Testing Cabozantinib in Patients With Advanced Pancreatic Neuroendocrine and Carcinoid Tumors
Summary
This phase III trial studies cabozantinib to see how well it works compared with placebo in treating patients with neuroendocrine or carcinoid tumors that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced). Cabozantinib is a chemotherapy drug known as a tyrosine kinase inhibitor, and it targets specific tyrosine kinase receptors, that when blocked, may slow tumor growth.
Timeline
- Start
- 2018-10-26
- Primary completion
- 2023-08-23
- Completion
- 2027-09-01
Outcome
Met primary endpoint
registry analysis (superiority test); Arm Ia (Cabozantinib S-malate, Extra-pancreatic NET Cohort [epNET]) vs Arm IIa (Placebo, Extra-pancreatic NET Cohort [epNET]); p <0.0001; One-sided unstratified log-rank NCT03375320 ↗
registry analysis (superiority test); Arm Ib (Cabozantinib S-malate, Pancreatic NET Cohort [pNET]) vs Arm IIb (Placebo, Pancreatic NET Cohort [pNET]); p <0.0001; One-sided unstratified log-rank NCT03375320 ↗
release “Approval based on pivotal CABINET Phase III trial which demonstrated a 77% and 62% reduction in the risk of disease progression or death versus placebo” ipsen.com ↗
release “The trial was stopped early after an interim analysis showed superior efficacy associated with cabozantinib as compared to placebo in each of the two cohorts.” exelixis.com ↗
Publications
- Strosberg JR, Zemla T, Geyer S, Pulsipher S, Ou FS, Behr S, Raj N, Vijayvergia N, Dasari A, O'Reilly EM, Meyerhardt JA, Wolin EM, Halfdanarson TR, Chan JA. Cabozantinib for advanced grade 3 neuroendocrine tumors: subgroup analysis of the phase 3 CABINET trial (Alliance A021602). Endocr Relat Cancer. 2026 Jan 24;33(1):e250415. doi: 10.1530/ERC-25-0415. Print 2026 Jan 1.
- Chan JA, Geyer S, Zemla T, Knopp MV, Behr S, Pulsipher S, Ou FS, Dueck AC, Acoba J, Shergill A, Wolin EM, Halfdanarson TR, Konda B, Trikalinos NA, Tawfik B, Raj N, Shaheen S, Vijayvergia N, Dasari A, Strosberg JR, Kohn EC, Kulke MH, O'Reilly EM, Meyerhardt JA. Phase 3 Trial of Cabozantinib to Treat Advanced Neuroendocrine Tumors. N Engl J Med. 2025 Feb 13;392(7):653-665. doi: 10.1056/NEJMoa2403991. Epub 2024 Sep 16.
- Kunz PL. Angiogenesis inhibitors in neuroendocrine tumours: finally coming of age. Lancet Oncol. 2020 Nov;21(11):1395-1397. doi: 10.1016/S1470-2045(20)30560-X. No abstract available.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cabozantinib | Small molecule | 60 mg | Oral |