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Telotristat Etiprate - Expanded Treatment for Patients With Carcinoid Syndrome Symptoms (TELEPATH)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02026063
Recruitment Status : Completed
First Posted : January 1, 2014
Results First Posted : September 17, 2019
Last Update Posted : September 17, 2019
Sponsor:
Information provided by (Responsible Party):
Lexicon Pharmaceuticals

Brief Summary:
The primary objective of this study is to evaluate the long-term safety and tolerability of orally administered telotristat etiprate.

Condition or disease Intervention/treatment Phase
Carcinoid Syndrome Drug: Telotristat etiprate Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 124 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicenter, Long-term Extension Study to Further Evaluate the Safety and Tolerability of Telotristat Etiprate (LX1606)
Actual Study Start Date : January 14, 2014
Actual Primary Completion Date : September 12, 2018
Actual Study Completion Date : September 12, 2018


Arm Intervention/treatment
Experimental: 250 mg Telotristat Etiprate
One telotristat etiprate (250 mg) tablet administered three times daily.
Drug: Telotristat etiprate
Telotristat etiprate tablet (250 mg)
Other Name: LX1606

Experimental: 500 mg Telotristat Etiprate
Two telotristat etiprate (250 mg) tablets administered three times daily.
Drug: Telotristat etiprate
Telotristat etiprate tablet (250 mg)
Other Name: LX1606




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30) Score at Each Visit [ Time Frame: Baseline, Weeks 24, 48, 72 and 84 ]
    QLQ-C30 is a standardized 30-item scale to assess health-related quality of life composed of 5 functional scales (physical functioning [5 items], role functioning [2 items], emotional functioning [4 items], cognitive functioning [2 items], and social functioning [2 items]); 3 symptom scales (fatigue [3 items], nausea/vomiting [2 items], and pain [2 items]); a global health status (GHS) /quality of life (QOL) scale [2 items]; 6 single items (dyspnoea, insomnia, appetite loss, constipation, diarrhoea, and financial difficulties). 28 questions answered:1 (not at all) to 4 (very much) and 2 questions on overall health/QOL answered:1 (poor) to 7 (excellent). All of the scales and single-item measures are transformed to a score:0 to 100. For functioning scales and global QOL higher scores indicate better functioning (a positive change from Baseline indicates improvement); for symptom scales higher scores indicate more severe symptoms (a negative change from Baseline indicates improvement).

  2. Change From Baseline in Gastrointestinal Symptoms of Carcinoid Neuroendocrine Tumors (GI.NET21) Score at Each Visit [ Time Frame: Baseline, Weeks 24, 48, 72 and 84 ]
    GI.NET21 is a standardized 21-item scale composed of both multi-item scales and single-item measures that include 5 functional scales (gastrointestinal (GI) [5 items], endocrine [3 items], treatment-related [3 items], social functioning [3 items], and disease-related worries scale [DRWS] [3 items]) and 4 single items (muscle and bone pain symptom (BPS), sexual functioning, communication function (CF), body image and information about the disease). Each item is scored from 1 (not at all) to 4 (very much). All of the scales and single-item measures are transformed to a score of 0 to 100. For functioning scales higher scores indicate better functioning (a positive change from Baseline indicates improvement); for symptom scales higher scores indicate more severe symptoms (a negative change from Baseline indicates improvement).

  3. Percentage of Participants With Adequate Relief as Per Subjective Global Assessment Question [ Time Frame: Baseline, Weeks 12, 24, 36, 48, 60, 72 and 84 ]
    Participants were asked to respond to the following question: "In the past 7 days, have you had adequate relief of your carcinoid syndrome bowel complaints such as diarrhea, urgent need to have a bowel movement, abdominal pain, or discomfort? The percentage of participants reporting adequate relief (answered Yes) were reported.

  4. Change From Baseline in Subjective Global Assessment of Carcinoid Syndrome Symptoms on 11-Point Numeric Scale at Each Visit [ Time Frame: Baseline, Weeks 12, 24, 36, 48, 60, 72 and 84 ]
    Participants were asked the following question to assess global symptoms associated with carcinoid syndrome (CS) on an 11-point scale: "Rate the severity of your overall carcinoid symptoms over the past 7 days on a scale from 0 to 10, where 0=no symptoms and 10=worst symptoms ever experienced. A negative change from baseline indicated improvement.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Ongoing participation in a Phase 2 [LX1606.1-202-CS (NCT00853047), LX1606.1-203-CS (NCT01104415)] or Phase 3 [LX1606.1-301-CS (NCT01677910), LX1606.1-303-CS (NCT02063659)] study
  • Patients of childbearing potential must agree to use an adequate method of contraception (defined as having a failure rate of <1% per year) during the study and for 12 weeks after the Follow-up visit.
  • Ability and willingness to provide written informed consent

Exclusion Criteria:

  • Major protocol violations or tolerability concerns in a Phase 2 (eg, LX1606.1-202-CS, LX1606.1-203-CS) or Phase 3 (eg, LX1606.1-301-CS, LX1606.1-303-CS) study
  • Positive pregnancy test
  • Presence of any clinically significant findings at entry for medical history, laboratory values, or physical examination

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02026063


Locations
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United States, Alabama
Lexicon Investigational Site
Mobile, Alabama, United States, 36604
United States, California
Lexicon Investigational Site
Stanford, California, United States, 94305
United States, Iowa
Lexicon Investigational Site
Iowa City, Iowa, United States, 52242
United States, Kentucky
Lexicon Investigational Site
Lexington, Kentucky, United States, 40536
United States, Massachusetts
Lexicon Investigational Site
Boston, Massachusetts, United States, 02215
United States, New York
Lexicon Investigational Site
New York, New York, United States, 10029
United States, Pennsylvania
Lexicon Investigational Site
Philadelphia, Pennsylvania, United States, 19104
Australia, New South Wales
Lexicon Investigational Site
St. Leonards, New South Wales, Australia, 2065
Australia, Queensland
Lexicon Investigational Site
Herston, Queensland, Australia, 4029
Australia, Victoria
Lexicon Investigational Site
East Melbourne, Victoria, Australia, 3002
Belgium
Lexicon Investigational Site
Edegem, Belgium, B-2650
Lexicon Investigational Site
Ghent, Belgium, 9000
Lexicon Investigational Site
Yvoir, Belgium, 5530
Canada, Alberta
Lexicon Investgational Site
Calgary, Alberta, Canada, T2N4N2
Canada, Nova Scotia
Lexicon Investigational Site
Halifax, Nova Scotia, Canada, B0J1N0
France
Lexicon Investigational Site
Lille, France, 59037
Lexicon Investigational Site
Lyon, France, 69437
Lexicon Investigational Site
Villejuif, France, 94805
Germany
Lexicon Investigational Site
Bad Berka, Germany, 99437
Lexicon Investigational Site
Berlin, Germany, 13353
Lexicon Investigational Site
Essen, Germany, 45147
Lexicon Investigational Site
Hamburg, Germany, 20246
Lexicon Investigational Site
Marburg, Germany, 35043
Israel
Lexicon Investigational Site
Jerusalem, Israel, 91120
Italy
Lexicon Investigational Site
Milano, Italy, 20089
Lexicon Investigational Site
Milano, Italy, 20141
Lexicon Investigational Site
Pisa, Italy, 56124
Lexicon Investigational Site
Torino, Italy, 10043
Netherlands
Lexicon Investigational Site
Amsterdam, Netherlands, 1105AZ
Lexicon Investigational Site
Noord Holland, Netherlands, 1066CX
Lexicon Investigational Site
Noord-Brahant, Netherlands, 5631BM
Spain
Lexicon Investigational Site
Barcelona, Spain, 08035
Lexicon Investigational Site
Madrid, Spain, 28034
Lexicon Investigational Site
Seville, Spain, 41013
Sweden
Lexicon Investigational Site
Lund, Sweden, 22185
Lexicon Investigational Site
Uppsala, Sweden, 75185
United Kingdom
Lexicon Investigational Site
Coventry, United Kingdom, CV22DX
Lexicon Investigational Site
Glasgow, United Kingdom, G120YN
Lexicon Investigational Site
London, United Kingdom, NW32QG
Lexicon Investigational Site
London, United Kingdom, SE59RS
Lexicon Investigational Site
London, United Kingdom, W120HS
Lexicon Investigational Site
Manchester, United Kingdom, M204BX
Lexicon Investigational Site
Newcastle-Upon-Tyne, United Kingdom, NE14LP
Sponsors and Collaborators
Lexicon Pharmaceuticals
Investigators
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Study Director: Pablo Lapuerta, MD Lexicon Pharmaceuticals, Inc.
  Study Documents (Full-Text)

Documents provided by Lexicon Pharmaceuticals:
Study Protocol  [PDF] November 2, 2015
Statistical Analysis Plan  [PDF] November 24, 2014


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Responsible Party: Lexicon Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02026063    
Other Study ID Numbers: LX1606.1-302-CS
LX1606.302 ( Other Identifier: Lexicon Pharmaceuticals, Inc. )
2013-002596-18 ( EudraCT Number )
First Posted: January 1, 2014    Key Record Dates
Results First Posted: September 17, 2019
Last Update Posted: September 17, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Carcinoid Tumor
Malignant Carcinoid Syndrome
Syndrome
Serotonin Syndrome
Disease
Pathologic Processes
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Drug-Related Side Effects and Adverse Reactions
Chemically-Induced Disorders