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Study of Telotristat Etiprate (LX1606) in Participants With Symptomatic Carcinoid Syndrome | Clinical Trials | Clareo Health

COMPLETEDPHASE2

Study of Telotristat Etiprate (LX1606) in Participants With Symptomatic Carcinoid Syndrome

A Phase 2, Open-Label, Multi-Center, Serial Ascending-Dose, Dose-Finding Study to Evaluate the Safety and Tolerability of LX1606 in Subjects With Symptomatic Carcinoid Syndrome

NCT01104415•Lexicon Pharmaceuticals

View on ClinicalTrials.gov

Summary

The purpose of the study is to evaluate the safety and tolerability of orally administered telotristat etiprate (LX1606) in participants with symptomatic carcinoid syndrome.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Males and females, aged 18 and older
•Biopsy-proven metastatic carcinoid tumor of the gastrointestinal (GI) tract with disease extent confirmed by computed tomography (CT), magnetic resonance imaging (MRI), or radionuclide imaging
•Symptomatic carcinoid syndrome (≥4 bowel movements per day)
•Ability to provide written informed consent

Exclusion Criteria

•≥ 12 high-volume, watery bowel movements per day
•Sponsor-unacceptable clinical laboratory values for hematology and liver function tests at screening
•Karnofsky status ≤70% - unable to care for self
•Surgery within 60 days prior to screening
•A history of short bowel syndrome
•Life expectancy \< 12 months
•History of substance or alcohol abuse within 2 years prior to screening
•Administration of any investigational drug within 30 days of screening or any therapeutic protein or antibody within 90 days of screening

Locations (10)

Lexicon Investigational Site

Bad Berka, Germany

Lexicon Investigational Site

Berlin, Germany

Lexicon Investigational Site

Halle, Germany

Lexicon Investigational Site

Lübeck, Germany

Lexicon Investigational Site

Marburg, Germany

Lexicon Investigational Site

Munich, Germany

Lexicon Investigational Site

Basingstoke, United Kingdom

Lexicon Investigational Site

Cambridge, United Kingdom

Lexicon Investigational Site

London, United Kingdom

Lexicon Investigational Site

Manchester, United Kingdom

Key Dates

Start Date

June 15, 2010

Primary Completion Date

February 12, 2014

Completion Date

February 12, 2014

Last Updated

March 15, 2019

Enrollment

ACTUAL participants

Conditions

Carcinoid Syndrome

Interventions

Telotristat etiprate

DRUG

Carcinoid Syndrome Efficacy Study Featuring an Oral Daily Paltusotine Regimen

NCT07087054

Carcinoid SyndromeCarcinoid+7 more

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TERMINATEDNA

Enterade in Carcinoid/Non-Carcinoid Syndrome Neuroendocrine Tumor Patients With Quality of Life Limiting Bowel Frequency

NCT04073017

Neuroendocrine TumorCarcinoid Syndrome

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 15, 2019Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Study of Telotristat Etiprate (LX1606) in Participants With Symptomatic Carcinoid Syndrome

Inclusion Criteria

Exclusion Criteria

Carcinoid Syndrome Efficacy Study Featuring an Oral Daily Paltusotine Regimen

Enterade in Carcinoid/Non-Carcinoid Syndrome Neuroendocrine Tumor Patients With Quality of Life Limiting Bowel Frequency

An Open-label Study to Evaluate the Absorption, Metabolism, and Excretion of [14C]-Telotristat Etiprate in Males

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