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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT02063659




Registration number
NCT02063659
Ethics application status
Date submitted
12/02/2014
Date registered
14/02/2014
Date last updated
26/02/2018

Titles & IDs
Public title
Telotristat Etiprate for Carcinoid Syndrome Therapy
Scientific 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
Secondary ID [1] 0 0
LX1606.303
Secondary ID [2] 0 0
LX1606.1-303-CS
Universal Trial Number (UTN)
Trial acronym
TELECAST
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
Treatment: Drugs - Placebo

Experimental: 250 mg Telotristat Etiprate - 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.

Experimental: 500 mg Telotristat Etiprate - 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.

Placebo Comparator: Placebo - 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.


Treatment: Drugs: Telotristat etiprate
Telotristat etiprate tablets

Treatment: Drugs: Placebo
Placebo-matching telotristat etiprate tablets
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) in the Double-Blind Treatment Period
Timepoint [1] 0 0
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)
Primary outcome [2] 0 0
Primary: Percent Change From Baseline in Urinary 5-hydroxyindoleacetic Acid (u5-HIAA) Levels
Timepoint [2] 0 0
Baseline and 12 Weeks
Primary outcome [3] 0 0
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) in the Open-Label Extension Period
Timepoint [3] 0 0
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 [1] 0 0
Change From Baseline in the Number of Bowel Movements (BMs) Per Day Averaged Over 12 Weeks
Timepoint [1] 0 0
Baseline and 12 weeks
Secondary outcome [2] 0 0
Change From Baseline in Stool Form/Consistency Averaged Across All Time-Points
Timepoint [2] 0 0
Baseline and 12 Weeks
Secondary outcome [3] 0 0
Change From Baseline in the Number of Daily Cutaneous Flushing Episodes Averaged Across All Time-Points
Timepoint [3] 0 0
Baseline and 12 Weeks
Secondary outcome [4] 0 0
Change From Baseline in Abdominal Pain Averaged Across All Time-Points
Timepoint [4] 0 0
Baseline and 12 Weeks
Secondary outcome [5] 0 0
Change in the Frequency of Rescue Short-acting, Somatostatin Analog (SSA) Used to Treat Carcinoid Syndrome Symptoms Averaged Across All Time-Points
Timepoint [5] 0 0
Baseline and 12 weeks
Secondary outcome [6] 0 0
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
Timepoint [6] 0 0
Baseline and 12 Weeks

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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled 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
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

The people analysing the results/data
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
11/03/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
29/03/2016
Sample size
Target
Accrual to date
Final
76
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
Lexicon Investigational Site - Kogara
Recruitment hospital [2] 0 0
Lexicon Investigational Site - St. Leonards
Recruitment hospital [3] 0 0
Lexicon Investigational Site - Herston
Recruitment hospital [4] 0 0
Lexicon Investigational Site - East Melbourne
Recruitment postcode(s) [1] 0 0
2217 - Kogara
Recruitment postcode(s) [2] 0 0
2065 - St. Leonards
Recruitment postcode(s) [3] 0 0
4029 - Herston
Recruitment postcode(s) [4] 0 0
3002 - East Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
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
Gent
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
Clichy
Country [14] 0 0
France
State/province [14] 0 0
Lille
Country [15] 0 0
France
State/province [15] 0 0
Lyon
Country [16] 0 0
France
State/province [16] 0 0
Marseille
Country [17] 0 0
France
State/province [17] 0 0
Strasbourg
Country [18] 0 0
France
State/province [18] 0 0
Villejuif
Country [19] 0 0
Germany
State/province [19] 0 0
Bad Berka
Country [20] 0 0
Germany
State/province [20] 0 0
Berlin
Country [21] 0 0
Germany
State/province [21] 0 0
Hamburg
Country [22] 0 0
Germany
State/province [22] 0 0
Heidelberg
Country [23] 0 0
Germany
State/province [23] 0 0
Lubeck
Country [24] 0 0
Germany
State/province [24] 0 0
Mainz
Country [25] 0 0
Germany
State/province [25] 0 0
Marburg
Country [26] 0 0
Germany
State/province [26] 0 0
Munich
Country [27] 0 0
Germany
State/province [27] 0 0
Neuss
Country [28] 0 0
Israel
State/province [28] 0 0
Jerusalem
Country [29] 0 0
Netherlands
State/province [29] 0 0
Noord-Holland
Country [30] 0 0
Netherlands
State/province [30] 0 0
Noord Brahant
Country [31] 0 0
Netherlands
State/province [31] 0 0
Rotterdam
Country [32] 0 0
Spain
State/province [32] 0 0
Barcelona
Country [33] 0 0
Spain
State/province [33] 0 0
Madrid
Country [34] 0 0
Spain
State/province [34] 0 0
Sevilla
Country [35] 0 0
Sweden
State/province [35] 0 0
Uppsala
Country [36] 0 0
United Kingdom
State/province [36] 0 0
Basingstoke Hampshire
Country [37] 0 0
United Kingdom
State/province [37] 0 0
Coventry
Country [38] 0 0
United Kingdom
State/province [38] 0 0
London
Country [39] 0 0
United Kingdom
State/province [39] 0 0
Manchester
Country [40] 0 0
United Kingdom
State/province [40] 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 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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT02063659
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/NCT02063659