Study of Lanreotide Autogel in Non-functioning Entero-pancreatic Endocrine Tumours

Summary

The study will compare the difference between lanreotide Autogel and placebo on progression free survival in patients who have an endocrine tumour in the pancreas or intestines.

Timeline

Start

2006-06

Primary completion

2013-04

Completion

2013-04

Outcome

Met primary endpoint

registry Lanreotide (Autogel Formulation) vs Placebo; p <0.001; Hazard Ratio (HR) 0.47 (95% CI 0.30 to 0.73) NCT00353496 ↗

paper Lanreotide, as compared with placebo, was associated with significantly prolonged progression-free survival PMID 25014687 ↗

Publications

• Results Caplin ME, Pavel M, Cwikla JB, Phan AT, Raderer M, Sedlackova E, Cadiot G, Wolin EM, Capdevila J, Wall L, Rindi G, Langley A, Martinez S, Blumberg J, Ruszniewski P; CLARINET Investigators. Lanreotide in metastatic enteropancreatic neuroendocrine tumors. N Engl J Med. 2014 Jul 17;371(3):224-33. doi: 10.1056/NEJMoa1316158.
• Caplin ME, Pavel M, Phan AT, Cwikla JB, Sedlackova E, Thanh XT, Wolin EM, Ruszniewski P; CLARINET Investigators. Lanreotide autogel/depot in advanced enteropancreatic neuroendocrine tumours: final results of the CLARINET open-label extension study. Endocrine. 2021 Feb;71(2):502-513. doi: 10.1007/s12020-020-02475-2. Epub 2020 Oct 14.
• Lybaert W, Van Hul E, Woestenborghs H. Long-term disease control of a pancreatic neuroendocrine tumor with lanreotide autogel((R)): a case report. Case Rep Oncol. 2014 Sep 26;7(3):673-80. doi: 10.1159/000368207. eCollection 2014 Sep.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Lanreotide	Other / unclassified	120 mg	Subcutaneous

Indications