Telotristat Etiprate for Carcinoid Syndrome Therapy (TELECAST)
Carcinoid Syndrome
About this trial
This is an interventional treatment trial for Carcinoid Syndrome
Eligibility Criteria
Inclusion Criteria:
- Patients ≥ 18 years of age
- All patients of reproductive potential must agree to use an adequate method of contraception during the study and for 12 weeks after the Follow-up visit.
- Histopathologically-confirmed, well-differentiated metastatic neuroendocrine tumor
- Documented history of carcinoid syndrome
- Patient is able and willing to provide written informed consent prior to participation
Exclusion Criteria:
- Presence of diarrhea attributed to any condition other than carcinoid syndrome.
- Presence of 12 or more watery bowel movements per day
- Positive stool examination for enteric pathogens, pathogenic ova or parasites, of Clostridium difficile at Screening
- Karnofsky Performance Status ≤ 60%
- Presence of any clinically significant laboratory, medical history, or physical examination findings deemed unacceptable by the Investigator
- A history of short bowel syndrome
- History of constipation within 2 years of Screening
- Life expectancy < 12 months from Screening
Sites / Locations
- Lexicon Investigational Site
- Lexicon Investigational Site
- Lexicon Investigational Site
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- Lexicon Investigational Site
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- Lexicon Investigational Site
- Lexicon Investigational Site
- Lexicon Investigational Site
- Lexicon Investigational Site
- Lexicon Investigational Site
- Lexicon Investigational Site
- Lexicon Investigational Site
- Lexicon Investigational Site
- Lexicon Investigational Site
- Lexicon Investigational Site
- Lexicon Investigational Site
- Lexicon Investigational Site
- Lexicon Investigational Site
- Lexicon Investigational Site
- Lexicon Investigational Site
- Lexicon Investigational Site
- Lexicon Investigational Site
- Lexicon Investigational Site
- Lexicon Investigational Site
- Lexicon Investigational Site
- Lexicon Investigational Site
- Lexicon Investigational Site
- Lexicon Investigational Site
- Lexicon Investigational Site
- Lexicon Investigational Site
- Lexicon Investigative Site
- Lexicon Investigational Site
- Lexicon Investigational Site
- Lexicon Investigational Site
- Lexicon Investigational Site
- Lexicon Investigational Site
- Lexicon Investigational Site
- Lexicon Investigational Site
- Lexicon Investigational Site
- Lexicon Investigational Site
- Lexicon Investigational Site
- Lexicon Investigational Site
- Lexicon Investigational Site
- Lexicon Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Placebo Comparator
250 mg Telotristat Etiprate
500 mg Telotristat Etiprate
Placebo
Following a 3 to 4-week run-in period, participants were randomized to receive one 250 mg telotristat etiprate tablet and one placebo-matching telotristat etiprate tablet administered three times daily for 12 weeks, followed by a 36 week open-label extension period.
Following a 3 to 4-week run-in period, participants were randomized to receive one 250 mg telotristat etiprate tablet and one placebo-matching telotristat etiprate tablet administered three times daily for one week, followed by two 250 mg telotristat etiprate tablets administered three times daily for 11 weeks in the 12 week double-blind treatment period, followed by a 36 week open-label extension period.
Following a 3 to 4-week run-in period, participants were randomized to receive two placebo-matching telotristat etiprate tablets administered three times daily for 12 weeks, followed by a 36 week open-label extension period.