Zanzalintinib Versus Everolimus in Participants With Locally Advanced or Metastatic Neuroendocrine Tumors
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorExelixis
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Zanzalintinib
- Everolimus
Treatment groups
440 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov