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COMPLETEDPhase 2NCT01104415

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

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

Lead sponsor: Lexicon Pharmaceuticals•10 locations•View source on ClinicalTrials.gov

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Sponsors

Lead Sponsor

Lexicon Pharmaceuticals

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

No

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

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: March 15, 2019Terms

Trial snapshot

StatusCOMPLETED

PhasePHASE2

Enrollment15

Start dateJun 2010

Last updatedMar 15, 2019

Condition

Carcinoid Syndrome

Locations shown

Lexicon Investigational Site

Bad Berka

Lexicon Investigational Site

Berlin

Lexicon Investigational Site

Halle

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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: May 10, 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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