Back to resultsTelotristat Etiprate - Expanded Treatment for Patients With Carcinoid Syndrome Symptoms (TELEPATH)
Primary Purpose
Carcinoid Syndrome
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Telotristat etiprate
Sponsored by
About this trial
This is an interventional treatment trial for Carcinoid Syndrome
Eligibility 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
Sites / Locations
- Lexicon Investigational Site
- Lexicon Investigational Site
- Lexicon Investigational Site
- Lexicon Investigational Site
- Lexicon Investigational Site
- Lexicon Investigational Site
- Lexicon Investigational Site
- Lexicon Investigational Site
- Lexicon Investigational Site
- Lexicon Investigational Site
- Lexicon Investigational Site
- Lexicon Investigational Site
- Lexicon Investigational Site
- Lexicon Investgational Site
- Lexicon Investigational Site
- Lexicon Investigational Site
- Lexicon Investigational Site
- Lexicon Investigational Site
- Lexicon Investigational Site
- Lexicon Investigational Site
- Lexicon Investigational Site
- Lexicon Investigational Site
- Lexicon Investigational Site
- Lexicon Investigational Site
- Lexicon Investigational Site
- Lexicon Investigational Site
- Lexicon Investigational Site
- Lexicon Investigational Site
- Lexicon Investigational Site
- Lexicon Investigational Site
- Lexicon Investigational Site
- Lexicon Investigational Site
- Lexicon Investigational Site
- Lexicon Investigational Site
- Lexicon Investigational Site
- Lexicon Investigational Site
- Lexicon Investigational Site
- Lexicon Investigational Site
- Lexicon Investigational Site
- Lexicon Investigational Site
- Lexicon Investigational Site
- Lexicon Investigational Site
- Lexicon Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
250 mg Telotristat Etiprate
500 mg Telotristat Etiprate
Arm Description
One telotristat etiprate (250 mg) tablet administered three times daily.
Two telotristat etiprate (250 mg) tablets administered three times daily.
Outcomes
Primary Outcome Measures
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
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
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30) Score at Each Visit
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).
Change From Baseline in Gastrointestinal Symptoms of Carcinoid Neuroendocrine Tumors (GI.NET21) Score at Each Visit
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).
Percentage of Participants With Adequate Relief as Per Subjective Global Assessment Question
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.
Change From Baseline in Subjective Global Assessment of Carcinoid Syndrome Symptoms on 11-Point Numeric Scale at Each Visit
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.
Full Information
NCT ID
NCT02026063
First Posted
December 31, 2013
Last Updated
August 22, 2019
Sponsor
Lexicon Pharmaceuticals
1. Study Identification
Unique Protocol Identification Number
NCT02026063
Brief Title
Telotristat Etiprate - Expanded Treatment for Patients With Carcinoid Syndrome Symptoms
Acronym
TELEPATH
Official Title
A Multicenter, Long-term Extension Study to Further Evaluate the Safety and Tolerability of Telotristat Etiprate (LX1606)
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
January 14, 2014 (Actual)
Primary Completion Date
September 12, 2018 (Actual)
Study Completion Date
September 12, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lexicon Pharmaceuticals
4. Oversight
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The primary objective of this study is to evaluate the long-term safety and tolerability of orally administered telotristat etiprate.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carcinoid Syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
124 (Actual)
8. Arms, Groups, and Interventions
Arm Title
250 mg Telotristat Etiprate
Arm Type
Experimental
Arm Description
One telotristat etiprate (250 mg) tablet administered three times daily.
Arm Title
500 mg Telotristat Etiprate
Arm Type
Experimental
Arm Description
Two telotristat etiprate (250 mg) tablets administered three times daily.
Intervention Type
Drug
Intervention Name(s)
Telotristat etiprate
Other Intervention Name(s)
LX1606
Intervention Description
Telotristat etiprate tablet (250 mg)
Primary Outcome Measure Information:
Title
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Description
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.
Time Frame
First dose of study drug (Day 1) up to 15 days post last dose (approximately up to 236 weeks)
Secondary Outcome Measure Information:
Title
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30) Score at Each Visit
Description
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).
Time Frame
Baseline, Weeks 24, 48, 72 and 84
Title
Change From Baseline in Gastrointestinal Symptoms of Carcinoid Neuroendocrine Tumors (GI.NET21) Score at Each Visit
Description
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).
Time Frame
Baseline, Weeks 24, 48, 72 and 84
Title
Percentage of Participants With Adequate Relief as Per Subjective Global Assessment Question
Description
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.
Time Frame
Baseline, Weeks 12, 24, 36, 48, 60, 72 and 84
Title
Change From Baseline in Subjective Global Assessment of Carcinoid Syndrome Symptoms on 11-Point Numeric Scale at Each Visit
Description
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.
Time Frame
Baseline, Weeks 12, 24, 36, 48, 60, 72 and 84
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pablo Lapuerta, MD
Organizational Affiliation
Lexicon Pharmaceuticals, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Lexicon Investigational Site
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36604
Country
United States
Facility Name
Lexicon Investigational Site
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
Lexicon Investigational Site
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
Lexicon Investigational Site
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
Facility Name
Lexicon Investigational Site
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Lexicon Investigational Site
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Lexicon Investigational Site
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Lexicon Investigational Site
City
St. Leonards
State/Province
New South Wales
ZIP/Postal Code
2065
Country
Australia
Facility Name
Lexicon Investigational Site
City
Herston
State/Province
Queensland
ZIP/Postal Code
4029
Country
Australia
Facility Name
Lexicon Investigational Site
City
East Melbourne
State/Province
Victoria
ZIP/Postal Code
3002
Country
Australia
Facility Name
Lexicon Investigational Site
City
Edegem
ZIP/Postal Code
B-2650
Country
Belgium
Facility Name
Lexicon Investigational Site
City
Ghent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
Lexicon Investigational Site
City
Yvoir
ZIP/Postal Code
5530
Country
Belgium
Facility Name
Lexicon Investgational Site
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N4N2
Country
Canada
Facility Name
Lexicon Investigational Site
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B0J1N0
Country
Canada
Facility Name
Lexicon Investigational Site
City
Lille
ZIP/Postal Code
59037
Country
France
Facility Name
Lexicon Investigational Site
City
Lyon
ZIP/Postal Code
69437
Country
France
Facility Name
Lexicon Investigational Site
City
Villejuif
ZIP/Postal Code
94805
Country
France
Facility Name
Lexicon Investigational Site
City
Bad Berka
ZIP/Postal Code
99437
Country
Germany
Facility Name
Lexicon Investigational Site
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Facility Name
Lexicon Investigational Site
City
Essen
ZIP/Postal Code
45147
Country
Germany
Facility Name
Lexicon Investigational Site
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
Facility Name
Lexicon Investigational Site
City
Marburg
ZIP/Postal Code
35043
Country
Germany
Facility Name
Lexicon Investigational Site
City
Jerusalem
ZIP/Postal Code
91120
Country
Israel
Facility Name
Lexicon Investigational Site
City
Milano
ZIP/Postal Code
20089
Country
Italy
Facility Name
Lexicon Investigational Site
City
Milano
ZIP/Postal Code
20141
Country
Italy
Facility Name
Lexicon Investigational Site
City
Pisa
ZIP/Postal Code
56124
Country
Italy
Facility Name
Lexicon Investigational Site
City
Torino
ZIP/Postal Code
10043
Country
Italy
Facility Name
Lexicon Investigational Site
City
Amsterdam
ZIP/Postal Code
1105AZ
Country
Netherlands
Facility Name
Lexicon Investigational Site
City
Noord Holland
ZIP/Postal Code
1066CX
Country
Netherlands
Facility Name
Lexicon Investigational Site
City
Noord-Brahant
ZIP/Postal Code
5631BM
Country
Netherlands
Facility Name
Lexicon Investigational Site
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Lexicon Investigational Site
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Name
Lexicon Investigational Site
City
Seville
ZIP/Postal Code
41013
Country
Spain
Facility Name
Lexicon Investigational Site
City
Lund
ZIP/Postal Code
22185
Country
Sweden
Facility Name
Lexicon Investigational Site
City
Uppsala
ZIP/Postal Code
75185
Country
Sweden
Facility Name
Lexicon Investigational Site
City
Coventry
ZIP/Postal Code
CV22DX
Country
United Kingdom
Facility Name
Lexicon Investigational Site
City
Glasgow
ZIP/Postal Code
G120YN
Country
United Kingdom
Facility Name
Lexicon Investigational Site
City
London
ZIP/Postal Code
NW32QG
Country
United Kingdom
Facility Name
Lexicon Investigational Site
City
London
ZIP/Postal Code
SE59RS
Country
United Kingdom
Facility Name
Lexicon Investigational Site
City
London
ZIP/Postal Code
W120HS
Country
United Kingdom
Facility Name
Lexicon Investigational Site
City
Manchester
ZIP/Postal Code
M204BX
Country
United Kingdom
Facility Name
Lexicon Investigational Site
City
Newcastle-Upon-Tyne
ZIP/Postal Code
NE14LP
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
33940581
Citation
Horsch D, Anthony L, Gross DJ, Valle JW, Welin S, Benavent M, Caplin M, Pavel M, Bergsland E, Oberg 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.
Results Reference
derived
Learn more about this trial
Telotristat Etiprate - Expanded Treatment for Patients With Carcinoid Syndrome Symptoms
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