Zanzalintinib for Neuroendocrine Tumors

(STELLAR-311 Trial)

Recruiting at 1 trial location

Overseen By Exelixis Clinical Trials

Age: 18+

Sex: Any

Trial Phase: Phase 2 & 3

Sponsor: Exelixis

Must not be taking: VEGFR inhibitors, mTOR inhibitors

Disqualifiers: Neuroendocrine carcinomas, Medullary thyroid cancer, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 14 months

440 Participants Needed

Trial Summary

What is the purpose of this trial?

The primary purpose of this study is to assess the effectiveness of zanzalintinib compared to everolimus in participants with previously treated, unresectable, locally advanced or metastatic neuroendocrine tumors.

Research Team

Medical Director

Principal Investigator

Exelixis

Eligibility Criteria

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

My cancer can be measured by standard health scans.

My cancer is a well-differentiated, advanced or metastatic NET from the pancreas or another organ.

I have had treatments for my neuroendocrine tumor based on its location and how it functions.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either zanzalintinib or everolimus oral tablets once daily

14 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

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.

Participant Groups

Group I: Zanzalintinib Experimental Treatment 1 Intervention

Participants will receive zanzalintinib oral tablets once daily for up to 14 months.

Group II: Everolimus Active Control 1 Intervention

Participants will receive everolimus oral tablets once daily for up to 14 months.

Who Is Running the Clinical Trial?

Exelixis

Lead Sponsor

Trials

126

Recruited

20,500+

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