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

Use our guide to learn which trials are right for you!

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
Little Rock, Arkansas 72205
?
mi
from
Little Rock, AR
Click here to add this to my saved trials
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...
?
mi
from
Iowa City, IA
Click here to add this to my saved trials
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...
?
mi
from
San Francisco, CA
Click here to add this to my saved trials
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...
?
mi
from
Boston, MA
Click here to add this to my saved trials
Houston, Texas 77030
?
mi
from
Houston, TX
Click here to add this to my saved trials
?
mi
from
Indianapolis, IN
Click here to add this to my saved trials
McAllen, Texas 78503
?
mi
from
McAllen, TX
Click here to add this to my saved trials
8303 Dodge Street
Omaha, Nebraska 68114
(402) 354–4000
Nebraska Methodist Hospital Methodist Hospital is a general medical and surgical hospital in Omaha, NE....
?
mi
from
Omaha, NE
Click here to add this to my saved trials
Weslaco, Texas 78596
?
mi
from
Weslaco, TX
Click here to add this to my saved trials