Zanzalintinib for Neuroendocrine Tumors
(STELLAR-311 Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to compare the effectiveness of a new drug, zanzalintinib, with the existing treatment, everolimus, for individuals with certain types of neuroendocrine tumors. These tumors are advanced, inoperable, and have been previously treated with other methods. The trial seeks participants whose tumors, located in the pancreas or other areas, have continued to grow despite treatment. Those who have experienced tumor growth after previous treatments and meet these criteria may be suitable for this study. As a Phase 2 trial, this research focuses on assessing the effectiveness of zanzalintinib in an initial, smaller group of participants.
Do I need to stop my current medications to join the trial?
The trial does not specify if you need to stop taking your current medications. However, you cannot have had certain treatments like systemic chemotherapy or radiation therapy shortly before joining. It's best to discuss your specific medications with the trial team.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that zanzalintinib, when used with other treatments, is well-tolerated by cancer patients. One study combined it with nivolumab and reported a high response rate, suggesting its effectiveness. Although specific side effects were not listed, its testing in later trial phases suggests researchers have found it generally safe so far.
Everolimus, the treatment being compared in the trial, has already received FDA approval for other conditions. This approval indicates a known safety profile and confirms its general safety for use.
Overall, studies indicate that both zanzalintinib and everolimus are generally safe, though specific side effects may vary. Participants should discuss potential risks with trial coordinators or their healthcare providers.12345Why are researchers excited about this trial's treatments?
Zanzalintinib is unique because it targets neuroendocrine tumors with a novel approach, potentially offering a new option for patients who typically rely on treatments like somatostatin analogs or chemotherapy. Unlike these standard treatments, which often focus on controlling hormone production or inhibiting cell growth broadly, Zanzalintinib specifically targets pathways involved in tumor growth and survival, potentially leading to more effective outcomes. Researchers are excited about Zanzalintinib because it offers a targeted therapy that could improve efficacy and reduce side effects compared to more generalized treatment options.
What evidence suggests that this trial's treatments could be effective for neuroendocrine tumors?
Studies have shown promising results for zanzalintinib in treating neuroendocrine tumors. One study found that when combined with nivolumab, 63% of patients experienced tumor shrinkage. Additionally, 90% of participants either saw their tumors shrink or stop growing. In this trial, participants will receive either zanzalintinib or everolimus, a treatment option already in use. This study directly compares everolimus to zanzalintinib. These findings suggest that zanzalintinib could effectively treat neuroendocrine tumors by shrinking tumors or halting their growth.23678
Who Is on the Research Team?
Medical Director
Principal Investigator
Exelixis
Are You a Good Fit for This Trial?
This trial is for people with advanced or widespread neuroendocrine tumors, including pancreatic ones. Participants must have measurable disease, confirmed by tests and scans, and should have seen their cancer grow despite past treatments. They need to provide tumor tissue samples if possible.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either zanzalintinib or everolimus oral tablets once daily
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Everolimus
- Zanzalintinib
Trial Overview
The study compares the effectiveness of two drugs: Zanzalintinib and Everolimus. Patients who've had previous treatments for neuroendocrine tumors will be randomly assigned to receive either drug to see which one works better.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Participants will receive zanzalintinib oral tablets once daily.
Participants will receive everolimus oral tablets once daily.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Exelixis
Lead 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
Citations
1.
ir.exelixis.com
ir.exelixis.com/news-releases/news-release-details/exelixis-announces-encouraging-results-phase-1b2-stellar-002Press Release - Exelixis, Inc.
Zanzalintinib in combination with nivolumab demonstrated an objective response rate of 63% and a disease control rate of 90%.
Zanzalintinib Maintenance in Patients With High Grade ...
Histologically or cytologically confirmed high-grade poorly differentiated or well differentiated neuroendocrine tumor (with a Ki-67 of ≥20%), excluding small ...
Zanzalintinib for Neuroendocrine Tumors
In a phase II study involving 109 patients with advanced neuroendocrine tumors, sunitinib demonstrated a 16.7% objective response rate in pancreatic endocrine ...
4.
ir.exelixis.com
ir.exelixis.com/news-releases/news-release-details/exelixis-announces-detailed-results-phase-3-stellar-303-pivotalExelixis Announces Detailed Results from Phase 3 STELLAR ...
Zanzalintinib in combination with atezolizumab improved median overall survival to 10.9 months versus 9.4 months with regorafenib, and significantly reduced ...
5.
trial.medpath.com
trial.medpath.com/clinical-trial/c59371e1f1077e4d/nct06943755-zanzalintinib-everolimus-neuroendocrine-tumorsZanzalintinib Versus Everolimus in Participants With Locally ...
The primary purpose of this study is to assess the effectiveness of zanzalintinib compared to everolimus in participants with previously treated, unresectable, ...
6.
ir.exelixis.com
ir.exelixis.com/news-releases/news-release-details/exelixis-announces-zanzalintinib-combination-immune-checkpointExelixis Announces Zanzalintinib in Combination with an ...
Zanzalintinib in combination with atezolizumab demonstrated a statistically significant reduction in risk of death versus regorafenib in ...
7.
uclahealth.org
uclahealth.org/clinical-trials/zanzalintinib-versus-everolimus-participants-with-locallyZanzalintinib Versus Everolimus in Participants With ...
The primary purpose of this study is to assess the effectiveness of zanzalintinib compared to everolimus in participants with previously treated, unresectable, ...
Exelixis Announces Detailed Results from Phase 3 ...
Zanzalintinib in combination with atezolizumab improved median overall survival to 10.9 months versus 9.4 months with regorafenib, ...
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