Summary

for people ages 16 years and up (full criteria)
at Sacramento, California and other locations
study started
estimated completion

Description

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.

Official 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

Keywords

Differentiated Thyroid Cancer Thyroid cancer, papillary Papillary thyroid carcinoma Nonmedullary thyroid carcinoma Cancer of the thyroid Thyroid cancer Follicular thyroid cancer Thyroid cancer, follicular Hürthle cell cancer Thyroid Neoplasms Thyroid Diseases Cabozantinib

Eligibility

You can join if…

Open to people ages 16 years and up

  1. Histologically or cytologically confirmed diagnosis of Differentiated Thyroid Cancer (DTC)
  2. Measurable disease according to RECIST 1.1
  3. Previously treated with or deemed ineligible for treatment with Iodine- 131 for DTC
  4. 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

  1. Eastern Cooperative Oncology Group (ECOG) PS of 0 or 1

You CAN'T join if...

  1. 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)
  2. 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
  3. Receipt of any type of anticancer antibody (including investigational antibody) or systemic chemotherapy within 4 weeks before randomization
  4. Receipt of radiation therapy for bone metastasis within 2 weeks or any other radiation therapy within 4 weeks before randomization.
  5. Known brain metastases or cranial epidural disease unless adequately treated

Locations

  • Exelixis Clinical Site #98 accepting new patients
    Sacramento California 95817 United States
  • Exelixis Clinical Site #69 accepting new patients
    San Francisco California 94115 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Exelixis
Links
Sign up for this study
ID
NCT03690388
Phase
Phase 3
Study Type
Interventional
Last Updated