Study on Cabozantinib vs. Placebo for Thyroid Cancer Resistant to Radioiodine and Previous VEGFR Therapy
Sponsor: Exelixis
ClinicalTrials ID:NCT03690388
This clinical trial is testing whether the drug cabozantinib can help patients with differentiated thyroid cancer that no longer responds to radioiodine treatment and has worsened after previous VEGFR-targeted therapy. The study compares cabozantinib to a placebo to see if it can improve the time patients live without the cancer getting worse and increase the response rate to treatment.
Patient Parameters
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Program Overview
The purpose of this study is to find out if cabozantinib can help patients with differentiated thyroid cancer that has stopped responding to radioiodine treatment and has progressed after treatment with VEGFR-targeted therapies like lenvatinib or sorafenib. The study will compare cabozantinib to a placebo to see if it can extend the time patients live without their cancer worsening and improve the overall response to treatment.
Eligibility Criteria
Inclusion Criteria
- Have a confirmed diagnosis of differentiated thyroid cancer.
- Have cancer that can be measured using standard criteria.
- Have been treated with or are not eligible for iodine-131 treatment for thyroid cancer.
- Have previously been treated with at least one VEGFR-targeting drug, such as lenvatinib or sorafenib, for thyroid cancer. Up to two such treatments are allowed.
- Be in good overall health with an ECOG performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
Exclusion Criteria
- Have previously been treated with cabozantinib, a BRAF inhibitor, more than two VEGFR-targeting drugs, more than one immune checkpoint inhibitor, or more than one chemotherapy regimen.
- Have taken any small molecule kinase inhibitor within two weeks or five half-lives of the drug before starting the study.
- Have received any anticancer antibody or chemotherapy within four weeks before starting the study.
- Have had radiation therapy for bone metastasis within two weeks or any other radiation therapy within four weeks before starting the study.
- Have known brain metastases or disease in the brain's outer layer unless it has been adequately treated.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Exelixis Clinical Site #2 | 92658 | Newport Beach | California |
| Exelixis Clinical Site #98 | 95817 | Sacramento | California |
| Exelixis Clinical Site #69 | 94115 | San Francisco | California |
| Exelixis Clinical Site #10 | 94305 | Stanford | California |
| Exelixis Clinical Site #3 | 90502 | Torrance | California |
| Exelixis Clinical Site #9 | 80045 | Aurora | Colorado |
| Exelixis Clinical Site #21 | 06510 | New Haven | Connecticut |
| Exelixis Clinical Site #4 | 20010 | Washington D.C. | District of Columbia |
| Exelixis Clinical Site #94 | 33136 | Miami | Florida |
| Exelixis Clinical Site #93 | 32804 | Orlando | Florida |
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