Carcinoid SyndromePhase 3NCT01677910
TELESTAR (Telotristat Etiprate for Somatostatin Analogue Not Adequately Controlled Carcinoid Syndrome)
A Phase 3 study testing Telotristat etiprate in people with Carcinoid Syndrome, run by Lexicon Pharmaceuticals at 75 sites in 12 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoid Syndrome
- What is being tested?
- Telotristat etiprate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 135 participants
- Where
- 75 sitesin 12 countries
- Study dates
- 8 Jan 2013to 21 Mar 2016
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
75 sites in 12 countries.
75 sites in 12 countries
United States17 sites
Lexicon Investigational Site
Boston, Massachusetts, 02114
Lexicon Investigational Site
Boston, Massachusetts, 02215
Lexicon Investigational Site
Buffalo, New York, 14263
Lexicon Investigational Site
Durham, North Carolina, 27710
Lexicon Investigational Site
Fort Worth, Texas, 76104
Lexicon Investigational Site
Houston, Texas, 77030
Lexicon Investigational Site
Iowa City, Iowa, 52242
Lexicon Investigational Site
Kenner, Louisiana, 70065
Lexicon Investigational Site
Lexington, Kentucky, 40536
Lexicon Investigational Site
McAllen, Texas, 78503
Lexicon Investigational Site
Mobile, Alabama, 36604
Lexicon Investigational Site
New York, New York, 10029
Lexicon Investigational Site
Omaha, Nebraska, 68114
Lexicon Investigational Site
Orlando, Florida, 32806
Lexicon Investigational Site
Palo Alto, California, 94305
Lexicon Investigational Site
Philadelphia, Pennsylvania, 19104
Lexicon Investigational Site
San Francisco, California, 94115
Germany10 sites
Lexicon Investigational Site
Bad Berka, 99437
Lexicon Investigational Site
Berlin, 13353
Lexicon Investigational Site
Essen, 45147
Lexicon Investigational Site
Hamburg, 20246
Lexicon Investigational Site
Heidelberg, 69120
Lexicon Investigational Site
Lübeck, 23538
Lexicon Investigational Site
Mainz, 55131
Lexicon Investigational Site
Marburg, 35043
Lexicon Investigational Site
München, 81377
Lexicon Investigational Site
Neuss, 41464
Italy10 sites
Lexicon Investigational Site
Bologna, 40138
Lexicon Investigational Site
Ferrara, 44124
Lexicon Investigational Site
Milan, 20089
Lexicon Investigational Site
Milan, 20141
Lexicon Investigational Site
Modena, 41126
Lexicon Investigational Site
Naples, 80100
Lexicon Investigational Site
Orbassano, 10043
Lexicon Investigational Site
Perugia, 06156
Lexicon Investigational Site
Pisa, 56124
Lexicon Investigational Site
Rome, 00189
United Kingdom9 sites
Lexicon Investigational Site
Basingstoke-Hampshire, RG249NA
Lexicon Investigational Site
Coventry, CV2 2DX
Lexicon Investigational Site
Glasgow, G12OYN
Lexicon Investigational Site
Headington-Oxford, OX37LJ
Lexicon Investigational Site
London, NW32QG
Lexicon Investigational Site
London, SE59RS
Lexicon Investigational Site
London, W12 OHS
Lexicon Investigational Site
Manchester, M204BX
Lexicon Investigational Site
Newcastle upon Tyne, NE1 4LP
Australia6 sites
Lexicon Investigational Site
Fitzroy, Victoria, 3065
Lexicon Investigational Site
Freemantle, Western Australia, 6160
Lexicon Investigational Site
Herston, Queensland, 4029
Lexicon Investigational Site
Kogara, New South Wales, 2217
Lexicon Investigational Site
Saint Leanoards, New South Wales, 2065
Lexicon Investigational Site
Woodville South, 5011
France6 sites
Lexicon Investigational Site
Clichy, 92118
Lexicon Investigational Site
Lille, 59037
Lexicon Investigational Site
Lyon, 69437
Lexicon Investigational Site
Marseille, 13385
Lexicon Investigational Site
Strasbourg, 67098
Lexicon Investigational Site
Villejuif, 94805
Spain5 sites
Lexicon Investigational Site
Barcelona, 08035
Lexicon Investigational Site
Barcelona, 08907
Lexicon Investigational Site
Madrid, 28034
Lexicon Investigational Site
Madrid, 28040
Lexicon Investigational Site
Seville, 41013
Netherlands4 sites
Lexicon Investigational Site
Amsterdam, 1105 AZ
Lexicon Investigational Site
Noord-Brahant, 5631BM
Lexicon Investigational Site
Noord-Holland, 1066CX
Lexicon Investigational Site
Zuid-Holland, 3015E
Belgium3 sites
Lexicon Investigational Site
Edegem, B-2650
Lexicon Investigational Site
Ghent, 9000
Lexicon Investigational Site
Yvoir, B-5530
Canada2 sites
Lexicon Investigational Site
Calgary, Alberta, T2N 4N2
Lexicon Investigational Site
Halifax, Nova Scotia, B3H2Y9
Sweden2 sites
Lexicon Investigational Site
Lund, 22185
Lexicon Investigational Site
Uppsala, 75185
About this study
Official 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
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.
- Conditions
- Carcinoid Syndrome
- Being tested
- Telotristat etiprate, Placebo-matching telotristat etiprate
- Medical subject headings
- Serotonin Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telotristat etiprateDrug
Also called LX1606
Telotristat etiprate tablets.
Placebo-matching telotristat etiprateDrug
Placebo-matching telotristat etiprate tablets.
| Study group | Role | What they receive |
|---|---|---|
| 250 mg Telotristat Etiprate | Experimental | 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. Receives: Drug: Telotristat etiprate; Drug: Placebo-matching telotristat etiprate |
| 500 mg Telotristat Etiprate | Experimental | 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. Receives: Drug: Telotristat etiprate; Drug: Placebo-matching telotristat etiprate |
| Placebo | Placebo comparator | 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. Receives: Drug: Placebo-matching telotristat etiprate |
| Telotristat Etiprate Open-Label Extension | Experimental | 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. Receives: Drug: Telotristat etiprate; Drug: Placebo-matching telotristat etiprate |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 12 Weeks
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.
Measured: 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)
Number of Participants With 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.
Measured: 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 outcomes (3)
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.
Measured: Baseline and Week 12
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.
Measured: Baseline and 12 Weeks
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.
Measured: Baseline and 12 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2012 (estimated)
- Study start8 Jan 2013
- Primary completion21 Mar 2016
- Study completion21 Mar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Carcinoid SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants were randomized to one of three treatment arms in the double-blind treatment period. After completion of the double-blind treatment period, participants entered an open-label treatment period.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 135 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lexicon Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pablo Lapuerta, MD, Study director, Lexicon Pharmaceuticals, Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01677910
- Sponsor's protocol ID
- LX1606.1-301-CS
- Other IDs
- LX1606.301, 2012-003460-47
- Status last verified
- Jan 2018
- First submitted
- 30 Aug 2012
- Last updated
- 27 Feb 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 34598813Fust K, Maschio M, Kohli M, Singh S, Pritchard DM, Marteau F, Myrenfors P, Feuilly M. A Budget Impact Model of the Addition of Telotristat Ethyl Treatment to the Standard of Care in Patients with Uncontrolled Carcinoid Syndrome. Pharmacoeconomics. 2020 Jun;38(6):607-618. doi: 10.1007/s40273-020-00896-5.
PubMed 32157590Dillon 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.
PubMed 32146619Hudgens S, Ramage J, Kulke M, Bergsland E, Anthony L, Caplin M, Oberg K, Pavel M, Gable J, Banks P, Yang QM, Lapuerta P. Evaluation of meaningful change in bowel movement frequency for patients with carcinoid syndrome. J Patient Rep Outcomes. 2019 Oct 26;3(1):64. doi: 10.1186/s41687-019-0153-y.
PubMed 31655936Cella D, Beaumont JL, Hudgens S, Marteau F, Feuilly M, Houchard A, Lapuerta P, Ramage J, Pavel M, Horsch D, Kulke MH. Relationship Between Symptoms and Health-related Quality-of-life Benefits in Patients With Carcinoid Syndrome: Post Hoc Analyses From TELESTAR. Clin Ther. 2018 Dec;40(12):2006-2020.e2. doi: 10.1016/j.clinthera.2018.10.008. Epub 2018 Nov 24.
PubMed 30477789Weickert MO, Kaltsas G, Horsch D, Lapuerta P, Pavel M, Valle JW, Caplin ME, Bergsland E, Kunz PL, Anthony LB, Grande E, Oberg K, Welin S, Lombard-Bohas C, Ramage JK, Kittur A, Yang QM, Kulke MH. Changes in Weight Associated With Telotristat Ethyl in the Treatment of Carcinoid Syndrome. Clin Ther. 2018 Jun;40(6):952-962.e2. doi: 10.1016/j.clinthera.2018.04.006. Epub 2018 May 1.
PubMed 29724499
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT01677910
- Acronym / sponsor ID
- LX1606.1-301-CS
- Conditions
- Carcinoid Syndrome
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 135 participants (actual)
- Lead sponsor
- Lexicon PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 8 Jan 2013 (actual)
- Primary completion
- 21 Mar 2016 (actual)
- Study completion
- 21 Mar 2016 (actual)
- First posted
- 3 Sep 2012 (estimated)
- Results
- Posted 18 Sep 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- Participants were randomized to one of three treatment arms in the double-blind treatment period. After completion of the double-blind treatment period, participants entered an open-label treatment period.
| Arm | Type | Receives |
|---|---|---|
| 250 mg Telotristat Etiprate | Experimental | Drug: Telotristat etiprate, Drug: Placebo-matching telotristat etiprateFollowing 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. |
| 500 mg Telotristat Etiprate | Experimental | Drug: Telotristat etiprate, Drug: Placebo-matching telotristat etiprateFollowing 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 | Placebo comparator | Drug: Placebo-matching telotristat etiprateFollowing 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. |
| Telotristat Etiprate Open-Label Extension | Experimental | Drug: Telotristat etiprate, Drug: Placebo-matching telotristat etipratePatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
- Ability and willingness to provide written informed consent
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Telotristat etiprateAlso: LX1606Telotristat etiprate tablets. | Drug | 250 mg Telotristat Etiprate, 500 mg Telotristat Etiprate, Telotristat Etiprate Open-Label Extension |
| Placebo-matching telotristat etipratePlacebo-matching telotristat etiprate tablets. | Drug | 250 mg Telotristat Etiprate, 500 mg Telotristat Etiprate, Placebo, Telotristat Etiprate Open-Label Extension |
Primary outcome
Change From Baseline in the Number of Bowel Movements (BMs) Per Day Averaged Over 12 Weeks
Time frame: Baseline and 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.
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) in the Double-Blind Treatment Period
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 17.6 Weeks)
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.
Number of Participants With TEAEs in the Open-Label Extension Period
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 54.3 Weeks)
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.
3 secondary outcomes
Change From Baseline in Urinary 5-hydroxyindoleacetic Acid (u5-HIAA) Levels
Time frame: Baseline and Week 12
Change From Baseline in the Number of Daily Cutaneous Flushing Episodes Averaged Across All Time-Points
Time frame: Baseline and 12 Weeks
Change From Baseline in Abdominal Pain Averaged Across All Time-Points
Time frame: Baseline and 12 Weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34598813Srirajaskanthan 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.
- Derived from this study: PubMed 32157590Fust K, Maschio M, Kohli M, Singh S, Pritchard DM, Marteau F, Myrenfors P, Feuilly M. A Budget Impact Model of the Addition of Telotristat Ethyl Treatment to the Standard of Care in Patients with Uncontrolled Carcinoid Syndrome. Pharmacoeconomics. 2020 Jun;38(6):607-618. doi: 10.1007/s40273-020-00896-5.
- Derived from this study: PubMed 32146619Dillon 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.
- Derived from this study: PubMed 31655936Hudgens S, Ramage J, Kulke M, Bergsland E, Anthony L, Caplin M, Oberg K, Pavel M, Gable J, Banks P, Yang QM, Lapuerta P. Evaluation of meaningful change in bowel movement frequency for patients with carcinoid syndrome. J Patient Rep Outcomes. 2019 Oct 26;3(1):64. doi: 10.1186/s41687-019-0153-y.
- Derived from this study: PubMed 30477789Cella D, Beaumont JL, Hudgens S, Marteau F, Feuilly M, Houchard A, Lapuerta P, Ramage J, Pavel M, Horsch D, Kulke MH. Relationship Between Symptoms and Health-related Quality-of-life Benefits in Patients With Carcinoid Syndrome: Post Hoc Analyses From TELESTAR. Clin Ther. 2018 Dec;40(12):2006-2020.e2. doi: 10.1016/j.clinthera.2018.10.008. Epub 2018 Nov 24.
- Derived from this study: PubMed 29724499Weickert MO, Kaltsas G, Horsch D, Lapuerta P, Pavel M, Valle JW, Caplin ME, Bergsland E, Kunz PL, Anthony LB, Grande E, Oberg K, Welin S, Lombard-Bohas C, Ramage JK, Kittur A, Yang QM, Kulke MH. Changes in Weight Associated With Telotristat Ethyl in the Treatment of Carcinoid Syndrome. Clin Ther. 2018 Jun;40(6):952-962.e2. doi: 10.1016/j.clinthera.2018.04.006. Epub 2018 May 1.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pablo Lapuerta, MD study director
Lexicon Pharmaceuticals, Inc
75 sites in 12 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Telotristat etiprate in people with Carcinoid Syndrome, run by Lexicon Pharmaceuticals at 75 sites in 12 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 75 sites in United States, Germany, Italy, United Kingdom, Australia and 7 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Sep 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in the Number of Bowel Movements (BMs) Per Day Averaged Over 12 Weeks (time frame: Baseline and 12 Weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01677910, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2018.