Safety and Efficacy of 14-Day Dosing Interval of Lanreotide Autogel/Depot (LAN) for Patients wth Pancreatic or Midgut Neuroendocrine Tumours (NETs) Progressing on LAN Every 28 Days: The Prospective, Open-label, International, Phase 2 CLARINET FORTE Study

#1798

Introduction: CLARINET demonstrated the antitumour effect of LAN 120mg/28 days (standard interval) in metastatic gastroenteropancreatic NETs. If disease progresses (PD) on this dose, aggressive treatments (eg targeted therapies) are usually offered.

Aim(s): CLARINET FORTE will investigate the safety and antitumour efficacy of instead using LAN 120mg/14 days.

Materials and methods: Adults with well-differentiated, metastatic/locally advanced, unresectable, functioning/non-functioning, G1/G2, pancreatic (pNETs) or midgut NETs, ECOG PS 0–2, are eligible if radiological PD (central review, RECIST v1.0) occurred with first-line LAN 120mg/28 days ≤24 months previously. Patients (pNETs, n=50; midgut NETs, n=50) will receive LAN 120mg/every 14 days up to week 48 (pNETs)/96 (midgut NETs) unless they experience PD, die or toxicity/tolerability is unacceptable. Unless 25 events occur in each cohort, visits will continue every 12 weeks until PD, death or unacceptable toxicity/tolerability. A data safety monitoring board will oversee the study (NCT02651987; EudraCT–2014-005607-24).

Conference: 14th Annual ENETSConcerence (2017)

Presenting Author:

Authors: Pavel M, Dromain C, Majdi A, Houchard A,

Keywords: Lanreotide, dosing interval,