A Phase II/III, Multicenter, Randomized Open-Label Study of Zanzalintinib vs Everolimus in Participants With Previously Treated, Unresectable, Locally Advanced or Metastatic Neuroendocrine Tumors
Categories (click each to see list of all clinical trials associated with that category): GI (ONC), Pancreatic Cancer Center of Excellence - PCCE (ONC), Thoracic (ONC)
Current Status: Not open
Phase: II/III
Principal Investigator: Tenner, Laura
Contact Information:
Erin Drengler
edrengler@unmc.edu
Eligibility: https://clinicaltrials.gov/study/NCT06943755?term=NCT06943755&rank=1#participation-criteria
Summary
Primary Objectives: To evaluate PFS by BICR of zanzalintinib versus everolimus.
Secondary Objectives: -To evaluate ORR by BICR of zanzalintinib versus everolimus. -To evaluate OS of zanzalintinib versus everolimus. -To evaluate DOR by BICR of zanzalintinib versus everolimus. -To evaluate PFS, ORR, and DOR by Investigator review of zanzalintinib versus everolimus. -To evaluate DCR of zanzalintinib versus everolimus as assessed by BICR and by Investigator. -To evaluate HRQoL, disease-related symptoms, and other domains of zanzalintinib versus everolimus as assessed by EORTC QLQ-C30 and EORTC QLQ-GI.NET21 questionnaire instruments in participants with epNET and pNET. -To evaluate safety and tolerability of zanzalintinib compared to everolimus.
Exploratory Objectives: -To evaluate HRQoL of zanzalintinib versus everolimus as assessed by EQ-5D-5L in participants with epNET and pNET. -To characterize the pharmacokinetics of zanzalintinib and its potential metabolites in the experimental arm. -To investigate the relationship between biomarkers and the clinical activity, safety, and mechanism of action of zanzalintinib and everolimus in participants with epNET and pNET. -To characterize healthcare resource utilization of zanzalintinib versus everolimus in participants with epNET and pNET.