clinical Site #76

City

Charlotte

State/Province

North Carolina

ZIP/Postal Code

28204

Country

United States

Facility Name

Exelixis Clinical Site #19

City

Durham

State/Province

North Carolina

ZIP/Postal Code

27710

Country

United States

Facility Name

Exelixis Clinical Site #7

City

Cincinnati

State/Province

Ohio

ZIP/Postal Code

45219

Country

United States

Facility Name

Exelixis Clinical Site #5

City

Bethlehem

State/Province

Pennsylvania

ZIP/Postal Code

18015

Country

United States

Facility Name

Exelixis Clinical Site #1

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19104

Country

United States

Facility Name

Exelixis Clinical Site #75

City

Pittsburgh

State/Province

Pennsylvania

ZIP/Postal Code

15232

Country

United States

Facility Name

Exelixis Clinical Site #134

City

Charleston

State/Province

South Carolina

ZIP/Postal Code

29425

Country

United States

Facility Name

Exelixis Clinical Site #68

City

Nashville

State/Province

Tennessee

ZIP/Postal Code

37232

Country

United States

Facility Name

Exelixis Clinical Site #8

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

Facility Name

Exelixis Clinical Site #113

City

Seattle

State/Province

Washington

ZIP/Postal Code

98109

Country

United States

Facility Name

Exelixis Clinical Site #96

City

Pergamino

State/Province

Buenos Aires

ZIP/Postal Code

B2700CPM

Country

Argentina

Facility Name

Exelixis Clinical Site #97

City

Caba

ZIP/Postal Code

C1012AAR

Country

Argentina

Facility Name

Exelixis Clinical Site #129

City

Córdoba

ZIP/Postal Code

X5000AVE

Country

Argentina

Facility Name

Exelixis Clinical Site #17

City

St. Leonards

State/Province

New South Wales

ZIP/Postal Code

2065

Country

Australia

Facility Name

Exelixis Clinical Site #25

City

Waratah

State/Province

New South Wales

ZIP/Postal Code

2298

Country

Australia

Facility Name

Exelixis Clinical Site #86

City

Bedford Park

State/Province

South Australia

ZIP/Postal Code

5042

Country

Australia

Facility Name

Exelixis Clinical Site #24

City

Melbourne

State/Province

Victoria

ZIP/Postal Code

3004

Country

Australia

Facility Name

Exelixis Clinical Site #12

City

Herston

ZIP/Postal Code

4029

Country

Australia

Facility Name

Exelixis Clinical Site #62

City

Salzburg

ZIP/Postal Code

5020

Country

Austria

Facility Name

Exelixis Clinical Site #119

City

Vienna

ZIP/Postal Code

1090

Country

Austria

Facility Name

Exelixis Clinical Site #90

City

Anderlecht

ZIP/Postal Code

1070

Country

Belgium

Facility Name

Exelixis Clinical Site #31

City

Brussels

ZIP/Postal Code

1200

Country

Belgium

Facility Name

Exelixis Clinical Site #26

City

Edegem

ZIP/Postal Code

2650

Country

Belgium

Facility Name

Exelixis Clinical Site #74

City

Edegem

ZIP/Postal Code

2650

Country

Belgium

Facility Name

Exelixis Clinical Site #100

City

Gent

ZIP/Postal Code

9000

Country

Belgium

Facility Name

Exelixis Clinical Site #27

City

Namur

ZIP/Postal Code

5000

Country

Belgium

Facility Name

Exelixis Clinical Site #35

City

Cascavel

State/Province

Parana

ZIP/Postal Code

85806-300

Country

Brazil

Facility Name

Exelixis Clinical Site #39

City

Porto Alegre

State/Province

Rio Grande Do Sul

ZIP/Postal Code

90035-903

Country

Brazil

Facility Name

Exelixis Clinical Site #140

City

Porto Alegre

State/Province

Rio Grande Do Sul

ZIP/Postal Code

90050-170

Country

Brazil

Facility Name

Exelixis Clinical Site #38

City

Porto Alegre

State/Province

Rio Grande Do Sul

ZIP/Postal Code

90110-270

Country

Brazil

Facility Name

Exelixis Clinical Site #40

City

Sao Jose do Rio Preto

State/Province

Sao Paulo

ZIP/Postal Code

15090-000

Country

Brazil

Facility Name

Exelixis Clinical Site #116

City

Ribeirão Preto

State/Province

São Paulo

ZIP/Postal Code

14051-140

Country

Brazil

Facility Name

Exelixis Clinical Site #92

City

Rio De Janeiro

ZIP/Postal Code

20231-050

Country

Brazil

Facility Name

Exelixis Clinical Site #47

City

Sao Paulo

ZIP/Postal Code

01246-000

Country

Brazil

Facility Name

Exelixis Clinical Site #20

City

Calgary

State/Province

Alberta

ZIP/Postal Code

T2N 4N2

Country

Canada

Facility Name

Exelixis Clinical Site #18

City

Edmonton

State/Province

Alberta

ZIP/Postal Code

T6G 1Z2

Country

Canada

Facility Name

Exelixis Clinical Site #107

City

London

State/Province

Ontario

ZIP/Postal Code

N6A 5W9

Country

Canada

Facility Name

Exelixis Clinical Site #83

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M5G 2M9

Country

Canada

Facility Name

Exelixis Clinical Site #145

City

Osijek

ZIP/Postal Code

31000

Country

Croatia

Facility Name

Exelixis Clinical Site #137

City

Zagreb

ZIP/Postal Code

10000

Country

Croatia

Facility Name

Exelixis Clinical Site #138

City

Zagreb

ZIP/Postal Code

10000

Country

Croatia

Facility Name

Exelixis Clinical Site #105

City

Brno

ZIP/Postal Code

656 53

Country

Czechia

Facility Name

Exelixis Clinical Site #104

City

Olomouc

ZIP/Postal Code

779 00

Country

Czechia

Facility Name

Exelixis Clinical Site #32

City

Dijon

State/Province

Bourgogne-Franche-Comte

ZIP/Postal Code

21079

Country

France

Facility Name

Exelixis Clinical Site #44

City

Villejuif

State/Province

Ile De France

ZIP/Postal Code

94805

Country

France

Facility Name

Exelixis Clinical Site #67

City

Bordeaux

State/Province

Nouvelle - Aquitaine

ZIP/Postal Code

33075

Country

France

Facility Name

Exelixis Clinical Site #45

City

Angers

State/Province

Pays De La Loire

ZIP/Postal Code

4933

Country

France

Facility Name

Exelixis Clinical Site #72

City

Marseille

State/Province

Provence-Alpes-Cote d'Azur

ZIP/Postal Code

13915

Country

France

Facility Name

Exelixis Clinical Site #102

City

Besançon

ZIP/Postal Code

25030

Country

France

Facility Name

Exelixis Clinical Site #91

City

Lyon Cedex 08

ZIP/Postal Code

69373

Country

France

Facility Name

Exelixis Clinical Site #82

City

Nice

ZIP/Postal Code

06189

Country

France

Facility Name

Exelixis Clinical Site #152

City

Paris

ZIP/Postal Code

75013

Country

France

Facility Name

Exelixis Clinical Site #95

City

Strasbourg Cedex

ZIP/Postal Code

67065

Country

France

Facility Name

Exelixis Clinical Site #121

City

Tübingen

State/Province

Baden-Württemberg

ZIP/Postal Code

72076

Country

Germany

Facility Name

Exelixis Clinical Site #156

City

Würzburg

State/Province

Bayern

ZIP/Postal Code

97080

Country

Germany

Facility Name

Exelixis Clinical Site #125

City

Marburg

State/Province

Hesse

ZIP/Postal Code

35043

Country

Germany

Facility Name

Exelixis Clinical Site #163

City

Hannover

State/Province

Lower Saxony

ZIP/Postal Code

30625

Country

Germany

Facility Name

Exelixis Clinical Site #124

City

Magdeburg

State/Province

Sachsen-Anhalt

ZIP/Postal Code

39120

Country

Germany

Facility Name

Exelixis Clinical Site #151

City

Dresden

State/Province

Saxony

ZIP/Postal Code

01307

Country

Germany

Facility Name

Exelixis Clinical Site #155

City

Aachen

ZIP/Postal Code

52074

Country

Germany

Facility Name

Exelixis Clinical Site #131

City

Bonn

ZIP/Postal Code

53127

Country

Germany

Facility Name

Exelixis Clinical Site #154

City

Essen

ZIP/Postal Code

45147

Country

Germany

Facility Name

Exelixis Clinical Site #160

City

Freiburg

ZIP/Postal Code

79106

Country

Germany

Facility Name

Exelixis Clinical Site #159

City

Hamburg

ZIP/Postal Code

20246

Country

Germany

Facility Name

Exelixis Clinical Site #139

City

München

ZIP/Postal Code

81377

Country

Germany

Facility Name

Exelixis Clinical Site #28

City

Hong Kong

Country

Hong Kong

Facility Name

Exelixis Clinical Site #46

City

Budapest

ZIP/Postal Code

1122

Country

Hungary

Facility Name

Exelixis Clinical Site #37

City

Pecs

ZIP/Postal Code

7624

Country

Hungary

Facility Name

Exelixis Clinical Site #43

City

Haifa

ZIP/Postal Code

3109601

Country

Israel

Facility Name

Exelixis Clinical Site #41

City

Jerusalem

ZIP/Postal Code

9112001

Country

Israel

Facility Name

Exelixis Clinical Site #58

City

Petah tikva

ZIP/Postal Code

4941492

Country

Israel

Facility Name

Exelixis Clinical Site #109

City

Viagrande

State/Province

Catania

ZIP/Postal Code

95029

Country

Italy

Facility Name

Exelixis Clinical Site #135

City

Catania

State/Province

ZIP/Postal Code

95122

Country

Italy

Facility Name

Exelixis Clinical Site #132

City

Meldola

State/Province

Forlì - Cesena

ZIP/Postal Code

47017

Country

Italy

Facility Name

Exelixis Clinical Site #144

City

Genova

State/Province

ZIP/Postal Code

16132

Country

Italy

Facility Name

Exelixis Clinical Site #143

City

Rozzano

State/Province

Milano

ZIP/Postal Code

20089

Country

Italy

Facility Name

Exelixis Clinical Site #29

City

Pisa

State/Province

ZIP/Postal Code

56124

Country

Italy

Facility Name

Exelixis Clinical Site #120

City

Torino

State/Province

ZIP/Postal Code

10126

Country

Italy

Facility Name

Exelixis Clinical Site #103

City

Milano

ZIP/Postal Code

20133

Country

Italy

Facility Name

Exelixis Clinical Site #110

City

Milano

ZIP/Postal Code

20141

Country

Italy

Facility Name

Exelixis Clinical Site #115

City

Milano

ZIP/Postal Code

20149

Country

Italy

Facility Name

Exelixis Clinical Site #108

City

Napoli

ZIP/Postal Code

80131

Country

Italy

Facility Name

Exelixis Clinical Site #56

City

Napoli

ZIP/Postal Code

80131

Country

Italy

Facility Name

Exelixis Clinical Site #123

City

Padova

ZIP/Postal Code

35128

Country

Italy

Facility Name

Exelixis Clinical Site #87

City

Roma

ZIP/Postal Code

00144

Country

Italy

Facility Name

Exelixis Clinical Site #127

City

Roma

ZIP/Postal Code

00161

Country

Italy

Facility Name

Exelixis Clinical Site #111

City

Siena

ZIP/Postal Code

53100

Country

Italy

Facility Name

Exelixis Clinical Site #70

City

Busan

ZIP/Postal Code

49267

Country

Korea, Republic of

Facility Name

Exelixis Clinical Site #79

City

Gyeonggi-do

ZIP/Postal Code

10408

Country

Korea, Republic of

Facility Name

Exelixis Clinical Site #36

City

Seoul

ZIP/Postal Code

03080

Country

Korea, Republic of

Facility Name

Exelixis Clinical Site #34

City

Seoul

ZIP/Postal Code

05505

Country

Korea, Republic of

Facility Name

Exelixis Clinical Site #158

City

Tuxtla Gutiérrez

State/Province

Chiapas

ZIP/Postal Code

29038

Country

Mexico

Facility Name

Exelixis Clinical Site #133

City

Ciudad de Mèxico

ZIP/Postal Code

06100

Country

Mexico

Facility Name

Exelixis Clinical Site #147

City

Ciudad de México

ZIP/Postal Code

03100

Country

Mexico

Facility Name

Exelixis Clinical Site #148

City

Ciudad de México

ZIP/Postal Code

06700

Country

Mexico

Facility Name

Exelixis Clinical Site #161

City

San Luis Potosí

ZIP/Postal Code

78200

Country

Mexico

Facility Name

Exelixis Clinical Site #128

City

Amsterdam

State/Province

Noord-Holland

ZIP/Postal Code

1081 HV

Country

Netherlands

Facility Name

Exelixis Clinical Site #117

City

Leiden

State/Province

Zuid-Holland

ZIP/Postal Code

2333 ZA

Country

Netherlands

Facility Name

Exelixis Clinical Site #15

City

Warszawa

State/Province

Mazowieckie

ZIP/Postal Code

02-781

Country

Poland

Facility Name

Exelixis Clinical Site #61

City

Gliwice

State/Province

Slaskie

ZIP/Postal Code

44-101

Country

Poland

Facility Name

Exelixis Clinical Site #59

City

Poznan

State/Province

Wielkopolskie

ZIP/Postal Code

60-355

Country

Poland

Facility Name

Exelixis Clinical Site #149

City

Cluj-Napoca

State/Province

Cluj

ZIP/Postal Code

400015

Country

Romania

Facility Name

Exelixis Clinical Site #150

City

Craiova

State/Province

Dolj

ZIP/Postal Code

200385

Country

Romania

Facility Name

Exelixis Clinical Site #142

City

Timişoara

State/Province

Timis

ZIP/Postal Code

300166

Country

Romania

Facility Name

Exelixis Clinical Site #146

City

Bucuresti

ZIP/Postal Code

011863

Country

Romania

Facility Name

Exelixis Clinical Site #48

City

Obninsk

State/Province

Kaluzhiskiy Region

ZIP/Postal Code

249036

Country

Russian Federation

Facility Name

Exelixis Clinical Site #55

City

Kislino

State/Province

Kursk Region

ZIP/Postal Code

305524

Country

Russian Federation

Facility Name

Exelixis Clinical Site #157

City

Tyumen

State/Province

Tyumen Region

ZIP/Postal Code

625041

Country

Russian Federation

Facility Name

Exelixis Clinical Site #49

City

Moscow

ZIP/Postal Code

117036

Country

Russian Federation

Facility Name

Exelixis Clinical Site #53

City

Moscow

ZIP/Postal Code

121309

Country

Russian Federation

Facility Name

Exelixis Clinical Site #84

City

Moscow

ZIP/Postal Code

125284

Country

Russian Federation

Facility Name

Exelixis Clinical Site #85

City

Moscow

ZIP/Postal Code

155478

Country

Russian Federation

Facility Name

Exelixis Clinical Site #106

City

Omsk

ZIP/Postal Code

644013

Country

Russian Federation

Facility Name

Exelixis Clinical Site #89

City

Saint Petersburg

ZIP/Postal Code

198255

Country

Russian Federation

Facility Name

Exelixis Clinical Site #52

City

Samara

ZIP/Postal Code

443031

Country

Russian Federation

Facility Name

Exelixis Clinical Site #66

City

Yaroslavl

ZIP/Postal Code

150054

Country

Russian Federation

Facility Name

Exelixis Clinical Site #14

City

Barcelona

ZIP/Postal Code

08035

Country

Spain

Facility Name

Exelixis Clinical Site #99

City

Barcelona

ZIP/Postal Code

08036

Country

Spain

Facility Name

Exelixis Clinical Site #114

City

Madrid

ZIP/Postal Code

28027

Country

Spain

Facility Name

Exelixis Clinical Site #30

City

Madrid

ZIP/Postal Code

28033

Country

Spain

Facility Name

Exelixis Clinical Site #13

City

Madrid

ZIP/Postal Code

28034

Country

Spain

Facility Name

Exelixis Clinical Site #16

City

Madrid

ZIP/Postal Code

28040

Country

Spain

Facility Name

Exelixis Clinical Site #33

City

Madrid

ZIP/Postal Code

28041

Country

Spain

Facility Name

Exelixis Clinical Site #73

City

Madrid

ZIP/Postal Code

28046

Country

Spain

Facility Name

Exelixis Clinical Site #23

City

Madrid

ZIP/Postal Code

28050

Country

Spain

Facility Name

Exelixis Clinical Site #81

City

Málaga

ZIP/Postal Code

29010

Country

Spain

Facility Name

Exelixis Clinical Site #136

City

Tainan

ZIP/Postal Code

704

Country

Taiwan

Facility Name

Exelixis Clinical Site #112

City

Tainan

ZIP/Postal Code

71004

Country

Taiwan

Facility Name

Exelixis Clinical Site #77

City

Taipei

ZIP/Postal Code

10002

Country

Taiwan

Facility Name

Exelixis Clinical Site #101

City

Taipei

ZIP/Postal Code

11490

Country

Taiwan

Facility Name

Exelixis Clinical Site #126

City

Bangkok Noi

State/Province

Bangkok

ZIP/Postal Code

10700

Country

Thailand

Facility Name

Exelixis Clinical Site #122

City

Pathum Wan

State/Province

Bangkok

ZIP/Postal Code

10330

Country

Thailand

Facility Name

Exelixis Clinical Site #141

City

Ratchathewi

State/Province

Bangkok

ZIP/Postal Code

10400

Country

Thailand

Facility Name

Exelixis Clinical Site #130

City

Hat Yai

State/Province

Songkla

ZIP/Postal Code

90110

Country

Thailand

Facility Name

Exelixis Clinical Site #88

City

Birmingham

State/Province

England

ZIP/Postal Code

B15 2TH

Country

United Kingdom

Facility Name

Exelixis Clinical Site #71

City

Bristol

State/Province

England

ZIP/Postal Code

BS2 8ED

Country

United Kingdom

Facility Name

Exelixis Clinical Site #162

City

London

State/Province

England

ZIP/Postal Code

SW3 6JJ

Country

United Kingdom

Facility Name

Exelixis Clinical Site #51

City

Oxford

State/Province

England

ZIP/Postal Code

OX3 7LE

Country

United Kingdom

Facility Name

Exelixis Clinical Site #64

City

Aberdeen

State/Province

Scotland

ZIP/Postal Code

AB25 2ZN

Country

United Kingdom

Facility Name

Exelixis Clinical Site #50

City

Glasgow

State/Province

Scotland

ZIP/Postal Code

G12 0YN

Country

United Kingdom

Facility Name

Exelixis Clinical Site #60

City

Cardiff

State/Province

Wales

ZIP/Postal Code

CF14 2TL

Country

United Kingdom

Facility Name

Exelixis Clinical Site #65

City

Manchester

ZIP/Postal Code

M20 4BX

Country

United Kingdom

Facility Name

Exelixis Clinical Site #57

City

Sheffield

ZIP/Postal Code

S10 2SJ

Country

United Kingdom

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

34237250

Citation

Brose MS, Robinson B, Sherman SI, Krajewska J, Lin CC, Vaisman F, Hoff AO, Hitre E, Bowles DW, Hernando J, Faoro L, Banerjee K, Oliver JW, Keam B, Capdevila J. Cabozantinib for radioiodine-refractory differentiated thyroid cancer (COSMIC-311): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Oncol. 2021 Aug;22(8):1126-1138. doi: 10.1016/S1470-2045(21)00332-6. Epub 2021 Jul 5.

Results Reference

derived

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A Study of Cabozantinib Compared With Placebo in Subjects With Radioiodine-refractory Differentiated Thyroid Cancer Who Have Progressed After Prior Vascular Endothelial Growth Factor Receptor (VEGFR) -Targeted Therapy

Differentiated Thyroid Cancer

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial