Efficacy and Safety of Telotristat Etiprate in Patients with Carcinoid Syndrome not Adequately Controlled by Somatostatin Analog Therapy: Analysis of the Ongoing TELESTAR Extension Period

#1333

Introduction: TELESTAR was a pivotal, randomized phase 3 study evaluating telotristat etiprate (TE), a tryptophan hydroxylase inhibitor, among patients (pts) with carcinoid syndrome (CS). When added to somatostatin analogues (SSA), 250 mg tid and 500 mg tid TE each produced significantly greater bowel movement (BM) frequency reduction averaged over 12 weeks (wks) than placebo (PBO) plus SSA (p<0.001). Pts crossed over to open-label (OL) treatment with TE 500 mg tid after Wk 12. The extension phase (Wk 13 to Wk 48) is still ongoing

Aim(s): Examine initial efficacy and safety in the crossover (CO) to OL TE

Materials and methods: Changes from baseline (CFB) in BMs/day were examined at Wks 12, 24, and 36, and safety was reviewed.

Conference: 13th Annual ENETSConcerence (2016)

Presenting Author: Hörsch D

Authors: Hörsch D, Kulke M, Caplin M, Anthony L, Bergsland E,

Keywords: telotristat, carcinoid syndrome, tryptophan,