Zanzalintinib for Neuroendocrine Tumors
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests whether zanzalintinib, a new potential drug, can slow the progression of neuroendocrine tumors, a type of cancer affecting certain hormone-producing cells, after initial chemotherapy. It targets individuals with confirmed high-grade cancer who have completed an initial chemotherapy course with stable results or partial improvement. Participants must have measurable disease and must not have previously received treatment with zanzalintinib or cabozantinib. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to the development of a potentially effective therapy.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, you cannot take certain oral anticoagulants and must stop them at least 3 days or 5 half-lives before starting the trial. If you are on somatostatin analogue therapy for well-differentiated high-grade tumors, you can continue it.
Is there any evidence suggesting that zanzalintinib is likely to be safe for humans?
Previous studies have shown that zanzalintinib demonstrates promise in terms of safety when combined with other treatments. For instance, when used with atezolizumab, zanzalintinib lowered the risk of death compared to regorafenib, suggesting it can be relatively safe with other medications. Additionally, when combined with nivolumab, many patients experienced positive effects without serious health issues.
These findings offer some reassurance about its safety, but it's important to remember that zanzalintinib alone might have different effects. Always discuss potential side effects and safety concerns with healthcare providers before joining a trial.12345Why do researchers think this study treatment might be promising?
Zanzalintinib is unique because it introduces a new approach to treating neuroendocrine tumors by targeting specific pathways involved in tumor growth. Unlike standard treatments like somatostatin analogs or chemotherapy, which focus on controlling symptoms or destroying rapidly dividing cells, Zanzalintinib directly inhibits tyrosine kinases, which play a crucial role in the development and spread of these tumors. Researchers are excited about Zanzalintinib's potential to offer a more targeted and potentially less toxic treatment option, with the convenience of oral administration once daily.
What evidence suggests that zanzalintinib might be an effective treatment for neuroendocrine tumors?
Research has shown that zanzalintinib may help treat neuroendocrine tumors. One study demonstrated that, when combined with nivolumab, it resulted in a 63% rate of significant tumor shrinkage and a 90% rate of halting tumor growth. These findings suggest that zanzalintinib could effectively control tumor growth. In this trial, participants will receive zanzalintinib alone to evaluate its effectiveness in treating hard-to-treat neuroendocrine tumors. These results indicate that zanzalintinib might be a strong option for slowing tumor progression.14678
Who Is on the Research Team?
Nikolaos Trikalinos, M.D.
Principal Investigator
Washington University School of Medicine
Are You a Good Fit for This Trial?
This trial is for adults with high-grade neuroendocrine tumors, excluding lung and Merkel cell cancer. Participants must have stable disease or partial response after initial chemo, be able to consent, not pregnant, and agree to use contraception. They should have good organ function and performance status.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Chemotherapy
Participants receive initial cytotoxic chemotherapy
Maintenance Treatment
Participants receive zanzalintinib maintenance therapy in 28-day cycles
Follow-up
Participants are monitored for progression-free survival and overall survival
What Are the Treatments Tested in This Trial?
Interventions
- Zanzalintinib
Find a Clinic Near You
Who Is Running the Clinical Trial?
Washington University School of Medicine
Lead Sponsor
Exelixis
Industry Sponsor
Michael M. Morrissey
Exelixis
Chief Executive Officer since 2010
PhD in Chemistry from Harvard University, BSc in Chemistry from the University of Wisconsin
Vicki L. Goodman
Exelixis
Chief Medical Officer since 2022
MD