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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/NCT01677910




Registration number
NCT01677910
Ethics application status
Date submitted
30/08/2012
Date registered
3/09/2012
Date last updated
27/02/2018

Titles & IDs
Public title
TELESTAR (Telotristat Etiprate for Somatostatin Analogue Not Adequately Controlled Carcinoid Syndrome)
Scientific 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
Secondary ID [1] 0 0
LX1606.301
Secondary ID [2] 0 0
LX1606.1-301-CS
Universal Trial Number (UTN)
Trial acronym
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-matching telotristat etiprate

Experimental: 250 mg Telotristat Etiprate - 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.

Experimental: 500 mg Telotristat Etiprate - 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.

Placebo Comparator: Placebo - 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.

Experimental: Telotristat Etiprate Open-Label Extension - 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.


Treatment: Drugs: Telotristat etiprate
Telotristat etiprate tablets.

Treatment: Drugs: Placebo-matching telotristat etiprate
Placebo-matching telotristat etiprate tablets.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary 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
Primary outcome [2] 0 0
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) in the Double-Blind Treatment Period
Timepoint [2] 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 17.6 Weeks)
Primary outcome [3] 0 0
Number of Participants With 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 54.3 Weeks)
Secondary outcome [1] 0 0
Change From Baseline in Urinary 5-hydroxyindoleacetic Acid (u5-HIAA) Levels
Timepoint [1] 0 0
Baseline and Week 12
Secondary outcome [2] 0 0
Change From Baseline in the Number of Daily Cutaneous Flushing Episodes Averaged Across All Time-Points
Timepoint [2] 0 0
Baseline and 12 Weeks
Secondary outcome [3] 0 0
Change From Baseline in Abdominal Pain Averaged Across All Time-Points
Timepoint [3] 0 0
Baseline and 12 Weeks

Eligibility
Key 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
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(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

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 assessing the outcomes
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
8/01/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
21/03/2016
Sample size
Target
Accrual to date
Final
135
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
Recruitment hospital [1] 0 0
Lexicon Investigational Site - Kogara
Recruitment hospital [2] 0 0
Lexicon Investigational Site - Saint Leanoards
Recruitment hospital [3] 0 0
Lexicon Investigational Site - Herston
Recruitment hospital [4] 0 0
Lexicon Investigational Site - Fitzroy
Recruitment hospital [5] 0 0
Lexicon Investigational Site - Freemantle
Recruitment hospital [6] 0 0
Lexicon Investigational Site - Woodville South
Recruitment postcode(s) [1] 0 0
2217 - Kogara
Recruitment postcode(s) [2] 0 0
2065 - Saint Leanoards
Recruitment postcode(s) [3] 0 0
4029 - Herston
Recruitment postcode(s) [4] 0 0
3065 - Fitzroy
Recruitment postcode(s) [5] 0 0
6160 - Freemantle
Recruitment postcode(s) [6] 0 0
5011 - Woodville South
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
Florida
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United States of America
State/province [4] 0 0
Iowa
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United States of America
State/province [5] 0 0
Kentucky
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United States of America
State/province [6] 0 0
Louisiana
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United States of America
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Massachusetts
Country [8] 0 0
United States of America
State/province [8] 0 0
Nebraska
Country [9] 0 0
United States of America
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New York
Country [10] 0 0
United States of America
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North Carolina
Country [11] 0 0
United States of America
State/province [11] 0 0
Pennsylvania
Country [12] 0 0
United States of America
State/province [12] 0 0
Texas
Country [13] 0 0
Belgium
State/province [13] 0 0
Edegem
Country [14] 0 0
Belgium
State/province [14] 0 0
Gent
Country [15] 0 0
Belgium
State/province [15] 0 0
Yvoir
Country [16] 0 0
Canada
State/province [16] 0 0
Alberta
Country [17] 0 0
Canada
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Nova Scotia
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France
State/province [18] 0 0
Clichy
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France
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Lille
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France
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Lyon
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France
State/province [21] 0 0
Marseille
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France
State/province [22] 0 0
Strasbourg
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France
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Villejuif
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Germany
State/province [24] 0 0
Bad Berka
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Germany
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Berlin
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Germany
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Essen
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Germany
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Hamburg
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Germany
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Heidelberg
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Germany
State/province [29] 0 0
Lubeck
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Germany
State/province [30] 0 0
Mainz
Country [31] 0 0
Germany
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Marburg
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Germany
State/province [32] 0 0
Munchen
Country [33] 0 0
Germany
State/province [33] 0 0
Neuss
Country [34] 0 0
Israel
State/province [34] 0 0
Jerusalem
Country [35] 0 0
Italy
State/province [35] 0 0
Bologna
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Italy
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Ferrara
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Italy
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Milan
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Italy
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Modena
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Italy
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Napoli
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Italy
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Orbassano
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Italy
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Perugia
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Italy
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Pisa
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Italy
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Rome
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Netherlands
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Amsterdam
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Netherlands
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Noord-Brahant
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Netherlands
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Noord-Holland
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Netherlands
State/province [47] 0 0
Zuid-Holland
Country [48] 0 0
Spain
State/province [48] 0 0
Barcelona
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Spain
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Madrid
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Spain
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Seville
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Sweden
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Lund
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Sweden
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Uppsala
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United Kingdom
State/province [53] 0 0
Basingstoke-Hampshire
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United Kingdom
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Coventry
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United Kingdom
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Glasgow
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United Kingdom
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Headington-Oxford
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United Kingdom
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London
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United Kingdom
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Manchester
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United Kingdom
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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 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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01677910
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/NCT01677910