Study of Telotristat Etiprate (LX1606) in Participants With Symptomatic Carcinoid Syndrome Not Managed by Stable-Dose Octreotide Therapy
NCT ID: NCT00853047
Last Updated: 2018-12-26
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
23 participants
INTERVENTIONAL
2009-03-31
2014-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Telotristat Etiprate 150 mg Core Phase
Telotristat etiprate capsules,150 mg orally 3 times daily for 28 days in the double-blind treatment period (core phase) in combination with stable-dose octreotide long-acting release (LAR) depot therapy given once per month. Upon completion of 28-days of treatment, participants were eligible to enter the optional open-label extension period.
Telotristat etiprate
Telotristat etiprate capsules; orally 3 times daily.
Octreotide LAR Depot
A stable-dose octreotide LAR depot therapy; administered subcutaneously once per month.
Telotristat Etiprate 250 mg Core Phase
Telotristat etiprate capsules, 250 mg orally 3 times daily for 28 days in the double-blind treatment period in combination with stable-dose octreotide LAR depot therapy given once per month. Upon completion of 28-days of treatment, participants were eligible to enter the optional open-label extension period.
Telotristat etiprate
Telotristat etiprate capsules; orally 3 times daily.
Octreotide LAR Depot
A stable-dose octreotide LAR depot therapy; administered subcutaneously once per month.
Telotristat Etiprate 350 mg Core Phase
Telotristat etiprate capsules, 350 mg orally 3 times daily for 28 days in the double-blind treatment period in combination with stable-dose octreotide LAR depot therapy given once per month. Upon completion of 28-days of treatment, participants were eligible to enter the optional open-label extension period.
Telotristat etiprate
Telotristat etiprate capsules; orally 3 times daily.
Octreotide LAR Depot
A stable-dose octreotide LAR depot therapy; administered subcutaneously once per month.
Telotristat Etiprate 500 mg Core Phase
Telotristat etiprate capsules, 500 mg orally 3 times daily for 28 days in the double-blind treatment period in combination with a stable-dose octreotide LAR depot therapy given once per month. Upon completion of 28-days of treatment, participants were eligible to enter the optional open-label extension period.
Telotristat etiprate
Telotristat etiprate capsules; orally 3 times daily.
Octreotide LAR Depot
A stable-dose octreotide LAR depot therapy; administered subcutaneously once per month.
Placebo Core Phase
Placebo-matching telotristat etiprate capsules, orally 3 times daily for 28 days in the double-blind treatment period in combination with stable-dose octreotide LAR depot therapy given once per month. Upon completion of 28-days of treatment, participants were eligible to receive telotristat etiprate in the optional open-label extension period.
Octreotide LAR Depot
A stable-dose octreotide LAR depot therapy; administered subcutaneously once per month.
Placebo
Placebo-matching telotristat etiprate capsules; orally 3 times daily.
Telotristat Etiprate Open-Label Extension Phase
Telotristat etiprate at assigned dose level for 8 weeks in combination with stable-dose octreotide LAR depot therapy given once per month in the open-label extension period. Upon completion of the 8-week period, participants could enter an additional extension period of 172 weeks, receiving telotristat etiprate at the assigned dose or maximum tolerated dose (500 mg 3 times daily).
Telotristat etiprate
Telotristat etiprate capsules; orally 3 times daily.
Octreotide LAR Depot
A stable-dose octreotide LAR depot therapy; administered subcutaneously once per month.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Telotristat etiprate
Telotristat etiprate capsules; orally 3 times daily.
Octreotide LAR Depot
A stable-dose octreotide LAR depot therapy; administered subcutaneously once per month.
Placebo
Placebo-matching telotristat etiprate capsules; orally 3 times daily.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Lexicon Pharmaceuticals
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Pablo Lapuerta, MD
Role: STUDY_DIRECTOR
Lexicon Pharmaceuticals, Inc.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Hematology Oncology Services of Arkansas
Little Rock, Arkansas, United States
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, United States
St. Francis Medical Group Oncology and Hematology Specialists
Indianapolis, Indiana, United States
University of Iowa
Iowa City, Iowa, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
Nebraska Methodist Hospital
Omaha, Nebraska, United States
UT M.D. Anderson Cancer Center
Houston, Texas, United States
Texas Oncology - McAllen
McAllen, Texas, United States
Texas Oncology - Weslaco
Weslaco, Texas, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Gelhorn HL, Kulke MH, O'Dorisio T, Yang QM, Jackson J, Jackson S, Boehm KA, Law L, Kostelec J, Auguste P, Lapuerta P. Patient-reported Symptom Experiences in Patients With Carcinoid Syndrome After Participation in a Study of Telotristat Etiprate: A Qualitative Interview Approach. Clin Ther. 2016 Apr;38(4):759-68. doi: 10.1016/j.clinthera.2016.03.002. Epub 2016 Mar 31.
Kulke MH, O'Dorisio T, Phan A, Bergsland E, Law L, Banks P, Freiman J, Frazier K, Jackson J, Yao JC, Kvols L, Lapuerta P, Zambrowicz B, Fleming D, Sands A. Telotristat etiprate, a novel serotonin synthesis inhibitor, in patients with carcinoid syndrome and diarrhea not adequately controlled by octreotide. Endocr Relat Cancer. 2014 Oct;21(5):705-14. doi: 10.1530/ERC-14-0173. Epub 2014 Jul 10.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
LX1606.202
Identifier Type: OTHER
Identifier Source: secondary_id
LX1606.1-202-CS
Identifier Type: -
Identifier Source: org_study_id