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    The EU Clinical Trials Register currently displays   43846   clinical trials with a EudraCT protocol, of which   7282   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:2010-023580-18
    Sponsor's Protocol Code Number:62202-529
    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:2011-02-22
    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 number2010-023580-18
    A.3Full title of the trial
    Ensayo clínico fase II, de cetuximab en cáncer colorrectal metastático refractario con K-RAS mutado y genotipos FcyRII/IIIa favorables
    Phase II clinical study of cetuximab in refractory colorectal cancer with K-RAS mutated and favourable FcyRII/IIIa genotypes
    A.4.1Sponsor's protocol code number62202-529
    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 SponsorMerck, S.L
    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 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 5 mg/ml solución para perfusión
    D.2.1.1.2Name of the Marketing Authorisation holderMERCK KGAA
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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.3.4Pharmaceutical 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.3.9.3Other descriptive nameCETUXIMAB
    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.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
    Sujetos con CCRm, estadio IV, refractario al tratamiento estándar, que presentan el gen K-RAS mutado y genotipos Fc&#947;RII/IIIa favorables, con genotipos Fc&#947;RIIa-131H/H y/o Fc&#947;RIIIa 158V/V
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 13
    E.1.2Level LLT
    E.1.2Classification code 10010035
    E.1.2Term Cáncer colorrectal, estadio IV
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Determinar la tasa de respuestas objetivas (ORR; respuesta completa [RC] y parcial [RP]) obtenida con la monoterapia con cetuximab
    E.2.2Secondary objectives of the trial
    -Tiempo hasta la progresión (TTP)
    - Supervivencia libre de progresión (SLP)
    - Seguridad y Tolerabilidad
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1) Firma del Consentimiento Informado por el paciente
    2) Edad 18 años y < 70 años
    3) Estadio funcional 0-2 de la escala Eastern Cooperative Oncology Group (ECOG) (ver Apéndice J).
    4) Esperanza de vida de vida mayor de 2 meses
    5) Confirmación histológica de adenocarcinoma de colon o recto (CRC) con K-RAS mutado y genotipos Fc&#947;RIIa-131H/H y/o Fc&#947;RIIIa 158V/V favorables
    6) Expresión EGFR en muestra tumoral
    7) Enfermedad en estadio IV, metastásica, con al menos una lesión metastásica medible siguiendo los criterios RECIST v 1.1, documentada dentro de los 28 días previos a la inclusión.
    8) Muestra de tejido tumoral disponible para la evaluación del gen K-RAS y el genotipo Fc&#947;RII/IIIa
    9) Progresión de la enfermedad a tratamiento estandar y sin otra alternativa terapéutica
    10) Adecuada reserva medular, definida por:
    o hemoglobina >9,0 g/dl
    o recuento de plaquetas >100x109/L
    o recuento absoluto de neutrófilos (RAN) 1.5 x 109/L
    11) Adecuada función hepática y renal, definidas por:
    o Bilirrubina sérica 1.5 veces el límite superior de la normalidad (LSN)
    o Alanina aminotransferasa (ALT [SGPT]) y aspartato aminotransferasa (AST [SGOT]) 2.5 x LSN en ausencia de metástasis hepáticas y ALT (SGPT) y AST (SGOT) 5 x LSN, en presencia de metástasis hepáticas
    o Fosfatasa alcalina 2.5 x LSN o 5 en presencia de metástasis hepáticas o 10 en presencia de metástasis óseas
    o Aclaramiento de creatinina >50 ml/min (según la fórmula de Cockroft y Gault) o creatinina sérica <1.5 x LSN
    12) Adecuada recuperación tras cirugia, quimioterapia o radioterapia recientes. Deberá haber transcurrido al menos 4 semanas desde la cirugía mayor, quimioterapia, tratamiento con un producto en investigación o radioterapia previos
    13) Las mujeres en edad fértil deberán tener una prueba de embarazo negativa realizada en los 7 días previos a la inclusión. Las mujeres postmenopáusicas deben haber permanecido amenorreicas durante al menos 12 meses. Los pacientes de ambos sexos en edad fértil deberán utilizar un método anticonceptivo eficaz (por ejemplo: abstinencia, dispositivo intrauterino [DIU], anticonceptivo oral o método de doble barrera o ser quirúrgicamente estériles) comenzando en la firma del documento de consentimiento informado y hasta al menos 6 meses después de la finalización del tratamiento o de la última dosis, lo que ocurra primero.
    E.4Principal exclusion criteria
    1) Tratamiento previo con anticuerpos monoclonales dirigido contra EGFR
    2) Toxicidad, debida al tratamiento recibido previo, no resuelta a grado 1 antes de la inclusión del paciente en el estudio
    3) Enfermedad cardiovascular grave no controlada o insuficiencia cardiaca congestiva NYHA III o IV, angina de pecho inestable, antecedentes de infarto de miocardio en los últimos doce meses o arritmias importantes
    4) Enfermedad vascular significativa (ej aneurisma aórtico que requiera intervención quirúrgica, embolia pulmonar o trombosis arterial periférica reciente) dentro de los 6 meses previos al inicio del tratamiento del estudio
    5) Evidencia de existencia de metástasis cerebrales
    6) Antecedentes de enfermedad neurológica activa
    7) Antecedentes de crisis convulsiva no controlada
    8) Antecedentes de fibrosis pulmonar, daño pulmonar agudo o neumonía intersticial
    9) Infección conocida por el virus de la inmunodeficiencia humana o infección crónica por los virus de la hepatitis B o C o presencia de infecciones intercurrentes no controladas, severas u otras enfermedades concomitantes severas y no controladas
    10) Infección actual de grado 2 (NCI-CTCAE)
    11) Antecedentes de diabetes no controlada o hipertensión arterial (HTA) no controlada
    12) Alergia conocida o sospecha de alergia o hipersensibilidad a cetuximab
    13) Historia de otra enfermedad neoplásica diferente al cáncer colorrectal, durante los últimos 5 años previos al inicio del tratamiento del estudio, con la excepción de carcinomas curados de células basales de la piel, de cervix o de vejiga in situ tratada hace más de 2 años antes del reclutamiento
    14) Participación en los últimos 30 días en otro ensayo clínico con un fármaco en experimentación
    15) Embarazo o periodo de lactancia
    16) Cualquier problema médico, psicológico, psiquiátrico o social importante y no controlado que pueda interferir en la participación del sujeto en el estudio o la evaluación de los resultados del estudio
    17) Condiciones psicológicas, familiares y geográficas que no puedan permitir un adecuado seguimiento y adherencia con el protocolo del estudio
    E.5 End points
    E.5.1Primary end point(s)
    Tasa de Respuestas Objetivas (ORR; criterios RECIST v1.1)
    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 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 Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    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 Information not present in EudraCT
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    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 concerned3
    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
    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 months8
    E.8.9.1In the Member State concerned days0
    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) Yes
    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 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 state62
    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 Decision2011-05-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-04-04
    P. End of Trial
    P.End of Trial StatusCompleted
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