Back to resultsTELESTAR (Telotristat Etiprate for Somatostatin Analogue Not Adequately Controlled Carcinoid Syndrome)
Primary Purpose
Carcinoid Syndrome
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Telotristat etiprate
Placebo-matching telotristat etiprate
Sponsored by
About this trial
This is an interventional treatment trial for Carcinoid Syndrome
Eligibility Criteria
Inclusion Criteria:
- Histopathologically-confirmed, well-differentiated metastatic neuroendocrine tumor
- Documented history of carcinoid syndrome and currently experiencing ≥4 bowel movements per day during the Run-in period
- Currently receiving stable-dose somatostatin analog (SSA) therapy
Minimum dose of long-acting release (LAR) or depot SSA therapy
- Octreotide LAR at 30 mg every 4 weeks
- Lanreotide Depot at 120 mg every 4 weeks
- Patients who cannot tolerate SSA therapy at a level indicated above will be allowed to enter at their highest tolerated dose
- Ability and willingness to provide written informed consent
Exclusion Criteria:
- Presence of diarrhea attributed to any condition(s) other than carcinoid syndrome
- Karnofsky Performance status ≤60%
- Treatment with any tumor directed therapy, including interferon, chemotherapy, mechanistic target of rapamycin (mTOR) inhibitors <4 weeks prior to Screening, or hepatic embolization, radiotherapy, radiolabelled SSA, and/or tumor debulking <12 weeks prior to Screening
- History of short bowel syndrome (SBS)
- Clinically significant cardiac arrhythmia, bradycardia, tachycardia that would compromise patient safety or the outcome of the study
- Previous exposure to telotristat etiprate
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 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
- Lexicon Investigational Site
- Lexicon Investigational Site
- Lexicon Invetigational 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
- Lexicon Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Placebo Comparator
Experimental
Arm Label
250 mg Telotristat Etiprate
500 mg Telotristat Etiprate
Placebo
Telotristat Etiprate Open-Label Extension
Arm Description
Following a 3 to 4-week run-in period on stable-dose somatostatin analog (SSA) therapy (octreotide or lanreotide) participants were randomized to receive one 250 mg telotristat etiprate tablet plus one placebo-matching telotristat etiprate tablet administered three times daily for 12 Weeks in the double-blind treatment period, followed by a 36 week open-label extension period.
Following a 3 to 4-week run-in period on stable-dose SSA therapy (octreotide or lanreotide) participants were randomized to receive, one telotristat etiprate 250 mg plus one placebo-matching telotristat etiprate tablet administered 3 times daily for 1 week, followed by two telotristat etiprate (250 mg) tablets administered three times daily for 11 weeks in the double-blind treatment period, followed by a 36 week open-label extension period.
Following a 3 to 4-week run-in period on stable-dose SSA therapy (octreotide or lanreotide) participants were randomized to receive two placebo-matching telotristat etiprate tablets administered three times daily for 12 weeks in the double-blind treatment period, followed by a 36 week open-label extension period.
Patients previously assigned to 250 mg or 500 mg three times daily of telotristat etiprate were administered two 250 mg telotristat etiprate tablets three times daily in a 36 week open-label extension (OLE) period. Patients previously assigned to placebo were administered one 250 mg telotristat etiprate tablet plus one placebo-matching tablet three times daily for one week, followed by two 250 mg telotristat etiprate tablets three times daily for 35 weeks.
Outcomes
Primary Outcome Measures
Change From Baseline in the Number of Bowel Movements (BMs) Per Day Averaged Over 12 Weeks
Participants recorded the number of bowel movements per day in a daily diary. The total number of BMs per day were averaged over the 12-week period. A negative change from Baseline indicates improvement.
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) in the Double-Blind Treatment Period
An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. A TEAE was an AE reported after the first dose of randomized treatment on Day 1.
Number of Participants With TEAEs in the Open-Label Extension Period
An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. A TEAE was an AE reported after the first dose of randomized treatment on Day 1.
Secondary Outcome Measures
Change From Baseline in Urinary 5-hydroxyindoleacetic Acid (u5-HIAA) Levels
u5-HIAA is a standard test used in clinical practice to assess neuroendocrine tumor (NET) activity and is collected as a 24-hour urine specimen. A negative change from Baseline indicates improvement.
Change From Baseline in the Number of Daily Cutaneous Flushing Episodes Averaged Across All Time-Points
Participants recorded the number daily flushing episodes per day in a daily diary. The total number of flushing episodes per day were averaged over the 12-week period. A negative change from Baseline indicates improvement.
Change From Baseline in Abdominal Pain Averaged Across All Time-Points
Participants recorded abdominal pain in a daily diary. Participants evaluated the level of any abdominal pain using an 11-point numeric rating scale, where: 0=no pain to 10=worst pain ever experienced. The average daily abdominal pain was averaged over the 12-week period. A negative change from Baseline indicates improvement.
Full Information
NCT ID
NCT01677910
First Posted
August 30, 2012
Last Updated
January 26, 2018
Sponsor
Lexicon Pharmaceuticals
1. Study Identification
Unique Protocol Identification Number
NCT01677910
Brief Title
TELESTAR (Telotristat Etiprate for Somatostatin Analogue Not Adequately Controlled Carcinoid Syndrome)
Official Title
A Phase 3, Randomized, Placebo-controlled, Parallel Group, Multicenter, Double-blind Study to Evaluate the Efficacy and Safety of Telotristat Etiprate (LX1606) in Patients With Carcinoid Syndrome Not Adequately Controlled by Somatostatin Analog (SSA) Therapy
Study Type
Interventional
2. Study Status
Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
January 8, 2013 (Actual)
Primary Completion Date
March 21, 2016 (Actual)
Study Completion Date
March 21, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lexicon Pharmaceuticals
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The primary objective of the study is to confirm that at least 1 or more doses of telotristat etiprate compared to placebo is effective in reducing the number of daily bowel movements (BMs) from baseline averaged over the 12-week double-blind portion (Treatment Period) of the trial in patients not adequately controlled by current SSA therapy.
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
Model Description
Participants were randomized to one of three treatment arms in the double-blind treatment period. After completion of the double-blind treatment period, participants entered an open-label treatment period.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
135 (Actual)
8. Arms, Groups, and Interventions
Arm Title
250 mg Telotristat Etiprate
Arm Type
Experimental
Arm Description
Following a 3 to 4-week run-in period on stable-dose somatostatin analog (SSA) therapy (octreotide or lanreotide) participants were randomized to receive one 250 mg telotristat etiprate tablet plus one placebo-matching telotristat etiprate tablet administered three times daily for 12 Weeks in the double-blind treatment period, followed by a 36 week open-label extension period.
Arm Title
500 mg Telotristat Etiprate
Arm Type
Experimental
Arm Description
Following a 3 to 4-week run-in period on stable-dose SSA therapy (octreotide or lanreotide) participants were randomized to receive, one telotristat etiprate 250 mg plus one placebo-matching telotristat etiprate tablet administered 3 times daily for 1 week, followed by two telotristat etiprate (250 mg) tablets administered three times daily for 11 weeks in the double-blind treatment period, followed by a 36 week open-label extension period.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Following a 3 to 4-week run-in period on stable-dose SSA therapy (octreotide or lanreotide) participants were randomized to receive two placebo-matching telotristat etiprate tablets administered three times daily for 12 weeks in the double-blind treatment period, followed by a 36 week open-label extension period.
Arm Title
Telotristat Etiprate Open-Label Extension
Arm Type
Experimental
Arm Description
Patients previously assigned to 250 mg or 500 mg three times daily of telotristat etiprate were administered two 250 mg telotristat etiprate tablets three times daily in a 36 week open-label extension (OLE) period. Patients previously assigned to placebo were administered one 250 mg telotristat etiprate tablet plus one placebo-matching tablet three times daily for one week, followed by two 250 mg telotristat etiprate tablets three times daily for 35 weeks.
Intervention Type
Drug
Intervention Name(s)
Telotristat etiprate
Other Intervention Name(s)
LX1606
Intervention Description
Telotristat etiprate tablets.
Intervention Type
Drug
Intervention Name(s)
Placebo-matching telotristat etiprate
Intervention Description
Placebo-matching telotristat etiprate tablets.
Primary Outcome Measure Information:
Title
Change From Baseline in the Number of Bowel Movements (BMs) Per Day Averaged Over 12 Weeks
Description
Participants recorded the number of bowel movements per day in a daily diary. The total number of BMs per day were averaged over the 12-week period. A negative change from Baseline indicates improvement.
Time Frame
Baseline and 12 Weeks
Title
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) in the Double-Blind Treatment Period
Description
An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. A TEAE was an AE reported after the first dose of randomized treatment on Day 1.
Time Frame
First dose of study drug to within 30 days of last dose of study drug in the Double-Blind Treatment Period (Up to 17.6 Weeks)
Title
Number of Participants With TEAEs in the Open-Label Extension Period
Description
An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. A TEAE was an AE reported after the first dose of randomized treatment on Day 1.
Time Frame
First dose of study drug to within 30 days of last dose of study drug in the Open-Label Extension Period (Up to 54.3 Weeks)
Secondary Outcome Measure Information:
Title
Change From Baseline in Urinary 5-hydroxyindoleacetic Acid (u5-HIAA) Levels
Description
u5-HIAA is a standard test used in clinical practice to assess neuroendocrine tumor (NET) activity and is collected as a 24-hour urine specimen. A negative change from Baseline indicates improvement.
Time Frame
Baseline and Week 12
Title
Change From Baseline in the Number of Daily Cutaneous Flushing Episodes Averaged Across All Time-Points
Description
Participants recorded the number daily flushing episodes per day in a daily diary. The total number of flushing episodes per day were averaged over the 12-week period. A negative change from Baseline indicates improvement.
Time Frame
Baseline and 12 Weeks
Title
Change From Baseline in Abdominal Pain Averaged Across All Time-Points
Description
Participants recorded abdominal pain in a daily diary. Participants evaluated the level of any abdominal pain using an 11-point numeric rating scale, where: 0=no pain to 10=worst pain ever experienced. The average daily abdominal pain was averaged over the 12-week period. A negative change from Baseline indicates improvement.
Time Frame
Baseline and 12 Weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Histopathologically-confirmed, well-differentiated metastatic neuroendocrine tumor
Documented history of carcinoid syndrome and currently experiencing ≥4 bowel movements per day during the Run-in period
Currently receiving stable-dose somatostatin analog (SSA) therapy
Minimum dose of long-acting release (LAR) or depot SSA therapy
Octreotide LAR at 30 mg every 4 weeks
Lanreotide Depot at 120 mg every 4 weeks
Patients who cannot tolerate SSA therapy at a level indicated above will be allowed to enter at their highest tolerated dose
Ability and willingness to provide written informed consent
Exclusion Criteria:
Presence of diarrhea attributed to any condition(s) other than carcinoid syndrome
Karnofsky Performance status ≤60%
Treatment with any tumor directed therapy, including interferon, chemotherapy, mechanistic target of rapamycin (mTOR) inhibitors <4 weeks prior to Screening, or hepatic embolization, radiotherapy, radiolabelled SSA, and/or tumor debulking <12 weeks prior to Screening
History of short bowel syndrome (SBS)
Clinically significant cardiac arrhythmia, bradycardia, tachycardia that would compromise patient safety or the outcome of the study
Previous exposure to telotristat etiprate
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
Palo Alto
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
Lexicon Investigational Site
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
Lexicon Investigational Site
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
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
Kenner
State/Province
Louisiana
ZIP/Postal Code
70065
Country
United States
Facility Name
Lexicon Investigational Site
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
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
Omaha
State/Province
Nebraska
ZIP/Postal Code
68114
Country
United States
Facility Name
Lexicon Investigational Site
City
Buffalo
State/Province
New York
ZIP/Postal Code
14263
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
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
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
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Facility Name
Lexicon Investigational Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Lexicon Investigational Site
City
McAllen
State/Province
Texas
ZIP/Postal Code
78503
Country
United States
Facility Name
Lexicon Investigational Site
City
Kogara
State/Province
New South Wales
ZIP/Postal Code
2217
Country
Australia
Facility Name
Lexicon Investigational Site
City
Saint Leanoards
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
Fitzroy
State/Province
Victoria
ZIP/Postal Code
3065
Country
Australia
Facility Name
Lexicon Investigational Site
City
Freemantle
State/Province
Western Australia
ZIP/Postal Code
6160
Country
Australia
Facility Name
Lexicon Investigational Site
City
Woodville South
ZIP/Postal Code
5011
Country
Australia
Facility Name
Lexicon Investigational Site
City
Edegem
ZIP/Postal Code
B-2650
Country
Belgium
Facility Name
Lexicon Investigational Site
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
Lexicon Investigational Site
City
Yvoir
ZIP/Postal Code
B-5530
Country
Belgium
Facility Name
Lexicon Investigational Site
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4N2
Country
Canada
Facility Name
Lexicon Investigational Site
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H2Y9
Country
Canada
Facility Name
Lexicon Investigational Site
City
Clichy
ZIP/Postal Code
92118
Country
France
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
Marseille
ZIP/Postal Code
13385
Country
France
Facility Name
Lexicon Investigational Site
City
Strasbourg
ZIP/Postal Code
67098
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
Heidelberg
ZIP/Postal Code
69120
Country
Germany
Facility Name
Lexicon Investigational Site
City
Lubeck
ZIP/Postal Code
23538
Country
Germany
Facility Name
Lexicon Investigational Site
City
Mainz
ZIP/Postal Code
55131
Country
Germany
Facility Name
Lexicon Investigational Site
City
Marburg
ZIP/Postal Code
35043
Country
Germany
Facility Name
Lexicon Investigational Site
City
Munchen
ZIP/Postal Code
81377
Country
Germany
Facility Name
Lexicon Investigational Site
City
Neuss
ZIP/Postal Code
41464
Country
Germany
Facility Name
Lexicon Invetigational Site
City
Jerusalem
ZIP/Postal Code
91120
Country
Israel
Facility Name
Lexicon Investigational Site
City
Bologna
ZIP/Postal Code
40138
Country
Italy
Facility Name
Lexicon Investigational Site
City
Ferrara
ZIP/Postal Code
44124
Country
Italy
Facility Name
Lexicon Investigational Site
City
Milan
ZIP/Postal Code
20089
Country
Italy
Facility Name
Lexicon Investigational Site
City
Milan
ZIP/Postal Code
20141
Country
Italy
Facility Name
Lexicon Investigational Site
City
Modena
ZIP/Postal Code
41126
Country
Italy
Facility Name
Lexicon Investigational Site
City
Napoli
ZIP/Postal Code
80100
Country
Italy
Facility Name
Lexicon Investigational Site
City
Orbassano
ZIP/Postal Code
10043
Country
Italy
Facility Name
Lexicon Investigational Site
City
Perugia
ZIP/Postal Code
06156
Country
Italy
Facility Name
Lexicon Investigational Site
City
Pisa
ZIP/Postal Code
56124
Country
Italy
Facility Name
Lexicon Investigational Site
City
Rome
ZIP/Postal Code
00189
Country
Italy
Facility Name
Lexicon Investigational Site
City
Amsterdam
ZIP/Postal Code
1105 AZ
Country
Netherlands
Facility Name
Lexicon Investigational Site
City
Noord-Brahant
ZIP/Postal Code
5631BM
Country
Netherlands
Facility Name
Lexicon Investigational Site
City
Noord-Holland
ZIP/Postal Code
1066CX
Country
Netherlands
Facility Name
Lexicon Investigational Site
City
Zuid-Holland
ZIP/Postal Code
3015E
Country
Netherlands
Facility Name
Lexicon Investigational Site
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Lexicon Investigational Site
City
Barcelona
ZIP/Postal Code
08907
Country
Spain
Facility Name
Lexicon Investigational Site
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Name
Lexicon Investigational Site
City
Madrid
ZIP/Postal Code
28040
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
Basingstoke-Hampshire
ZIP/Postal Code
RG249NA
Country
United Kingdom
Facility Name
Lexicon Investigational Site
City
Coventry
ZIP/Postal Code
CV2 2DX
Country
United Kingdom
Facility Name
Lexicon Investigational Site
City
Glasgow
ZIP/Postal Code
G12OYN
Country
United Kingdom
Facility Name
Lexicon Investigational Site
City
Headington-Oxford
ZIP/Postal Code
OX37LJ
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
W12 OHS
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
NE1 4LP
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
34598813
Citation
Srirajaskanthan R, Pavel M, Kulke M, Clement D, Houchard A, Keeber L, Weickert MO. Weight Maintenance up to 48 Weeks in Patients With Carcinoid Syndrome Treated With Telotristat Ethyl: Pooled Data From the Open-Label Extensions of the Phase III Clinical Trials TELESTAR and TELECAST. Clin Ther. 2021 Oct;43(10):1779-1785. doi: 10.1016/j.clinthera.2021.08.014. Epub 2021 Sep 28.
Results Reference
derived
PubMed Identifier
32157590
Citation
Fust K, Maschio M, Kohli M, Singh S, Pritchard DM, Marteau F, Myrenfors P, Feuilly M. A Budget Impact Model of the Addition of Telotristat Ethyl Treatment to the Standard of Care in Patients with Uncontrolled Carcinoid Syndrome. Pharmacoeconomics. 2020 Jun;38(6):607-618. doi: 10.1007/s40273-020-00896-5.
Results Reference
derived
PubMed Identifier
32146619
Citation
Dillon JS, Kulke MH, Horsch D, Anthony LB, Warner RRP, Bergsland E, Welin S, O'Dorisio TM, Kunz PL, McKee C, Lapuerta P, Banks P, Pavel M. Time to Sustained Improvement in Bowel Movement Frequency with Telotristat Ethyl: Analyses of Phase III Studies in Carcinoid Syndrome. J Gastrointest Cancer. 2021 Mar;52(1):212-221. doi: 10.1007/s12029-020-00375-2.
Results Reference
derived
PubMed Identifier
31655936
Citation
Hudgens S, Ramage J, Kulke M, Bergsland E, Anthony L, Caplin M, Oberg K, Pavel M, Gable J, Banks P, Yang QM, Lapuerta P. Evaluation of meaningful change in bowel movement frequency for patients with carcinoid syndrome. J Patient Rep Outcomes. 2019 Oct 26;3(1):64. doi: 10.1186/s41687-019-0153-y.
Results Reference
derived
PubMed Identifier
30477789
Citation
Cella D, Beaumont JL, Hudgens S, Marteau F, Feuilly M, Houchard A, Lapuerta P, Ramage J, Pavel M, Horsch D, Kulke MH. Relationship Between Symptoms and Health-related Quality-of-life Benefits in Patients With Carcinoid Syndrome: Post Hoc Analyses From TELESTAR. Clin Ther. 2018 Dec;40(12):2006-2020.e2. doi: 10.1016/j.clinthera.2018.10.008. Epub 2018 Nov 24.
Results Reference
derived
PubMed Identifier
29724499
Citation
Weickert MO, Kaltsas G, Horsch D, Lapuerta P, Pavel M, Valle JW, Caplin ME, Bergsland E, Kunz PL, Anthony LB, Grande E, Oberg K, Welin S, Lombard-Bohas C, Ramage JK, Kittur A, Yang QM, Kulke MH. Changes in Weight Associated With Telotristat Ethyl in the Treatment of Carcinoid Syndrome. Clin Ther. 2018 Jun;40(6):952-962.e2. doi: 10.1016/j.clinthera.2018.04.006. Epub 2018 May 1.
Results Reference
derived
Learn more about this trial
TELESTAR (Telotristat Etiprate for Somatostatin Analogue Not Adequately Controlled Carcinoid Syndrome)
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