Trial Review

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
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/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
Scientific title
A Multicenter, Long-term Extension Study to Further Evaluate the Safety and Tolerability of Telotristat Etiprate (LX1606)
Secondary ID [1] 0 0
LX1606.302
Secondary ID [2] 0 0
LX1606.1-302-CS
Universal Trial Number (UTN)
Trial acronym
TELEPATH
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Carcinoid Syndrome 0 0
Condition category
Condition code
Cancer 0 0 0 0
Neuroendocrine tumour (NET)
Other 0 0 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Interventional
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)
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Timepoint [1] 0 0
First dose of study drug (Day 1) up to 15 days post last dose (approximately up to 236 weeks)
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
Timepoint [1] 0 0
Baseline, Weeks 24, 48, 72 and 84
Secondary outcome [2] 0 0
Change From Baseline in Gastrointestinal Symptoms of Carcinoid Neuroendocrine Tumors (GI.NET21) Score at Each Visit
Timepoint [2] 0 0
Baseline, Weeks 24, 48, 72 and 84
Secondary outcome [3] 0 0
Percentage of Participants With Adequate Relief as Per Subjective Global Assessment Question
Timepoint [3] 0 0
Baseline, Weeks 12, 24, 36, 48, 60, 72 and 84
Secondary outcome [4] 0 0
Change From Baseline in Subjective Global Assessment of Carcinoid Syndrome Symptoms on 11-Point Numeric Scale at Each Visit
Timepoint [4] 0 0
Baseline, Weeks 12, 24, 36, 48, 60, 72 and 84

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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
14/01/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
12/09/2018
Sample size
Target
Accrual to date
Final
124
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
Lexicon Investigational Site - St. Leonards
Recruitment hospital [2] 0 0
Lexicon Investigational Site - Herston
Recruitment hospital [3] 0 0
Lexicon Investigational Site - East Melbourne
Recruitment postcode(s) [1] 0 0
2065 - St. Leonards
Recruitment postcode(s) [2] 0 0
4029 - Herston
Recruitment postcode(s) [3] 0 0
3002 - East Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Iowa
Country [4] 0 0
United States of America
State/province [4] 0 0
Kentucky
Country [5] 0 0
United States of America
State/province [5] 0 0
Massachusetts
Country [6] 0 0
United States of America
State/province [6] 0 0
New York
Country [7] 0 0
United States of America
State/province [7] 0 0
Pennsylvania
Country [8] 0 0
Belgium
State/province [8] 0 0
Edegem
Country [9] 0 0
Belgium
State/province [9] 0 0
Ghent
Country [10] 0 0
Belgium
State/province [10] 0 0
Yvoir
Country [11] 0 0
Canada
State/province [11] 0 0
Alberta
Country [12] 0 0
Canada
State/province [12] 0 0
Nova Scotia
Country [13] 0 0
France
State/province [13] 0 0
Lille
Country [14] 0 0
France
State/province [14] 0 0
Lyon
Country [15] 0 0
France
State/province [15] 0 0
Villejuif
Country [16] 0 0
Germany
State/province [16] 0 0
Bad Berka
Country [17] 0 0
Germany
State/province [17] 0 0
Berlin
Country [18] 0 0
Germany
State/province [18] 0 0
Essen
Country [19] 0 0
Germany
State/province [19] 0 0
Hamburg
Country [20] 0 0
Germany
State/province [20] 0 0
Marburg
Country [21] 0 0
Israel
State/province [21] 0 0
Jerusalem
Country [22] 0 0
Italy
State/province [22] 0 0
Milano
Country [23] 0 0
Italy
State/province [23] 0 0
Pisa
Country [24] 0 0
Italy
State/province [24] 0 0
Torino
Country [25] 0 0
Netherlands
State/province [25] 0 0
Amsterdam
Country [26] 0 0
Netherlands
State/province [26] 0 0
Noord Holland
Country [27] 0 0
Netherlands
State/province [27] 0 0
Noord-Brahant
Country [28] 0 0
Spain
State/province [28] 0 0
Barcelona
Country [29] 0 0
Spain
State/province [29] 0 0
Madrid
Country [30] 0 0
Spain
State/province [30] 0 0
Seville
Country [31] 0 0
Sweden
State/province [31] 0 0
Lund
Country [32] 0 0
Sweden
State/province [32] 0 0
Uppsala
Country [33] 0 0
United Kingdom
State/province [33] 0 0
Coventry
Country [34] 0 0
United Kingdom
State/province [34] 0 0
Glasgow
Country [35] 0 0
United Kingdom
State/province [35] 0 0
London
Country [36] 0 0
United Kingdom
State/province [36] 0 0
Manchester
Country [37] 0 0
United Kingdom
State/province [37] 0 0
Newcastle-Upon-Tyne

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Lexicon Pharmaceuticals
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The primary objective of this study is to evaluate the long-term safety and tolerability of
orally administered telotristat etiprate.
Trial website
https://clinicaltrials.gov/ct2/show/NCT02026063
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Pablo Lapuerta, MD
Address 0 0
Lexicon Pharmaceuticals, Inc.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT02026063