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CBEZ235Z2401: Randomized Phase II Study of BEZ235 or Everolimus (EVE) in Patients with Advanced Pancreatic Neuroendocrine Tumors (pNET)

#1196

Introduction: EVE is an mTOR inhibitor (mTORi) approved for the treatment of advanced pNETs. BEZ235, a dual mTOR/PI3K inhibitor, may provide greater PI3K pathway inhibition and enhanced antitumor effects.

Aim(s): To present selected secondary endpoints (safety and overall response rate [ORR; RECIST v1.0]) from this open label, randomized, ph II trial (NCT01628913; cut-off Oct 2014).

Materials and methods: Eligible pts had advanced, well-differentiated pNETs, no prior mTORi, and disease progression within the past year. Randomization (1:1) was stratified by somatostatin analog use and baseline chromogranin A and/or neuron specific enolase levels. Pts received BEZ235 (400 mg bid) or EVE (10 mg qd).

Conference: 12th Annual ENETSConcerence (2015)

Presenting Author:

Authors: Libutti S, Garcia-Carbonero R, Wolin E, Custodio A, Yao J,

Keywords: pNET, BEZ235, everolimus,

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