Telotristat Etiprate Produces Clinical and Biochemical Responses in Patients with Symptomatic Carcinoid Syndrome: Preliminary Results of an Ongoing Phase 2, Multicenter, Open-label, Serial-ascending, European Study

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Introduction: Excess serotonin (5-HT) may cause gastrointestinal (GI) symptoms (e.g., diarrhea) in carcinoid syndrome (CS) patients. Telotristat etiprate is an oral serotonin synthesis inhibitor designed to reduce peripheral 5-HT levels and alleviate GI distress.

Aim(s): This study evaluates the safety and tolerability of intrapatient dose escalation, (150, 250, 350, and 500 mg tid) of telotristat etiprate in symptomatic CS patients, averaging >4 bowel movements (BM)/day, either therapy-naïve or receiving somatostatin analogues.

Materials and methods: Objectives include symptomatic response (change in: number of BM/day, stool form/consistency, sensation of urgency to defecate, severity of nausea, abdominal pain/discomfort, and cutaneous flushing episodes), global assessment of symptoms, assessment of plasma drug concentrations, and pharmacodynamic measures. Dose strength was increased following two weeks of therapy with no dose-limiting toxicity (DLT). The maximum dose for each patient was extended for an additional four weeks. If a DLT occurs, the dose is reduced to prior level.

Conference: 9th Annual ENETSConcerence (2012)

Presenting Author:

Authors: Pavel M, Wiedenmann B, Seufferlein T, Freiman J, Law L,

Keywords: carcinoid syndrome, telotristat etiprate ,