Study of Telotristat Etiprate (LX1606) in Participants With Symptomatic Carcinoid Syndrome
NCT ID: NCT01104415
Last Updated: 2019-03-15
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
15 participants
INTERVENTIONAL
2010-06-15
2014-02-12
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Telotristat etiprate - Core Phase
Following a 2-week Run-In Period, participants received telotristat etiprate capsules at a starting dose of 150 mg, orally three times daily (TID) for 14 days in the Core Phase. Dose escalations (250 mg, 350 mg, 500 mg) occurred serially every 14 days, up to a maximum dosage of telotristat etiprate 500 mg TID, as guided by specific clinical criteria for dose escalation. Upon completion of 12 weeks of treatment, participants were eligible to receive telotristat etiprate in the optional Open-label Extension Period.
Telotristat etiprate
Telotristat etiprate capsules orally three times daily.
Telotristat etiprate - Extension Period
Participants received telotristat etiprate at their highest tolerated dose (250 mg or 500 mg), orally, TID for 124 weeks in the Open-label Extension Period. If neither dose was tolerated participants were discontinued from the study and completed the 2-week Follow-up Visit.
Telotristat etiprate
Telotristat etiprate capsules orally three times daily.
Interventions
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Telotristat etiprate
Telotristat etiprate capsules orally three times daily.
Other Intervention Names
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Eligibility Criteria
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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
* Symptomatic carcinoid syndrome (≥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
* 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
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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
Bad Berka, , Germany
Lexicon Investigational Site
Berlin, , Germany
Lexicon Investigational Site
Halle, , Germany
Lexicon Investigational Site
Lübeck, , Germany
Lexicon Investigational Site
Marburg, , Germany
Lexicon Investigational Site
Munich, , Germany
Lexicon Investigational Site
Basingstoke, , United Kingdom
Lexicon Investigational Site
Cambridge, , United Kingdom
Lexicon Investigational Site
London, , United Kingdom
Lexicon Investigational Site
Manchester, , United Kingdom
Countries
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References
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Pavel M, Horsch D, Caplin M, Ramage J, Seufferlein T, Valle J, Banks P, Lapuerta P, Sands A, Zambrowicz B, Fleming D, Wiedenmann B. Telotristat etiprate for carcinoid syndrome: a single-arm, multicenter trial. J Clin Endocrinol Metab. 2015 Apr;100(4):1511-9. doi: 10.1210/jc.2014-2247. Epub 2015 Jan 30.
Other Identifiers
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LX1606.203, LX1032
Identifier Type: OTHER
Identifier Source: secondary_id
2009-016973-13
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
LX1606.1-203-CS
Identifier Type: -
Identifier Source: org_study_id
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