A Study of Experimental Cabozantinib Compared to Placebo For Differentiated Thyroid Cancer

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Age: 16 years or older
Gender:
Any
Healthy Volunteers: No
Keywords: thyroid cancer, chemotherapy, differentiated thyroid cancer
Type: Drug study, Phase 3
Target:
3 Participants
Investigator:
Description
This study is for patients with differentiated thyroid cancer (DTC) that has progressed.

Participants will receive either experimental cabozantinib (XL184) or placebo tablets. Placebo tablets look like the study drug tablets, but do not contain any active ingredients.

Cabozantinib is an oral anticancer drug. It is approved for another kind of thyroid cancer (medullary thyroid cancer).

The purpose of this study is to test the effect of cabozantinib compared with a placebo. It will be tested in patients whose disease has progressed. Patients in this study have received prior VEGFR treatment for their thyroid cancer. VEGFR is treatment with drugs that inhibit growth of tumor blood vessels. We want to find out if cabozantinib is effective in treating DTC. This study will also examine how safe cabozantinib is and how well people with DTC tolerate cabozantinib.
This study requires

The study team will make sure you qualify to take part in the study. Qualified participants will receive detailed information about the study. This may include a list of study-related tests and procedures.

Who can participate

Inclusion criteria:

  1. Histologically or cytologically confirmed diagnosis of Differentiated Thyroid Cancer (DTC)
  2. Measurable disease according to RECIST 1.1
  3. Previously treated with or deemed ineligible for treatment with Iodine- 131 for DTC
  4. 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
  5. Eastern Cooperative Oncology Group (ECOG) PS of 0 or 1

Exclusion criteria:

  1. 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)
  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
Benefits and risks of participating
BENEFITS:

We cannot promise any benefits to you as a result of taking part in this research study.


RISKS:

The study team will discuss the risks associated with taking part in this research study.
Compensation
You will not be paid to take part in this research study.
Resources
Schedule
Study duration and period
The total treatment duration in this study is expected to be about 9 months for each participant.
Recruitment period
From July 22, 2019
Location
UC Davis Comprehensive Cancer Center
4501 X Street
Sacramento, CA 95817
Research Topic
Conditions:
  • Differentiated Thyroid Cancer

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