Informations générales (source: ClinicalTrials.gov)
A Phase 2/3, Multicenter, Randomized Open-Label Study of Zanzalintinib vs Everolimus in Participants With Previously Treated, Unresectable, Locally Advanced or Metastatic Neuroendocrine Tumors
Interventional
Phase 2/Phase 3
Exelixis (Voir sur ClinicalTrials)
juillet 2025
juin 2029
23 juillet 2026
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.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT GUSTAVE ROUSSY | Julien HADOUX | 08/06/2026 09:50:04 | Contacter | ||
Critères
Tous
- 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.