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Clinical Trials Search at Vanderbilt-Ingram Cancer Center

A Study of Cabozantinib Compared With Placebo in Subjects With Radioiodine-refractory Differentiated Thyroid Cancer Who Have Progressed After Prior VEGFR-targeted Therapy

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.
Thyroid
Phase III
Both
Mol. targeted/Immunotherapy/Biologics
Blinded Drug, Cabozantinib, XL184
Gilbert, Jill
International
Vanderbilt University
09-25-2019
Treatment
VICCHN1918
NCT03690388

Eligibility

16 Years
BOTH
NO
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

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