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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

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

Recruiting Locations

Exelixis Clinical Site #43
Birmingham, Alabama 35294

Exelixis Clinical Site #36
Phoenix, Arizona 85054

Exelixis Clinical Site #42
Tucson, Arizona 85724

Exelixis Clinical Site #18
Beverly Hills, California 90211

Exelixis Clinical Site #16
Los Angeles, California 90033

Exelixis Clinical Site #54
Palo Alto, California 94305

Exelixis Clinical Site #12
Santa Monica, California 90404

Exelixis Clinical Site #29
Vallejo, California 94589

Exelixis Clinical Site #19
Washington D.C., District of Columbia 20007

Exelixis Clinical Site #35
Jacksonville, Florida 32224

Exelixis Clinical Site #11
Tampa, Florida 33612

Exelixis Clinical Site #9
Lexington, Kentucky 40536

Exelixis Clinical Site #23
Metairie, Louisiana 70006

Exelixis Clinical Site #8
Boston, Massachusetts 02215

Exelixis Clinical Site #47
Detroit, Michigan 48202

Exelixis Clinical Site #1
Grand Rapids, Michigan 49546

Exelixis Clinical Site #38
Rochester, Minnesota 55905

Exelixis Clinical Site #5
St Louis, Missouri 63110

Exelixis Clinical Site #25
Omaha, Nebraska 68198

Exelixis Clinical Site #14
Albuquerque, New Mexico 87131

Exelixis Clinical Site #59
Buffalo, New York 14263

Exelixis Clinical Site #7
New York, New York 10029

Exelixis Clinical Site #53
Rochester, New York 14642

Exelixis Clinical Site #17
Chapel Hill, North Carolina 27599

Exelixis Clinical Site #6
Durham, North Carolina 27710

Exelixis Clinical Site #57
Fargo, North Dakota 58102

Exelixis Clinical Site #39
Cleveland, Ohio 44106

Exelixis Clinical Site #28
Columbus, Ohio 43221

Exelixis Clinical Site #27
Portland, Oregon 97210

Exelixis Clinical Site #20
Philadelphia, Pennsylvania 19104

Exelixis Clinical Site #21
Pittsburgh, Pennsylvania 15232

Exelixis Clinical Site #24
Knoxville, Tennessee 37920

Exelixis Clinical Site #65
Nashville, Tennessee 37232

Exelixis Clinical Site #10
Dallas, Texas 75264

Exelixis Clinical Site #15
Salt Lake City, Utah 84112

Exelixis Clinical Site #3
Charlottesville, Virginia 22903

Exelixis Clinical Site #13
Fairfax, Virginia 22031

Exelixis Clinical Site #34
Seattle, Washington 98109

Exelixis Clinical Site #31
Milwaukee, Wisconsin 53226

Exelixis Clinical Site #2
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

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.