A Study of Cabozantinib Compared With Placebo in Subjects With Radioiodine-refractory Differentiated Thyroid Cancer Who Have Progressed After Prior VEGFR-targeted Therapy
Trial Status: Active
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.
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
California
Palo Alto
Stanford Cancer Institute Palo Alto
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Sacramento
University of California Davis Comprehensive Cancer Center
Status: CLOSED_TO_ACCRUAL
San Francisco
UCSF Medical Center-Mount Zion
Status: ADMINISTRATIVELY_COMPLETE
Contact: Helen Diller Family Comprehensive Cancer Center
Phone: 877-827-3222
Email:
cancertrials@ucsf.edu
Colorado
Aurora
University of Colorado Hospital
Status: CLOSED_TO_ACCRUAL
Florida
Miami
University of Miami Miller School of Medicine-Sylvester Cancer Center
Status: ACTIVE
Tampa
Moffitt Cancer Center
Status: CLOSED_TO_ACCRUAL_AND_INTERVENTION
Kentucky
Lexington
University of Kentucky / Markey Cancer Center
Status: ACTIVE
Michigan
Ann Arbor
University of Michigan Comprehensive Cancer Center
Status: ACTIVE
Detroit
Wayne State University / Karmanos Cancer Institute
Status: CLOSED_TO_ACCRUAL
Missouri
Saint Louis
Siteman Cancer Center at Washington University
Status: CLOSED_TO_ACCRUAL_AND_INTERVENTION
North Carolina
Durham
Duke University Medical Center
Status: ACTIVE
Pennsylvania
Philadelphia
University of Pennsylvania / Abramson Cancer Center
Status: ACTIVE
Pittsburgh
University of Pittsburgh Cancer Institute (UPCI)
Status: ACTIVE
South Carolina
Charleston
Medical University of South Carolina
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Tennessee
Nashville
Vanderbilt University / Ingram Cancer Center
Status: CLOSED_TO_ACCRUAL
Texas
Houston
M D Anderson Cancer Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Washington
Seattle
Fred Hutch / University of Washington Cancer Consortium
Status: ACTIVE
Trial Phase Phase III
Trial Type Treatment
Lead Organization
Exelixis Inc
- Primary ID XL184-311
- Secondary IDs NCI-2018-03334
- Clinicaltrials.gov ID NCT03690388