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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

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 VEGFR-Targeted therapy.

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