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    Summary
    EudraCT Number:2013-002596-18
    Sponsor's Protocol Code Number:LX1606.1-302-CS
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2013-12-13
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2013-002596-18
    A.3Full title of the trial
    A Multicenter, Long-term Extension Study to Further Evaluate the Safety and Tolerability of Telotristat Etiprate (LX1606)
    Estudio multicéntrico de extensión a largo plazo para evaluar con mayor detalle la seguridad y tolerabilidad del etiprato de telotristat (LX1606)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Multicenter, Long-term Extension Study to Further Evaluate the Safety and Tolerability of Telotristat Etiprate (LX1606)
    Estudio multicéntrico de extensión a largo plazo para evaluar con mayor detalle la seguridad y tolerabilidad del etiprato de telotristat (LX1606)
    A.3.2Name or abbreviated title of the trial where available
    TELEPATH (Telotristat Etiprate ? Expanded Treatment for Patients with Carcinoid Syndrome Symptoms)
    A.4.1Sponsor's protocol code numberLX1606.1-302-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 pointPenny Logan
    B.5.3 Address:
    B.5.3.1Street Address8800 Technology Forest Place
    B.5.3.2Town/ cityThe Woodlands
    B.5.3.3Post codeTX 77381
    B.5.3.4CountryUnited States
    B.5.4Telephone number001281863 3260
    B.5.5Fax number001281863 8088
    B.5.6E-mailplogan@lexpharma.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleComparator
    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.3.10 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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Carcinoid Syndrome
    Síndrome Carcinoide
    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.
    Conjunto de síntomas debido a un tumor carcinoide que produce demasiadas hormonas, que provocan múltiples síntomas como la diarrea, enrojecimiento, la
    necesidad urgente de evacuar el intestino.
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.1
    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 this study is to evaluate the long-term safety and tolerability of orally administered telotristat etiprate
    El objetivo principal de este estudio consiste en evaluar la seguridad y la tolerabilidad del etiprato de telotristat administrado por vía oral durante el tratamiento a largo plazo
    E.2.2Secondary objectives of the trial
    To evaluate long-term changes in patients? quality of life (QOL)
    Evaluar los cambios de la calidad de vida (CdV) del paciente a largo plazo
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients must meet all of the following criteria to be considered eligible to participate in the study:
    1. Ongoing participation 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
    2. 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 entry are confirmatory in the absence of a clear postmenopausal history.
    3. Ability and willingness to provide written informed consent prior to participation in any study-related procedure
    Para que los pacientes se consideren idóneos para participar en el estudio deben cumplir todos los criterios siguientes:
    1. Participación en curso en un estudio en fase 2 (p. ej., LX1606.1-202-CS, LX1606.1-203-CS) o en fase 3 (p. ej., LX1606.1-301-CS, LX1606.1-303-CS)
    2. Las pacientes que puedan tener hijos deben aceptar usar un método anticonceptivo adecuado (definido como aquel que tiene una tasa de fracasos de <1 % por año) durante el estudio y las 12 semanas posteriores a la visita de seguimiento. Los métodos anticonceptivos adecuados para las pacientes o sus parejas incluyen los preservativos con gel espermicida, el diafragma con gel espermicida, la espiral (dispositivo intrauterino), la esterilización quirúrgica, la vasectomía, la píldora anticonceptiva por vía oral, las inyecciones de progesterona de liberación lenta, los implantes de progesterona y la abstinencia durante el estudio y las 12 semanas posteriores a la visita de seguimiento.
    a. Las mujeres que pueden tener hijos se definen como aquellas que no se han sometido a esterilización quirúrgica o las que no están en período posmenopáusico. La posmenopausia se define como la ausencia de menstruación durante al menos 2 años. Si fuera necesario, un resultado de >50 UI/l en la determinación de la hormona foliculoestimulante (FSH) en la entrada es confirmatorio, si no hay antecedentes claros de posmenopausia.
    3. Capacidad y disposición para proporcionar un consentimiento informado por escrito antes de participar en cualquier procedimiento relacionado con el estudio.
    E.4Principal exclusion criteria
    Patients who meet any of the following criteria will be excluded from participating in the study:
    1. 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
    2. Positive pregnancy test
    3. Presence of any clinically significant findings at entry for medical history, laboratory values, 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
    No podrán participar en el estudio los pacientes que cumplan alguno de los criterios siguientes:
    1. Infracción grave del protocolo o problemas de tolerabilidad en un estudio en fase 2 (p. ej., LX1606.1-202-CS, LX1606.1-203-CS) o en fase 3 (p. ej., LX1606.1-301-CS, LX1606.1-303-CS)
    2. Prueba de embarazo positiva
    3. Presencia de cualquier hallazgo clínicamente importante en la historia clínica, la analítica o la exploración física de entrada (relativo a la población de pacientes) que, según el criterio del investigador o del monitor médico, podría comprometer la seguridad del paciente o el resultado del estudio.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint is to evaluate the long-term safety and tolerability of orally administered telotristat etiprate.
    El criterio de valoración principal de la eficacia del estudio consiste en evaluar la seguridad y la tolerabilidad del etiprato de telotristat administrado por vía oral durante el tratamiento a largo plazo
    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
    El análisis final y en cada visita se harán al acabar el estudio
    E.5.2Secondary end point(s)
    Secondary efficacy endpoint is to evaluate changes in patients? QOL over multiple years of therapy.

    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
    El criterio de valoración secundario de la eficacia es evaluar las variaciones de la CdV de los pacientes durante varios años de tratamiento.
    Los criterios de valoración de la seguridad son los siguientes:
    ? Incidencia de AADT, sospecha de reacciones adversas, AA que llevan al abandono del estudio, AAG y muertes.
    ? Resultados actuales y variaciones con respecto a la situación inicial en los análisis clínicos
    ? Resultados actuales y variaciones con respecto a la situación inicial en las constantes vitales
    ? Resultados actuales y variaciones con respecto a la situación inicial en la exploración física
    ? Resultados actuales y variaciones en los resultados con respecto a la situación inicial del ECG
    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
    El análisis final y en cada visita se harán al acabar el estudio
    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 No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    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 No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Dos dosis diferentes de LX1606
    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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA62
    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
    Belgium
    Canada
    France
    Israel
    Italy
    Netherlands
    Sweden
    United Kingdom
    United States
    Australia
    Brazil
    Germany
    Spain
    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 months11
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months8
    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: 112
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 48
    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 state8
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 106
    F.4.2.2In the whole clinical trial 160
    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 this study the patients will continue the standard of care available for this indication in the respective country.
    Tras la finalización de este estudio los pacientes continuarán con el tratamiento estándar disponible para esta indicación en el país correspondiente.
    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 Decision2014-01-31
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-01-08
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-09-12
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