Status:
COMPLETED
Study of Telotristat Etiprate (LX1606) in Participants With Symptomatic Carcinoid Syndrome Not Managed by Stable-Dose Octreotide Therapy
Lead Sponsor:
Lexicon Pharmaceuticals
Conditions:
Carcinoid Syndrome
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to evaluate the safety and tolerability of telotristat etiprate (LX1606) versus a placebo control in participants with symptomatic carcinoid syndrome not managed by stable...
Eligibility Criteria
Inclusion
- 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
- Symptoms not managed by stable-dose long-acting octreotide therapy (≥4 bowel movements per day)
- Ability to provide written informed consent
Exclusion
- ≥12 high volume, watery bowel movements per day associated with a clinical syndrome of volume contraction, dehydration, or hypotension compatible with a "pancreatic cholera"-type clinical syndrome
- 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
- Previous exposure to a tryptophan hydroxylase (TPH) inhibitor
- Administration of any investigational drug within 30 days of screening or any therapeutic protein or antibody within 90 days of screening
Key Trial Info
Start Date :
March 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2014
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT00853047
Start Date
March 1 2009
End Date
June 1 2014
Last Update
December 26 2018
Active Locations (9)
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1
Hematology Oncology Services of Arkansas
Little Rock, Arkansas, United States, 72205
2
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, United States, 94115
3
St. Francis Medical Group Oncology and Hematology Specialists
Indianapolis, Indiana, United States, 46237
4
University of Iowa
Iowa City, Iowa, United States, 52242