Zanzalintinib Versus Everolimus in Participants With Locally Advanced or Metastatic Neuroendocrine Tumors

Summary

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.

Interventions

• Zanzalintinib · DRUG

  Administered as specified in the treatment arm.

• Everolimus · DRUG

  Administered as specified in the treatment arm.

Published eligibility criteria

Verbatim from the registry. Only the site can decide how these apply to a specific patient.

Key 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.

Sites (120)

• The University of Alabama at Birmingham, Birmingham, Alabama · RECRUITING
• Mayo Clinic Hospital, Phoenix, Arizona · RECRUITING
• The University of Arizona Cancer Center, Tucson, Arizona · RECRUITING
• Cedars-Sinai Medical Center, Beverly Hills, California · RECRUITING
• Norris Comprehensive Cancer Center, Los Angeles, California · RECRUITING
• Stanford Cancer Center, Palo Alto, California · RECRUITING
• UCLA Health - Santa Monica Cancer Care, Santa Monica, California · RECRUITING
• Kaiser Permanente Medical Center, Vallejo, California · RECRUITING
• Georgetown University, Washington D.C., District of Columbia · RECRUITING
• Mayo Clinic - Florida, Jacksonville, Florida · RECRUITING
• AdventHealth Orlando, Orlando, Florida · RECRUITING
• Moffitt Cancer Center, Tampa, Florida · RECRUITING
• University of Kentucky Markey Cancer Center, Lexington, Kentucky · RECRUITING
• East Jefferson General Hospital, Metairie, Louisiana · RECRUITING
• Dana-Farber Cancer Institute, Boston, Massachusetts · RECRUITING
• Henry Ford Cancer- Detroit, Detroit, Michigan · RECRUITING
• The Cancer and Hematology Centers, Grand Rapids, Michigan · RECRUITING
• Mayo Clinic, Rochester, Minnesota · RECRUITING
• Siteman Cancer Center, St Louis, Missouri · RECRUITING
• University of Nebraska Medical Center, Omaha, Nebraska · RECRUITING
• University of New Mexico Comprehensive Cancer Center, Albuquerque, New Mexico · RECRUITING
• Roswell Park Cancer Institute, Buffalo, New York · RECRUITING
• Icahan School of Medicine at Mount Sinai, New York, New York · RECRUITING
• University of Rochester Medical Center, Rochester, New York · RECRUITING
• University of North Carolina at Chapel Hill, Chapel Hill, North Carolina · RECRUITING
• Duke University Medical Center, Durham, North Carolina · RECRUITING
• Sanford Roger Maris Cancer Center, Fargo, North Dakota · RECRUITING
• University Hospitals Cleveland Medical Center, Cleveland, Ohio · RECRUITING
• The Ohio State University Comprehensive Cancer Center, Columbus, Ohio · RECRUITING
• Oregon Health and Science University, Portland, Oregon · RECRUITING
• University of Pennsylvania, Philadelphia, Pennsylvania · RECRUITING
• University of Pittsburgh Medical Center (UPMC) Hillman Cancer Center, Pittsburgh, Pennsylvania · RECRUITING
• University of Tennessee Medical Center, Knoxville, Tennessee · RECRUITING
• Henry-Joyce Cancer Clinic, Nashville, Tennessee · RECRUITING
• Texas Oncology- Baylor Charles A. Sammons Cancer Center, Dallas, Texas · RECRUITING
• Huntsman Cancer Institute, University of Utah, Salt Lake City, Utah · RECRUITING
• University of Virginia, Charlottesville, Virginia · RECRUITING
• Virginia Cancer Specialists - Fairfax Office, Fairfax, Virginia · RECRUITING
• Fred Hutchinson Cancer Center, Seattle, Washington · RECRUITING
• Froedtert Hospital and the Medical College of Wisconsin, Milwaukee, Wisconsin · RECRUITING
• Monash Health, Clayton, Australia · RECRUITING
• Royal Brisbane and Women's Hospital, Herston, Australia · RECRUITING
• Peter MacCallum Cancer Centre, Melbourne, Australia · RECRUITING
• Fiona Stanley Hospital, Murdoch, Australia · RECRUITING
• GenesisCare North Shore, St Leonards, Australia · RECRUITING
• The Queen Elizabeth Hospital, Woodville South, Australia · RECRUITING
• Medical University of Graz, Graz, Austria · RECRUITING
• Paracelsus Medical University Hospital Salzburg, Salzburg, Austria · RECRUITING
• Medical University of Vienna, Vienna, Austria · RECRUITING
• Institut Jules Bordet, Brussels, Belgium · RECRUITING
• UZ Leuven, Leuven, Belgium · RECRUITING
• Cliniques Universitaires Saint-Luc (UCLouvain), Woluwe-Saint-Lambert, Belgium · RECRUITING
• Verspeeten Family Cancer Center - London Health Sciences Centre, London, Canada · RECRUITING
• The Ottawa Hospital Cancer Center, Ottawa, Canada · RECRUITING
• Sunnybrook Health Sciences Centre, Toronto, Canada · RECRUITING
• Humanity and Health Clinical Trial Centre, Hong Kong, China · RECRUITING
• Prince of Wales Hospital, Hong Kong, China · RECRUITING
• Queen Mary Hospital, Hong Kong, China · RECRUITING
• Centre Hospitalier Universitaire de Caen Normandie, Caen, France · RECRUITING
• CHU Beaujon, Clichy, France · RECRUITING
• Centre Hospitalier Universitaire (CHU) de Lille - Hôpital Claude Huriez, Lille, France · RECRUITING
• Hospices Civils de Lyon, Lyon, France · RECRUITING
• Hôpital Timone, Marseille, France · RECRUITING
• CHU de Montpellier Hôpital Saint Eloi, Montpellier, France · RECRUITING
• Centre Hospitalier Universitaire Nantes, Nantes, France · RECRUITING
• Centre Eugéne Marquis, Rennes, France · RECRUITING
• CHRU Strasbourg Hôpital Hautepierre, Strasbourg, France · RECRUITING
• Centre Hospitalier Universitaire (CHU) Toulouse, Toulouse, France · RECRUITING
• Gustave Roussy, Villejuif, France · RECRUITING
• Evangelische Lungenklinik, Berlin, Germany · RECRUITING
• Universitätsklinik Erlangen, Erlangen, Germany · RECRUITING
• Universitätsklinikum Gießen und Marburg GmbH, Standort Marburg, Marburg, Germany · RECRUITING
• Universitätsklinikum Tübingen, Tübingen, Germany · RECRUITING
• University Hospital Würzburg, Würzburg, Germany · RECRUITING
• Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico, Bologna, Italy · RECRUITING
• Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST s.r.l., Meldola, Italy · RECRUITING
• Humanitas Mirasole S.p.A., Milan, Italy · RECRUITING
• Instituto Europeo di Oncologia, Milan, Italy · RECRUITING
• Istituto Nazionale Tumori IRCCS - Fondazione Pascale, Naples, Italy · RECRUITING
• Azienda Ospedaliero-Universitaria San Luigi Gonzaga, Orbassano to, Italy · RECRUITING
• Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone, Palermo, Italy · RECRUITING
• Azienda Ospedaliero-Universitaria Policlinico Umberto I, Roma, Italy · RECRUITING
• Azienda Ospedaliero-Universitaria Sant'Andrea, Roma, Italy · RECRUITING
• Het Netherlands Kanker Institut (NKI)/ Antoni van Leeuwenhoek, Amsterdam, Netherlands · RECRUITING
• Amsterdam UMC, Amsterdam, Netherlands · RECRUITING
• Maastricht Universitair Medisch Centrum, Maastricht, Netherlands · RECRUITING
• Maxima Medisch Centrum, Veldhoven, Netherlands · RECRUITING
• Narodowy Instytut Onkologii im. Marii Skłodowskiej-Curie - Państwowy Instytut Badawczy, Oddział w Gliwicach, Gliwice, Poland · RECRUITING
• Śląskiego Uniwersytet Medyczny w Katowicach, Katowice, Poland · RECRUITING
• Samodzielny Publiczny Zakład Opieki Zdrowotnej Szpital Uniwesytecki w Krakowie, Krakow, Poland · RECRUITING
• Narodowy Instytut Onkologii im. Marii Skłodowskiej-Curie - Państwowy Instytut Badawczy, Warsaw, Poland · RECRUITING
• FutureMeds Wrocław, Wroclaw, Poland · RECRUITING
• Pan American Center for Oncology Trials, LLC, San Juan, Puerto Rico · RECRUITING
• FDI Clinical Resesarch, San Juan, Puerto Rico · WITHDRAWN
• Korea University Anam Hospital, Seoul, South Korea · RECRUITING
• Seoul National University Hospital, Seoul, South Korea · RECRUITING
• Severence Hospital, Yonsei University Health System, Seoul, South Korea · RECRUITING
• Asan Medical Center, Seoul, South Korea · RECRUITING
• Samsung Medical Center, Seoul, South Korea · RECRUITING
• Hospital Universitario Vall D'Hebron, Barcelona, Spain · RECRUITING
• Hospital General Universitario Gregorio Marañón, Madrid, Spain · RECRUITING
• Hospital Universitario Ramón y Cajal, Madrid, Spain · RECRUITING
• Hospital Universitario 12 de Octubre, Madrid, Spain · RECRUITING
• Hospital Universitario La Paz, Madrid, Spain · RECRUITING
• Hospital General Universitario J.M Morales Meseguer, Murcia, Spain · RECRUITING
• Hospital Universitario Central de Asturias, Oviedo, Spain · RECRUITING
• Hospital Universitario Marqués de Valdecilla, Santander, Spain · RECRUITING
• Hospital Clínico Universitario de Santiago de Compostela, Santiago de Compostela, Spain · RECRUITING
• Hospital Universitario Vigen Del Rocío, Seville, Spain · RECRUITING
• Hospital Universitario y Politécnico La Fe, Valencia, Spain · RECRUITING
• Hospital Universitario Miguel Servet, Zaragoza, Spain · RECRUITING
• University Hospitals Birmingham NHS Foundation Trust, Birmingham, United Kingdom · RECRUITING
• Velindre Cancer Center, Cardiff, United Kingdom · RECRUITING
• NHS Greater Glasgow and Clyde, Glasgow, United Kingdom · RECRUITING
• The Clatterbridge Cancer Centre, Liverpool, United Kingdom · RECRUITING
• Guy's and St Thomas' NHS Foundation Trust, London, United Kingdom · RECRUITING
• King's College Hospital NHS Foundation Trust, London, United Kingdom · RECRUITING
• Oxford University Hospitals NHS Foundation Trust, Oxford, United Kingdom · RECRUITING
• Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, United Kingdom · RECRUITING
• Swansea Bay University Health Board, Swansea, United Kingdom · RECRUITING