Trial intelligence / Profile preview

CLARINET FORTE: Lanreotide Autogel every 14 days in progressive NETs

NCT02651987Phase 2

Key facts

Status: Completed
Start: Dec 2015
Primary completion: Oct 2019
Countries: 10
Sponsor: Ipsen
Modality: Peptides

Drugs: lanreotide
Conditions: Pancreatic neuroendocrine tumor (PanNET)midgut neuroendocrine tumor (MNET)

Overview

Phase 2, open-label, single-arm trial of lanreotide in Pancreatic neuroendocrine tumor (PanNET) and midgut neuroendocrine tumor (MNET), sponsored by Ipsen. Primary endpoint: Median Progression Free Survival at 103 weeks. Started Dec 2015; status: completed.

Design

1 arm

Study design: Non-randomizedOpen-label

Lanreotide Autogel q14d
Lanreotide Autogel 120 mg administered every 14 days.

Who it enrols

Patients with grade 1 or 2, metastatic or locally advanced, unresectable pancreatic or midgut NETs who have progressed on standard Lanreotide Autogel 120 mg every 28 days.

Endpoints

Primary

Median Progression Free Survival103 weeks

Secondary

Median Time to Progression103 weeks
Percentage of Subjects Alive and Progression Free96 weeks
Overall Survival103 weeks
Objective Response Rate96 weeks
Disease Control Rate48 weeks
Best Overall Response Rate103 weeks
Median Duration of Stable Disease103 weeks
Factors Associated With PFSDay 1

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