Study of Telotristat Etiprate (LX1606) in Participants With Symptomatic Carcinoid Syndrome Not Managed by Stable-Dose Octreotide Therapy



Status:Completed
Conditions:Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:12/27/2018
Start Date:March 2009
End Date:June 2014

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A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled, Ascending, Multidose Study To Determine Safety and Tolerability of Orally Administered LX1606 in Subjects With Symptomatic Carcinoid Syndrome Refractory to Stable-Dose Octreotide Long-Acting Release Depot Therapy

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.


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
We found this trial at
9
sites
8303 Dodge Street
Omaha, Nebraska 68114
(402) 354–4000
Nebraska Methodist Hospital Methodist Hospital is a general medical and surgical hospital in Omaha, NE....
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Omaha, NE
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101 Jessup Hall
Iowa City, Iowa 52242
(319) 335-3500
University of Iowa With just over 30,000 students, the University of Iowa is one of...
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Iowa City, IA
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1600 Divisadero Street
San Francisco, California 94115
888.689.8273
UCSF Helen Diller Family Comprehensive Cancer Center UCSF’s long tradition of excellence in cancer research...
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San Francisco, CA
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450 Brookline Ave
Boston, Massachusetts 2215
617-632-3000
Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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Boston, MA
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Houston, Texas 77030
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Houston, TX
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Indianapolis, IN
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Little Rock, Arkansas 72205
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Little Rock, AR
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McAllen, Texas 78503
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McAllen, TX
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Weslaco, Texas 78596
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Weslaco, TX
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