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.
Active, not recruiting
Phase 3
| Drug | Synonyms | Arms |
|---|---|---|
| Cabozantinib | XL184, Cabometyx® | Cabozantinib |
| Placebo | Placebo |
| Name | Type | Description | Interventions |
|---|---|---|---|
| Cabozantinib | Experimental | cabozantinib (60 mg) once daily orally (qd) |
|
| Placebo | Placebo Comparator | placebo once daily orally (qd) |
|
Inclusion Criteria:
1. Histologically or cytologically confirmed diagnosis of Differentiated Thyroid Cancer
(DTC)
2. Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST)
1.1
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
| Maximum Eligible Age: | N/A |
| Minimum Eligible Age: | 16 Years |
| Eligible Gender: | All |
| Healthy Volunteers: | No |
| Measure: | Progression Free Survival (PFS) |
| Time Frame: | Up to approximately twenty months after the first subject is randomized. Time from randomization to the earlier of the following events: radiographic PD as determined by the blinded independent central review (BIRC) or death due to any cause. |
| Safety Issue: | |
| Description: | Time to the earlier of either radiographic progressive disease (PD) or death from any cause. |
| Phase: | Phase 3 |
| Primary Purpose: | Interventional |
| Overall Status: | Active, not recruiting |
| Lead Sponsor: | Exelixis |
July 15, 2021
