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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
440
Administered as specified in the treatment arm.
Administered as specified in the treatment arm.
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
PFS Per RECIST 1.1 as Assessed by Investigator
Time frame: Up to 48 months
Objective Response Rate (ORR) Per RECIST 1.1 as Assessed by BICR and Investigator
Time frame: Up to 48 months
Overall Survival (OS)
Time frame: Up to 60 months
Duration of Response (DOR) Per RECIST 1.1 as Assessed by BICR and Investigator
Time frame: Up to 48 months
Disease Control Rate (DCR) Per RECIST 1.1 as Assessed by BICR and Investigator
Time frame: 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
Time frame: 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
Time frame: Up to 48 months
Number of Participants With Adverse Events
Time frame: Up to 48 months
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Exelixis Clinical Site #18
Beverly Hills, California, United States
RECRUITINGExelixis Clinical Site #16
Los Angeles, California, United States
RECRUITINGExelixis Clinical Site #12
Santa Monica, California, United States
RECRUITINGExelixis Clinical Site #19
Washington D.C., District of Columbia, United States
RECRUITINGExelixis Clinical Site #11
Tampa, Florida, United States
RECRUITINGExelixis Clinical Site #9
Lexington, Kentucky, United States
RECRUITINGExelixis Clinical Site #23
Metairie, Louisiana, United States
RECRUITINGExelixis Clinical Site #8
Boston, Massachusetts, United States
RECRUITINGExelixis Clinical Site #1
Grand Rapids, Michigan, United States
RECRUITINGExelixis Clinical Site #5
St Louis, Missouri, United States
RECRUITING...and 15 more locations