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Clinical Trials in the Netherlands / NCT03690388
Active, not recruiting Phase 3

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

NCT03690388 · tracked via the Priya Life Science Netherlands tracker
Sponsor
Phase
Phase 3
Started
2018-10-05
Last updated
2025-09-25

Condition(s) studied

Differentiated Thyroid Cancer

Investigational drug(s) / intervention(s)

Cabozantinib →Placebo

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

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

Study 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

Sex
ALL
Min age
16 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (164)

FacilityCityRegionStatus
Exelixis Clinical Site #2 Newport Beach California
Exelixis Clinical Site #98 Sacramento California
Exelixis Clinical Site #69 San Francisco California
Exelixis Clinical Site #10 Stanford California
Exelixis Clinical Site #3 Torrance California
Exelixis Clinical Site #9 Aurora Colorado
Exelixis Clinical Site #21 New Haven Connecticut
Exelixis Clinical Site #4 Washington D.C. District of Columbia
Exelixis Clinical Site #94 Miami Florida
Exelixis Clinical Site #93 Orlando Florida
Exelixis Clinical Site #6 Tampa Florida
Exelixis Clinical Site #164 Chicago Illinois
Exelixis Clinical Site #54 Lexington Kentucky
Exelixis Clinical Site #153 Boston Massachusetts
Exelixis Clinical Site #80 Ann Arbor Michigan
Exelixis Clinical Site #78 Detroit Michigan
Exelixis Clinical Site #22 Detroit Michigan
Exelixis Clinical Site #63 Columbia Missouri
Exelixis Clinical Site #42 St Louis Missouri
Exelixis Clinical Site #11 Omaha Nebraska
Exelixis Clinical Site #118 Morristown New Jersey
Exelixis Clinical Site #76 Charlotte North Carolina
Exelixis Clinical Site #19 Durham North Carolina
Exelixis Clinical Site #7 Cincinnati Ohio
Exelixis Clinical Site #5 Bethlehem Pennsylvania
Exelixis Clinical Site #1 Philadelphia Pennsylvania
Exelixis Clinical Site #75 Pittsburgh Pennsylvania
Exelixis Clinical Site #134 Charleston South Carolina
Exelixis Clinical Site #68 Nashville Tennessee
Exelixis Clinical Site #8 Houston Texas
Exelixis Clinical Site #113 Seattle Washington
Exelixis Clinical Site #96 Pergamino Buenos Aires
Exelixis Clinical Site #97 Caba Argentina
Exelixis Clinical Site #129 Córdoba Argentina
Exelixis Clinical Site #17 St Leonards New South Wales
Exelixis Clinical Site #25 Waratah New South Wales
Exelixis Clinical Site #86 Bedford Park South Australia
Exelixis Clinical Site #24 Melbourne Victoria
Exelixis Clinical Site #12 Herston Australia
Exelixis Clinical Site #62 Salzburg Austria

+ 124 more sites — see the full list on the official registry below.

On this site

📄 Cabometyx (cabozantinib) drug profile →

More Exelixis trials in the Netherlands

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03690388 on ClinicalTrials.gov ↗ ← All trials in the Netherlands