TELEPATH (Expanded Treatment for Carcinoid Syndrome Symptoms)
Research type
Research Study
Full title
A Multicenter, Long-term Extension Study to Further Evaluate the Safety and Tolerability of Telotristat Etiprate (LX1606)
IRAS ID
140107
Contact name
Martyn Caplin
Contact email
Sponsor organisation
Lexicon Pharmaceuticals, Inc.
Eudract number
2013-002596-18
ISRCTN Number
not provided
Research summary
Carcinoid syndrome (CS) is a group of symptoms associated with carcinoid tumours, which are mostly derived from the midgut. They often produce and release large amounts of the chemical messenger 5-hydroxytryptamine (5-HT/serotonin). 5-HT is reportedly involved in various gastrointestinal (GI) disorders. Therefore, such excess of 5-HT is believed to be responsible for the severe diarrhoea and other symptoms of CS.
The current standard of care for patients with CS is symptom management using man-made somatostatin analogs (SSA), but not all patients are suitably controlled and after 12-18 months many patients become resistant to SSA. Also, some patients with CS do not receive SSAs either because of their extensive side effects, requirement for frequent intramuscular injections, or local patterns of care.
Telotristat etiprate is taken orally and inhibits an enzyme involved in the synthesis of 5-HT, called tryptophan hydroxylase (TPH), targeting the cells of the GI tract responsible for 5-HT synthesis in carcinoid tumours. Thus, telotristat etiprate should alleviate the GI and possibly other symptoms due to excess 5-HT in carcinoid patients without central nervous system (brain and spinal cord)-related adverse events.
This extension study will allow for continued access to telotristat etiprate after patients have completed the required study visits in ongoing Phase 2 and Phase 3 studies and allow for the collection of long term safety and efficacy data. Participants will be in the study for up to 50 weeks, including treatment and follow-up. Blood, and urine collection will be performed throughout the study. The study will include 160 patients across Europe, North and South America, the Middle East and Australia. A pharmaceutical company is funding this study.
REC name
London - Brent Research Ethics Committee
REC reference
13/LO/1618
Date of REC Opinion
2 Dec 2013
REC opinion
Further Information Favourable Opinion