Clinical Trials | 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

The University of Virginia Comprehensive Cancer Center is enrolling adults ages 18 and over with previously treated, unresectable, locally advanced or metastatic neuroendocrine tumors for a research study. The purpose of the study is to compare the effectiveness of the investigational drug, zanzalintinib, to the drug everolimus. “Investigational” means that zanzalintinib has not been approved by any Regulatory Agency (such as the FDA) for use as a prescription medication. Participants who enter the study will be put into one of two possible study treatment groups randomly, like the flip of a coin. Participants in one group will take zanzalintinib once each day. Participants in the other group will receive everolimus to take once each day. Both you and your study doctor will know which study treatment you have been assigned. Participants taking everolimus, whose disease worsens based on scan results, will have the option to switch study treatments and begin taking zanzalintinib. Study duration will be up to 14 weeks. The study involves receiving the study treatment drug, as well as coming in for study visits, which include exams, laboratory tests, imaging scans, procedures such as having your blood drawn, and talking to the study doctor. If you decide to take part in this research study, you will need to visit the study site for screening to see if you qualify for this study. After screening, if you are eligible to participate in the study you will have clinic visit assessments every 2 weeks for the first 8 weeks, and then every 4 weeks until you discontinue taking the study treatment (up to 14 weeks on treatment). Once you discontinue the study drug you will be asked to come to clinic for an End of Treatment visit, and then you will have a follow-up period where the study team will ask you questions every 12 weeks, either in your clinic visit or by telephone. You may be in this study for up to 5 years. The study drugs, zanzalintinib or everolimus and all study-related procedures and visits will be provided at no charge to you or your insurance company. Medications that reduce certain expected side effects may be provided to you per standard of care. Standard medical care that you receive while participating in this study, e.g. visits and treatment for ongoing health issues like high blood pressure, diabetes, or heart problems as examples, will be billed to your insurer and/or you in the ordinary manner. Additional information can be found here: https://clinicaltrials.gov/study/NCT06943755 [email protected]