The CLARINET study: Assessing the effect of lanreotide autogel on tumor progression-free survival in patients with nonfunctioning gastroenteropancreatic neuroendocrine tumors.

Abstract

TPS4153 Background: Somatostatin analogs (SSAs) provide good symptom control in patients with neuroendrocine tumors (NETs). Clinical studies suggest SSAs also stabilize tumor growth. In a previous double-blind study (PROMID) in a mixed functioning and non-functioning gastroenteroNET population (n=85), octreotide LAR significantly increased time to tumor progression compared with placebo. The CLARINET study is being undertaken to explore the antiproliferative effects of SSAs in a more homogeneous population. Specifically, the CLARINET study is a double-blind, placebo-controlled trial assessing the effect of 120 mg of lanreotide Autogel (lanreotide Depot in the USA) on progression-free survival in patients with non-functioning gastroenteropancreatic NETs (GEP-NETs). Methods: CLARINET is a 96-week, multinational study being conducted in collaboration with UKI NETS and ENETS in patients with well or moderately differentiated non-functioning GEP-NETs and a proliferation index (Ki67) of <10%. Patients are stratified by prior tumor progression status and presence/absence of previous therapies, and treated with lanreotide Autogel 120 mg or placebo. The primary endpoint is time to either disease progression (using Response Evaluation Criteria In Solid Tumors) or death. Two baseline computed tomography scans (≥12 weeks apart) are being performed, followed by additional scans at intervals up to 96 weeks. Secondary endpoints include proportion of patients alive and without tumor progression at 48 and 96 weeks, time to progression, overall survival, safety, quality of life, plasma chromogranin A levels, tumor markers, and pharmacokinetic parameters. The primary study population for the analysis will be the intention-to-treat population. Recruitment is now complete (n=204) and, thus far, the drug safety monitoring committee has identified no safety concerns. The trial is registered with ClinicalTrials.gov (NCT NCT00353496).