Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT02026063
Registration number
NCT02026063
Ethics application status
Date submitted
31/12/2013
Date registered
1/01/2014
Date last updated
17/09/2019
Titles & IDs
Public title
Telotristat Etiprate - Expanded Treatment for Patients With Carcinoid Syndrome Symptoms
Query!
Scientific title
A Multicenter, Long-term Extension Study to Further Evaluate the Safety and Tolerability of Telotristat Etiprate (LX1606)
Query!
Secondary ID [1]
0
0
LX1606.302
Query!
Secondary ID [2]
0
0
LX1606.1-302-CS
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
TELEPATH
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Carcinoid Syndrome
0
0
Query!
Condition category
Condition code
Cancer
0
0
0
0
Query!
Neuroendocrine tumour (NET)
Query!
Other
0
0
0
0
Query!
Research that is not of generic health relevance and not applicable to specific health categories listed above
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Treatment: Drugs - Telotristat etiprate
Experimental: 250 mg Telotristat Etiprate - One telotristat etiprate (250 mg) tablet administered three times daily.
Experimental: 500 mg Telotristat Etiprate - Two telotristat etiprate (250 mg) tablets administered three times daily.
Treatment: Drugs: Telotristat etiprate
Telotristat etiprate tablet (250 mg)
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Query!
Assessment method [1]
0
0
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.
Query!
Timepoint [1]
0
0
First dose of study drug (Day 1) up to 15 days post last dose (approximately up to 236 weeks)
Query!
Secondary outcome [1]
0
0
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30) Score at Each Visit
Query!
Assessment method [1]
0
0
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).
Query!
Timepoint [1]
0
0
Baseline, Weeks 24, 48, 72 and 84
Query!
Secondary outcome [2]
0
0
Change From Baseline in Gastrointestinal Symptoms of Carcinoid Neuroendocrine Tumors (GI.NET21) Score at Each Visit
Query!
Assessment method [2]
0
0
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).
Query!
Timepoint [2]
0
0
Baseline, Weeks 24, 48, 72 and 84
Query!
Secondary outcome [3]
0
0
Percentage of Participants With Adequate Relief as Per Subjective Global Assessment Question
Query!
Assessment method [3]
0
0
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.
Query!
Timepoint [3]
0
0
Baseline, Weeks 12, 24, 36, 48, 60, 72 and 84
Query!
Secondary outcome [4]
0
0
Change From Baseline in Subjective Global Assessment of Carcinoid Syndrome Symptoms on 11-Point Numeric Scale at Each Visit
Query!
Assessment method [4]
0
0
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.
Query!
Timepoint [4]
0
0
Baseline, Weeks 12, 24, 36, 48, 60, 72 and 84
Query!
Eligibility
Key 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
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key 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
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Non-randomised trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Open (masking not used)
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 3
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
14/01/2014
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
12/09/2018
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
124
Query!
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Query!
Recruitment hospital [1]
0
0
Lexicon Investigational Site - St. Leonards
Query!
Recruitment hospital [2]
0
0
Lexicon Investigational Site - Herston
Query!
Recruitment hospital [3]
0
0
Lexicon Investigational Site - East Melbourne
Query!
Recruitment postcode(s) [1]
0
0
2065 - St. Leonards
Query!
Recruitment postcode(s) [2]
0
0
4029 - Herston
Query!
Recruitment postcode(s) [3]
0
0
3002 - East Melbourne
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
Alabama
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
California
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
Iowa
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
Kentucky
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
Massachusetts
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
New York
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
Pennsylvania
Query!
Country [8]
0
0
Belgium
Query!
State/province [8]
0
0
Edegem
Query!
Country [9]
0
0
Belgium
Query!
State/province [9]
0
0
Ghent
Query!
Country [10]
0
0
Belgium
Query!
State/province [10]
0
0
Yvoir
Query!
Country [11]
0
0
Canada
Query!
State/province [11]
0
0
Alberta
Query!
Country [12]
0
0
Canada
Query!
State/province [12]
0
0
Nova Scotia
Query!
Country [13]
0
0
France
Query!
State/province [13]
0
0
Lille
Query!
Country [14]
0
0
France
Query!
State/province [14]
0
0
Lyon
Query!
Country [15]
0
0
France
Query!
State/province [15]
0
0
Villejuif
Query!
Country [16]
0
0
Germany
Query!
State/province [16]
0
0
Bad Berka
Query!
Country [17]
0
0
Germany
Query!
State/province [17]
0
0
Berlin
Query!
Country [18]
0
0
Germany
Query!
State/province [18]
0
0
Essen
Query!
Country [19]
0
0
Germany
Query!
State/province [19]
0
0
Hamburg
Query!
Country [20]
0
0
Germany
Query!
State/province [20]
0
0
Marburg
Query!
Country [21]
0
0
Israel
Query!
State/province [21]
0
0
Jerusalem
Query!
Country [22]
0
0
Italy
Query!
State/province [22]
0
0
Milano
Query!
Country [23]
0
0
Italy
Query!
State/province [23]
0
0
Pisa
Query!
Country [24]
0
0
Italy
Query!
State/province [24]
0
0
Torino
Query!
Country [25]
0
0
Netherlands
Query!
State/province [25]
0
0
Amsterdam
Query!
Country [26]
0
0
Netherlands
Query!
State/province [26]
0
0
Noord Holland
Query!
Country [27]
0
0
Netherlands
Query!
State/province [27]
0
0
Noord-Brahant
Query!
Country [28]
0
0
Spain
Query!
State/province [28]
0
0
Barcelona
Query!
Country [29]
0
0
Spain
Query!
State/province [29]
0
0
Madrid
Query!
Country [30]
0
0
Spain
Query!
State/province [30]
0
0
Seville
Query!
Country [31]
0
0
Sweden
Query!
State/province [31]
0
0
Lund
Query!
Country [32]
0
0
Sweden
Query!
State/province [32]
0
0
Uppsala
Query!
Country [33]
0
0
United Kingdom
Query!
State/province [33]
0
0
Coventry
Query!
Country [34]
0
0
United Kingdom
Query!
State/province [34]
0
0
Glasgow
Query!
Country [35]
0
0
United Kingdom
Query!
State/province [35]
0
0
London
Query!
Country [36]
0
0
United Kingdom
Query!
State/province [36]
0
0
Manchester
Query!
Country [37]
0
0
United Kingdom
Query!
State/province [37]
0
0
Newcastle-Upon-Tyne
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Query!
Name
Lexicon Pharmaceuticals
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief summary
The primary objective of this study is to evaluate the long-term safety and tolerability of orally administered telotristat etiprate.
Query!
Trial website
https://clinicaltrials.gov/study/NCT02026063
Query!
Trial related presentations / publications
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.
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Pablo Lapuerta, MD
Query!
Address
0
0
Lexicon Pharmaceuticals, Inc.
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Type
Other Details
Attachment
Study protocol
https://cdn.clinicaltrials.gov/large-docs/63/NCT02026063/Prot_000.pdf
Statistical analysis plan
https://cdn.clinicaltrials.gov/large-docs/63/NCT02026063/SAP_001.pdf
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT02026063
Download to PDF