What is the Purpose of this Study?
The purpose of this study is to evaluate the effectiveness of an experimental drug called zanzalintinib compared to the standard-of-care treatment, everolimus, in treating people with locally advanced or metastatic neuroendocrine tumors. Zanzalintinib is a type of cancer treatment that works by blocking signals that help tumors grow and therefore may reduce or stop cancer cells from growing and spreading. Researchers aim to determine the effectiveness of zanzalintinib in shutting down these signals and slowing tumor growth compared to everolimus. Everolimus is a cancer drug that has been approved by the U.S. Food and Drug Administration (FDA) for use in people with most types of neuroendocrine tumors. Participants will be randomly assigned to 1 of 2 treatment groups. One group will receive zanzalintinib once daily, and the other group will receive everolimus once daily. Study procedures also include physical exams, completing questionnaires, collection of urine and blood samples, and imaging scans. Researchers will evaluate the length of time cancer is not growing or spreading in participants when treated with zanzalintinib compared to everolimus. They will also evaluate whether zanzalintinib can shrink tumors and help participants live longer compared to everolimus. This information will help researchers learn whether zanzalintinib can be used to treat neuroendocrine cancer.
Eligibility
- * Histologically confirmed, locally advanced/unresectable or metastatic, well-differentiated Grade 1, 2, or 3 NETs of pancreatic origin or extra-pancreatic origin.
- * Allowed prior lines of therapy, based on the site of NET and functional status.
- * Documented radiographic disease progression per RECIST 1.1, as assessed by the Investigator based on imaging assessments (computed tomography \[CT\] or magnetic resonance imaging \[MRI\]) within 12 months before randomization.
- * Measurable disease according to RECIST 1.1 as determined by the Investigator.
Where can I participate?
CS Cancer at Cedars-Sinai Medical Center : Abrahm Levi
More about this Clinical Trial
What is the full name of this clinical trial?
XL092-311: A Phase 2/3, multicenter, randomized open-label study of zanzalintinib vs everolimus in participants with previously treated, unresectable, locally advanced or metastatic neuroendocrine tumors