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    The EU Clinical Trials Register currently displays   43893   clinical trials with a EudraCT protocol, of which   7300   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).

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    Summary
    EudraCT Number:2006-007062-11
    Sponsor's Protocol Code Number:TTD-06-05
    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:2007-06-19
    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 number2006-007062-11
    A.3Full title of the trial
    ESTUDIO FASE II, MULTICÉNTRICO, ABIERTO, NO RANDOMIZADO PARA EVALUAR LA SEGURIDAD Y EFICACIA DE CETUXIMAB (ERBITUX®) EN COMBINACIÓN CON OXALIPLATINO Y CAPECITABINA (XELOX) DURANTE 12 SEMANAS SEGUIDO DE UN TRATAMIENTO DE MANTENIMIENTO CON CETUXIMAB MÁS CAPECITABINA COMO TRATAMIENTO DE PRIMERA LÍNEA EN PACIENTES ANCIANOS CON CÁNCER COLORRECTAL METASTÁTICO.
    A.3.2Name or abbreviated title of the trial where available
    TTD-06-05
    A.4.1Sponsor's protocol code numberTTD-06-05
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorGrupo de Tratamiento de los Tumores Digestivos (TTD)
    B.1.3.4CountrySpain
    B.3.1 and B.3.2Status of the sponsor
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 Yes
    D.2.1.1.1Trade name Erbitux 5mg/ml
    D.2.1.1.2Name of the Marketing Authorisation holderMerck KGaA
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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.3.1Product nameCetuximab
    D.3.2Product code EMD271786
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNcetuximab
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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 Yes
    D.3.11.13.1Other medicinal product typeAnticuerpo Monoclonal
    D.IMP: 2
    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 Yes
    D.2.1.1.1Trade name Xeloda
    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.3.1Product nameXeloda
    D.3.4Pharmaceutical form
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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.IMP: 3
    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 Yes
    D.2.1.1.1Trade name Eloxatin
    D.2.1.1.2Name of the Marketing Authorisation holderSanofi Aventis
    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.3.1Product nameEloxatin
    D.3.4Pharmaceutical form Powder and solvent for solution for infusion
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntravenous use
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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
    Pacientes ancianos con cáncer colorrectal metastásico
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Evaluar la tasa de respuestas objetivas confirmadas al tratamiento en combinación de cetuximab, oxaliplatino y capecitabina durante 4 ciclos seguido de tratamiento con cetuximab y capecitabina como primera línea de tratamiento en pacientes ancianos con cáncer colorrectal metastásico.
    E.2.2Secondary objectives of the trial
    Control de enfermedad (respuestas objetivas y estabilizaciones)
    • Perfil de seguridad
    • Tiempo hasta la progresión y supervivencia libre de progresión
    • Tiempo al fracaso del tratamiento
    • Determinar el tiempo hasta el inicio de la respuesta
    • Duración de la respuesta
    • Supervivencia global
    • Valorar factores genéticos y proteicos como posibles factores predictivos de respuesta y toxicidad al tratamiento en estudio (amplificación del gen del EGFR mediante FISH, número de repeticiones de la secuencia CA en el intrón 1, los niveles séricos del dominio extracelular del EGFR, expresión de EGFR, AKT, MAPK, PTEN y mutaciones de EGFR, PI3KCA, K-RAS y B-RAF).
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Estudio de factores genéticos y proteicos en tejido tumoral para la determinación de posibles factores predictivos de respuesta al tratamiento del estudio TTD-06-05.
    E.3Principal inclusion criteria
    Firma del consentimiento informado por escrito antes de realizar cualquier procedimiento específico del estudio
    • Diagnóstico histológico de carcinoma colorrectal.
    • Pacientes ≥ 70 años.
    • Carcinoma colorrectal metastático no resecable y/o no operable.
    • Presencia de al menos una lesión medible bidimensionalmente; las lesiones índice no deben estar en una zona irradiada previamente.
    • Estado funcional de Karnofsky ≥ 80% en el momento de entrada en el estudio.
    • Esperanza de vida mayor de 3 meses.
    • Disponibilidad de tejido tumoral para la evaluación inmunohistoquímica de la expresión de EGFR.
    • Los pacientes no pueden haber recibido tratamiento con quimioterapia para la enfermedad avanzada o metastásica. Se pueden incluir pacientes con las siguientes características: a. Recurrencia después de tratamiento neo adyuvante y/o adyuvante con 5-fluorouracilo/ácido folínico o con capecitabina. Pueden haber recibido o no tratamiento también con radioterapia. Deben haber tenido un intervalo libre de enfermedad de más de 12 meses desde que finalizaron el tratamiento. No se aceptan pacientes que hayan recibido tratamiento complementario con combinaciones de oxaliplatino y/o irinotecan, independientemente del intervalo libre de recurrencia. b. Recurrencia después de un tratamiento quirúrgico y/o radioterápico sin tratamiento sistémico adyuvante. c. Enfermedad metastásica diagnosticada de novo.
    • Adecuada reserva medular: a. Hemoglobina ≥ 9 gr/dL b. Cifra absoluta de neutrófilos ≥ 2,0 x 109/L. c. Recuento de plaquetas ≥ 100 x 109/L.
    • Función renal adecuada para la inclusión del paciente en el ensayo, definida como un aclaramiento de creatinina ≥ 30 ml/min medido por la fórmula de Cockcroft-Gault.
    • Adecuada función hepática: a. Bilirrubina total < 1.5 xLSN. b. ASAT (SGOT) y/o ALAT (SGPT) y/o fosfatasa alcalina ≤ 2.5 x LSN (≤ 5 x LSN si hay metástasis hepáticas).
    E.4Principal exclusion criteria
    Diagnóstico o sospecha de metástasis cerebrales y/o leptomeníngeas.
    • Cirugía y/o radioterapia (excluyendo la biopsia diagnóstica) durante las 4 semanas previas a la inclusión en el estudio.
    • Tratamiento crónico concomitante sistémico con inmunoterapia, quimioterapia o tratamiento hormonal para el cáncer.
    • Administración previa de anticuerpos monoclonales, agentes inhibidores de la transducción de señales del EGFR o tratamiento dirigido contra el EGFR.
    • Participación en otro ensayo clínico con medicamentos en los 30 días previos.
    • Participación previa en un ensayo clínico en el cual podría haber recibido tratamiento con cetuximab (independientemente de si recibió o no tratamiento con cetuximab).
    • Neoplasia en los 5 años previos a la entrada en el estudio a excepción de carcinoma de células basales de la piel o carcinoma de cervix pre-invasivo.
    • Síndrome de malabsorción, pérdida de la integridad de tracto gastrointestinal superior o enfermedad inflamatoria crónica intestinal, oclusión o suboclusión intestinal u otras patologías que, a criterio de investigador, puedan alterar la absorción del medicamento.
    • Evidencia de reacción alérgica grado 3 ó 4 a cualquiera de los componentes del tratamiento o a las fluoropirimidinas.
    • Neuropatía periférica clínicamente relevante.
    • Enfermedad coronaria clínicamente significativa o historia de infarto de miocardio en los 12 meses previos o riesgo elevado de descompensación de la insuficiencia cardiaca o arritmia no controlada.
    • Infección activa grave (que requiera antibióticos intravenosos) incluyendo tuberculosis activa y diagnóstico de infección por HIV.
    • Abuso conocido de alcohol y drogas.
    • Incapacidad legal o capacidad legal limitada .
    • Cualquier alteración médica o psicológica que, en opinión del investigador, no permita al paciente concluir el estudio u obtener el consentimiento informado.
    • Pacientes catalogados como frágiles o delicados según los siguientes criterios:
    - Dependencia en una o más actividades de la vida diaria según la escala formal de actividades de la vida diaria –AVD– de Katz. o Tres o más entidades comórbidas mediante la evaluación de la presencia de los siguientes procesos: insuficiencia cardíaca congestiva; valvulopatía cardíaca; coronariopatía; enfermedad pulmonar crónica –obstructiva o restrictiva–; enfermedad cerebrovascular; neuropatías periféricas; insuficiencia renal crónica; hipertensión; diabetes; neoplasias concomitantes; enfermedades vasculares del colágeno; hepatopatía crónica; y artritis incapacitante.
    - Presencia de síndromes geriátricos: demencia moderada-severa; delirios en situación de estrés (infección urinaria o respiratoria, angina o fármacos); depresión moderada-severa que interfiere con la actividad habitual del paciente; caídas frecuentes (3 o más al mes); desatención (¿quién podría ayudarle en caso de emergencia?); incontinencia urinaria en ausencia de estrés, infección, diuréticos o hiperplasia prostática; incontinencia fecal en ausencia de diarrea o laxantes; fracturas osteoporóticas de huesos largos o aplastamientos vertebrales.
    E.5 End points
    E.5.1Primary end point(s)
    Evaluar la tasa de respuestas objetivas confirmadas al tratamiento en combinación de cetuximab, oxaliplatino y capecitabina durante 4 ciclos seguido de tratamiento con cetuximab y capecitabina como primera línea de tratamiento en pacientes ancianos con cáncer colorrectal metastásico.
    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 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 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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    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) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    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 concerned12
    E.8.5The trial involves multiple Member States No
    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 Information not present in EudraCT
    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
    El final del ensayo se define como el momento en el que todos los pacientes hayan
    realizado la primera visita de seguimiento después de la visita de final del estudio.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months26
    E.8.9.1In the Member State concerned days
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) No
    F.1.3Elderly (>=65 years) Yes
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state53
    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 Decision2007-06-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-05-04
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2008-08-21
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