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Telotristat Etiprate for Carcinoid Syndrome Therapy (TELECAST)

Primary Purpose

Carcinoid Syndrome

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Telotristat etiprate
Placebo
Sponsored by
Lexicon Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Carcinoid Syndrome

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients ≥ 18 years of age
  • All patients of reproductive potential must agree to use an adequate method of contraception during the study and for 12 weeks after the Follow-up visit.
  • Histopathologically-confirmed, well-differentiated metastatic neuroendocrine tumor
  • Documented history of carcinoid syndrome
  • Patient is able and willing to provide written informed consent prior to participation

Exclusion Criteria:

  • Presence of diarrhea attributed to any condition other than carcinoid syndrome.
  • Presence of 12 or more watery bowel movements per day
  • Positive stool examination for enteric pathogens, pathogenic ova or parasites, of Clostridium difficile at Screening
  • Karnofsky Performance Status ≤ 60%
  • Presence of any clinically significant laboratory, medical history, or physical examination findings deemed unacceptable by the Investigator
  • A history of short bowel syndrome
  • History of constipation within 2 years of Screening
  • Life expectancy < 12 months from Screening

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 Investigative 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 Type

Experimental

Experimental

Placebo Comparator

Arm Label

250 mg Telotristat Etiprate

500 mg Telotristat Etiprate

Placebo

Arm Description

Following a 3 to 4-week run-in period, participants were randomized to receive one 250 mg telotristat etiprate tablet and one placebo-matching telotristat etiprate tablet administered three times daily for 12 weeks, followed by a 36 week open-label extension period.

Following a 3 to 4-week run-in period, participants were randomized to receive one 250 mg telotristat etiprate tablet and one placebo-matching telotristat etiprate tablet administered three times daily for one week, followed by two 250 mg telotristat etiprate tablets administered three times daily for 11 weeks in the 12 week double-blind treatment period, followed by a 36 week open-label extension period.

Following a 3 to 4-week run-in period, participants were randomized to receive two placebo-matching telotristat etiprate tablets administered three times daily for 12 weeks, followed by a 36 week open-label extension period.

Outcomes

Primary Outcome Measures

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.
Primary: Percent 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.
Number of Participants With Treatment-Emergent Adverse Events (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 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.
Change From Baseline in Stool Form/Consistency Averaged Across All Time-Points
Participants assessed stool form/consistency of a BM using the Bristol Stool Form Scale where: 1=hard lumps to 7=watery liquid. The daily scores were averaged over the 12-week period. A negative change 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.
Change in the Frequency of Rescue Short-acting, Somatostatin Analog (SSA) Used to Treat Carcinoid Syndrome Symptoms Averaged Across All Time-Points
The frequency (the number of times) the participant used rescue with SSA to control symptoms was recorded in a daily diary. The daily number of rescue treatments with SSA was averaged over the 12- week period. A negative change from Baseline (less use of SSA) indicates improvement.
Change From Baseline in the Number of Daily BMs Averaged Over the 12-Week Double-Blind Period, Among Participants Who Were Not Receiving SSA Therapy at Baseline
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.

Full Information

First Posted
February 12, 2014
Last Updated
January 26, 2018
Sponsor
Lexicon Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT02063659
Brief Title
Telotristat Etiprate for Carcinoid Syndrome Therapy
Acronym
TELECAST
Official Title
A Phase 3, Randomized, Placebo-controlled, Multicenter, Double-blind Study to Evaluate the Safety and Efficacy of Telotristat Etiprate (LX1606) in Patients With Carcinoid Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
March 11, 2014 (Actual)
Primary Completion Date
March 29, 2016 (Actual)
Study Completion Date
March 29, 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 purpose of the study is to evaluate the effect of telotristat etiprate versus placebo on the incidence of treatment-emergent adverse events and on 5-hydroxyindoleacetic acid (5-HIAA) levels.

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
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
76 (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, participants were randomized to receive one 250 mg telotristat etiprate tablet and one placebo-matching telotristat etiprate tablet administered three times daily for 12 weeks, 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, participants were randomized to receive one 250 mg telotristat etiprate tablet and one placebo-matching telotristat etiprate tablet administered three times daily for one week, followed by two 250 mg telotristat etiprate tablets administered three times daily for 11 weeks in the 12 week 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, participants were randomized to receive two placebo-matching telotristat etiprate tablets administered three times daily for 12 weeks, followed by a 36 week open-label extension period.
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
Intervention Description
Placebo-matching telotristat etiprate tablets
Primary Outcome Measure Information:
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 17.1 Weeks)
Title
Primary: Percent 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 12 Weeks
Title
Number of Participants With Treatment-Emergent Adverse Events (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 52.6 Weeks)
Secondary 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
Change From Baseline in Stool Form/Consistency Averaged Across All Time-Points
Description
Participants assessed stool form/consistency of a BM using the Bristol Stool Form Scale where: 1=hard lumps to 7=watery liquid. The daily scores were averaged over the 12-week period. A negative change indicates improvement.
Time Frame
Baseline and 12 Weeks
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
Title
Change in the Frequency of Rescue Short-acting, Somatostatin Analog (SSA) Used to Treat Carcinoid Syndrome Symptoms Averaged Across All Time-Points
Description
The frequency (the number of times) the participant used rescue with SSA to control symptoms was recorded in a daily diary. The daily number of rescue treatments with SSA was averaged over the 12- week period. A negative change from Baseline (less use of SSA) indicates improvement.
Time Frame
Baseline and 12 weeks
Title
Change From Baseline in the Number of Daily BMs Averaged Over the 12-Week Double-Blind Period, Among Participants Who Were Not Receiving SSA Therapy at Baseline
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients ≥ 18 years of age All patients of reproductive potential must agree to use an adequate method of contraception during the study and for 12 weeks after the Follow-up visit. Histopathologically-confirmed, well-differentiated metastatic neuroendocrine tumor Documented history of carcinoid syndrome Patient is able and willing to provide written informed consent prior to participation Exclusion Criteria: Presence of diarrhea attributed to any condition other than carcinoid syndrome. Presence of 12 or more watery bowel movements per day Positive stool examination for enteric pathogens, pathogenic ova or parasites, of Clostridium difficile at Screening Karnofsky Performance Status ≤ 60% Presence of any clinically significant laboratory, medical history, or physical examination findings deemed unacceptable by the Investigator A history of short bowel syndrome History of constipation within 2 years of Screening Life expectancy < 12 months from Screening
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
Stanford
State/Province
California
ZIP/Postal Code
94305
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
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
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
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
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
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
Gent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
Lexicon Investigational Site
City
Yvoir
ZIP/Postal Code
5530
Country
Belgium
Facility Name
Lexicon Investigational 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
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
69347
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
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
Munich
ZIP/Postal Code
81377
Country
Germany
Facility Name
Lexicon Investigational Site
City
Neuss
ZIP/Postal Code
41464
Country
Germany
Facility Name
Lexicon Investigational Site
City
Jerusalem
ZIP/Postal Code
91120
Country
Israel
Facility Name
Lexicon Investigational Site
City
Amsterdam
State/Province
Noord-Holland
ZIP/Postal Code
1066X
Country
Netherlands
Facility Name
Lexicon Investigational Site
City
Amsterdam
State/Province
Noord-Holland
ZIP/Postal Code
1105 AZ
Country
Netherlands
Facility Name
Lexicon Investigational Site
City
Noord Brahant
ZIP/Postal Code
5631BM
Country
Netherlands
Facility Name
Lexicon Investigative Site
City
Rotterdam
ZIP/Postal Code
3015 CE
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
Sevilla
ZIP/Postal Code
41013
Country
Spain
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
CV22DX
Country
United Kingdom
Facility Name
Lexicon Investigational Site
City
London
ZIP/Postal Code
NW3 2QG
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
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
29330194
Citation
Pavel M, Gross DJ, Benavent M, Perros P, Srirajaskanthan R, Warner RRP, Kulke MH, Anthony LB, Kunz PL, Horsch D, Weickert MO, Lapuerta P, Jiang W, Kassler-Taub K, Wason S, Fleming R, Fleming D, Garcia-Carbonero R. Telotristat ethyl in carcinoid syndrome: safety and efficacy in the TELECAST phase 3 trial. Endocr Relat Cancer. 2018 Mar;25(3):309-322. doi: 10.1530/ERC-17-0455. Epub 2018 Jan 12.
Results Reference
derived

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Telotristat Etiprate for Carcinoid Syndrome Therapy

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