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

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Exelixis
Study ID
NCT06943755
Phase
PHASE2/PHASE3
Status
Recruiting

Conditions

  • Extra-Pancreatic Neuroendocrine Tumor (epNET)
  • Pancreatic Neuroendocrine Tumor (pNET)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Zanzalintinib — DRUG
    Administered as specified in the treatment arm.
  • Everolimus — DRUG
    Administered as specified in the treatment arm.

Study Details

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.

Key Dates

First listed
Apr 24, 2025
Start date
Jul 21, 2025
Status verified
Jul 2026
Primary completion
Jun 30, 2029
Completion
Jun 30, 2029

Study Design

Enrollment
440 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Everolimus
    Participants will receive everolimus oral tablets once daily.
  • Experimental: Zanzalintinib
    Participants will receive zanzalintinib oral tablets once daily.

Primary Outcome Measure

Progression-Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version (RECIST) 1.1 as Assessed by Blinded Independent Central Review (BICR) [ Time Frame: Up to 48 months ]

Central Contacts

  • Exelixis Clinical Trials
    1-888-EXELIXIS (888-393-5494)
  • Backup or International
    650-837-7400

Locations (40)

FacilityCityStateZIPSite coordinators
The University of Alabama at BirminghamBirminghamAlabama35294-
Mayo Clinic HospitalPhoenixArizona85054-
The University of Arizona Cancer CenterTucsonArizona85724-
Cedars-Sinai Medical CenterBeverly HillsCalifornia90211-
Norris Comprehensive Cancer CenterLos AngelesCalifornia90033-
Stanford Cancer CenterPalo AltoCalifornia94305-
UCLA Health - Santa Monica Cancer CareSanta MonicaCalifornia90404-
Kaiser Permanente Medical CenterVallejoCalifornia94589-
Georgetown UniversityWashington D.C.District of Columbia20007-
Mayo Clinic - FloridaJacksonvilleFlorida32224-
AdventHealth OrlandoOrlandoFlorida32804-
Moffitt Cancer CenterTampaFlorida33612-
University of Kentucky Markey Cancer CenterLexingtonKentucky40536-
East Jefferson General HospitalMetairieLouisiana70006-
Dana-Farber Cancer InstituteBostonMassachusetts02215-
Henry Ford Cancer- DetroitDetroitMichigan48202-
The Cancer and Hematology CentersGrand RapidsMichigan49546-
Mayo ClinicRochesterMinnesota55905-
Siteman Cancer CenterSt LouisMissouri63110-
University of Nebraska Medical CenterOmahaNebraska68198-
University of New Mexico Comprehensive Cancer CenterAlbuquerqueNew Mexico87131-
Roswell Park Cancer InstituteBuffaloNew York14263-
Icahan School of Medicine at Mount SinaiNew YorkNew York10029-
University of Rochester Medical CenterRochesterNew York14642-
University of North Carolina at Chapel HillChapel HillNorth Carolina27599-
Duke University Medical CenterDurhamNorth Carolina27710-
Sanford Roger Maris Cancer CenterFargoNorth Dakota58102-
University Hospitals Cleveland Medical CenterClevelandOhio44106-
The Ohio State University Comprehensive Cancer CenterColumbusOhio43221-
Oregon Health and Science UniversityPortlandOregon97210-
University of PennsylvaniaPhiladelphiaPennsylvania19104-
University of Pittsburgh Medical Center (UPMC) Hillman Cancer CenterPittsburghPennsylvania15232-
University of Tennessee Medical CenterKnoxvilleTennessee37920-
Henry-Joyce Cancer ClinicNashvilleTennessee37232-
Texas Oncology- Baylor Charles A. Sammons Cancer CenterDallasTexas75264-
Huntsman Cancer Institute, University of UtahSalt Lake CityUtah84112-
University of VirginiaCharlottesvilleVirginia22903-
Virginia Cancer Specialists - Fairfax OfficeFairfaxVirginia22031-
Fred Hutchinson Cancer CenterSeattleWashington98109-
Froedtert Hospital and the Medical College of WisconsinMilwaukeeWisconsin53226-

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