Zanzalintinib Versus Everolimus in Participants With Locally Advanced or Metastatic Neuroendocrine Tumors
Recruiting · NCT06943755 · Interventional (participants receive a specific treatment) · Lead sponsor: Exelixis
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2, Phase 3
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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.
- Archival tumor tissue is required, if available. If archival tumor tissue is not available, a fresh biopsy may be submitted if it can be safely and feasibly obtained. Every attempt should be made to provide tumor tissue.
- Key
Exclusion criteria
- Histologically confirmed neuroendocrine carcinomas (including small cell lung cancer), medullary thyroid cancer, pheochromocytoma, paraganglioma, Merkel cell carcinoma, and mixed neuroendocrine non-neuroendocrine neoplasm (MiNEN).
- Prior treatment with a vascular endothelial growth factor receptor (VEGFR) -targeting tyrosine kinase inhibitor or a mammalian target of rapamycin (mTOR) inhibitor.
- Systemic chemotherapy and any liver-directed or other ablative therapy within 4 weeks before randomization.
- Systemic radionuclide therapy within 6 weeks before randomization.
- Radiation therapy for bone metastases within 2 weeks, any other radiation therapy, except as indicated above, within 4 weeks before randomization.
- Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Where it is running
60 locations listed across 25 US states.
- The University of Alabama at Birmingham - Birmingham, Alabama, United States
- Mayo Clinic Hospital - Phoenix, Arizona, United States
- The University of Arizona Cancer Center - Tucson, Arizona, United States
- Cedars-Sinai Medical Center - Beverly Hills, California, United States
- Norris Comprehensive Cancer Center - Los Angeles, California, United States
- Stanford Cancer Center - Palo Alto, California, United States
- UCLA Health - Santa Monica Cancer Care - Santa Monica, California, United States
- Kaiser Permanente Medical Center - Vallejo, California, United States
- Georgetown University - Washington D.C., District of Columbia, United States
- Mayo Clinic - Florida - Jacksonville, Florida, United States
- AdventHealth Orlando - Orlando, Florida, United States
- Moffitt Cancer Center - Tampa, Florida, United States
- University of Kentucky Markey Cancer Center - Lexington, Kentucky, United States
- East Jefferson General Hospital - Metairie, Louisiana, United States
- Dana-Farber Cancer Institute - Boston, Massachusetts, United States
- Henry Ford Cancer- Detroit - Detroit, Michigan, United States
- The Cancer and Hematology Centers - Grand Rapids, Michigan, United States
- Mayo Clinic - Rochester, Minnesota, United States
- Siteman Cancer Center - St Louis, Missouri, United States
- University of Nebraska Medical Center - Omaha, Nebraska, United States
- University of New Mexico Comprehensive Cancer Center - Albuquerque, New Mexico, United States
- Roswell Park Cancer Institute - Buffalo, New York, United States
- Icahan School of Medicine at Mount Sinai - New York, New York, United States
- University of Rochester Medical Center - Rochester, New York, United States
- University of North Carolina at Chapel Hill - Chapel Hill, North Carolina, United States
- Duke University Medical Center - Durham, North Carolina, United States
- Sanford Roger Maris Cancer Center - Fargo, North Dakota, United States
- University Hospitals Cleveland Medical Center - Cleveland, Ohio, United States
- The Ohio State University Comprehensive Cancer Center - Columbus, Ohio, United States
- Oregon Health and Science University - Portland, Oregon, United States
- University of Pennsylvania - Philadelphia, Pennsylvania, United States
- University of Pittsburgh Medical Center (UPMC) Hillman Cancer Center - Pittsburgh, Pennsylvania, United States
- University of Tennessee Medical Center - Knoxville, Tennessee, United States
- Henry-Joyce Cancer Clinic - Nashville, Tennessee, United States
- Texas Oncology- Baylor Charles A. Sammons Cancer Center - Dallas, Texas, United States
- Huntsman Cancer Institute, University of Utah - Salt Lake City, Utah, United States
- University of Virginia - Charlottesville, Virginia, United States
- Virginia Cancer Specialists - Fairfax Office - Fairfax, Virginia, United States
- Fred Hutchinson Cancer Center - Seattle, Washington, United States
- Froedtert Hospital and the Medical College of Wisconsin - Milwaukee, Wisconsin, United States
- Het Netherlands Kanker Institut (NKI)/ Antoni van Leeuwenhoek - Amsterdam, Netherlands
- Amsterdam UMC - Amsterdam, Netherlands
- Hospital Universitario Vall D'Hebron - Barcelona, Spain
- Evangelische Lungenklinik - Berlin, Germany
- University Hospitals Birmingham NHS Foundation Trust - Birmingham, United Kingdom
- Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico - Bologna, Italy
- Institut Jules Bordet - Brussels, Belgium
- Centre Hospitalier Universitaire de Caen Normandie - Caen, France
- Velindre Cancer Center - Cardiff, United Kingdom
- Monash Health - Clayton, Australia
- CHU Beaujon - Clichy, France
- Universitätsklinik Erlangen - Erlangen, Germany
- ENETS Center of Excellence, University Hospital Essen - Essen, Germany
- NHS Greater Glasgow and Clyde - Glasgow, United Kingdom
- Narodowy Instytut Onkologii im. Marii Skłodowskiej-Curie - Państwowy Instytut Badawczy, Oddział w Gliwicach - Gliwice, Poland
- Medical University of Graz - Graz, Austria
- Royal Brisbane and Women's Hospital - Herston, Australia
- Humanity and Health Clinical Trial Centre - Hong Kong, China
- Prince of Wales Hospital - Hong Kong, China
- Queen Mary Hospital - Hong Kong, China
Showing 60 of 124 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →