Overview
Study of Telotristat Etiprate (LX1606) in Participants With Symptomatic Carcinoid Syndrome Not Managed by Stable-Dose Octreotide Therapy
Status:
Completed
Completed
Trial end date:
2014-06-01
2014-06-01
Target enrollment:
0
0
Participant gender:
All
All
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-dose long-acting octreotide therapy. Following determination of the maximally tolerated or effective dose, cohort expansion will occur to confirm effect on symptoms and safety profile.Phase:
Phase 2Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Lexicon PharmaceuticalsTreatments:
Octreotide
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
- Symptoms not managed by stable-dose long-acting octreotide therapy (≥4 bowel movements
per day)
- Ability to provide written informed consent
Exclusion Criteria:
- ≥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