Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
76 participants
INTERVENTIONAL
2014-03-11
2016-03-29
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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250 mg Telotristat Etiprate
Following a 3 to 4-week run-in period, participants were randomized to receive one 250 mg telotristat etiprate tablet and one placebo-matching telotristat etiprate tablet administered three times daily for 12 weeks, followed by a 36 week open-label extension period.
Telotristat etiprate
Telotristat etiprate tablets
Placebo
Placebo-matching telotristat etiprate tablets
500 mg Telotristat Etiprate
Following a 3 to 4-week run-in period, participants were randomized to receive one 250 mg telotristat etiprate tablet and one placebo-matching telotristat etiprate tablet administered three times daily for one week, followed by two 250 mg telotristat etiprate tablets administered three times daily for 11 weeks in the 12 week double-blind treatment period, followed by a 36 week open-label extension period.
Telotristat etiprate
Telotristat etiprate tablets
Placebo
Placebo-matching telotristat etiprate tablets
Placebo
Following a 3 to 4-week run-in period, participants were randomized to receive two placebo-matching telotristat etiprate tablets administered three times daily for 12 weeks, followed by a 36 week open-label extension period.
Placebo
Placebo-matching telotristat etiprate tablets
Interventions
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Telotristat etiprate
Telotristat etiprate tablets
Placebo
Placebo-matching telotristat etiprate tablets
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* All patients of reproductive potential must agree to use an adequate method of contraception during the study and for 12 weeks after the Follow-up visit.
* Histopathologically-confirmed, well-differentiated metastatic neuroendocrine tumor
* Documented history of carcinoid syndrome
* Patient is able and willing to provide written informed consent prior to participation
Exclusion Criteria
* Presence of 12 or more watery bowel movements per day
* Positive stool examination for enteric pathogens, pathogenic ova or parasites, of Clostridium difficile at Screening
* Karnofsky Performance Status ≤ 60%
* Presence of any clinically significant laboratory, medical history, or physical examination findings deemed unacceptable by the Investigator
* A history of short bowel syndrome
* History of constipation within 2 years of Screening
* Life expectancy \< 12 months from Screening
18 Years
ALL
No
Sponsors
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Lexicon Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Pablo Lapuerta, MD
Role: STUDY_DIRECTOR
Lexicon Pharmaceuticals, Inc.
Locations
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Lexicon Investigational Site
Stanford, California, United States
Lexicon Investigational Site
Orlando, Florida, United States
Lexicon Investigational Site
Iowa City, Iowa, United States
Lexicon Investigational Site
Lexington, Kentucky, United States
Lexicon Investigational Site
Boston, Massachusetts, United States
Lexicon Investigational Site
Buffalo, New York, United States
Lexicon Investigational Site
New York, New York, United States
Lexicon Investigational Site
Philadelphia, Pennsylvania, United States
Lexicon Investigational Site
Kogara, New South Wales, Australia
Lexicon Investigational Site
St Leonards, New South Wales, Australia
Lexicon Investigational Site
Herston, Queensland, Australia
Lexicon Investigational Site
East Melbourne, Victoria, Australia
Lexicon Investigational Site
Edegem, , Belgium
Lexicon Investigational Site
Ghent, , Belgium
Lexicon Investigational Site
Yvoir, , Belgium
Lexicon Investigational Site
Calgary, Alberta, Canada
Lexicon Investigational Site
Halifax, Nova Scotia, Canada
Lexicon Investigational Site
Clichy, , France
Lexicon Investigational Site
Lille, , France
Lexicon Investigational Site
Lyon, , France
Lexicon Investigational Site
Marseille, , France
Lexicon Investigational Site
Strasbourg, , France
Lexicon Investigational Site
Villejuif, , France
Lexicon Investigational Site
Bad Berka, , Germany
Lexicon Investigational Site
Berlin, , Germany
Lexicon Investigational Site
Hamburg, , Germany
Lexicon Investigational Site
Heidelberg, , Germany
Lexicon Investigational Site
Lübeck, , Germany
Lexicon Investigational Site
Mainz, , Germany
Lexicon Investigational Site
Marburg, , Germany
Lexicon Investigational Site
Munich, , Germany
Lexicon Investigational Site
Neuss, , Germany
Lexicon Investigational Site
Jerusalem, , Israel
Lexicon Investigational Site
Amsterdam, North Holland, Netherlands
Lexicon Investigational Site
Amsterdam, North Holland, Netherlands
Lexicon Investigational Site
Noord Brahant, , Netherlands
Lexicon Investigative Site
Rotterdam, , Netherlands
Lexicon Investigational Site
Barcelona, , Spain
Lexicon Investigational Site
Barcelona, , Spain
Lexicon Investigational Site
Madrid, , Spain
Lexicon Investigational Site
Madrid, , Spain
Lexicon Investigational Site
Seville, , Spain
Lexicon Investigational Site
Uppsala, , Sweden
Lexicon Investigational Site
Basingstoke Hampshire, , United Kingdom
Lexicon Investigational Site
Coventry, , United Kingdom
Lexicon Investigational Site
London, , United Kingdom
Lexicon Investigational Site
London, , United Kingdom
Lexicon Investigational Site
London, , United Kingdom
Lexicon Investigational Site
Manchester, , United Kingdom
Lexicon Investigational Site
Newcastle upon Tyne, , United Kingdom
Countries
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References
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Srirajaskanthan R, Pavel M, Kulke M, Clement D, Houchard A, Keeber L, Weickert MO. Weight Maintenance up to 48 Weeks in Patients With Carcinoid Syndrome Treated With Telotristat Ethyl: Pooled Data From the Open-Label Extensions of the Phase III Clinical Trials TELESTAR and TELECAST. Clin Ther. 2021 Oct;43(10):1779-1785. doi: 10.1016/j.clinthera.2021.08.014. Epub 2021 Sep 28.
Dillon JS, Kulke MH, Horsch D, Anthony LB, Warner RRP, Bergsland E, Welin S, O'Dorisio TM, Kunz PL, McKee C, Lapuerta P, Banks P, Pavel M. Time to Sustained Improvement in Bowel Movement Frequency with Telotristat Ethyl: Analyses of Phase III Studies in Carcinoid Syndrome. J Gastrointest Cancer. 2021 Mar;52(1):212-221. doi: 10.1007/s12029-020-00375-2.
Pavel M, Gross DJ, Benavent M, Perros P, Srirajaskanthan R, Warner RRP, Kulke MH, Anthony LB, Kunz PL, Horsch D, Weickert MO, Lapuerta P, Jiang W, Kassler-Taub K, Wason S, Fleming R, Fleming D, Garcia-Carbonero R. Telotristat ethyl in carcinoid syndrome: safety and efficacy in the TELECAST phase 3 trial. Endocr Relat Cancer. 2018 Mar;25(3):309-322. doi: 10.1530/ERC-17-0455. Epub 2018 Jan 12.
Other Identifiers
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LX1606.303
Identifier Type: OTHER
Identifier Source: secondary_id
2013-001543-31
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
LX1606.1-303-CS
Identifier Type: -
Identifier Source: org_study_id
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