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Trials / Active Not Recruiting

Active Not RecruitingNCT03690388

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

Status
Active Not Recruiting
Phase
Phase 3
Study type
Interventional
Enrollment
187 (actual)
Sponsor
Exelixis · Industry
Sex
All
Age
16 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
DRUGCabozantinibTablets containing 60-mg or 20-mg cabozantinib once daily orally.
DRUGPlaceboTablets containing placebo equivalent of 60-mg or 20-mg cabozantinib once daily orally.

Timeline

Start date
2018-10-05
Primary completion
2020-08-19
Completion
2026-07-31
First posted
2018-10-01
Last updated
2025-09-25
Results posted
2023-05-18

Locations

164 sites across 25 countries: United States, Argentina, Australia, Austria, Belgium, Brazil, Canada, Croatia, Czechia, France, Germany, Hong Kong, Hungary, Israel, Italy, Mexico, Netherlands, Poland, Romania, Russia, South Korea, Spain, Taiwan, Thailand, United Kingdom

Regulatory

Source: ClinicalTrials.gov record NCT03690388. Inclusion in this directory is not an endorsement.