A Study of Cabozantinib Compared With Placebo in Subjects With Radioiodine-refractory Differentiated Thyroid Cancer Who Have Progressed After Prior Vascular Endothelial Growth Factor Receptor (VEGFR) -Targeted Therapy

Not Recruiting

Trial ID: NCT03690388


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 vascular endothelial growth factor receptor (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 Vascular Endothelial Growth Factor Receptor (VEGFR) -Targeted Therapy

Stanford Investigator(s)

A. Dimitrios Colevas, MD
A. Dimitrios Colevas, MD

Professor of Medicine (Oncology) and, by courtesy, of Otolaryngology - Head & Neck Surgery (OHNS) and of Radiation Oncology (Radiation Therapy)


Inclusion Criteria:

   1. Histologically or cytologically confirmed diagnosis of Differentiated Thyroid Cancer

   2. Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST)

   3. Previously treated with or deemed ineligible for treatment with Iodine- 131 for
   differentiated thyroid cancer (DTC)

   4. Previously treated with at least one of the following vascular endothelial growth
   factor receptor (VEGFR)-targeting tyrosine kinase inhibitor (TKI) agents for DTC:
   lenvatinib or sorafenib. Note: Up to two prior VEGFR-targeting TKI agents are allowed

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

Exclusion Criteria:

   1. Prior treatment with any of the following: Cabozantinib; Selective small-molecule
   v-raf murine sarcoma viral oncogene homolog B1 (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


drug: Cabozantinib

drug: Placebo

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Michelle Jun

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