Recruiting | Phase III
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 VEGFR-targeted therapy
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 VEGFR-Targeted therapy.
- Cabozantinib arm: Oral cabozantinib (60 mg) once a day
- Placebo arm: Oral cabozantinib-matched placebo once a day
- The study will randomize to placebo to crossover to receive cabozantinib upon experiencing disease progression.
No further follow-up is required once completed the post-treatment follow-up visit.
Key Participation Requirements:
Male or Female
19 years and older
Histologically or cytologically confirmed diagnosis of differential thyroid cancer including papillary, follicular, and other variants.
Selective small-molecule BRAF kinase inhibitor.
More than 2 VEGFR-targeting TKI agents.
More than 1 immune checkpoint inhibitor therapy and more than 1 systemic chemotherapy regimen.
Patients must sign an approved informed consent and authorization permitting release of personal health information.
Methodist Health System Trial Code:
For more information, visit the U.S. National Library of Medicine clinical trial database.