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

March 20, 2024 updated by: Exelixis

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

187

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Caba, Argentina, C1012AAR
        • Exelixis Clinical Site #97
      • Córdoba, Argentina, X5000AVE
        • Exelixis Clinical Site #129
    • Buenos Aires
      • Pergamino, Buenos Aires, Argentina, B2700CPM
        • Exelixis Clinical Site #96
  • Australia
      • Herston, Australia, 4029
        • Exelixis Clinical Site #12
    • New South Wales
      • St. Leonards, New South Wales, Australia, 2065
        • Exelixis Clinical Site #17
      • Waratah, New South Wales, Australia, 2298
        • Exelixis Clinical Site #25
    • South Australia
      • Bedford Park, South Australia, Australia, 5042
        • Exelixis Clinical Site #86
    • Victoria
      • Melbourne, Victoria, Australia, 3004
        • Exelixis Clinical Site #24
  • Austria
      • Salzburg, Austria, 5020
        • Exelixis Clinical Site #62
      • Vienna, Austria, 1090
        • Exelixis Clinical Site #119
  • Belgium
      • Anderlecht, Belgium, 1070
        • Exelixis Clinical Site #90
      • Brussels, Belgium, 1200
        • Exelixis Clinical Site #31
      • Edegem, Belgium, 2650
        • Exelixis Clinical Site #26
      • Edegem, Belgium, 2650
        • Exelixis Clinical Site #74
      • Gent, Belgium, 9000
        • Exelixis Clinical Site #100
      • Namur, Belgium, 5000
        • Exelixis Clinical Site #27
  • Brazil
      • Rio De Janeiro, Brazil, 20231-050
        • Exelixis Clinical Site #92
      • Sao Paulo, Brazil, 01246-000
        • Exelixis Clinical Site #47
    • Parana
      • Cascavel, Parana, Brazil, 85806-300
        • Exelixis Clinical Site #35
    • Rio Grande Do Sul
      • Porto Alegre, Rio Grande Do Sul, Brazil, 90035-903
        • Exelixis Clinical Site #39
      • Porto Alegre, Rio Grande Do Sul, Brazil, 90050-170
        • Exelixis Clinical Site #140
      • Porto Alegre, Rio Grande Do Sul, Brazil, 90110-270
        • Exelixis Clinical Site #38
    • Sao Paulo
      • Sao Jose do Rio Preto, Sao Paulo, Brazil, 15090-000
        • Exelixis Clinical Site #40
    • São Paulo
      • Ribeirão Preto, São Paulo, Brazil, 14051-140
        • Exelixis Clinical Site #116
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 4N2
        • Exelixis Clinical Site #20
      • Edmonton, Alberta, Canada, T6G 1Z2
        • Exelixis Clinical Site #18
    • Ontario
      • London, Ontario, Canada, N6A 5W9
        • Exelixis Clinical Site #107
      • Toronto, Ontario, Canada, M5G 2M9
        • Exelixis Clinical Site #83
  • Croatia
      • Osijek, Croatia, 31000
        • Exelixis Clinical Site #145
      • Zagreb, Croatia, 10000
        • Exelixis Clinical Site #137
      • Zagreb, Croatia, 10000
        • Exelixis Clinical Site #138
  • Czechia
      • Brno, Czechia, 656 53
        • Exelixis Clinical Site #105
      • Olomouc, Czechia, 779 00
        • Exelixis Clinical Site #104
  • France
      • Besançon, France, 25030
        • Exelixis Clinical Site #102
      • Lyon Cedex 08, France, 69373
        • Exelixis Clinical Site #91
      • Nice, France, 06189
        • Exelixis Clinical Site #82
      • Paris, France, 75013
        • Exelixis Clinical Site #152
      • Strasbourg Cedex, France, 67065
        • Exelixis Clinical Site #95
    • Bourgogne-Franche-Comte
      • Dijon, Bourgogne-Franche-Comte, France, 21079
        • Exelixis Clinical Site #32
    • Ile De France
      • Villejuif, Ile De France, France, 94805
        • Exelixis Clinical Site #44
    • Nouvelle - Aquitaine
      • Bordeaux, Nouvelle - Aquitaine, France, 33075
        • Exelixis Clinical Site #67
    • Pays De La Loire
      • Angers, Pays De La Loire, France, 4933
        • Exelixis Clinical Site #45
    • Provence-Alpes-Cote d'Azur
      • Marseille, Provence-Alpes-Cote d'Azur, France, 13915
        • Exelixis Clinical Site #72
  • Germany
      • Aachen, Germany, 52074
        • Exelixis Clinical Site #155
      • Bonn, Germany, 53127
        • Exelixis Clinical Site #131
      • Essen, Germany, 45147
        • Exelixis Clinical Site #154
      • Freiburg, Germany, 79106
        • Exelixis Clinical Site #160
      • Hamburg, Germany, 20246
        • Exelixis Clinical Site #159
      • München, Germany, 81377
        • Exelixis Clinical Site #139
    • Baden-Württemberg
      • Tübingen, Baden-Württemberg, Germany, 72076
        • Exelixis Clinical Site #121
    • Bayern
      • Würzburg, Bayern, Germany, 97080
        • Exelixis Clinical Site #156
    • Hesse
      • Marburg, Hesse, Germany, 35043
        • Exelixis Clinical Site #125
    • Lower Saxony
      • Hannover, Lower Saxony, Germany, 30625
        • Exelixis Clinical Site #163
    • Sachsen-Anhalt
      • Magdeburg, Sachsen-Anhalt, Germany, 39120
        • Exelixis Clinical Site #124
    • Saxony
      • Dresden, Saxony, Germany, 01307
        • Exelixis Clinical Site #151
  • Hong Kong
      • Hong Kong, Hong Kong
        • Exelixis Clinical Site #28
  • Hungary
      • Budapest, Hungary, 1122
        • Exelixis Clinical Site #46
      • Pecs, Hungary, 7624
        • Exelixis Clinical Site #37
  • Israel
      • Haifa, Israel, 3109601
        • Exelixis Clinical Site #43
      • Jerusalem, Israel, 9112001
        • Exelixis Clinical Site #41
      • Petah tikva, Israel, 4941492
        • Exelixis Clinical Site #58
  • Italy
      • Milano, Italy, 20133
        • Exelixis Clinical Site #103
      • Milano, Italy, 20141
        • Exelixis Clinical Site #110
      • Milano, Italy, 20149
        • Exelixis Clinical Site #115
      • Napoli, Italy, 80131
        • Exelixis Clinical Site #108
      • Napoli, Italy, 80131
        • Exelixis Clinical Site #56
      • Padova, Italy, 35128
        • Exelixis Clinical Site #123
      • Roma, Italy, 00144
        • Exelixis Clinical Site #87
      • Roma, Italy, 00161
        • Exelixis Clinical Site #127
      • Siena, Italy, 53100
        • Exelixis Clinical Site #111
    • CT
      • Catania, CT, Italy, 95122
        • Exelixis Clinical Site #135
    • Catania
      • Viagrande, Catania, Italy, 95029
        • Exelixis Clinical Site #109
    • Forlì - Cesena
      • Meldola, Forlì - Cesena, Italy, 47017
        • Exelixis Clinical Site #132
    • GE
      • Genova, GE, Italy, 16132
        • Exelixis Clinical Site #144
    • Milano
      • Rozzano, Milano, Italy, 20089
        • Exelixis Clinical Site #143
    • PI
      • Pisa, PI, Italy, 56124
        • Exelixis Clinical Site #29
    • TO
      • Torino, TO, Italy, 10126
        • Exelixis Clinical Site #120
  • Korea, Republic of
      • Busan, Korea, Republic of, 49267
        • Exelixis Clinical Site #70
      • Gyeonggi-do, Korea, Republic of, 10408
        • Exelixis Clinical Site #79
      • Seoul, Korea, Republic of, 03080
        • Exelixis Clinical Site #36
      • Seoul, Korea, Republic of, 05505
        • Exelixis Clinical Site #34
  • Mexico
      • Ciudad de Mèxico, Mexico, 06100
        • Exelixis Clinical Site #133
      • Ciudad de México, Mexico, 03100
        • Exelixis Clinical Site #147
      • Ciudad de México, Mexico, 06700
        • Exelixis Clinical Site #148
      • San Luis Potosí, Mexico, 78200
        • Exelixis Clinical Site #161
    • Chiapas
      • Tuxtla Gutiérrez, Chiapas, Mexico, 29038
        • Exelixis Clinical Site #158
  • Netherlands
    • Noord-Holland
      • Amsterdam, Noord-Holland, Netherlands, 1081 HV
        • Exelixis Clinical Site #128
    • Zuid-Holland
      • Leiden, Zuid-Holland, Netherlands, 2333 ZA
        • Exelixis Clinical Site #117
  • Poland
    • Mazowieckie
      • Warszawa, Mazowieckie, Poland, 02-781
        • Exelixis Clinical Site #15
    • Slaskie
      • Gliwice, Slaskie, Poland, 44-101
        • Exelixis Clinical Site #61
    • Wielkopolskie
      • Poznan, Wielkopolskie, Poland, 60-355
        • Exelixis Clinical Site #59
  • Romania
      • Bucuresti, Romania, 011863
        • Exelixis Clinical Site #146
    • Cluj
      • Cluj-Napoca, Cluj, Romania, 400015
        • Exelixis Clinical Site #149
    • Dolj
      • Craiova, Dolj, Romania, 200385
        • Exelixis Clinical Site #150
    • Timis
      • Timişoara, Timis, Romania, 300166
        • Exelixis Clinical Site #142
  • Russian Federation
      • Moscow, Russian Federation, 117036
        • Exelixis Clinical Site #49
      • Moscow, Russian Federation, 121309
        • Exelixis Clinical Site #53
      • Moscow, Russian Federation, 125284
        • Exelixis Clinical Site #84
      • Moscow, Russian Federation, 155478
        • Exelixis Clinical Site #85
      • Omsk, Russian Federation, 644013
        • Exelixis Clinical Site #106
      • Saint Petersburg, Russian Federation, 198255
        • Exelixis Clinical Site #89
      • Samara, Russian Federation, 443031
        • Exelixis Clinical Site #52
      • Yaroslavl, Russian Federation, 150054
        • Exelixis Clinical Site #66
    • Kaluzhiskiy Region
      • Obninsk, Kaluzhiskiy Region, Russian Federation, 249036
        • Exelixis Clinical Site #48
    • Kursk Region
      • Kislino, Kursk Region, Russian Federation, 305524
        • Exelixis Clinical Site #55
    • Tyumen Region
      • Tyumen, Tyumen Region, Russian Federation, 625041
        • Exelixis Clinical Site #157
  • Spain
      • Barcelona, Spain, 08035
        • Exelixis Clinical Site #14
      • Barcelona, Spain, 08036
        • Exelixis Clinical Site #99
      • Madrid, Spain, 28027
        • Exelixis Clinical Site #114
      • Madrid, Spain, 28033
        • Exelixis Clinical Site #30
      • Madrid, Spain, 28034
        • Exelixis Clinical Site #13
      • Madrid, Spain, 28040
        • Exelixis Clinical Site #16
      • Madrid, Spain, 28041
        • Exelixis Clinical Site #33
      • Madrid, Spain, 28046
        • Exelixis Clinical Site #73
      • Madrid, Spain, 28050
        • Exelixis Clinical Site #23
      • Málaga, Spain, 29010
        • Exelixis Clinical Site #81
  • Taiwan
      • Tainan, Taiwan, 704
        • Exelixis Clinical Site #136
      • Tainan, Taiwan, 71004
        • Exelixis Clinical Site #112
      • Taipei, Taiwan, 10002
        • Exelixis Clinical Site #77
      • Taipei, Taiwan, 11490
        • Exelixis Clinical Site #101
  • Thailand
    • Bangkok
      • Bangkok Noi, Bangkok, Thailand, 10700
        • Exelixis Clinical Site #126
      • Pathum Wan, Bangkok, Thailand, 10330
        • Exelixis Clinical Site #122
      • Ratchathewi, Bangkok, Thailand, 10400
        • Exelixis Clinical Site #141
    • Songkla
      • Hat Yai, Songkla, Thailand, 90110
        • Exelixis Clinical Site #130
  • United Kingdom
      • Manchester, United Kingdom, M20 4BX
        • Exelixis Clinical Site #65
      • Sheffield, United Kingdom, S10 2SJ
        • Exelixis Clinical Site #57
    • England
      • Birmingham, England, United Kingdom, B15 2TH
        • Exelixis Clinical Site #88
      • Bristol, England, United Kingdom, BS2 8ED
        • Exelixis Clinical Site #71
      • London, England, United Kingdom, SW3 6JJ
        • Exelixis Clinical Site #162
      • Oxford, England, United Kingdom, OX3 7LE
        • Exelixis Clinical Site #51
    • Scotland
      • Aberdeen, Scotland, United Kingdom, AB25 2ZN
        • Exelixis Clinical Site #64
      • Glasgow, Scotland, United Kingdom, G12 0YN
        • Exelixis Clinical Site #50
    • Wales
      • Cardiff, Wales, United Kingdom, CF14 2TL
        • Exelixis Clinical Site #60
  • United States
    • California
      • Newport Beach, California, United States, 92658
        • Exelixis Clinical Site #2
      • Sacramento, California, United States, 95817
        • Exelixis Clinical Site #98
      • San Francisco, California, United States, 94115
        • Exelixis Clinical Site #69
      • Stanford, California, United States, 94305
        • Exelixis Clinical Site #10
      • Torrance, California, United States, 90502
        • Exelixis Clinical Site #3
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Exelixis Clinical Site #9
    • Connecticut
      • New Haven, Connecticut, United States, 06510
        • Exelixis Clinical Site #21
    • District of Columbia
      • Washington, District of Columbia, United States, 20010
        • Exelixis Clinical Site #4
    • Florida
      • Miami, Florida, United States, 33136
        • Exelixis Clinical Site #94
      • Orlando, Florida, United States, 32804
        • Exelixis Clinical Site #93
      • Tampa, Florida, United States, 33612
        • Exelixis Clinical Site #6
    • Illinois
      • Chicago, Illinois, United States, 60637
        • Exelixis Clinical Site #164
    • Kentucky
      • Lexington, Kentucky, United States, 40536
        • Exelixis Clinical Site #54
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Exelixis Clinical Site #153
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • Exelixis Clinical Site #80
      • Detroit, Michigan, United States, 48201
        • Exelixis Clinical Site #78
      • Detroit, Michigan, United States, 48202
        • Exelixis Clinical Site #22
    • Missouri
      • Columbia, Missouri, United States, 65212
        • Exelixis Clinical Site #63
      • Saint Louis, Missouri, United States, 63110
        • Exelixis Clinical Site #42
    • Nebraska
      • Omaha, Nebraska, United States, 68114
        • Exelixis Clinical Site #11
    • New Jersey
      • Morristown, New Jersey, United States, 07962
        • Exelixis Clinical Site #118
    • North Carolina
      • Charlotte, North Carolina, United States, 28204
        • Exelixis Clinical Site #76
      • Durham, North Carolina, United States, 27710
        • Exelixis Clinical Site #19
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • Exelixis Clinical Site #7
    • Pennsylvania
      • Bethlehem, Pennsylvania, United States, 18015
        • Exelixis Clinical Site #5
      • Philadelphia, Pennsylvania, United States, 19104
        • Exelixis Clinical Site #1
      • Pittsburgh, Pennsylvania, United States, 15232
        • Exelixis Clinical Site #75
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Exelixis Clinical Site #134
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Exelixis Clinical Site #68
    • Texas
      • Houston, Texas, United States, 77030
        • Exelixis Clinical Site #8
    • Washington
      • Seattle, Washington, United States, 98109
        • Exelixis Clinical Site #113

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Histologically or cytologically confirmed diagnosis of Differentiated Thyroid Cancer (DTC)
  2. Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
  3. Previously treated with or deemed ineligible for treatment with Iodine- 131 for differentiated thyroid cancer (DTC)
  4. 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
  5. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1

Exclusion Criteria:

  1. 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)
  2. 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
  3. Receipt of any type of anticancer antibody (including investigational antibody) or systemic chemotherapy within 4 weeks before randomization
  4. Receipt of radiation therapy for bone metastasis within 2 weeks or any other radiation therapy within 4 weeks before randomization.
  5. Known brain metastases or cranial epidural disease unless adequately treated

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
Experimental: Cabozantinib
cabozantinib (60 mg) once daily orally (qd)
Drug: Cabozantinib
Tablets containing 60-mg or 20-mg cabozantinib once daily orally.
Other Names:
  • XL184
  • Cabometyx®
Placebo Comparator: Placebo
placebo once daily orally (qd)
Drug: Placebo
Tablets containing placebo equivalent of 60-mg or 20-mg cabozantinib once daily orally.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression Free Survival (PFS)
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.
Time to the earlier of either radiographic progressive disease (PD) or death from any cause.
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.
Objective Response Rate (ORR)
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.
Proportion of subjects with the best overall response of complete response (CR) or partial response (PR).
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Exelixis

Collaborators

Ipsen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 5, 2018

Primary Completion (Actual)

August 19, 2020

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

September 26, 2018

First Submitted That Met QC Criteria

September 27, 2018

First Posted (Actual)

October 1, 2018

Study Record Updates

Last Update Posted (Actual)

March 22, 2024

Last Update Submitted That Met QC Criteria

March 20, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • XL184-311

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

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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