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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 | Clinical Trials | Clareo Health

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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

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

NCT03690388•Exelixis

View on ClinicalTrials.gov

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.

Eligibility

Age

16 - No limit years

Sex

ALL

Healthy Volunteers

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

Locations (164)

Exelixis Clinical Site #2

Newport Beach, California, United States

Exelixis Clinical Site #98

Sacramento, California, United States

Exelixis Clinical Site #69

San Francisco, California, United States

Exelixis Clinical Site #10

Stanford, California, United States

Exelixis Clinical Site #3

Torrance, California, United States

Exelixis Clinical Site #9

Aurora, Colorado, United States

Exelixis Clinical Site #21

New Haven, Connecticut, United States

Exelixis Clinical Site #4

Washington D.C., District of Columbia, United States

Exelixis Clinical Site #94

Miami, Florida, United States

Exelixis Clinical Site #93

Orlando, Florida, United States

Key Dates

Start Date

October 5, 2018

Primary Completion Date

August 19, 2020

Completion Date

July 31, 2026

Last Updated

September 25, 2025

Enrollment

187

ACTUAL participants

Conditions

Differentiated Thyroid Cancer

Interventions

Cabozantinib

DRUG

Placebo

DRUG

F-18 Tetrafluoroborate PET/CT in Differentiated Thyroid Cancer

NCT07436455

Thyroid CancerDifferentiated Thyroid Cancer

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RECRUITING

Targeted Therapy to Increase RAI Uptake in Metastatic DTC

NCT05024929

Papillary Thyroid CancerPediatric Cancer+1 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 25, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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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

Inclusion Criteria

Exclusion Criteria

F-18 Tetrafluoroborate PET/CT in Differentiated Thyroid Cancer

Targeted Therapy to Increase RAI Uptake in Metastatic DTC

Camrelizumab in Combination With Apatinib in Patients With Radioactive Iodine-refractory Differentiated Thyroid Cancer

Study of AIC100 CAR T Cells in Relapsed/Refractory Thyroid Cancer

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