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    The EU Clinical Trials Register currently displays   43614   clinical trials with a EudraCT protocol, of which   7207   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:2011-005547-27
    Sponsor's Protocol Code Number:GO28074
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2012-08-07
    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 number2011-005547-27
    A.3Full title of the trial
    A PHASE II, MULTICENTER, OPEN-LABEL, RANDOMIZED STUDY EVALUATING THE EFFICACY AND SAFETY OF FOLFIRI + MEHD7945A VERSUS FOLFIRI + CETUXIMAB IN SECOND LINE IN PATIENTS WITH KRAS WILD-TYPE METASTATIC COLORECTAL CANCER
    ESTUDIO DE FASE II, ALEATORIZADO, MULTICÉNTRICO Y ABIERTO PARA EVALUAR LA EFICACIA Y LA SEGURIDAD DE FOLFIRI + MEHD7945A FRENTE A FOLFIRI + CETUXIMAB COMO TRATAMIENTO DE SEGUNDA LÍNEA EN PACIENTES CON CÁNCER COLORRECTAL METASTÁSICO CON KRAS ALELO SALVAJE
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study of the investigational drug MEHD7945A compared to the anticancer drug cetuximab when combined with standard chemotherapy in patients with colorectal cancer without mutation in the KRAS gene (Kras wild type).
    ESTUDIO DEL MEDICAMENTO EN INVESTIGACIÓN MEHD7945A COMPARADO CON CETUXIMAB CUANDO SE COMBINA CON QUIMIOTERAPIA ESTANDAR EN PACIENTES CON CÁNCER COLORRECTAL METASTÁSICO SIN MUTACIÓN EN EL GEN KRAS (CON KRAS ALELO SALVAJE)
    A.4.1Sponsor's protocol code numberGO28074
    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 SponsorGenentech, 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 supportGenentech Inc. c/o F. Hoffmann-La Roche Ltd.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGenentech Inc. c/o F. Hoffmann-La Roche Ltd.
    B.5.2Functional name of contact pointTrial Information Support Line-TISL
    B.5.3 Address:
    B.5.3.1Street AddressGrenzacherstrasse 124
    B.5.3.2Town/ cityBasel
    B.5.3.3Post code4070
    B.5.3.4CountrySwitzerland
    B.5.4Telephone number----
    B.5.5Fax number----
    B.5.6E-mailglobal.rochegenentechtrials@roche.com
    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.3.1Product nameMEHD7945A
    D.3.2Product code MEHD7945A (RO5541078)
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    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 INNMEHD7945A
    D.3.9.2Current sponsor codeMEHD7945A (RO5541078)
    D.3.9.3Other descriptive nameAnti-HER3/EGFR DAF, DL11f, RO5541078
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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) 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 Yes
    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: 2
    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 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 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 nameErbitux
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    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.3.9.1CAS number 205923564
    D.3.9.2Current sponsor codeRO5469926
    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) 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 Yes
    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
    Colorectal cancer that does not carry mutation in the KRAS gene
    cancer colorrectal sin mutación en gen KRAS
    E.1.1.1Medical condition in easily understood language
    Colorectal cancer that does not carry mutation in the KRAS gene
    cancer colorrectal sin mutación en gen KRAS
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10001167
    E.1.2Term Adenocarcinoma of colon
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10010029
    E.1.2Term Colorectal cancer NOS
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10038019
    E.1.2Term Rectal adenocarcinoma
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    1-To evaluate the efficacy, as measured by PFS, of FOLFIRI + MEHD7945A (administered every 2 weeks) versus FOLFIRI + cetuximab (administered weekly) in patients with KRAS wild-type mCRC
    2- To evaluate the efficacy, as measured by PFS, of FOLFIRI + MEHD7945A (administered every 2 weeks) versus FOLFIRI + cetuximab (administered weekly) in patients with KRAS wild-type mCRC whose tumors express low levels of HER3
    ? Evaluar la eficacia, medida por la supervivencia libre de progresión (SSP), de FOLFIRI + MEHD7945A (administrados cada 2 semanas) frente a FOLFIRI + cetuximab (administrados cada semana) en pacientes con cáncer colorrectal metastásico (CCRm) con KRAS alelo salvaje
    ? Evaluar la eficacia, medida por la SSP, de FOLFIRI + MEHD7945A (administrados cada 2 semanas) frente a FOLFIRI + cetuximab (administrados cada semana) en pacientes con CCRm con KRAS alelo salvaje cuyos tumores expresan concentraciones bajas de HER3
    E.2.2Secondary objectives of the trial
    ?To evaluate the efficacy, as measured by objective response rate, duration of objective response, and overall survival, of FOLFIRI + MEHD7945A (administered every 2 weeks) versus FOLFIRI + cetuximab (administered weekly) in patients with KRAS wild-type mCRC
    ?To evaluate the efficacy, as measured by objective response rate, duration of objective response, and overall survival, of FOLFIRI + MEHD7945A (administered every 2 weeks) versus FOLFIRI + cetuximab (administered weekly) in patients with KRAS wild-type mCRC whose tumors express low levels of HER3
    ?To evaluate the efficacy, as measured by PFS, objective response rate, duration of objective response, and overall survival, of FOLFIRI + MEHD7945A (administered every 2 weeks) versus FOLFIRI + cetuximab (administered weekly) in patients with KRAS wild-type mCRC whose tumors express high levels of HRG
    Evaluar la eficacia, medida por la tasa de respuesta objetiva, la duración de la respuesta objetiva y la supervivencia global, de FOLFIRI + MEHD7945A (administrados cada 2 semanas) frente a FOLFIRI + cetuximab (administrados cada semana) en pacientes con CCRm con KRAS alelo salvaje
    ? Evaluar la eficacia, medida por la tasa de respuesta objetiva, la duración de la respuesta objetiva y la supervivencia global, de FOLFIRI + MEHD7945A (administrados cada 2 semanas) frente a FOLFIRI + cetuximab (administrados cada semana) en pacientes con CCRm con KRAS alelo salvaje cuyos tumores expresan concentraciones bajas de HER3
    - Evaluar la eficacia, medida por la SSP, la tasa de respuesta objetiva, la duración de la respuesta objetiva y la supervivencia global, de FOLFIRI + MEHD7945A (administrados cada 2 semanas) frente a FOLFIRI + cetuximab (administrados cada semana) en pacientes con CCRm con KRAS alelo salvaje cuyos tumores expresan concentraciones altas de HRG
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    ?Histologically or cytologically confirmed adenocarcinoma of the colon and/or rectum cancer with wildtype Kras status
    ?Progressive disease on or after a first-line oxaliplatin-containing chemotherapy regimen for mCRC
    ?Availability and willingness to provide archival tumor tissue for biomarker testing
    ?Age ?18 years
    ?Male and female
    ?Life expectancy ?12 weeks
    ?ECOG 0 or 1
    ?Disease that is measurable per RECIST v1.1
    ?Adequate hematologic and end-organ function
    - Adenocarcinoma de colon o recto con estado de KRAS alelo salvaje confirmado histológica o citológicamente
    - Progresión de la enfermedad durante o después de la quimioterapia de primera línea con oxaliplatino para el CCRm
    - Consentimiento para proporcionar tejido tumoral de archivo obligatorio para el estudio de biomarcadores
    - Edad ? 18 años
    - hombres o mujeres
    - Esperanza de vida ? 12 semanas
    - Estado funcional según la escala ECOG de 0-1
    - Enfermedad medible conforme a los criterios RECIST v1.1
    - Función hematológica y posibles órganos afectados adecuada
    E.4Principal exclusion criteria
    ?Prior treatment with irinotecan
    ?Prior treatment with an investigational or approved HER-targeted agent
    ?Last anti tumor therapy within 4 weeks prior to Day 1 of the study treatment with exception of oxaliplatin-containing chemotherapy and palliative radiotherapy
    ?Leptomeningeal disease as the only manifestation of the current malignancy
    ?Major surgical procedure within 4 weeks prior to Day 1 of the study treatment
    ?Current severe, uncontrolled systemic disease
    ?History of cardiac heart failure of any New York Heart Association criteria or serious cardiac arrhythmia requiring treatment
    ?History of myocardial infarction within 6 months prior to Day 1 of the study treatment, or history of unstable angina
    ?Clinically significant history of liver disease, including active viral, alcoholic, or other hepatitis; cirrhosis; or current alcohol abuse
    ?Clinically significant gastrointestinal bleeding within 6 months prior to Day 1 of the study treatment
    ?History of ILD
    ?History of severe (Grade 3 or 4) allergic or hypersensitivity reaction to therapeutic antibodies that required discontinuation of therapy
    ?Untreated or progressing CNS metastases
    ?Women during pregnancy or lactation
    Tratamiento previo con irinotecán
    ? Tratamiento previo con un fármaco dirigido a HER, en investigación o aprobado
    ? Último tratamiento antineoplásico en las 4 semanas anteriores al día 1 del ciclo 1, incluyendo quimioterapia, tratamientos biológicos, en investigación u hormonales, o radioterapia
    Intervención de cirugía mayor en las 4 semanas anteriores al día 1 del ciclo 1
    ? Enfermedad leptomeníngea como única manifestación de la neoplasia maligna actual
    - Enfermedad generalizada actual grave no controlada
    - Antecedentes de insuficiencia cardiaca de cualquier grado según la New York Heart Association o arritmia cardiaca grave que precise tratamiento
    - Antecedentes de infarto de miocardio en los 6 meses anteriores al día 1 del ciclo 1 o antecedentes de angina de pecho inestable.
    ? Hepatopatía conocida clínicamente significativa, como hepatitis activa viral, alcohólica o de otro tipo, cirrosis o alcoholismo actual
    - Hemorragia digestiva clínicamente significativa en los 6 meses anteriores al día 1 del ciclo 1
    - Antecedentes de reacción alérgica o hipersensibilidad intensa (de grados 3 o 4) a anticuerpos terapéuticos que haya requerido la interrupción del tratamiento
    -Metástasis del SNC no tratadas/activas
    -Embarazo o lactancia
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint for this study is PFS which will be determined for all patients and for subset of biomarker-positive patients with Kras wild type mCRC. PFS is defined as the time from randomization to documented disease progression assessed by the investigator or death on study, whichever occurs first.
    El criterio principal de valoración en este estudio es la SSP en todos los pacientes con CCRm en todos los pacientes con CCRm con KRAS alelo salvaje y en pacientes con CCRm con KRAS alelo salvaje cuyos tumores expresen concentraciones bajas de HER3). La SSP se define desde la randomización a la ELP valorada por el investigador o la muerte en el estudi, lo que ocurra primero.
    E.5.1.1Timepoint(s) of evaluation of this end point
    See section E.5.1
    ver sección E.5.1
    E.5.2Secondary end point(s)
    ?Objective response, duration of objective response, and overall survival for all patients and for subset of biomarker-positive patients with Kras wild type mCRC.
    ?Incidence, nature, and severity of adverse events, graded according to the NCI CTCAE v4.0
    ?Clinically significant changes in vital signs, physical findings, and clinical laboratory results during and following administration of study treatment
    ?MEHD7945A minimum (Cmin) and maximum (Cmax) serum concentration prior to and after infusion at select time points for patients on Arm A
    ?Plasma concentrations of 5-FU, irinotecan, and SN-38 prior to and after infusion at select time points for patients on Arm A
    ?Serum anti-therapy antibodies (ATAs) to MEHD7945A prior to infusion at select time points for patients on Arm A
    E.5.2.1Timepoint(s) of evaluation of this end point
    See section E.5.2
    Ver sección E.5.2
    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 Yes
    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 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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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) Yes
    E.8.2.2Placebo No
    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 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 EEA80
    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
    Australia
    Belgium
    Canada
    France
    Germany
    Italy
    Romania
    Spain
    United Kingdom
    United States
    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
    This study will be considered completed at the time of the last scheduled clinic visit for the last patient in study, or the date at which the last data point required for efficacy analysis or safety follow up is received and confirmed, whichever is later.
    LVLS, o la fecha en la que se recibe y se confirma el último dato requerido para análisis del seguimiento de eficacia o seguridad, lo que ocurra más tarde.
    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 months9
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months9
    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: 95
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 25
    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 state40
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 80
    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)
    Patients who have shown a demonstrable benefit from MEHD7945A treatment during this study may be given the opportunity to continue MEHD7945A treatment as part of an extension study.
    Pacientes que demuestren beneficio del tratamiento con MEHD7945A durante el estudio pueden tener la oportundiad de continuar con tratamiento MEHD7945A como parte de un estudio de extensión.
    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 Decision2012-11-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-11-09
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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