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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
187
Tablets containing 60-mg or 20-mg cabozantinib once daily orally.
Tablets containing placebo equivalent of 60-mg or 20-mg cabozantinib once daily orally.
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
Progression Free Survival (PFS)
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.
Objective Response Rate (ORR)
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.
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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
...and 154 more locations