Telotristat Ethyl in Carcinoid Syndrome: Safety and Efficacy Results of an Open-Label Extension of the TELECAST Phase 3 Clinical Trial

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Introduction: TELECAST assessed telotristat ethyl (TE), a tryptophan hydroxylase inhibitor, in patients (pts) with carcinoid syndrome (CS) with ≥1 CS symptom/sign and a mean 2.5 bowel movements (BMs) per day. Pts were somatostatin analog treated (89%), with gastrointestinal (90%; [diarrhea, 70%]) and cardiac disorders (42%), including carcinoid heart disease. At Week (W) 12, TE (250 and 500 mg 3×/day; tid) significantly reduced urinary 5-hydroxyindoleacetic acid (u5-HIAA) and BMs/day vs placebo (pbo) (p≤0.008). After W12, pts crossed over to an open-label extension (OLE) with TE 500 mg tid (W13–48).

Aim(s): To provide additional OLE data on TE safety and activity.

Materials and methods: A 7-day blinded titration was included at OLE start. Safety and efficacy were assessed up to W48.

Conference: 14th Annual ENETSConcerence (2017)

Presenting Author:

Authors: Pavel M, Benavent M, Perros P, Srirajaskanthan R, Warner R,

Keywords: serotonin, safety,