Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43871   clinical trials with a EudraCT protocol, of which   7290   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2012-003460-47
    Sponsor's Protocol Code Number:LX1606.1-301-CS
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2012-11-30
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedGermany - BfArM
    A.2EudraCT number2012-003460-47
    A.3Full title of the trial
    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
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Research Study of the Efficacy and Safety of Telotristat Etiprate for Carcinoid Syndrome Patients, Who Do Not Respond to Somatostatin Analogue Therapy
    A.3.2Name or abbreviated title of the trial where available
    TELESTAR (Telotristat Etiprate for Somatostatin Analogue Refractory Carcinoid Syndrome)
    A.4.1Sponsor's protocol code numberLX1606.1-301-CS
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorLexicon Pharmaceuticals, Inc.
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportLexicon Pharmaceuticals, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationLexicon Pharmaceuticals Inc
    B.5.2Functional name of contact pointMelissa Green
    B.5.3 Address:
    B.5.3.1Street Address350 Carter Road
    B.5.3.2Town/ cityPrincenton
    B.5.3.3Post codeNJ 08540
    B.5.3.4CountryUnited States
    B.5.4Telephone number001609-466-5562
    B.5.5Fax number001609-466-5562
    B.5.6E-mailmgreen@lexpharma.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community Yes
    D.2.5.1Orphan drug designation numberEMEA/OD/047/09
    D.3 Description of the IMP
    D.3.1Product nameTelotristat Etiprate
    D.3.2Product code LX1606
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNtelotristat etiprate
    D.3.9.1CAS number 1137608-69-5
    D.3.9.2Current sponsor codeLX1606 Hippurate
    D.3.9.3Other descriptive nameLP-778914 (free base)
    D.3.9.4EV Substance CodeNA
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number250
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboFilm-coated tablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    refractory carcinoid syndrome
    E.1.1.1Medical condition in easily understood language
    A complex of symptoms due to a carcinoid tumor producing too many hormones, which cause multiple symptoms like diarrhea, flushing, urgent need for a bowel movement.
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.1
    E.1.2Level PT
    E.1.2Classification code 10007270
    E.1.2Term Carcinoid syndrome
    E.1.2System Organ Class 10014698 - Endocrine disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of the study is to confirm that at least 1 or more dose groups of telotristat etiprate compared to placebo is effective in reducing the change from baseline in 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.
    The primary safety objective is to assess the overall safety

    E.2.2Secondary objectives of the trial
    To assess the effects of telotristat etiprate versus placebo over the 12-
    week double-blind portion of the study in patients who are not
    adequately controlled by current SSA therapy as determined by:
    •Change from baseline in urinary 5-hydroxyindoleacetic acid (5-HIAA)
    levels at Week 12
    •Change from baseline in the daily number of cutaneous flushing
    episodes averaged across all time points
    •Change from baseline in abdominal pain averaged across all time points
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    pharmacogenomic research
    populational pharmacokinetics
    E.3Principal inclusion criteria
    1.Patients ≥18 years of age at the time of the Screening visit
    2.Histopathologically-confirmed, well-differentiated metastatic NET with extent documented by computed tomography (CT), magnetic resonance imaging (MRI), or radionuclide imaging
    3.A documented history of CS, and currently experiencing an average of ≥4 bowel movements per day during the Run-in Period. Confirmation of eligibility will be determined by measuring the mean number of BM
    4.Currently receiving a stable-dose SSA therapy. For the purposes of this study, stable-dose SSA therapy is defined as long acting release (LAR) or Depot SSA therapy or a continuous subcutaneous infusion via a pump. Patients must have been receiving the same dose level and frequency for at least 3 months prior to entering the Run-in Period.
    5.Minimum dose of LAR or Depot SSA therapy (higher dose or more frequent intervals will exceed minimum dose). SSA therapy must be approved for use in CS in the patient’s country of residence or prescribers’ country of practice.
    a.Octreotide LAR at 30 mg every 4 weeks
    b.Lanreotide Depot at 120 mg every 4 weeks
    c.Patients who cannot tolerate SSA therapy at a level indicated above will be allowed to enter at their highest tolerated dose
    6.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. Adequate methods of contraception for patients or partner include condoms with spermicide gel, diaphragm with spermicide gel, coil (intrauterine device), surgical sterilization, vasectomy, oral contraceptive pill, depot progesterone injections, progesterone implant, and abstinence during the study and for 12 weeks after the Follow-up Visit.
    a. Childbearing potential is defined as those who have not undergone surgical sterilization, or those who are not considered postmenopausal. Postmenopause is defined as absence of menstruation for at least 2 years. If necessary, follicle-stimulating hormone (FSH) results >50 IU/L at Screening are confirmatory in the absence of a clear postmenopausal history.
    7.Ability and willingness to provide written informed consent prior to participation in any study-related procedure
    E.4Principal exclusion criteria
    Patients who meet any of the following criteria will be excluded from participating in the study:
    1.Presence of diarrhea attributed to any condition(s) other than CS (including, but not limited to fat malabsorption or bile acid malabsorption)
    2.Presence of more than 12 watery BMs per day associated with volume contraction, dehydration, or hypotension compatible with a “pancreatic cholera”-type clinical syndrome, as judged by the Investigator
    3.Positive stool examination for enteric pathogens, pathogenic ova or parasites, or Clostridium difficile at Screening
    4.Karnofsky Performance Status ≤60%
    5.Clinical laboratory values for hematology (at Screening):
    a.Absolute neutrophil count (ANC) ≤1500 cells/mm3; or
    b.Platelets ≤75,000 cells/mm3; or
    c.Hemoglobin (Hgb) ≤9 g/dL for males and ≤8 g/dL for females
    6.Hepatic laboratory values (at Screening) such that:
    a.Aspartate transaminase (AST), or alanine aminotransferase (ALT):
    •≥5.5 x upper limit of normal (ULN) if patient has documented history of hepatic metastases; or
    •≥2.5 x ULN if patient does not have documented history of hepatic metastases
    b.Total bilirubin >1.5 x ULN (unless patient has a documented history of Gilbert’s Syndrome); or
    c.Alkaline phosphatase (ALP) ≥5 x ULN, if total bilirubin is >ULN
    •No upper limit on the ALP value if the total bilirubin is ≤ULN
    7.Serum creatinine ≥1.5 x ULN
    8.Treatment with any tumor directed therapy including, but not limited to: interferon, chemotherapy, mTOR inhibitors ≤4 weeks prior to Screening; or hepatic embolization, radiotherapy, radiolabelled SSA, and/or tumor debulking ≤12 weeks prior to Screening
    9.Major surgery defined as procedures requiring general anesthesia or major regional anesthesia within 8 weeks prior to Screening
    10.A history of short bowel syndrome (SBS)
    11.Pregnant or nursing (lactating) women
    12.Positive pregnancy test
    13.Life expectancy <12 months from the Screening visit
    14.Presence of any clinically significant findings at Screening medical history, or physical examination (relative to patient population) that, in the Investigator’s or Medical Monitor’s opinion, would compromise patient safety or the outcome of the study
    15.Any other clinically significant laboratory abnormality at Screening that would compromise patient safety or the outcome of the study
    16.Clinically significant cardiac arrhythmia, bradycardia, tachycardia that would compromise patient safety or the outcome of the study
    17.A history of substance or alcohol abuse within 2 years prior to Screening
    18.Administration of any investigational agent within 30 days of Screening or investigational therapeutic protein or antibody within 90 days prior to Screening
    19.Previous exposure to telotristat etiprate
    20.Patients who are currently committed to an institution by virtue of an order issued either by judicial or administrative authorities
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint is the change from baseline in the number of daily BMs averaged over the 12 week double blind portion (Treatment Period) of the trial.
    Safety endpoints are as follows:
    •Incidence of TEAEs, suspected adverse reaction, AEs leading to discontinuation from the study, SAEs, and deaths
    •Actual and change from baseline in clinical laboratory results
    •Actual and change from baseline in vital signs results
    •Actual and change from baseline in physical examinations
    •Actual and change from baseline in ECG findings
    E.5.1.1Timepoint(s) of evaluation of this end point
    at each visit and the final analysis will be done at the end of the study
    E.5.2Secondary end point(s)
    Secondary efficacy endpoints include:
    •Change from baseline in urinary 5-HIAA levels at Week 12
    •Change from baseline in the number of daily cutaneous flushing
    episodes averaged across all time points
    •Change from baseline in abdominal pain averaged across all time points
    •Proportion of patients with durable response, defined as the proportion
    of responders with ≥30% reduction in daily number of BMs for ≥50% of
    time over the double-blind portion of the study
    E.5.2.1Timepoint(s) of evaluation of this end point
    at each visit and the final analysis will be done at the end of the study
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    there is a 12-week double-blind treatment phase and then for 36 weeks open label treatment phase
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    two different doses of LX1606
    E.8.2.4Number of treatment arms in the trial3
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA45
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Australia
    Belgium
    Brazil
    Canada
    France
    Germany
    Ireland
    Israel
    Italy
    Netherlands
    Spain
    Sweden
    Ukraine
    United Kingdom
    United States
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months8
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 90
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 15
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state14
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 81
    F.4.2.2In the whole clinical trial 105
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    After the end of the study the patients will continue the standard of care available for this indication in the respective country. Another option, assuming adequate clinical benefit is observed, patients may receive further treatment of study drug in an extension study.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2013-03-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-04-02
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-03-17
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Thu May 02 17:24:19 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA