Zanzalintinib Versus Everolimus in Participants With Locally Advanced or Metastatic Neuroendocrine Tumors
Phase 2
Not yet recruiting
- Conditions
- Pancreatic Neuroendocrine Tumor (pNET)Extra-Pancreatic Neuroendocrine Tumor (epNET)
- Interventions
- Registration Number
- NCT06943755
- Lead Sponsor
- Exelixis
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 440
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/Exclusion criteria may apply.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Zanzalintinib Zanzalintinib Participants will receive zanzalintinib oral tablets once daily for up to 14 months. Everolimus Everolimus Participants will receive everolimus oral tablets once daily for up to 14 months.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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