Telotristat Etiprate for Carcinoid Syndrome Therapy

Completed · Phase 3 · Has a placebo group

Conditions studied: Carcinoid Syndrome

In brief

The purpose of the study is to evaluate the effect of telotristat etiprate versus placebo on the incidence of treatment-emergent adverse events and on 5-hydroxyindoleacetic acid (5-HIAA) levels.

Key facts

Study ID

NCT02063659

Run by

Lexicon Pharmaceuticals

People needed

76

Starts

2014-03-11

Expected to finish

2016-03-29

Last updated by the study team

2018-02-26

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Lexicon Investigational Site — Stanford, California, United States
• Lexicon Investigational Site — Orlando, Florida, United States
• Lexicon Investigational Site — Iowa City, Iowa, United States
• Lexicon Investigational Site — Lexington, Kentucky, United States
• Lexicon Investigational Site — Boston, Massachusetts, United States
• Lexicon Investigational Site — Buffalo, New York, United States
• Lexicon Investigational Site — New York, New York, United States
• Lexicon Investigational Site — Philadelphia, Pennsylvania, United States
• Lexicon Investigational Site — Kogara, New South Wales, Australia
• Lexicon Investigational Site — St Leonards, New South Wales, Australia
• Lexicon Investigational Site — Herston, Queensland, Australia
• Lexicon Investigational Site — East Melbourne, Victoria, Australia
• Lexicon Investigational Site — Edegem, Belgium
• Lexicon Investigational Site — Ghent, Belgium
• Lexicon Investigational Site — Yvoir, Belgium
• Lexicon Investigational Site — Calgary, Alberta, Canada
• Lexicon Investigational Site — Halifax, Nova Scotia, Canada
• Lexicon Investigational Site — Clichy, France
• Lexicon Investigational Site — Lille, France
• Lexicon Investigational Site — Lyon, France
• Lexicon Investigational Site — Marseille, France
• Lexicon Investigational Site — Strasbourg, France
• Lexicon Investigational Site — Villejuif, France
• Lexicon Investigational Site — Bad Berka, Germany
• Lexicon Investigational Site — Berlin, Germany

Full record on ClinicalTrials.gov

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