Telotristat Etiprate Produces Clinical and Biochemical Responses in Patients with Carcinoid Syndrome: Results of a Phase 2, Multicenter, Open-label, Serial-Ascending Study

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Introduction: Excess serotonin (5-HT) in patients (pts) with carcinoid syndrome (CS) is associated with symptoms including increased bowel movement (BM) frequency.

Aim(s): We evaluated the safety/tolerability of telotristat etiprate in CS with intrapatient dose escalation/2 weeks (150, 250, 350, and 500 mg tid) in pts averaging >4 BM/day, with/without concomitant somatostatin analogs.

Materials and methods: Efficacy objectives included evaluation of change in BM/day, stool form, abdominal pain, flushing, adequate relief (AR) of gastrointestinal symptoms, and urinary 5-hydroxyindoleacetic acid (u5-HIAA) levels. The maximum dose/patient was extended for 4 weeks, (total 12 weeks dosing). If a dose limiting toxicity occurred, the dose was reduced to the prior level.

Conference: 10th Annual ENETSConcerence (2013)

Presenting Author:

Authors: Pavel M, Wiedenmann B, Caplin M, Hörsch D, Freiman J,

Keywords: symptom relief, diarrhea,