AzTrials
AzTrials

Carcinoid SyndromePhase 3TELEPATHNCT02026063

Telotristat Etiprate - Expanded Treatment for Patients With Carcinoid Syndrome Symptoms

A Phase 3 study testing Telotristat etiprate in people with Carcinoid Syndrome, run by Lexicon Pharmaceuticals at 43 sites in 12 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The primary objective of this study is to evaluate the long-term safety and tolerability of orally administered telotristat etiprate. 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?
No, everyone receives an active treatment
How many people
124 participants
Where
43 sitesin 12 countries
Study dates
14 Jan 2014to 12 Sep 2018
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

  • 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

Who cannot join

  • 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

Trial locations and contacts

43 sites in 12 countries.

43 sites in 12 countries

United States7 sites

  • Lexicon Investigational Site

    Boston, Massachusetts, 02215

  • Lexicon Investigational Site

    Iowa City, Iowa, 52242

  • Lexicon Investigational Site

    Lexington, Kentucky, 40536

  • Lexicon Investigational Site

    Mobile, Alabama, 36604

  • Lexicon Investigational Site

    New York, New York, 10029

  • Lexicon Investigational Site

    Philadelphia, Pennsylvania, 19104

  • Lexicon Investigational Site

    Stanford, California, 94305

Other trials in United States

United Kingdom7 sites

  • Lexicon Investigational Site

    Coventry, CV22DX

  • Lexicon Investigational Site

    Glasgow, G120YN

  • Lexicon Investigational Site

    London, NW32QG

  • Lexicon Investigational Site

    London, SE59RS

  • Lexicon Investigational Site

    London, W120HS

  • Lexicon Investigational Site

    Manchester, M204BX

  • Lexicon Investigational Site

    Newcastle upon Tyne, NE14LP

Other trials in United Kingdom

Germany5 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

    Marburg, 35043

Other trials in Germany

Italy4 sites

  • Lexicon Investigational Site

    Milan, 20089

  • Lexicon Investigational Site

    Milan, 20141

  • Lexicon Investigational Site

    Pisa, 56124

  • Lexicon Investigational Site

    Torino, 10043

Other trials in Italy

Australia3 sites

  • Lexicon Investigational Site

    East Melbourne, Victoria, 3002

  • Lexicon Investigational Site

    Herston, Queensland, 4029

  • Lexicon Investigational Site

    St Leonards, New South Wales, 2065

Other trials in Australia

Belgium3 sites

  • Lexicon Investigational Site

    Edegem, B-2650

  • Lexicon Investigational Site

    Ghent, 9000

  • Lexicon Investigational Site

    Yvoir, 5530

Other trials in Belgium

France3 sites

  • Lexicon Investigational Site

    Lille, 59037

  • Lexicon Investigational Site

    Lyon, 69437

  • Lexicon Investigational Site

    Villejuif, 94805

Other trials in France

Netherlands3 sites

  • Lexicon Investigational Site

    Amsterdam, 1105AZ

  • Lexicon Investigational Site

    Noord Holland, 1066CX

  • Lexicon Investigational Site

    Noord-Brahant, 5631BM

Other trials in Netherlands

Spain3 sites

  • Lexicon Investigational Site

    Barcelona, 08035

  • Lexicon Investigational Site

    Madrid, 28034

  • Lexicon Investigational Site

    Seville, 41013

Other trials in Spain

Canada2 sites

  • Lexicon Investgational Site

    Calgary, Alberta, T2N4N2

  • Lexicon Investigational Site

    Halifax, Nova Scotia, B0J1N0

Other trials in Canada

Sweden2 sites

  • Lexicon Investigational Site

    Lund, 22185

  • Lexicon Investigational Site

    Uppsala, 75185

Other trials in Sweden

Israel1 site

  • Lexicon Investigational Site

    Jerusalem, 91120

Other trials in Israel

About this study

Official title: A Multicenter, Long-term Extension Study to Further Evaluate the Safety and Tolerability of Telotristat Etiprate (LX1606)

The primary objective of this study is to evaluate the long-term safety and tolerability of orally administered telotristat etiprate.

Being tested
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 tablet (250 mg)

Study groups in NCT02026063
Study groupRoleWhat they receive
250 mg Telotristat EtiprateExperimentalOne telotristat etiprate (250 mg) tablet administered three times daily.
Receives: Drug: Telotristat etiprate
500 mg Telotristat EtiprateExperimentalTwo telotristat etiprate (250 mg) tablets administered three times daily.
Receives: Drug: Telotristat etiprate

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants With Treatment-Emergent Adverse Events (TEAEs)

    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.

    Measured: First dose of study drug (Day 1) up to 15 days post last dose (approximately up to 236 weeks)

Secondary outcomes (4)

  1. Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30) Score at Each Visit

    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).

    Measured: Baseline, Weeks 24, 48, 72 and 84

  2. Change From Baseline in Gastrointestinal Symptoms of Carcinoid Neuroendocrine Tumors (GI.NET21) Score at Each Visit

    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).

    Measured: Baseline, Weeks 24, 48, 72 and 84

  3. Percentage of Participants With Adequate Relief as Per Subjective Global Assessment Question

    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.

    Measured: Baseline, Weeks 12, 24, 36, 48, 60, 72 and 84

  4. Change From Baseline in Subjective Global Assessment of Carcinoid Syndrome Symptoms on 11-Point Numeric Scale at Each Visit

    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.

    Measured: Baseline, Weeks 12, 24, 36, 48, 60, 72 and 84

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Jan 2014 (estimated)
  2. Study start14 Jan 2014
  3. Primary completion12 Sep 2018
  4. Study completion12 Sep 2018

Resources

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
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
124 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02026063
Sponsor's protocol ID
LX1606.1-302-CS
Other IDs
LX1606.302, 2013-002596-18
Acronym
TELEPATH
Status last verified
Aug 2019
First submitted
31 Dec 2013
Last updated
17 Sep 2019
Data monitoring committee
Yes
FDA-regulated device
No

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.

    PubMed 33940581

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 43 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 3 inclusion and 3 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 17 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 43 sites in United States, United Kingdom, Germany, Italy, 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. 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 17 Sep 2019). 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?

Number of Participants With Treatment-Emergent Adverse Events (TEAEs) (time frame: First dose of study drug (Day 1) up to 15 days post last dose (approximately up to 236 weeks)). 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 NCT02026063, which also lists 1 linked publication.

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 17 Sep 2019.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in