Patient Interviews in TELESTAR, a Phase 3 Study of Telotristat Etiprate, Report Meaningful Improvement in Carcinoid Syndrome Abstract #1354

Introduction: Telotristat etiprate (TE) reduces serotonin production. In TELESTAR, a phase 3 study in patients (pts) with carcinoid syndrome (CS) on somatostatin analogues with ≥4 bowel movements (BM) per day, TE significantly reduced BM frequency (freq). Overall (n=135), durable response (DR, ≥30% reduction in BMs/day for ≥50% of the study period) was observed in 44% (250 mg tid) and 42% (500 mg tid), vs 20% on placebo (PBO); p≤0.02 for each TE vs. PBO. A subset with similar demographics to the overall trial was interviewed.
Aim(s): To assess pt reported impact of treatment (tx) on CS and whether symptom changes were meaningful.
Materials and methods: Participating sites were asked to invite (prior to randomization) all eligible pts to phone interviews scheduled at the end of the double-blind tx period. Pts and interviewers were blinded to tx.
Conference: 13th Annual ENETS conference (2016)
Category: Medical treatment - Others
Presenting Author: Marianne Pavel

To read results and conclusion, please login ...

Further abstracts you may be interested in

#131 Efficacy and safety results from a Phase II study of pasireotide (SOM230) in the treatment of patients with metastatic NETs refractory or resistant to octreotide LAR
Introduction: Pasireotide, a multi-receptor targeted somatostatin analogue, has 30-, 5- and 39-fold greater affinity for sst1,3 and sst5 receptors, respectively, and a slightly lower affinity for sst2, than octreotide. Because of this multi-receptor binding profile, pasireotide may be effective in controlling symptoms of carcinoid syndrome in patients with gastroenteropancreatic neuroendocrine tumors (NETs) who are no longer responsive to currently available somatostatin analogues.
Conference: 7th Annual ENETS Conference (2010)
Category: Clinical
Presenting Author: Dr Larry K Kvols
#661 Telotristat Etiprate Produces Clinical and Biochemical Responses in Patients with Carcinoid Syndrome: Results of a Phase 2, Multicenter, Open-label, Serial-Ascending Study
Introduction: Excess serotonin (5-HT) in patients (pts) with carcinoid syndrome (CS) is associated with symptoms including increased bowel movement (BM) frequency.
Conference: 10th Annual ENETS Conference (2013)
Category: Medical treatment - Others
Presenting Author: Marianne Pavel
#1856 Relationship Between Symptoms and HRQoL Benefits in Patients (pts) with Carcinoid Syndrome (CS): A Post-Hoc Analysis of Telotristat Ethyl (TE) TELESTAR Trial
Introduction: TELESTAR previously demonstrated the efficacy and safety of TE in pts with CS experiencing >4 Bowel Movements (BM) per day despite stable-dose somatostatin analog therapy. Significantly higher rates of Durable Response (DR, predefined as Bowel Movement (BM) frequency reduction ≥30% from baseline for ≥50% of the 12 week double blind period) were observed with TE (TE 250mg: 44%, TE 500mg: 42%) vs placebo (20%).
Conference: 14th Annual ENETS conference (2017)
Category: Medical treatment - Others
Presenting Author: Florence Marteau
#1940 Impact of Concomitant Medication on Efficacy of Telotristat Ethyl – A Post Hoc Subgroup Analysis of the Phase 3 TELESTAR Study in Carcinoid Syndrome
Introduction: The tryptophan hydroxylase inhibitor telotristat ethyl (TE) significantly reduced bowel movement (BM) frequency versus placebo (pbo) in patients (pts) with carcinoid syndrome (CS) in the TELESTAR study.
Conference: 14th Annual ENETS conference (2017)
Category: Medical treatment - Targeted therapies
Presenting Author: Lowell Anthony
Keywords: serotonin, diarrhea
#1942 Telotristat Ethyl in Carcinoid Syndrome: Safety and Efficacy Results of an Open-Label Extension of the TELECAST Phase 3 Clinical Trial
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).
Conference: 14th Annual ENETS conference (2017)
Category: Medical treatment - SMS analogues, interferon
Presenting Author: Dr. Marianne Pavel
Keywords: serotonin, safety