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

• Status: Completed
• Trial end date: 2014-02-12
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Lexicon Pharmaceuticals

Criteria

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