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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
Sponsor:
Information provided by (Responsible Party):
Lexicon Pharmaceuticals

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Carcinoid Syndrome
Intervention Drug: Telotristat etiprate
Enrollment 124
Recruitment Details  
Pre-assignment Details Participants whose participation was ongoing in 1 of the following studies [LX1606.1-202-CS (NCT00853047), LX1606.1-203-CS (NCT01104415), LX1606.1-301-CS (NCT01677910), LX1606.1-303-CS (NCT02063659)] were eligible to enroll in this long-term safety study at the same dose received in the previous (parent) study.
Arm/Group Title Telotristat Etiprate 250 mg Telotristat Etiprate 500 mg
Hide Arm/Group Description Participants were treated with telotristat etiprate in a previous study for 9 to 46 months. Participants received one telotristat etiprate (250 mg) tablet three times daily (tid) up to an additional 228 weeks in this long-term extension study. Participants were treated with telotristat etiprate in a previous study for 9 to 46 months. Participants received two telotristat etiprate (250 mg) tablets tid up to an additional 204 weeks in this long-term extension study.
Period Title: Overall Study
Started 22 102
Completed 13 53
Not Completed 9 49
Reason Not Completed
Physician Decision             0             10
Noncompliance with Study Drug             1             1
Withdrawal of Consent             1             6
Adverse Event             5             20
Lack of Efficacy             0             4
Lost to Follow-up             0             1
Reason not Specified             2             7
Arm/Group Title Telotristat Etiprate 250 mg Telotristat Etiprate 500 mg Total
Hide Arm/Group Description Participants were treated with telotristat etiprate in a previous study for 9 to 46 months. Participants received one telotristat etiprate (250 mg) tablet three times daily (tid) up to an additional 228 weeks in this long-term extension study. Participants were treated with telotristat etiprate in a previous study for 9 to 46 months. Participants received two telotristat etiprate (250 mg) tablets tid up to an additional 204 weeks in this long-term extension study. Total of all reporting groups
Overall Number of Baseline Participants 22 102 124
Hide Baseline Analysis Population Description
Safety Population included all participants who received any fraction of a dose of telotristat etiprate during the study.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 22 participants 102 participants 124 participants
64.5  (7.60) 63.4  (10.33) 63.6  (9.88)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants 102 participants 124 participants
Female
14
  63.6%
41
  40.2%
55
  44.4%
Male
8
  36.4%
61
  59.8%
69
  55.6%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Race Number Analyzed 22 participants 102 participants 124 participants
White
22
 100.0%
93
  91.2%
115
  92.7%
Black or African American
0
   0.0%
2
   2.0%
2
   1.6%
American Indian or Alaska Native
0
   0.0%
1
   1.0%
1
   0.8%
Other
0
   0.0%
6
   5.9%
6
   4.8%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Ethnicity Number Analyzed 22 participants 102 participants 124 participants
Hispanic or Latino
0
   0.0%
1
   1.0%
1
   0.8%
Not Hispanic or Latino
22
 100.0%
100
  98.0%
122
  98.4%
Unknown
0
   0.0%
1
   1.0%
1
   0.8%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 22 participants 102 participants 124 participants
Canada 1 6 7
Sweden 0 8 8
Netherlands 1 8 9
Belgium 1 3 4
United States 3 28 31
United Kingdom 5 12 17
Italy 0 6 6
Israel 7 0 7
France 0 5 5
Australia 1 5 6
Germany 3 11 14
Spain 0 10 10
1.Primary Outcome
Title Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Hide 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)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population included all participants who received any fraction of a dose of telotristat etiprate during the study.
Arm/Group Title Telotristat Etiprate 250 mg Telotristat Etiprate 500 mg
Hide Arm/Group Description:
Participants were treated with telotristat etiprate in a previous study for 9 to 46 months. Participants received one telotristat etiprate (250 mg) tablet three times daily (tid) up to an additional 228 weeks in this long-term extension study.
Participants were treated with telotristat etiprate in a previous study for 9 to 46 months. Participants received two telotristat etiprate (250 mg) tablets tid up to an additional 204 weeks in this long-term extension study.
Overall Number of Participants Analyzed 22 102
Measure Type: Count of Participants
Unit of Measure: Participants
22
 100.0%
100
  98.0%
2.Secondary Outcome
Title Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30) Score at Each Visit
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Per-Protocol (PP) population=participants who received telotristat etiprate;had no major protocol deviations that interfered with collection/interpretation of efficacy data. Number analyzed=participants with data at given time-point.Participants were combined for this outcome measure as they received dose adjustments per investigator's discretion.
Arm/Group Title Telotristat Etiprate (All Participants)
Hide Arm/Group Description:
Participants were treated with telotristat etiprate in a previous study for 9 to 46 months. Telotristat etiprate (250 or 500 mg) one or two tablets administered tid up to an additional 228 weeks (250 mg) or up to an additional 204 weeks (500 mg) in this long-term extension study.
Overall Number of Participants Analyzed 124
Mean (Standard Deviation)
Unit of Measure: score on a scale
GHS/QOL, Baseline Number Analyzed 118 participants
60.664  (17.4627)
GHS/QOL, Change at Week 24 Number Analyzed 102 participants
-0.980  (17.9878)
GHS/QOL, Change at Week 48 Number Analyzed 88 participants
-4.261  (17.3239)
GHS/QOL, Change at Week 72 Number Analyzed 77 participants
-1.840  (17.0795)
GHS/QOL, Change at Week 84 Number Analyzed 54 participants
0.309  (14.5660)
Physical functioning, Baseline Number Analyzed 120 participants
79.958  (20.3109)
Physical functioning, Change at Week 24 Number Analyzed 103 participants
-2.670  (13.6888)
Physical functioning, Change at Week 48 Number Analyzed 90 participants
-2.667  (13.2129)
Physical functioning, Change at Week 72 Number Analyzed 78 participants
-3.077  (14.8758)
Physical functioning, Change at Week 84 Number Analyzed 55 participants
-1.939  (9.8275)
Role functioning, Baseline Number Analyzed 119 participants
73.810  (26.9766)
Role functioning, Change at Week 24 Number Analyzed 102 participants
-4.248  (23.9965)
Role functioning, Change at Week 48 Number Analyzed 89 participants
-5.431  (27.1518)
Role functioning, Change at Week 72 Number Analyzed 77 participants
-4.329  (23.9399)
Role functioning, Change at Week 84 Number Analyzed 54 participants
-1.543  (21.5414)
Emotional functioning, Baseline Number Analyzed 118 participants
75.683  (21.6630)
Emotional functioning, Change at Week 24 Number Analyzed 102 participants
-1.552  (17.5010)
Emotional functioning, Change at Week 48 Number Analyzed 88 participants
-0.852  (17.5549)
Emotional functioning, Change at Week 72 Number Analyzed 77 participants
-1.623  (19.7313)
Emotional functioning, Change at Week 84 Number Analyzed 54 participants
3.858  (14.3621)
Cognitive functioning, Baseline Number Analyzed 118 participants
78.955  (21.7283)
Cognitive functioning, Change at Week 24 Number Analyzed 102 participants
0.000  (18.1668)
Cognitive functioning, Change at Week 48 Number Analyzed 88 participants
-1.515  (16.8830)
Cognitive functioning, Change at Week 72 Number Analyzed 77 participants
-1.299  (22.2568)
Cognitive functioning, Change at Week 84 Number Analyzed 54 participants
3.086  (18.0478)
Social functioning, Baseline Number Analyzed 118 participants
74.011  (24.1220)
Social functioning, Change at Week 24 Number Analyzed 102 participants
-1.797  (21.2258)
Social functioning, Change at Week 48 Number Analyzed 88 participants
-4.167  (24.5327)
Social functioning, Change at Week 72 Number Analyzed 77 participants
-1.732  (26.0151)
Social functioning, Change at Week 84 Number Analyzed 54 participants
-0.617  (20.7215)
Fatigue, Baseline Number Analyzed 120 participants
33.981  (24.7530)
Fatigue, Change at Week 24 Number Analyzed 103 participants
4.800  (21.3903)
Fatigue, Change at Week 48 Number Analyzed 90 participants
7.284  (20.9473)
Fatigue, Change at Week 72 Number Analyzed 78 participants
6.054  (19.3320)
Fatigue, Change at Week 84 Number Analyzed 55 participants
4.444  (17.8394)
Nausea and vomiting, Baseline Number Analyzed 119 participants
9.104  (13.3312)
Nausea and vomiting, Change at Week 24 Number Analyzed 103 participants
1.618  (15.0371)
Nausea and vomiting, Change at Week 48 Number Analyzed 90 participants
0.556  (14.8757)
Nausea and vomiting, Change at Week 72 Number Analyzed 78 participants
2.137  (20.3432)
Nausea and vomiting, Change at Week 84 Number Analyzed 55 participants
-1.212  (15.3339)
Pain, Baseline Number Analyzed 120 participants
26.528  (25.0579)
Pain, Change at Week 24 Number Analyzed 103 participants
3.722  (21.8845)
Pain, Change at Week 48 Number Analyzed 90 participants
6.481  (22.9930)
Pain, Change at Week 72 Number Analyzed 78 participants
1.709  (26.5351)
Pain, Change at Week 84 Number Analyzed 55 participants
-4.848  (22.3774)
Dyspnea, Baseline Number Analyzed 120 participants
18.611  (24.7474)
Dyspnea, Change at Week 24 Number Analyzed 103 participants
1.294  (19.7602)
Dyspnea, Change at Week 48 Number Analyzed 89 participants
5.618  (22.0399)
Dyspnea, Change at Week 72 Number Analyzed 78 participants
2.564  (21.3331)
Dyspnea, Change at Week 84 Number Analyzed 55 participants
6.667  (16.2288)
Insomnia, Baseline Number Analyzed 120 participants
26.389  (28.6307)
Insomnia, Change at Week 24 Number Analyzed 103 participants
3.560  (26.3679)
Insomnia, Change at Week 48 Number Analyzed 90 participants
3.704  (27.1144)
Insomnia, Change at Week 72 Number Analyzed 78 participants
2.564  (24.4827)
Insomnia, Change at Week 84 Number Analyzed 55 participants
0.000  (21.2762)
Appetite loss, Baseline Number Analyzed 119 participants
13.165  (21.3563)
Appetite loss, Change at Week 24 Number Analyzed 102 participants
3.595  (26.0772)
Appetite loss, Change at Week 48 Number Analyzed 89 participants
3.745  (21.5780)
Appetite loss, Change at Week 72 Number Analyzed 78 participants
10.256  (27.5543)
Appetite loss, Change at Week 84 Number Analyzed 55 participants
4.848  (22.6061)
Constipation, Baseline Number Analyzed 118 participants
7.345  (16.3854)
Constipation, Change at Week 24 Number Analyzed 102 participants
3.595  (18.7079)
Constipation, Change at Week 48 Number Analyzed 88 participants
0.379  (17.8645)
Constipation, Change at Week 72 Number Analyzed 77 participants
4.762  (20.7423)
Constipation, Change at Week 84 Number Analyzed 54 participants
3.086  (19.7134)
Diarrhea, Baseline Number Analyzed 118 participants
42.090  (33.3128)
Diarrhea, Change at Week 24 Number Analyzed 102 participants
1.961  (29.9701)
Diarrhea, Change at Week 48 Number Analyzed 88 participants
5.682  (34.7300)
Diarrhea, Change at Week 72 Number Analyzed 76 participants
3.947  (32.1879)
Diarrhea, Change at Week 84 Number Analyzed 53 participants
0.000  (31.3513)
Financial difficulties, Baseline Number Analyzed 118 participants
18.079  (28.1240)
Financial difficulties, Change at Week 24 Number Analyzed 102 participants
-0.327  (15.9034)
Financial difficulties, Change at Week 48 Number Analyzed 87 participants
1.533  (19.6270)
Financial difficulties, Change at Week 72 Number Analyzed 77 participants
0.433  (25.0692)
Financial difficulties, Change at Week 84 Number Analyzed 54 participants
-1.235  (19.3857)
3.Secondary Outcome
Title Change From Baseline in Gastrointestinal Symptoms of Carcinoid Neuroendocrine Tumors (GI.NET21) Score at Each Visit
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
PP population included the participants who received telotristat etiprate; had no major protocol deviations that interfered with collection/interpretation of efficacy data. Number analyzed=participants with data at given time-point. Participants were combined for this outcome measure as they received dose adjustments per investigator's discretion.
Arm/Group Title Telotristat Etiprate (All Participants)
Hide Arm/Group Description:
Participants were treated with telotristat etiprate in a previous study for 9 to 46 months. Telotristat etiprate (250 or 500 mg) one or two tablets administered tid up to an additional 228 weeks (250 mg) or up to an additional 204 weeks (500 mg) in this long-term extension study.
Overall Number of Participants Analyzed 124
Mean (Standard Deviation)
Unit of Measure: score on a scale
Endocrine scale, Baseline Number Analyzed 120 participants
25.000  (20.6367)
Endocrine scale, Change at Week 24 Number Analyzed 103 participants
1.726  (15.8483)
Endocrine scale, Change at Week 48 Number Analyzed 90 participants
1.111  (17.0717)
Endocrine scale, Change at Week 72 Number Analyzed 78 participants
1.425  (19.8082)
Endocrine scale, Change at Week 84 Number Analyzed 54 participants
4.938  (21.2213)
GI symptoms scale, Baseline Number Analyzed 120 participants
25.014  (17.9343)
GI symptoms scale, Change at Week 24 Number Analyzed 103 participants
3.576  (14.9243)
GI symptoms scale, Change at Week 48 Number Analyzed 90 participants
3.759  (16.7890)
GI symptoms scale, Change at Week 72 Number Analyzed 78 participants
1.581  (19.0823)
GI symptoms scale, Change at Week 84 Number Analyzed 54 participants
-0.278  (17.3137)
Treatment scale, Baseline Number Analyzed 101 participants
10.176  (14.6370)
Treatment scale, Change at Week 24 Number Analyzed 80 participants
-0.486  (13.7849)
Treatment scale, Change at Week 48 Number Analyzed 66 participants
1.684  (14.0873)
Treatment scale, Change at Week 72 Number Analyzed 58 participants
0.575  (18.8668)
Treatment scale, Change at Week 84 Number Analyzed 35 participants
2.063  (20.4384)
Social function scale, Baseline Number Analyzed 120 participants
32.037  (22.8748)
Social function scale, Change at Week 24 Number Analyzed 103 participants
3.128  (16.4229)
Social function scale, Change at Week 48 Number Analyzed 90 participants
2.160  (22.4658)
Social function scale, Change at Week 72 Number Analyzed 77 participants
1.587  (21.3052)
Social function scale, Change at Week 84 Number Analyzed 54 participants
0.000  (18.4415)
DRWS, Baseline Number Analyzed 120 participants
36.713  (26.9224)
DRWS, Change at Week 24 Number Analyzed 103 participants
1.456  (20.4932)
DRWS, Change at Week 48 Number Analyzed 90 participants
-1.049  (22.5767)
DRWS, Change at Week 72 Number Analyzed 77 participants
-0.289  (26.5962)
DRWS, Change at Week 84 Number Analyzed 54 participants
-3.601  (22.4868)
Muscle and BPS, Baseline Number Analyzed 120 participants
30.833  (27.7250)
Muscle and BPS, Change at Week 24 Number Analyzed 102 participants
-3.268  (21.7546)
Muscle and BPS, Change at Week 48 Number Analyzed 90 participants
7.407  (31.9088)
Muscle and BPS, Change at Week 72 Number Analyzed 76 participants
-1.316  (25.2048)
Muscle and BPS, Change at Week 84 Number Analyzed 54 participants
2.469  (24.9543)
Sexual function, Baseline Number Analyzed 91 participants
30.769  (36.5928)
Sexual function, Change at Week 24 Number Analyzed 62 participants
2.151  (29.4893)
Sexual function, Change at Week 48 Number Analyzed 58 participants
-2.299  (24.0711)
Sexual function, Change at Week 72 Number Analyzed 51 participants
-3.922  (24.6280)
Sexual function, Change at Week 84 Number Analyzed 36 participants
-1.852  (19.4274)
Information and CF, Baseline Number Analyzed 120 participants
2.500  (9.8186)
Information and CF, Change at Week 24 Number Analyzed 103 participants
3.236  (17.1591)
Information and CF, Change at Week 48 Number Analyzed 90 participants
0.741  (13.1995)
Information and CF, Change at Week 72 Number Analyzed 77 participants
1.299  (13.7241)
Information and CF, Change at Week 84 Number Analyzed 54 participants
5.556  (25.6978)
Body image, Baseline Number Analyzed 119 participants
11.765  (21.5187)
Body image, Change at Week 24 Number Analyzed 100 participants
6.333  (24.4789)
Body image, Change at Week 48 Number Analyzed 89 participants
5.618  (23.1573)
Body image, Change at Week 72 Number Analyzed 76 participants
6.579  (28.8134)
Body image, Change at Week 84 Number Analyzed 53 participants
3.774  (27.4721)
4.Secondary Outcome
Title Percentage of Participants With Adequate Relief as Per Subjective Global Assessment Question
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
PP population included the participants who received telotristat etiprate; had no major protocol deviations that interfered with collection/interpretation of efficacy data. Number analyzed=participants with data at given time-point. Participants were combined for this outcome measure as they received dose adjustments per investigator's discretion.
Arm/Group Title Telotristat Etiprate (All Participants)
Hide Arm/Group Description:
Participants were treated with telotristat etiprate in a previous study for 9 to 46 months. Telotristat etiprate (250 or 500 mg) one or two tablets administered tid up to an additional 228 weeks (250 mg) or up to an additional 204 weeks (500 mg) in this long-term extension study.
Overall Number of Participants Analyzed 124
Measure Type: Number
Unit of Measure: percentage of participants
Baseline Number Analyzed 99 participants
61.6
Week 12 Number Analyzed 106 participants
64.2
Week 24 Number Analyzed 104 participants
52.9
Week 36 Number Analyzed 95 participants
57.9
Week 48 Number Analyzed 95 participants
61.1
Week 60 Number Analyzed 89 participants
55.1
Week 72 Number Analyzed 77 participants
58.4
Week 84 Number Analyzed 55 participants
67.3
5.Secondary Outcome
Title Change From Baseline in Subjective Global Assessment of Carcinoid Syndrome Symptoms on 11-Point Numeric Scale at Each Visit
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
PP population included the participants who received telotristat etiprate; had no major protocol deviations that interfered with collection/interpretation of efficacy data. Number analyzed=participants with data at given time-point. Participants were combined for this outcome measure as they received dose adjustments per investigator's discretion.
Arm/Group Title Telotristat Etiprate (All Participants)
Hide Arm/Group Description:
Participants were treated with telotristat etiprate in a previous study for 9 to 46 months. Telotristat etiprate (250 or 500 mg) one or two tablets administered tid up to an additional 228 weeks (250 mg) or up to an additional 204 weeks (500 mg) in this long-term extension study.
Overall Number of Participants Analyzed 124
Mean (Standard Deviation)
Unit of Measure: score on a scale
Baseline Number Analyzed 92 participants
3.022  (1.9214)
Change at Week 12 Number Analyzed 86 participants
0.558  (2.4428)
Change at Week 24 Number Analyzed 78 participants
0.654  (2.2553)
Change at Week 36 Number Analyzed 73 participants
0.630  (2.2944)
Change at Week 48 Number Analyzed 71 participants
1.056  (2.5684)
Change at Week 60 Number Analyzed 66 participants
0.576  (1.9773)
Change at Week 72 Number Analyzed 60 participants
0.483  (2.2661)
Change at Week 84 Number Analyzed 45 participants
0.644  (2.2172)
Time Frame First dose of study drug (Day 1) up to 15 days post last dose (approximately up to 236 weeks)
Adverse Event Reporting Description Safety population included all participants who received any fraction of a dose of telotristat etiprate during the study.
 
Arm/Group Title Telotristat Etiprate 250 mg Telotristat Etiprate 500 mg
Hide Arm/Group Description Participants were treated with telotristat etiprate in a previous study for 9 to 46 months. Participants received one telotristat etiprate (250 mg) tablet three times daily (tid) up to an additional 228 weeks in this long-term extension study. Participants were treated with telotristat etiprate in a previous study for 9 to 46 months. Participants received two telotristat etiprate (250 mg) tablets tid up to an additional 204 weeks in this long-term extension study.
All-Cause Mortality
Telotristat Etiprate 250 mg Telotristat Etiprate 500 mg
Affected / at Risk (%) Affected / at Risk (%)
Total   2/22 (9.09%)   18/102 (17.65%) 
Hide Serious Adverse Events
Telotristat Etiprate 250 mg Telotristat Etiprate 500 mg
Affected / at Risk (%) Affected / at Risk (%)
Total   12/22 (54.55%)   54/102 (52.94%) 
Blood and lymphatic system disorders     
Anaemia  1  0/22 (0.00%)  2/102 (1.96%) 
Anaemia of chronic disease  1  0/22 (0.00%)  1/102 (0.98%) 
Coagulopathy  1  0/22 (0.00%)  1/102 (0.98%) 
Leukocytosis  1  0/22 (0.00%)  1/102 (0.98%) 
Cardiac disorders     
Acute coronary syndrome  1  0/22 (0.00%)  2/102 (1.96%) 
Cardiac arrest  1  0/22 (0.00%)  1/102 (0.98%) 
Cardiopulmonary failure  1  0/22 (0.00%)  1/102 (0.98%) 
Myocardial infarction  1  0/22 (0.00%)  1/102 (0.98%) 
Endocrine disorders     
Basedow's disease  1  1/22 (4.55%)  0/102 (0.00%) 
Carcinoid crisis  1  0/22 (0.00%)  1/102 (0.98%) 
Eye disorders     
Visual impairment  1  0/22 (0.00%)  1/102 (0.98%) 
Gastrointestinal disorders     
Abdominal pain  1  0/22 (0.00%)  6/102 (5.88%) 
Diarrhoea  1  0/22 (0.00%)  4/102 (3.92%) 
Intestinal obstruction  1  0/22 (0.00%)  2/102 (1.96%) 
Nausea  1  0/22 (0.00%)  2/102 (1.96%) 
Small intestinal obstruction  1  0/22 (0.00%)  2/102 (1.96%) 
Subileus  1  1/22 (4.55%)  1/102 (0.98%) 
Vomiting  1  0/22 (0.00%)  2/102 (1.96%) 
Ascites  1  0/22 (0.00%)  1/102 (0.98%) 
Constipation  1  0/22 (0.00%)  1/102 (0.98%) 
Gastrointestinal haemorrhage  1  0/22 (0.00%)  1/102 (0.98%) 
Intestinal perforation  1  0/22 (0.00%)  1/102 (0.98%) 
Localised intraabdominal fluid collection  1  0/22 (0.00%)  1/102 (0.98%) 
General disorders     
Disease progression  1  2/22 (9.09%)  11/102 (10.78%) 
General physical health deterioration  1  0/22 (0.00%)  3/102 (2.94%) 
Death  1  0/22 (0.00%)  2/102 (1.96%) 
Complication of device insertion  1  0/22 (0.00%)  1/102 (0.98%) 
Device failure  1  0/22 (0.00%)  1/102 (0.98%) 
Pyrexia  1  0/22 (0.00%)  1/102 (0.98%) 
Hepatobiliary disorders     
Hepatic failure  1  0/22 (0.00%)  2/102 (1.96%) 
Acute hepatic failure  1  0/22 (0.00%)  1/102 (0.98%) 
Cholangitis  1  0/22 (0.00%)  1/102 (0.98%) 
Cholecystitis  1  0/22 (0.00%)  1/102 (0.98%) 
Gallbladder perforation  1  0/22 (0.00%)  1/102 (0.98%) 
Hyperbilirubinaemia  1  0/22 (0.00%)  1/102 (0.98%) 
Infections and infestations     
Pneumonia  1  0/22 (0.00%)  3/102 (2.94%) 
Sepsis  1  1/22 (4.55%)  2/102 (1.96%) 
Abdominal wall abscess  1  0/22 (0.00%)  1/102 (0.98%) 
Campylobacter gastroenteritis  1  0/22 (0.00%)  1/102 (0.98%) 
Infection  1  0/22 (0.00%)  1/102 (0.98%) 
Meningitis  1  0/22 (0.00%)  1/102 (0.98%) 
Meningitis bacterial  1  0/22 (0.00%)  1/102 (0.98%) 
Perihepatic abscess  1  0/22 (0.00%)  1/102 (0.98%) 
Septic shock  1  0/22 (0.00%)  1/102 (0.98%) 
Injury, poisoning and procedural complications     
Anastomotic leak  1  0/22 (0.00%)  1/102 (0.98%) 
Femoral neck fracture  1  0/22 (0.00%)  1/102 (0.98%) 
Hip fracture  1  0/22 (0.00%)  1/102 (0.98%) 
Incisional hernia  1  0/22 (0.00%)  1/102 (0.98%) 
Post procedural haematoma  1  0/22 (0.00%)  1/102 (0.98%) 
Post procedural haemorrhage  1  0/22 (0.00%)  1/102 (0.98%) 
Upper limb fracture  1  1/22 (4.55%)  0/102 (0.00%) 
Wound  1  0/22 (0.00%)  1/102 (0.98%) 
Investigations     
Investigation  1  1/22 (4.55%)  1/102 (0.98%) 
Blood creatinine increased  1  0/22 (0.00%)  1/102 (0.98%) 
General physical condition abnormal  1  0/22 (0.00%)  1/102 (0.98%) 
Hepatic enzyme increased  1  1/22 (4.55%)  0/102 (0.00%) 
Laparoscopy  1  1/22 (4.55%)  0/102 (0.00%) 
Liver function test abnormal  1  0/22 (0.00%)  1/102 (0.98%) 
Metabolism and nutrition disorders     
Decreased appetite  1  0/22 (0.00%)  1/102 (0.98%) 
Hyponatraemia  1  1/22 (4.55%)  0/102 (0.00%) 
Musculoskeletal and connective tissue disorders     
Flank pain  1  0/22 (0.00%)  1/102 (0.98%) 
Musculoskeletal pain  1  0/22 (0.00%)  1/102 (0.98%) 
Osteochondritis  1  1/22 (4.55%)  0/102 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Neuroendocrine tumour  1  2/22 (9.09%)  4/102 (3.92%) 
Breast cancer  1  0/22 (0.00%)  1/102 (0.98%) 
Carcinoid tumour  1  0/22 (0.00%)  1/102 (0.98%) 
Chronic myeloid leukaemia  1  1/22 (4.55%)  0/102 (0.00%) 
Malignant neoplasm progression  1  0/22 (0.00%)  1/102 (0.98%) 
Metastases to bone  1  0/22 (0.00%)  1/102 (0.98%) 
Metastases to central nervous system  1  0/22 (0.00%)  1/102 (0.98%) 
Metastases to ovary  1  1/22 (4.55%)  0/102 (0.00%) 
Metastases to testicle  1  0/22 (0.00%)  1/102 (0.98%) 
Metastatic carcinoid tumour  1  0/22 (0.00%)  1/102 (0.98%) 
Neoplasm  1  0/22 (0.00%)  1/102 (0.98%) 
Squamous cell carcinoma of skin  1  0/22 (0.00%)  1/102 (0.98%) 
Hepatic neoplasm  1  1/22 (4.55%)  0/102 (0.00%) 
Nervous system disorders     
Cervicobrachial syndrome  1  0/22 (0.00%)  1/102 (0.98%) 
Syncope  1  1/22 (4.55%)  2/102 (1.96%) 
Haemorrhagic stroke  1  1/22 (4.55%)  1/102 (0.98%) 
Cerebral ischaemia  1  0/22 (0.00%)  1/102 (0.98%) 
Hepatic encephalopathy  1  0/22 (0.00%)  1/102 (0.98%) 
Loss of consciousness  1  0/22 (0.00%)  1/102 (0.98%) 
Metabolic encephalopathy  1  0/22 (0.00%)  1/102 (0.98%) 
Sciatica  1  0/22 (0.00%)  1/102 (0.98%) 
Spinal cord compression  1  0/22 (0.00%)  1/102 (0.98%) 
Subarachnoid haemorrhage  1  0/22 (0.00%)  1/102 (0.98%) 
Psychiatric disorders     
Confusional state  1  1/22 (4.55%)  0/102 (0.00%) 
Depression  1  0/22 (0.00%)  1/102 (0.98%) 
Mental status changes  1  0/22 (0.00%)  1/102 (0.98%) 
Renal and urinary disorders     
Renal failure acute  1  0/22 (0.00%)  2/102 (1.96%) 
Haematuria  1  0/22 (0.00%)  1/102 (0.98%) 
Ureteric obstruction  1  0/22 (0.00%)  1/102 (0.98%) 
Urinary retention  1  0/22 (0.00%)  1/102 (0.98%) 
Urinary tract obstruction  1  0/22 (0.00%)  1/102 (0.98%) 
Respiratory, thoracic and mediastinal disorders     
Chronic obstructive pulmonary disease  1  0/22 (0.00%)  1/102 (0.98%) 
Dyspnoea  1  0/22 (0.00%)  1/102 (0.98%) 
Hypoxia  1  0/22 (0.00%)  1/102 (0.98%) 
Pneumonia aspiration  1  0/22 (0.00%)  1/102 (0.98%) 
Pneumonitis  1  0/22 (0.00%)  1/102 (0.98%) 
Pulmonary embolism  1  0/22 (0.00%)  1/102 (0.98%) 
Pulmonary oedema  1  0/22 (0.00%)  1/102 (0.98%) 
Respiratory failure  1  0/22 (0.00%)  1/102 (0.98%) 
Surgical and medical procedures     
Radiotherapy  1  0/22 (0.00%)  2/102 (1.96%) 
Ileocolectomy  1  0/22 (0.00%)  1/102 (0.98%) 
Vascular disorders     
Embolism  1  0/22 (0.00%)  1/102 (0.98%) 
Hypertensive crisis  1  0/22 (0.00%)  1/102 (0.98%) 
1
Term from vocabulary, MedDRA (15.1)
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Telotristat Etiprate 250 mg Telotristat Etiprate 500 mg
Affected / at Risk (%) Affected / at Risk (%)
Total   22/22 (100.00%)   100/102 (98.04%) 
Blood and lymphatic system disorders     
Anaemia  1  2/22 (9.09%)  11/102 (10.78%) 
Gastrointestinal disorders     
Diarrhoea  1  9/22 (40.91%)  35/102 (34.31%) 
Nausea  1  5/22 (22.73%)  36/102 (35.29%) 
Abdominal pain  1  3/22 (13.64%)  37/102 (36.27%) 
Constipation  1  3/22 (13.64%)  22/102 (21.57%) 
Vomiting  1  1/22 (4.55%)  24/102 (23.53%) 
Abdominal pain upper  1  2/22 (9.09%)  13/102 (12.75%) 
Flatulence  1  1/22 (4.55%)  7/102 (6.86%) 
Abdominal distension  1  0/22 (0.00%)  6/102 (5.88%) 
Small intestinal obstruction  1  0/22 (0.00%)  6/102 (5.88%) 
Glossodynia  1  2/22 (9.09%)  0/102 (0.00%) 
General disorders     
Fatigue  1  4/22 (18.18%)  28/102 (27.45%) 
Pyrexia  1  1/22 (4.55%)  20/102 (19.61%) 
Disease progression  1  2/22 (9.09%)  16/102 (15.69%) 
Oedema peripheral  1  1/22 (4.55%)  17/102 (16.67%) 
Asthenia  1  0/22 (0.00%)  15/102 (14.71%) 
Chest discomfort  1  2/22 (9.09%)  2/102 (1.96%) 
Infections and infestations     
Nasopharyngitis  1  2/22 (9.09%)  9/102 (8.82%) 
Urinary tract infection  1  2/22 (9.09%)  9/102 (8.82%) 
Influenza  1  2/22 (9.09%)  8/102 (7.84%) 
Upper respiratory tract infection  1  0/22 (0.00%)  6/102 (5.88%) 
Investigations     
Weight decreased  1  1/22 (4.55%)  15/102 (14.71%) 
Gamma-glutamyltransferase increased  1  3/22 (13.64%)  3/102 (2.94%) 
Investigation  1  3/22 (13.64%)  3/102 (2.94%) 
Blood glucose increased  1  2/22 (9.09%)  1/102 (0.98%) 
Metabolism and nutrition disorders     
Decreased appetite  1  3/22 (13.64%)  13/102 (12.75%) 
Dehydration  1  0/22 (0.00%)  7/102 (6.86%) 
Hypokalaemia  1  0/22 (0.00%)  6/102 (5.88%) 
Vitamin D deficiency  1  0/22 (0.00%)  6/102 (5.88%) 
Musculoskeletal and connective tissue disorders     
Back pain  1  0/22 (0.00%)  17/102 (16.67%) 
Arthralgia  1  1/22 (4.55%)  15/102 (14.71%) 
Musculoskeletal pain  1  0/22 (0.00%)  8/102 (7.84%) 
Flank pain  1  1/22 (4.55%)  6/102 (5.88%) 
Pain in extremity  1  2/22 (9.09%)  5/102 (4.90%) 
Neck pain  1  2/22 (9.09%)  4/102 (3.92%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Neuroendocrine tumour  1  2/22 (9.09%)  5/102 (4.90%) 
Nervous system disorders     
Dizziness  1  1/22 (4.55%)  10/102 (9.80%) 
Headache  1  1/22 (4.55%)  10/102 (9.80%) 
Syncope  1  1/22 (4.55%)  10/102 (9.80%) 
Psychiatric disorders     
Depression  1  2/22 (9.09%)  11/102 (10.78%) 
Depressed mood  1  0/22 (0.00%)  9/102 (8.82%) 
Insomnia  1  1/22 (4.55%)  8/102 (7.84%) 
Renal and urinary disorders     
Urinary incontinence  1  2/22 (9.09%)  0/102 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Dyspnoea  1  3/22 (13.64%)  11/102 (10.78%) 
Cough  1  2/22 (9.09%)  10/102 (9.80%) 
Skin and subcutaneous tissue disorders     
Pruritus  1  0/22 (0.00%)  8/102 (7.84%) 
Rash  1  0/22 (0.00%)  6/102 (5.88%) 
Surgical and medical procedures     
Radiotherapy  1  2/22 (9.09%)  2/102 (1.96%) 
Vascular disorders     
Flushing  1  4/22 (18.18%)  13/102 (12.75%) 
Hypertension  1  1/22 (4.55%)  13/102 (12.75%) 
1
Term from vocabulary, MedDRA (15.1)
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Institution must provide any proposed publication or presentation to Sponsor for Sponsor's review, comment and approval at least thirty (30) days prior to the proposed submission for publication date or the proposed presentation date. Sponsor shall have the right to have deleted from the final version of the publication any confidential information, proprietary information, or patentable subject matter.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Pablo Lapuerta, MD
Organization: Lexicon Pharmaceuticals, Inc.
Phone: 281-863-3000
EMail: plapuerta@lexpharma.com
Layout table for additonal information
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 Submitted: December 31, 2013
First Posted: January 1, 2014
Results First Submitted: August 22, 2019
Results First Posted: September 17, 2019
Last Update Posted: September 17, 2019