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Clinical Trial 19818

Cancer Type: Head & Neck
Interventions:Cabozantinib (XL 184); Placebo ()

Study Type: Treatment
Phase of Study: Phase III
Investigators:

  • Valentina Tarasova

Call 813-745-6100
or 1-800-679-0775
Overview

Study Title

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

Summary

Objective

The objective of this study is to evaluate the effect of cabozantinib compared with placebo on PFS and ORR in subjects with RAI-refractory DTC who have progressed after prior VEGFR-targeted therapy.

Inclusion Criteria

  • Histologically or cytologically confirmed diagnosis of Differentiated Thyroid Cancer (DTC)
  • Measurable disease according to RECIST 1.1
  • Previously treated with or deemed ineligible for treatment with Iodine- 131 for DTC
  • Previously treated with at least one of the following VEGFR-targeting TKI agents for DTC: lenvatinib or sorafenib. Note: Up to two prior VEGFR-targeting TKI agents are allowed
  • Eastern Cooperative Oncology Group (ECOG) PS of 0 or 1

  • Exclusion Criteria

  • Prior treatment with any of the following: Cabozantinib; Selective small-molecule 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)
  • 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
  • Receipt of any type of anticancer antibody (including investigational antibody) or systemic chemotherapy within 4 weeks before randomization
  • Receipt of radiation therapy for bone metastasis within 2 weeks or any other radiation therapy within 4 weeks before randomization.
  • Known brain metastases or cranial epidural disease unless adequately treated