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| ID | Type | Description | Link |
|---|---|---|---|
| 2025-521043-20-00 | EU Trial (CTIS) Number | ||
| 1011801 | Other Identifier | IRAS |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Zanzalintinib | Experimental | Participants will receive zanzalintinib oral tablets once daily. |
|
| Everolimus | Active Comparator | Participants will receive everolimus oral tablets once daily. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Zanzalintinib | Drug | Administered as specified in the treatment arm. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression-Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version (RECIST) 1.1 as Assessed by Blinded Independent Central Review (BICR) | Up to 48 months |
| Measure | Description | Time Frame |
|---|---|---|
| PFS Per RECIST 1.1 as Assessed by Investigator | Up to 48 months | |
| Objective Response Rate (ORR) Per RECIST 1.1 as Assessed by BICR and Investigator | Up to 48 months | |
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Key Inclusion Criteria:
Key Exclusion Criteria:
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Exelixis Clinical Trials | Contact | 1-888-EXELIXIS (888-393-5494) | druginfo@exelixis.com | |
| Backup or International | Contact | 650-837-7400 |
| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Exelixis | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Alabama at Birmingham | Recruiting | Birmingham | Alabama | 35294 | United States | |
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| Everolimus | Drug | Administered as specified in the treatment arm. |
|
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| Overall Survival (OS) |
| Up to 60 months |
| Duration of Response (DOR) Per RECIST 1.1 as Assessed by BICR and Investigator | Up to 48 months |
| Disease Control Rate (DCR) Per RECIST 1.1 as Assessed by BICR and Investigator | Up to 48 months |
| Change From Baseline in Participant-Reported Global Health Status (GHS) and Disease-Related Symptoms as Assessed by European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30) Score | Up to 48 months |
| Change From Baseline in Participant-Reported GHS and Disease-Related Symptoms as Assessed by EORTC Gastrointestinal Neuroendocrine Tumor module (QLQ-GI.NET21) Score | Up to 48 months |
| Number of Participants With Adverse Events | Up to 48 months |
| Mayo Clinic Hospital |
| Recruiting |
| Phoenix |
| Arizona |
| 85054 |
| United States |
| The University of Arizona Cancer Center | Recruiting | Tucson | Arizona | 85724 | United States |
| Cedars-Sinai Medical Center | Recruiting | Beverly Hills | California | 90211 | United States |
| Norris Comprehensive Cancer Center | Recruiting | Los Angeles | California | 90033 | United States |
| Stanford Cancer Center | Recruiting | Palo Alto | California | 94305 | United States |
| UCLA Health - Santa Monica Cancer Care | Recruiting | Santa Monica | California | 90404 | United States |
| Kaiser Permanente Medical Center | Recruiting | Vallejo | California | 94589 | United States |
| Georgetown University | Recruiting | Washington D.C. | District of Columbia | 20007 | United States |
| Mayo Clinic - Florida | Recruiting | Jacksonville | Florida | 32224 | United States |
| AdventHealth Orlando | Recruiting | Orlando | Florida | 32804 | United States |
| Moffitt Cancer Center | Recruiting | Tampa | Florida | 33612 | United States |
| University of Kentucky Markey Cancer Center | Recruiting | Lexington | Kentucky | 40536 | United States |
| East Jefferson General Hospital | Recruiting | Metairie | Louisiana | 70006 | United States |
| Dana-Farber Cancer Institute | Recruiting | Boston | Massachusetts | 02215 | United States |
| Henry Ford Caner- Detroit | Recruiting | Detroit | Michigan | 48202 | United States |
| The Cancer and Hematology Centers | Recruiting | Grand Rapids | Michigan | 49546 | United States |
| Mayo Clinic | Recruiting | Rochester | Minnesota | 55905 | United States |
| Siteman Cancer Center | Recruiting | St Louis | Missouri | 63110 | United States |
| University of Nebraska Medical Center | Recruiting | Omaha | Nebraska | 68198 | United States |
| University of New Mexico Comprehensive Cancer Center | Recruiting | Albuquerque | New Mexico | 87131 | United States |
| Roswell Park Cancer Institute | Recruiting | Buffalo | New York | 14263 | United States |
| Icahan School of Medicine at Mount Sinai | Recruiting | New York | New York | 10029 | United States |
| University of Rochester Medical Center | Recruiting | Rochester | New York | 14642 | United States |
| University of North Carolina at Chapel Hill | Recruiting | Chapel Hill | North Carolina | 27599 | United States |
| Duke University Medical Center | Recruiting | Durham | North Carolina | 27710 | United States |
| Sanford Roger Maris Cancer Center | Recruiting | Fargo | North Dakota | 58102 | United States |
| University Hospitals Cleveland Medical Center | Recruiting | Cleveland | Ohio | 44106 | United States |
| The Ohio State University Comprehensive Cancer Center | Recruiting | Columbus | Ohio | 43221 | United States |
| Oregon Health and Science University | Recruiting | Portland | Oregon | 97210 | United States |
| University of Pennsylvania | Recruiting | Philadelphia | Pennsylvania | 19104 | United States |
| University of Pittsburgh Medical Center (UPMC) Hillman Cancer Center | Recruiting | Pittsburgh | Pennsylvania | 15232 | United States |
| University of Tennessee Medical Center | Recruiting | Knoxville | Tennessee | 37920 | United States |
| Henry-Joyce Cancer Clinic | Recruiting | Nashville | Tennessee | 37232 | United States |
| Texas Oncology- Baylor Charles A. Sammons Cancer Center | Recruiting | Dallas | Texas | 75264 | United States |
| Huntsman Cancer Institute, University of Utah | Recruiting | Salt Lake City | Utah | 84112 | United States |
| University of Virginia | Recruiting | Charlottesville | Virginia | 22903 | United States |
| Virginia Cancer Specialists - Fairfax Office | Recruiting | Fairfax | Virginia | 22031 | United States |
| Fred Hutchinson Cancer Center | Recruiting | Seattle | Washington | 98109 | United States |
| Froedtert Hospital and the Medical College of Wisconsin | Recruiting | Milwaukee | Wisconsin | 53226 | United States |
| Monash Health | Recruiting | Clayton | 3168 | Australia |
| Royal Brisbane and Women's Hospital | Recruiting | Herston | 4029 | Australia |
| Fiona Stanley Hospital | Recruiting | Murdoch | WA 6150 | Australia |
| GenesisCare North Shore | Recruiting | St Leonards | 2065 | Australia |
| The Queen Elizabeth Hospital | Recruiting | Woodville South | 5011 | Australia |
| Medical University of Graz | Recruiting | Graz | 8036 | Austria |
| Paracelsus Medical University Hospital Salzburg | Recruiting | Salzburg | 5020 | Austria |
| Cliniques Universitaires Saint-Luc (UCLouvain) | Recruiting | Woluwe-Saint-Lambert | 1200 | Belgium |
| Verspeeten Family Cancer Center - London Health Sciences Centre | Recruiting | London | N6A 5W9 | Canada |
| The Ottawa Hospital Cancer Center | Recruiting | Ottawa | K1H8L6 | Canada |
| Sunnybrook Health Sciences Centre | Recruiting | Toronto | M4N3M5 | Canada |
| Humanity and Health Clinical Trial Centre | Recruiting | Hong Kong | China |
| Prince of Wales Hospital | Recruiting | Hong Kong | China |
| Queen Mary Hospital | Recruiting | Hong Kong | China |
| CHU de Montpellier Hôpital Saint Eloi | Recruiting | Montpellier | 34 295 | France |
| Gustave Roussy | Recruiting | Villejuif | 94800 | France |
| Evangelische Lungenklinik | Recruiting | Berlin | 13125 | Germany |
| Universitätsklinikum Gießen und Marburg GmbH, Standort Marburg | Recruiting | Marburg | 35043 | Germany |
| Universitätsklinikum Tübingen | Recruiting | Tübingen | 72076 | Germany |
| University Hospital Würzburg | Recruiting | Würzburg | 97080 | Germany |
| Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST s.r.l. | Recruiting | Meldola | 47014 | Italy |
| Instituto Europeo di Oncologia | Recruiting | Milan | Italy |
| Istituto Nazionale Tumori IRCCS - Fondazione Pascale | Recruiting | Naples | 80131 | Italy |
| Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone | Recruiting | Palermo | 90127 | Italy |
| Azienda Ospedaliero-Universitaria Policlinico Umberto I | Recruiting | Roma | 00161 | Italy |
| Het Netherlands Kanker Institut (NKI)/ Antoni van Leeuwenhoek | Recruiting | Amsterdam | 1066 CX | Netherlands |
| Maastricht Universitair Medisch Centrum | Recruiting | Maastricht | 6229 HX | Netherlands |
| Maxima Medisch Centrum | Recruiting | Veldhoven | 5504 DB | Netherlands |
| Narodowy Instytut Onkologii im. Marii Skłodowskiej-Curie - Państwowy Instytut Badawczy, Oddział w Gliwicach | Recruiting | Gliwice | 44-102 | Poland |
| Śląskiego Uniwersytet Medyczny w Katowicach | Recruiting | Katowice | 40-514 | Poland |
| Samodzielny Publiczny Zakład Opieki Zdrowotnej Szpital Uniwesytecki w Krakowie | Recruiting | Krakow | 30-688 | Poland |
| Narodowy Instytut Onkologii im. Marii Skłodowskiej-Curie - Państwowy Instytut Badawczy | Recruiting | Warsaw | 02-034 | Poland |
| FutureMeds Wrocław | Recruiting | Wroclaw | 53-673 | Poland |
| Pan American Center for Oncology Trials, LLC | Recruiting | San Juan | 00909 | Puerto Rico |
| FDI Clinical Resesarch | Withdrawn | San Juan | 00927 | Puerto Rico |
| Korea University Anam Hospital | Recruiting | Seoul | 02841 | South Korea |
| Seoul National University Hospital | Recruiting | Seoul | 03080 | South Korea |
| Severence Hospital, Yonsei University Health System | Recruiting | Seoul | 03722 | South Korea |
| Asan Medical Center | Recruiting | Seoul | 05505 | South Korea |
| Samsung Medical Center | Recruiting | Seoul | 06351 | South Korea |
| Hospital Universitario Vall D'Hebron | Recruiting | Barcelona | 08029 | Spain |
| Hospital Universitario Ramón y Cajal | Recruiting | Madrid | 28034 | Spain |
| Hospital Universitario 12 de Octubre | Recruiting | Madrid | 28041 | Spain |
| Hospital Universitario La Paz | Recruiting | Madrid | 28046 | Spain |
| Hospital General Universitario J.M Morales Meseguer | Recruiting | Murcia | 30008 | Spain |
| Hospital Universitario Central de Asturias | Recruiting | Oviedo | 33011 | Spain |
| Hospital Universitario Marqués de Valdecilla | Recruiting | Santander | 39008 | Spain |
| Hospital Clínico Universitario de Santiago de Compostela | Recruiting | Santiago de Compostela | 15706 | Spain |
| Hospital Universitario Vigen Del Rocío | Recruiting | Seville | 41013 | Spain |
| Hospital Universitario y Politécnico La Fe | Recruiting | Valencia | 46026 | Spain |
| Hospital Universitario Miguel Servet | Recruiting | Zaragoza | 50009 | Spain |
| The Clatterbridge Cancer Centre | Recruiting | Liverpool | L7 8YA | United Kingdom |
| Guy's and St Thomas' NHS Foundation Trust | Recruiting | London | SE1 9RT | United Kingdom |
| King's College Hospital NHS Foundation Trust | Recruiting | London | SE5 9RS | United Kingdom |
| Oxford University Hospitals NHS Foundation Trust | Recruiting | Oxford | OX3 7LE | United Kingdom |
| Sheffield Teaching Hospitals NHS Foundation Trust | Recruiting | Sheffield | S10 2SJ | United Kingdom |
| Swansea Bay University Health Board | Recruiting | Swansea | SA2 8QA | United Kingdom |
| ID | Term |
|---|---|
| D007516 | Adenoma, Islet Cell |
| D009362 | Neoplasm Metastasis |
| D018358 | Neuroendocrine Tumors |
| ID | Term |
|---|---|
| D000236 | Adenoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D010190 | Pancreatic Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004701 | Endocrine Gland Neoplasms |
| D004066 | Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009380 | Neoplasms, Nerve Tissue |
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| ID | Term |
|---|---|
| D000068338 | Everolimus |
| ID | Term |
|---|---|
| D020123 | Sirolimus |
| D018942 | Macrolides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
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