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A Randomized Open-label Phase II Study of Everolimus Alone or in Combination with Pasireotide LAR in Advanced, Progressive Pancreatic Neuroendocrine Tumors (pNET): COOPERATE-2 Trial

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Introduction: Pasireotide is a somatostatin analog (SSA) that targets somatostatin receptor subtypes 1-3 and 5. An earlier phase I study showed antitumor activity of everolimus+pasireotide LAR (EVE+PAS) in NET.

Aim(s): To assess the efficacy and safety of EVE+PAS compared to EVE alone in patients (pts) with advanced, progressive pNET.

Materials and methods: We performed a randomized, open-label, phase II study of EVE±PAS in pts with advanced G1/G2 pNET; stratified by prior SSA use, baseline CgA and/or NSE. Primary endpoint was PFS. Secondary endpoints included RECIST-defined tumor response rate, overall survival (OS), and safety.

Conference: 12th Annual ENETSConcerence (2015)

Presenting Author:

Authors: Kulke M, Ruszniewski P, Van Cutsem E, Valle J, De Herder W,

Keywords: everolimus, pNET, pasireotide LAR,

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