Telotristat Etiprate - Expanded Treatment for Patients With Carcinoid Syndrome Symptoms

Completed · Phase 3

Conditions studied: Carcinoid Syndrome

In brief

The primary objective of this study is to evaluate the long-term safety and tolerability of orally administered telotristat etiprate.

Key facts

Study ID

NCT02026063

Run by

Lexicon Pharmaceuticals

People needed

124

Starts

2014-01-14

Expected to finish

2018-09-12

Last updated by the study team

2019-09-17

Who can join

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

You may qualify if…

• Ongoing participation in a Phase 2 [LX1606.1-202-CS (NCT00853047), LX1606.1-203-CS (NCT01104415)] or Phase 3 [LX1606.1-301-CS (NCT01677910), LX1606.1-303-CS (NCT02063659)] study
• Patients of childbearing potential must agree to use an adequate method of contraception (defined as having a failure rate of <1% per year) during the study and for 12 weeks after the Follow-up visit.
• Ability and willingness to provide written informed consent

You may not qualify if…

• Major protocol violations or tolerability concerns in a Phase 2 (eg, LX1606.1-202-CS, LX1606.1-203-CS) or Phase 3 (eg, LX1606.1-301-CS, LX1606.1-303-CS) study
• Positive pregnancy test
• Presence of any clinically significant findings at entry for medical history, laboratory values, or physical examination

Where it is running

• Lexicon Investigational Site — Mobile, Alabama, United States
• Lexicon Investigational Site — Stanford, California, 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 — New York, New York, United States
• Lexicon Investigational Site — Philadelphia, Pennsylvania, United States
• 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 Investgational Site — Calgary, Alberta, Canada
• Lexicon Investigational Site — Halifax, Nova Scotia, Canada
• Lexicon Investigational Site — Lille, France
• Lexicon Investigational Site — Lyon, France
• Lexicon Investigational Site — Villejuif, France
• Lexicon Investigational Site — Bad Berka, Germany
• Lexicon Investigational Site — Berlin, Germany
• Lexicon Investigational Site — Essen, Germany
• Lexicon Investigational Site — Hamburg, Germany
• Lexicon Investigational Site — Marburg, Germany
• Lexicon Investigational Site — Jerusalem, Israel
• Lexicon Investigational Site — Milan, Italy

Full record on ClinicalTrials.gov

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