RT Journal Article
T1 Telotristat ethyl in carcinoid syndrome: safety and efficacy in the TELECAST phase 3 trial.
A1 Pavel, Marianne
A1 Gross, David J
A1 Benavent, Marta
A1 Perros, Petros
A1 Srirajaskanthan, Raj
A1 Warner, Richard R P
A1 Kulke, Matthew H
A1 Anthony, Lowell B
A1 Kunz, Pamela L
A1 Hörsch, Dieter
A1 Weickert, Martin O
A1 Lapuerta, Pablo
A1 Jiang, Wenjun
A1 Kassler-Taub, Kenneth
A1 Wason, Suman
A1 Fleming, Rosanna
A1 Fleming, Douglas
A1 Garcia-Carbonero, Rocio
K1 5-HIAA
K1 carcinoid syndrome
K1 metastatic neuroendocrine tumor
K1 serotonin
K1 somatostatin analog
AB Telotristat ethyl, a tryptophan hydroxylase inhibitor, was efficacious and well tolerated in the phase 3 TELESTAR study in patients with carcinoid syndrome (CS) experiencing ≥4 bowel movements per day (BMs/day) while on somatostatin analogs (SSAs). TELECAST, a phase 3 companion study, assessed the safety and efficacy of telotristat ethyl in patients with CS (diarrhea, flushing, abdominal pain, nausea or elevated urinary 5-hydroxyindoleacetic acid (u5-HIAA)) with <4 BMs/day on SSAs (or ≥1 symptom or ≥4 BMs/day if not on SSAs) during a 12-week double-blind treatment period followed by a 36-week open-label extension (OLE). The primary safety and efficacy endpoints were incidence of treatment-emergent adverse events (TEAEs) and percent change from baseline in 24-h u5-HIAA at week 12. Patients (N = 76) were randomly assigned (1:1:1) to receive placebo or telotristat ethyl 250 mg or 500 mg 3 times per day (tid); 67 continued receiving telotristat ethyl 500 mg tid during the OLE. Through week 12, TEAEs were generally mild to moderate in severity; 5 (placebo), 1 (telotristat ethyl 250 mg) and 3 (telotristat ethyl 500 mg) patients experienced serious events, and the rate of TEAEs in the OLE was comparable. At week 12, significant reductions in u5-HIAA from baseline were observed, with Hodges-Lehmann estimators of median treatment differences from placebo of -54.0% (95% confidence limits, -85.0%, -25.1%, P < 0.001) and -89.7% (95% confidence limits, -113.1%, -63.9%, P < 0.001) for telotristat ethyl 250 mg and 500 mg. These results support the safety and efficacy of telotristat ethyl when added to SSAs in patients with CS diarrhea
PB BioScientifica Ltd.
YR 2018
FD 2018-01-12
LK http://hdl.handle.net/10668/12005
UL http://hdl.handle.net/10668/12005
LA en
NO Pavel M, Gross DJ, Benavent M, Perros P, Srirajaskanthan R, Warner RRP, et al. Telotristat ethyl in carcinoid syndrome: safety and efficacy in the TELECAST phase 3 trial. Endocr Relat Cancer. 2018 Mar;25(3):309-322.
DS RISalud
RD Sep 19, 2025