TELESTAR (Telotristat Etiprate for SSA Refractory Carcinoid Syndrome)
Research type
Research Study
Full title
A Phase 3, Randomized, Placebo-controlled, Parallel-group, Multicenter, Double-blind Study to Evaluate the Efficacy and Safety of Telotristat Etiprate (LX1606) in Patients with Carcinoid Syndrome Refractory to Somatostatin Analog (SSA) Therapy
IRAS ID
114803
Contact name
Martyn Caplin
Sponsor organisation
Lexicon Pharmaceuticals, Inc.
Eudract number
2012-003460-47
Clinicaltrials.gov Identifier
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 carcinoid syndrome is symptom management using man-made somatostatin analogs (SSA). SSA are given by injection either two or three times daily or monthly and not all patients are suitably controlled. Also after 12-18 months, many patients become resistant to SSA. SSA can also be associated with pain at injection site, fatty stools, gall stones and abdominal discomfort. 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. The effectiveness of Telotristat Etiprate compared to placebo in reducing the number of daily bowel movements, stool consistency, number of skifluhing episodes, abdominal pain and other GI symptoms in patients resistant to current SSA therapy will be assessed. Overall, subjects could be in the trial for up to 54 weeks (4-week Run-In, 12-week Treatment, 36-week Extension and 2-week Follow-up) and attend up to 15 study visits, though some of these may be held at the patient??s home. Blood, stool and 24-hour urine collection will be performed throughout the study. The study will include a maximum of 105 patients across Europe, North America and Australia. A pharmaceutical company is funding this study.
REC name
London - Brent Research Ethics Committee
REC reference
12/LO/1966
Date of REC Opinion
2 Jan 2013
REC opinion
Favourable Opinion