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:2006-000834-11
    Sponsor's Protocol Code Number:TTD-06-01
    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:2010-03-15
    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 number2006-000834-11
    A.3Full title of the trial
    Estudio multicéntrico fase II, abierto, de tratamiento con cetuximab y capecitabina en primera línea de tratamiento en pacientes ancianos con un cáncer colorrectal metastático
    A.4.1Sponsor's protocol code numberTTD-06-01
    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 sponsorNon-Commercial
    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
    D.2.1.1.2Name of the Marketing Authorisation holderMerck KGaA
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    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 nameErbitux
    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 typenot less then
    D.3.10.3Concentration number2
    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.2.1.1.2Name of the Marketing Authorisation holderRoche Farma
    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 Tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNCapecitabina
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150 o 500
    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
    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
    Tasa de respuesta objetiva confirmada a cetuximab y capecitabina en primera línea de tratamiento
    E.2.2Secondary objectives of the trial
    Control de la enfermedad (respuestas objetivas mas estabilizaciones de la enfermedad)
    Seguridad del tratamiento
    Tiempo a la progresión y supervivencia libre de progresión
    Tiempo al fracaso del tratamiento
    Duración de la respuesta
    Determinar el tiempo hasta el inicio de la respuesta
    Supervivencia global
    Correlacionar los parámetros de eficacia con la expresión de EGFR determinada mediante inmunohistoquímica.
    Valorar factores genéticos y proteicos como posibles factores predictivos de respuesta y toxicidad al tratamiento en estudio.
    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 con cetuximab y capecitabina.
    E.3Principal inclusion criteria
    - Consentimiento informado por escrito.
    - Hombres y mujeres => 70 años.
    - Diagnóstico de CCR confirmado histológicamente.
    - Carcinoma colorrectal metastásico 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.
    - Disponibilidad de tejido tumoral para la evaluación inmunohistoquímica de la expresión de EGFR.
    - Estado funcional de Karnofsky ³ 80% en el momento de la inclusión en el estudio.
    - Esperanza de vida superior a los 3 meses.
    - Los pacientes no habrán recibido quimioterapia para la enfermedad avanzada/metastática. Se incluirán pacientes de las siguientes características: 1. Recurrencia tras un tratamiento adyuvante con 5-fluorouracilo/ácido folínico o capecitabina +/- radioterapia con un intervalo libre de enfermedad > a 12 meses desde la finalización del mismo. 2. Recurrencia tras un tratamiento quirúrgico y/o radioterápico sin tratamiento sistémico adyuvante. 3. Diagnóstico de novo de la enfermedad.
    - Una función hepática adecuada, definida por aspartato aminotransferasa (ASAT/SGOT) y alanina aminotransferasa (ALAT/SGPT) <= 2,5 x LSN (<= 5 x LSN si hay metástasis hepáticas) y un valor de bilirrubina total < 1,5 x LSN.
    - Función renal adecuada para la inclusión del paciente en el ensayo, definida como un aclaramiento de creatinina, medido por la fórmula de Cockcroft-Gault, >= 30 ml/min.
    - Función hematológica adecuada, definida mediante el recuento de neutrófilos >= 2,0 x 109/l , plaquetas >= 100 X 109/l y hemoglobina >= 9 g/dl.
    E.4Principal exclusion criteria
    - Metástasis cerebrales y/o leptomeníngeas documentadas o sospechadas.
    - Cirugía (excluyendo la biopsia para diagnóstico) y/o radioterapia en las 4 semanas previas a la inclusión en el estudio.
    - Participación en otro ensayo clínico con medicación en los últimos 30 días.
    - Administración crónica y concomitante de inmunoterapia sistémica, quimioterapia, hormonoterapia y cualquier otro fármaco en fase de investigación.
    - Tumor maligno previo en los últimos 5 años, excepto antecedentes de carcinoma basocelular de piel o carcinoma pre-invasivo de cervix.
    - Cualquier fármaco en investigación en las 4 semanas anteriores a la inclusión.
    - Administración previa de anticuerpos monoclonales, inhibidores de la transducción de la señal de EGFR o tratamiento dirigido al EGFR.
    - Participación previa en un estudio que incluyese la posibilidad de ser asignado a un tratamiento con cetuximab (recibiese o no el tratamiento con cetuximab).
    - Oclusión intestinal aguda o subaguda o antecedentes de enfermedad intestinal inflamatoria.
    - Pacientes con un síndrome de malabsorción conocido o falta de la integridad física del tubo digestivo superior.
    - Reacción alérgica conocida de grado 3 ó 4 a cualquiera de los componentes del tratamiento u otras fluoropirimidinas.
    - Antecedentes de reacciones graves e inesperadas al tratamiento con fluoropirimidinas, y/o pacientes con una probada deficiencia de dihidropirimidina dehidrogenasa (DPD).
    - Coronariopatía clínicamente relevante o antecedentes de infarto de miocardio en los últimos 12 meses.
    - Abuso de alcohol/drogas conocido.
    - Incapacidad legal o capacidad legal limitada.
    - Cualquier trastorno médico o psicológico que, en opinión del investigador, no permita al paciente finalizar el estudio o firmar el consentimiento informado
    - Pacientes catalogados como delicados o “frágiles” por cumplir cualquiera de 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.
    *Tres o más entidades comórbidas mediante la evaluación de la presencia de los siguientes procesos: insuficiencia cardíaca congestiva; valvulopatia cardiaca; 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)
    Tasa de respuesta objetiva confirmada de cetuximab y capecitabina en primera línea de tratamiento en pacientes ancianos con CCR avanzado
    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 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) 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 No
    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 No
    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.8.5The 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 Information not present in EudraCT
    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 months29
    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 Information not present in EudraCT
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    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 state45
    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)
    El manejo clínico estándar aplica. A los pacientes que no sufran una recaída se les realizará seguimiento hasta los 5 años tras fin de tratamiento antes de ser discontinuados y después, según el manejo clínico que corresponde de acuerdo con la enfermedad en estudio.
    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 Decision2006-06-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-05-05
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2007-07-31
    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-Sun May 05 21:50:54 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA