Telotristat Etiprate - Expanded Treatment for Patients With Carcinoid Syndrome Symptoms (TELEPATH)
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ClinicalTrials.gov Identifier: NCT02026063 |
Recruitment Status :
Completed
First Posted : January 1, 2014
Results First Posted : September 17, 2019
Last Update Posted : September 17, 2019
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Sponsor:
Lexicon Pharmaceuticals
Information provided by (Responsible Party):
Lexicon Pharmaceuticals
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Tracking Information | ||||
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First Submitted Date ICMJE | December 31, 2013 | |||
First Posted Date ICMJE | January 1, 2014 | |||
Results First Submitted Date ICMJE | August 22, 2019 | |||
Results First Posted Date ICMJE | September 17, 2019 | |||
Last Update Posted Date | September 17, 2019 | |||
Actual Study Start Date ICMJE | January 14, 2014 | |||
Actual Primary Completion Date | September 12, 2018 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) [ Time Frame: First dose of study drug (Day 1) up to 15 days post last dose (approximately up to 236 weeks) ] An adverse event (AE) is defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. An AE includes any noxious, pathological, or unintended change in anatomical, physiological, or metabolic functions as indicated by physical signs or symptoms occurring in any phase of the clinical study whether or not considered related to the study medication. A TEAE is an AE that occurs or worsens after receiving study drug.
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Original Primary Outcome Measures ICMJE |
Incidence of treatment-emergent adverse events [ Time Frame: 50 weeks ] | |||
Change History | ||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
Quality of Life measures [ Time Frame: Baseline and every 24 weeks ] EORTC QLQ-C30 (a questionnaire developed to assess the quality of life of cancer patients) and GI.NET21 (module intended for use among patients with G.I.-related neuroendocrine tumours) quality of life questionnaires
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Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Telotristat Etiprate - Expanded Treatment for Patients With Carcinoid Syndrome Symptoms | |||
Official Title ICMJE | A Multicenter, Long-term Extension Study to Further Evaluate the Safety and Tolerability of Telotristat Etiprate (LX1606) | |||
Brief Summary | The primary objective of this study is to evaluate the long-term safety and tolerability of orally administered telotristat etiprate. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 3 | |||
Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Carcinoid Syndrome | |||
Intervention ICMJE | Drug: Telotristat etiprate
Telotristat etiprate tablet (250 mg)
Other Name: LX1606
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Study Arms ICMJE |
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Publications * | Hörsch D, Anthony L, Gross DJ, Valle JW, Welin S, Benavent M, Caplin M, Pavel M, Bergsland E, Öberg K, Kassler-Taub KB, Binder P, Banks P, Lapuerta P, Kulke MH. Long-Term Treatment with Telotristat Ethyl in Patients with Carcinoid Syndrome Symptoms: Results from the TELEPATH Study. Neuroendocrinology. 2022;112(3):298-310. doi: 10.1159/000516958. Epub 2021 May 3. | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
124 | |||
Original Estimated Enrollment ICMJE |
160 | |||
Actual Study Completion Date ICMJE | September 12, 2018 | |||
Actual Primary Completion Date | September 12, 2018 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Australia, Belgium, Canada, France, Germany, Israel, Italy, Netherlands, Spain, Sweden, United Kingdom, United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT02026063 | |||
Other Study ID Numbers ICMJE | LX1606.1-302-CS LX1606.302 ( Other Identifier: Lexicon Pharmaceuticals, Inc. ) 2013-002596-18 ( EudraCT Number ) |
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Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE | Not Provided | |||
Current Responsible Party | Lexicon Pharmaceuticals | |||
Original Responsible Party | Same as current | |||
Current Study Sponsor ICMJE | Lexicon Pharmaceuticals | |||
Original Study Sponsor ICMJE | Same as current | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Lexicon Pharmaceuticals | |||
Verification Date | August 2019 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |