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    Summary
    EudraCT Number:2012-000398-21
    Sponsor's Protocol Code Number:ESTEVE-SIGM-202
    National Competent Authority:Greece - EOF
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2012-08-08
    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 ConcernedGreece - EOF
    A.2EudraCT number2012-000398-21
    A.3Full title of the trial
    A proof-of-concept phase 2, randomized, placebo-controlled, double blind, multicentre clinical trial in 2 parallel groups to evaluate the efficacy and safety of E-52862 for reducing the incidence and severity of oxaliplatin-induced peripheral neuropathy in patients treated for colorectal cancer.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Clinical trial to evaluate the efficacy and safety of E-52862 for reducing oxaliplatin-induced peripheral neuropathy in patients treated for colorectal cancer.
    A.4.1Sponsor's protocol code numberESTEVE-SIGM-202
    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 SponsorLaboratorios del Dr. Esteve, S.A.
    B.1.3.4CountrySpain
    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 supportLaboratorios del Dr. Esteve S.A.
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationLaboratorios del Dr. Esteve S.A.
    B.5.2Functional name of contact pointStudy Medical Monitor
    B.5.3 Address:
    B.5.3.1Street AddressAvda. Mare de Dèu de Montserrat, 221
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08041
    B.5.3.4CountrySpain
    B.5.4Telephone number+34934466131NA
    B.5.5Fax number+34934466110NA
    B.5.6E-mailsvidela@esteve.es
    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 No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.2Product code E-52862
    D.3.4Pharmaceutical form Capsule, hard
    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.3.9.1CAS number 878141-96-9
    D.3.9.2Current sponsor codeE-52862
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number400
    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 placeboCapsule, hard
    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
    OXL-induced chronic neuropathy.
    E.1.1.1Medical condition in easily understood language
    OXL-induced chronic neuropathy.
    E.1.1.2Therapeutic area Diseases [C] - Symptoms and general pathology [C23]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10029350
    E.1.2Term Neurotoxicity
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    •To establish the efficacy of E-52862 to reduce the incidence and the severity of OXL-induced chronic neuropathy in patients treated for colorectal cancer.
    •To explore the efficacy of E-52862 to reduce the severity and duration of OXL-induced acute neuropathy.
    •To evaluate whether E-52862 can raise the cumulative total dose of OXL than can be delivered without dose-limiting chronic neuropathy.
    •To explore the incidence of dose-reduction, dose-delays and discontinuation of oxaliplatin due to symptomatic neuropathy grade 3 or 4.
    •To explore the incidence of adverse events by severity, of serious adverse events, of adverse events leading to E 52862 discontinuation and of adverse events related to E-52862 by severity.
    •To assess E-52862 plasma exposure associated with the treatment.
    •Establecer la eficacia de E-52862 en la reducción de la incidencia y la severidad de la neuropatía crónica inducida por oxaliplatino en pacientes tratados por cáncer colorrectal.
    •Explorar la eficacia de E-52862 en la reducción de la severidad y la duración de la neuropatía aguda inducida por oxaliplatino.
    •Evaluar si E-52862 es capaz de incrementar la dosis total acumulada de oxaliplatino que puede administrarse sin una neuropatía crónica limitante de la dosis.
    •Explorar la incidencia de las reducciones de la dosis, los retrasos de la dosis y abandonos del oxaliplatino por neuropatía sintomática de grado 3 o 4.
    •Explorar la incidencia de acontecimientos adversos según su severidad, acontecimientos adversos graves, acontecimientos adversos que lleven al abandono de E-52862 y acontecimientos adversos relacionados con E-52862 según su severidad
    •Evaluar las concentraciones plasmáticas de E-52862 a lo largo del tratamiento.
    E.2.2Secondary objectives of the trial
    Not applicable.
    No aplicable.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Plasma concentration substudy: Final version, March 21th, 2012. It will be carried out only in patients recruited at Bellvitge Hospital. The objective is assess individual E-52862 plasma exposure associated with treatment.
    Genetics substudy: Final version, March 21th, 2012. It will evaluate different genetic models and different allele frequencies that might be involved in genetic susceptibility to CIPN severity.
    Subestudio de concentración plasmática: Versión final de fecha 21 de marzo de 2012. Se realizará sólo en los pacientes incluidos en el Hospital de Bellvitge. Tendrá como objeto la determinación de las concentraciones plasmáticas individuales de E-52862 a lo largo del tratamiento. Subestudio genético: Versión final de fecha 21 de marzo de 2012. Evaluará los diferentes modelos genéticos y las diferentes frecuencias de alelos que pudieran intervenir en la susceptibilidad genética a la severidad de la neuropatia periférica inducida por quimioterapia.
    E.3Principal inclusion criteria
    -Being of either sex aged 18 to 80 years.
    -Having a diagnosis of colorectal cancer made within the prior 2 years.
    -Having not received chemotherapy with cytotoxic drugs in the past.
    -Being schedule to start and adjuvant or palliative 6-month chemotherapy regimen for the treatment of their colorectal cancer that includes OXL at a scheduled dose in the first cycle > or equal 60 mg/m2 in a 2-hour infusion (protocols FOLFOX4 and FOLFOX6, with or without cetuximab or bevacizumab supplementation).
    -Having with a Karnofsky performance status score > or = 70 at screening visit.
    -Provide a written informed consent to participate in the study.
    - Edad entre 18 y 80 años.
    - Diagnóstico de cancer colorectal en los dos años previos.
    - No haber recibido tratamiento quimioterápico con fármacos citotóxicos en el pasado.
    - Estar programado para iniciar un regimen de quimioterapia adyuvante o paliativo de 6 meses para el tratamiento del cancer colorectal que incluya OXL con una dosis programada en el primer ciclo > o igual a 60 mg/m2 en infusión de 2 horas (protocolos FOLFOX4 y FOLFOX6, con o sin cetuximab o bevacizumab añadido).
    - Tener un índice > o igual que 70 en la escala de Karnofsky en la visita de selección.
    - Otorgar el consentimiento informado por escrito para participar en el estudio.
    E.4Principal exclusion criteria
    -Pregnant or nursing women. Fertile women must use a reliable contraceptive method to participate in the study.
    -Patients with any neurologic condition that might interfere with the evaluation of the study objectives, in particular sensory neuropathies (post-herpetic neuralgia, diabetic neuropathy, HIV-related polyneuropathy, central lesions of the somatosensory system such as multiple sclerosis, etc).
    -Patients with serious and unstable mental illness (symptoms or treatment) that, in the opinion of the investigator, might hamper the conduct of the study.
    -Patients who have been treated within 30 days prior to screening, are currently treated, or plan to be treated with another investigational product or device during the intended duration of this clinical trial.
    -Patients with second or third degree atrioventricular blockade not corrected with a pacemaker or any clinically significant abnormality in the 12 lead electrocardiogram as determined by the investigator.
    -Patients with abnormal liver function, renal function impairment or bone marrow impairment in a blood test within 14 days prior to, or at screening.
    -Patients receiving or who plan to receive any forbidden treatment during the study.
    -Having a peripheral sensory neuropathy of any NCI-CTCAE grade (>1) at screening visit.
    -Patients with symptoms suggesting brain metastasis.
    -Patients with uncontrolled concurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
    -Patients with a life expectancy shorter than 4 months.
    -Patients lacking the capacity to understand and provide the required information to achieve the objectives of the study.
    -Mujeres embarazadas o en periodo de lactancia. Las mujeres fértiles deben usar un método anticonceptivo seguro para participar en el estudio.
    -Pacientes con cualquier condición neurológica que pueda interferir en la evaluación de los objetivos del estudio, en particular, neuropatías sensoriales (neurolgia post-herpética, neuropatía diabética, polineuropatía asociada a VIH, lesiones centrales del sistema neurosensorial como la esclerosis múltiple, etc).
    -Pacientes con enfermedad mental grave e inestable (síntomas o tratamiento) que, en opinion del investigador, pueda afectar al desarrollo del estudio.
    -Pacientes que han sido tratados en los 30 días previos a la visita de selección, están tratados actualmente o tienen programado ser tratados con algún producto en investigación durante el periodo de este estudio.
    -Pacientes con segundo o tercer grado de bloqueo atrioventricular no corregido con marcapasos o cualquier otra anomalía clínicamente significativa en el electrocardiograma de 12 derivaciones de acuerdo al criterio del investigador.
    -Pacientes con función hepática anormal, función renal alterada o alteración de la medula ósea en una muestra de sangre dentro de los 14 días previos o en el momento de la selección.
    -Pacientes que están recibiendo o tienen planeado recibir cualquier tipo de medicación prohibida durante el estudio.
    -Neuropatía periférica sensorial con cualquier grado de NCI-CTCAE (>1) en la visita de selección.
    -Pacientes con síntomas sugestivos de metástasis cerebrales.
    -Pacientes con enfermedad concomitante no controlada incluyendo pero no limitada a infección activa, fallo cardiaco congestivo sintomático, angina de pecho inestable, arritmia cardiaca, enfermedad psiquiátrica o situación social que podría limitar el cumplimiento de los requisitos del estudio.
    -Pacientes con esperanza de vida inferior a 4 meses.
    -Pacientes que no tienen capacidad para entender y dar la información requerida para alcanzar los objetivos del estudio.
    E.5 End points
    E.5.1Primary end point(s)
    Efficacy endpoints:
    -Evolution of the clinical Total Neuropathy Score (cTNS).
    -Change from baseline of the reduced Total Neuropathy Score (rTNS).
    -Evolution of cold-induced pain intensity.
    -Change from baseline of the number and duration of signs and symptoms of OXL-induced acute neuropathy assessed with the specific OXL-induced neuropathy questionnaire.
    -Level of peripheral sensory neuropathy toxicity at each visit assessed with the National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) criteria.
    -Time to the first occurrence of NCI-CTCAE grade 2, 3 or 4 symptomatic neuropathy.
    -Change from baseline of the amplitudes of sensory and motor nerve action potentials and of the sensitive and motor nerve conduction velocities measured in the nerve conduction tests.
    -Evolution of patients's quality of life assessed with the Quality of Life Questionnaire C30 (QLQ-C30) with the module for chemotherapy-induced neuropathy (QLQ-CIPN20).
    -Proportion of patients who meet any of the following definitions of neuropathy at the end of the study: a) at least subclinical neuropathy: cTNS >2, b) manifest neuropathy: rTNS > or equal 5, c) symptomatic neuropathy: grade >1 NCI-CTCAE toxicity, and d) severe neuropathy: grade > or =3 NCI-CTCAE toxicity.
    -Incidence of dose-reduction, dose-delays and discontinuation of oxaliplatin due to symptomatic neuropathy grade 3 or 4.
    -Total cumulative dose of OXL administered.

    Safety endpoitns:
    -Incidence of adverse events by severity, of serious adverse events, of adverse events leading to E-52862 discontinuation and of adverse events related to E-52862 by severity. Values for these variables will be obtained in all visits of the study, except in the screening visit.
    -E-52862 plasma concentration associated with the treatment.
    Variables de eficacia:
    -Evolución del índice de Neuropatía Total.
    -Cambios desde basal en el Indice de Neuropatía total reducido.
    -Evolución de la intensidad del dolor inducida por frío.
    -Cambios desde basal en el número y duración de signos y síntomas de neuropatía aguda asociada a OXL con el cuestionario específico de neuropatía inducida por oxaliplatino.
    -Nivel de toxicidad neuropática sensorial periférica en cada visita de acuerdo a los criterios del National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE).
    -Tiempo hasta la primera neuropatía sintomática de grado 2, 3 ó 4 NCI-CTCAE.
    -Cambios desde basal en las amplitudes de los potenciales de los nervios sensoriales y motores y en las velocidades de conducción motoras y sensitivas medidas por pruebas de conducción nerviosa.
    -Evolución de la calidad de vida de los pacientes evaluada con el Cuestionario de Calidad de Vida C30 (QLQ-C30) con el módulo de neuropatía inducida por quimioterapia (QLQ-CIPN20).
    -Proporción de pacientes que cumplen alguna de las definiciones de neuropatía al final del estudio: a) neuropatía subclinica minima: cTNS >2, b) neuropatía manifiesta: rTNS > o igual 5, c) neuropatía sintomática: grado >1 toxicidad NCI-CTCAE, y d) neuropatía severa: grado > o =3 toxicidad NCI-CTCAE.
    -Incidencia en la reducción de dosis, retraso de dosis y discontinuación de oxaliplatino debido a la neuropatía sintomática grado 3 ó 4.
    -Dosis total acumulada de OXL administrado.

    Variables de seguridad:
    -Incidencia de acontecimientos adversos por intensidad y gravedad y acontecimientos adversos que dan lugar a la discontinuación de E-52862 y acontecimientos adversos graves relacionados con E-52862. Los valores de estas variables se obtendrán en todas las visitas excepto en la visita de selección.
    -Concentraciones plasmáticas de E-52862 asociadas con el tratamiento.
    E.5.1.1Timepoint(s) of evaluation of this end point
    At the end of the study.
    A la finalización del estudio.
    E.5.2Secondary end point(s)
    Not applicable.
    No aplicable.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Not applicable.
    No aplicable.
    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 No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Treatment adherence by plasma concentrations.
    Adherencia al tratamiento mediante concentraciones plasmáticas.
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.4.1Number of sites anticipated in Member State concerned1
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA5
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    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
    Last Patient Last Visit
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months8
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    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: 70
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 50
    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 state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 120
    F.4.2.2In the whole clinical trial 120
    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)
    Expected normal treament.
    Tratamiento de acuerdo a la práctica clínica habitual.
    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 Decision2012-07-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-06-19
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2014-12-23
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