drugset / Trial / NCT01744249
Sandostatin LAR and Axitinib vs Pbo in Pnts With Advanced Well-differentiated Non-pancreatic Neuroendocrine Carcinomas
Phase 2/3
Completed
256 enrolled
Spanish Group for Research in Neuroendocrine Tumors
Pfizer · collab
RandomizedParallel-groupQuadruple-blindTreatment
Summary
Assess whether therapy with axitinib, a potent angiogenic inhibitor of the tyrosine kinase receptors of VEGF bioavailable by oral administration, is capable of improving PFS in patients with advanced G1-G2 NETs of nonpancreatic origin with progressive disease documented in the 12 months prior to entering the study.
Timeline
- Start
- 2011-11
- Primary completion
- 2023-12-31
- Completion
- 2023-12-31
Outcome
Missed primary endpoint
registry analysis (superiority test); Axitinib + Sandostatin LAR vs Placebo + Sandostatin LAR; p = 0.324; Cox Proportional Hazard 0.86 (95% CI 0.65 to 1.15) NCT01744249 ↗
paper although the primary study end point was not met. PMID 41719493 ↗
Publications
- Garcia-Carbonero R, Benavent M, Jimenez-Fonseca P, Alonso-Gordoa T, Teule A, Custodio A, Tafuto S, La Casta A, Spada F, Lopez C, Ibrahim T, Iranzo V, Garcia-Alfonso P, Gonzalez-Flores E, Villanueva Silva MJ, Grande E, Panzuto F, Crespo G, Navarro M, Castellano D, Hernando J, Morales-Herrero R, Iglesias Alvarez G, Soldevilla B, Capdevila J. Axitinib and Long-Acting Octreotide in Advanced Extrapancreatic Neuroendocrine Tumors: A Randomized, Double-Blind, Placebo-Controlled, Phase III Clinical Trial (AXINET, GETNE 1107). J Clin Oncol. 2026 Mar 20;44(9):774-786. doi: 10.1200/JCO-25-01808. Epub 2026 Feb 20.
- 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 | Axitinib | Small molecule | 5 mg | Oral |
| Background | Octreotide | Peptide | 30 mg | Intramuscular |