Integrated placebo-controlled safety analysis from clinical studies of telotristat ethyl for the treatment of carcinoid syndrome

Kulke, Matthew H.; Hörsch, Dieter; Caplin, Martyn; Anthony, Lowell; Bergsland, Emily K.; Öberg, Kjell; Welin, Staffan; Warner, Richard R.P.; Bohas, C. Lombard; Kunz, Pamela L.; Grande, Enrique; Valle, Juan W.; Lapuerta, Pablo; Banks, Phillip; Jackson, Simon; Jiang, Wenjun; Biran, T.; Pavel, Marianne

doi:10.1093/annonc/mdw369.07

Cited by 3 publications

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“…The results of these studies were consistent and showed a significant reduction in bowel movement frequency (with patient reported improvement of QoL) and a sustained, significant decrease in urinary HIAA. These early clinical studies supported the conduct of a placebo-controlled, double-blind, phase III clinical trial (TELESTAR) of 211 patients with carcinoid syndrome randomly assigned to placebo ( n = 71) or TE 250 mg ( n = 70) or TE 500 mg ( n = 70), each given 3 times per day for 12 weeks [ 75 , 78 ]. Patients who qualified for TELESTAR were on stable-dose SA therapy at enrolment, continued SA therapy throughout study period, and had ≥4 bowel movements per day.…”

Section: Somatostatin Analogs Tryptophan Hydroxylase Inhibitors mentioning

confidence: 98%

Management Options for Advanced Low or Intermediate Grade Gastroenteropancreatic Neuroendocrine Tumors: Review of Recent Literature

Neychev

Kebebew

2017

International Journal of Surgical Oncology

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Our understanding of the biology, genetics, and natural history of neuroendocrine tumors (NETs) of the gastrointestinal tract and pancreas has improved considerably in the last several decades and the spectrum of available therapeutic options is rapidly expanding. The management of patients with metastatic low or intermediate grade NETs has been revolutionized by the development of new treatment strategies such as molecular targeting therapies with everolimus and sunitinib, somatostatin analogs, tryptophan hydroxylase inhibitors, and peptide receptor radionuclide therapy that can be used alone or as a multimodal approach with or without surgery. To further define and clarify the utility, appropriateness, and the sequence of the growing list of available therapies for this patient population will require more high level evidence; however, data from well-designed randomized phase III clinical trials is rapidly accumulating that will further stimulate development of new management strategies. It is therefore important to thoroughly review emerging evidence and report major findings in frequent updates, which will expand our knowledge and contribute to a better understanding, characterization, and management of advanced NETs.

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Section: Somatostatin Analogs Tryptophan Hydroxylase Inhibitors mentioning

confidence: 98%

Management Options for Advanced Low or Intermediate Grade Gastroenteropancreatic Neuroendocrine Tumors: Review of Recent Literature

Neychev

Kebebew

2017

International Journal of Surgical Oncology

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Telotristat ethyl: proof of principle and the first oral agent in the management of well-differentiated metastatic neuroendocrine tumor and carcinoid syndrome diarrhea

Masab

Saif

2017

Cancer Chemother Pharmacol

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Telotristat Ethyl: First Global Approval

Markham

2017

Drugs

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Telotristat ethyl (Xermelo™) is a peripheral tryptophan hydroxylase (TPH) inhibitor that was developed by Lexicon Pharmaceuticals, Inc. for the treatment of carcinoid syndrome. Many neuroendocrine tumours secrete serotonin (5-HT) into the blood stream, resulting in a number of symptoms, notably diarrhoea. Telotristat ethyl inhibits TPH, thereby reducing the production of 5-HT. In February 2017, telotristat ethyl was approved in the USA for the treatment of carcinoid syndrome diarrhoea in combination with somatostatin analog (SSA) therapy in adults inadequately controlled by SSA therapy. This article summarizes the milestones in the development of telotristat ethyl leading to this first global approval.

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Integrated placebo-controlled safety analysis from clinical studies of telotristat ethyl for the treatment of carcinoid syndrome

Cited by 3 publications

References 0 publications

Management Options for Advanced Low or Intermediate Grade Gastroenteropancreatic Neuroendocrine Tumors: Review of Recent Literature

Management Options for Advanced Low or Intermediate Grade Gastroenteropancreatic Neuroendocrine Tumors: Review of Recent Literature

Telotristat ethyl: proof of principle and the first oral agent in the management of well-differentiated metastatic neuroendocrine tumor and carcinoid syndrome diarrhea

Telotristat Ethyl: First Global Approval

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