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

Purpose

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.

Conditions

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

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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.

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.

Study Design

Phase
Phase 2/Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Sequential Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Active Comparator
Everolimus 		Participants will receive everolimus oral tablets once daily.
  • Drug: Everolimus
    Administered as specified in the treatment arm.
    Other names:
    • Afinitor
Experimental
Zanzalintinib 		Participants will receive zanzalintinib oral tablets once daily.
  • Drug: Zanzalintinib
    Administered as specified in the treatment arm.
    Other names:
    • XL092

Recruiting Locations

The University of Alabama at Birmingham
Birmingham, Alabama 35294

Mayo Clinic Hospital
Phoenix, Arizona 85054

The University of Arizona Cancer Center
Tucson, Arizona 85724

Cedars-Sinai Medical Center
Beverly Hills, California 90211

Norris Comprehensive Cancer Center
Los Angeles, California 90033

Stanford Cancer Center
Palo Alto, California 94305

UCLA Health - Santa Monica Cancer Care
Santa Monica, California 90404

Kaiser Permanente Medical Center
Vallejo, California 94589

Georgetown University
Washington D.C., District of Columbia 20007

Mayo Clinic - Florida
Jacksonville, Florida 32224

AdventHealth Orlando
Orlando, Florida 32804

Moffitt Cancer Center
Tampa, Florida 33612

University of Kentucky Markey Cancer Center
Lexington, Kentucky 40536

East Jefferson General Hospital
Metairie, Louisiana 70006

Dana-Farber Cancer Institute
Boston, Massachusetts 02215

Henry Ford Cancer- Detroit
Detroit, Michigan 48202

The Cancer and Hematology Centers
Grand Rapids, Michigan 49546

Mayo Clinic
Rochester, Minnesota 55905

Siteman Cancer Center
St Louis, Missouri 63110

University of Nebraska Medical Center
Omaha, Nebraska 68198

University of New Mexico Comprehensive Cancer Center
Albuquerque, New Mexico 87131

Roswell Park Cancer Institute
Buffalo, New York 14263

Icahan School of Medicine at Mount Sinai
New York, New York 10029

University of Rochester Medical Center
Rochester, New York 14642

University of North Carolina at Chapel Hill
Chapel Hill, North Carolina 27599

Duke University Medical Center
Durham, North Carolina 27710

Sanford Roger Maris Cancer Center
Fargo, North Dakota 58102

University Hospitals Cleveland Medical Center
Cleveland, Ohio 44106

The Ohio State University Comprehensive Cancer Center
Columbus, Ohio 43221

Oregon Health and Science University
Portland, Oregon 97210

University of Pennsylvania
Philadelphia, Pennsylvania 19104

University of Pittsburgh Medical Center (UPMC) Hillman Cancer Center
Pittsburgh, Pennsylvania 15232

University of Tennessee Medical Center
Knoxville, Tennessee 37920

Henry-Joyce Cancer Clinic
Nashville, Tennessee 37232

Texas Oncology- Baylor Charles A. Sammons Cancer Center
Dallas, Texas 75264

Huntsman Cancer Institute, University of Utah
Salt Lake City, Utah 84112

University of Virginia
Charlottesville, Virginia 22903

Virginia Cancer Specialists - Fairfax Office
Fairfax, Virginia 22031

Fred Hutchinson Cancer Center
Seattle, Washington 98109

Froedtert Hospital and the Medical College of Wisconsin
Milwaukee, Wisconsin 53226

Pan American Center for Oncology Trials, LLC
San Juan, Puerto Rico 00909

More Details

Status
Recruiting
Sponsor
Exelixis

Study Contact

Exelixis Clinical Trials
1-888-EXELIXIS (888-393-5494)
druginfo@exelixis.com