Extra-Pancreatic Neuroendocrine Tumor (epNET), Pancreatic Neuroendocrine Tumor (pNET)
Conditions
Keywords
Metastatic Cancer, Locally Advanced Cancer, Neuroendocrine Tumor (NET)
Brief summary
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.
Interventions
DRUGZanzalintinib
Administered as specified in the treatment arm.
DRUGEverolimus
Administered as specified in the treatment arm.
Sponsors
Exelixis
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key 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. Key
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/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version (RECIST) 1.1 as Assessed by Blinded Independent Central Review (BICR) | Up to 48 months |
Secondary
| Measure | Time frame |
|---|---|
| PFS Per RECIST 1.1 as Assessed by Investigator | Up to 48 months |
| Objective Response Rate (ORR) Per RECIST 1.1 as Assessed by BICR and Investigator | Up to 48 months |
| Overall Survival (OS) | Up to 60 months |
| Duration of Response (DOR) Per RECIST 1.1 as Assessed by BICR and Investigator | Up to 48 months |
| Disease Control Rate (DCR) Per RECIST 1.1 as Assessed by BICR and Investigator | 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 | 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 | Up to 48 months |
| Number of Participants With Adverse Events | Up to 48 months |
Countries
Australia, Austria, Belgium, Brazil, Canada, China, France, Germany, Italy, Netherlands, Poland, Puerto Rico, South Korea, Spain, Taiwan, United Kingdom, United States
Contacts
CONTACTExelixis Clinical Trials
CONTACTBackup or International
STUDY_DIRECTORMedical Director
Exelixis
Outcome results
None listed