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    The EU Clinical Trials Register currently displays   43861   clinical trials with a EudraCT protocol, of which   7284   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:2005-004676-20
    Sponsor's Protocol Code Number:20050181
    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:2006-05-08
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2005-004676-20
    A.3Full title of the trial
    "A Randomized, Multicenter Phase 3 Study to Compare the Efficacy of Panitumumab in Combination with Chemotherapy to the Efficacy of Chemotherapy Alone in Patients with Previously Treated Metastatic Colorectal Cancer"

    “Estudio aleatorizado, multicéntrico, de fase 3 para comparar la eficacia de Panitumumab en combinación con quimioterapia frente a la eficacia de quimioterapia sola en pacientes con cáncer colorrectal metastásico tratado previamente”
    A.4.1Sponsor's protocol code number20050181
    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 SponsorAmgen Inc
    B.1.3.4CountryUnited Kingdom
    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 Information not present in EudraCT
    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 namePanitumumab
    D.3.2Product code AMG954
    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.3.9.2Current sponsor codeAMG954
    D.3.9.3Other descriptive namePanitumumab
    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) 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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    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
    2nd line metastatic colorectal cancer in combination with chemotherapy.
    2ª línea en cáncer colorrectal metastásico en combinación con quimioterapia.
    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 el efecto del tratamiento de panitumumab más FOLFIRI, sobre la superpervivencia global (OS) y la supervivencia libre de progresión (PFS), en comparación con FOLFIRI solo como terapia de segunda línea en cáncer colorrectal metastásico.
    E.2.2Secondary objectives of the trial
    Evaluar la tasa de respuesta objetiva (ORR) global, el tiempo hasta la progresión (TTP), la duración de la respuesta (DOR) y la seguridad (incidencia de AA y cambios significativos en los valores de laboratorio).
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    •Adenocarcinoma de colon o recto confirmado histológicamente o citológicamente en pacientes que presentan enfermedad metastásica.
    •Uno y sólo un régimen previo de quimioterapia para el CCRm que consista en una quimioterapia de primera línea basada en fluoropirimidina. (se permite una quimioterapia previa adyuvante basada en fluoropirimidina).
    •Progresión de la enfermedad documentada radiológicamente según criterios RECIST modificados mientras recibe la quimioterapia previa basada en fluoropirimidina para el CCRm o ≤6 meses después de la última dosis.
    •Al menos una lesión medible unidimensionalmente, de 20 mm como mínimo, según criterios RECIST modificados. (Deben evaluarse todas las localizaciones de la enfermedad ≤28 días antes de la inclusión).
    •Estado de actividad de 0, 1 ó 2 según el Eastern Cooperative Oncology Group. (ECOG).
    •Disponibilidad de tejido tumoral incluido en parafina procedente del tumor primario o metástasis para análisis central del EGFr y las pruebas de biomarcador.
    •Hombre o mujer ≥ 18 años de edad.
    •Función hematológica (a ≤ 7 días de la aleatorización):
    Recuento absoluto de neutrófilos (RAN) ≥ 1,5 x 109/L
    Recuento de plaquetas ≥ 100 x 109/L
    Hemoglobina ≥9 g/dL
    •Función renal (a ≤ 7 días de la aleatorización):
    Creatinina ≤ 1,5 veces x el límite superior de la normalidad (LSN)
    •Función hepática (a ≤ 7 días de la aleatorización):
    Aspartato aminotransferasa (AST) ≤ 3 x LSN (si metástasis hepáticas ≤ 5 x LSN)
    Alanino aminotransferasa (ALT) ≤ 3 x LSN (si metástasis hepáticas ≤ 5 x LSN)
    Bilirrubina total ≤ 1,5 x LSN
    •Función metabólica (a ≤ 7 días de la aleatorización) según:
    Magnesio ≥ limite inferior de la normalidad
    •Prueba de embarazo negativa a ≤72 horas de la aleatorización (sólo en mujeres
    en edad fértil).
    •Capaz de comprender, firmar y fechar un formulario de consentimiento informado
    aprobado por el CEIC/IRB.
    •Esperanza de vida ≥3 meses.
    E.4Principal exclusion criteria
    •Antecedentes o presencia conocida de metástasis en el sistema nervioso central (SNC).
    •Antecedentes de otro cáncer primario, excepto:
    Cáncer cervical tratado in situ con intención curativa, o
    Cáncer de piel no melanomatoso resecado con intención curativa, u
    Otro tumor sólido primario tratado curativamente sin presencia de enfermedad
    activa conocida y sin tratamiento administrado durante ≥ 5 años antes de la
    aleatorización.
    •Tratamiento previo con irinotecán.
    •Tratamiento previo con anticuerpos anti-EGFr (p. ej., cetuximab) o con moléculas
    pequeñas inhibidoras del EGFr (p. ej., erlotinib).
    •Quimioterapia sistémica, hormonoterapia, inmunoterapia o anticuerpos/proteínas experimentales o aprobados (p. ej., bevacizumab) ≤ 30 días antes de la aleatorización.
    •Toxicidades no resueltas de un tratamiento sistémico previo que, según la opinión del investigador, hacen que el paciente no sea apto para la aleatorización.
    •Radioterapia ≤ 14 días antes de la aleatorización. Los pacientes deben haberse recuperado de todas las toxicidades relacionadas con la radioterapia.
    •Infección activa que requiere tratamiento sistémico o cualquier infección incontrolada ≤ 14 días antes de la aleatorización.
    •Medicación anticonvulsiva inductora del enzima CYP3A4 (p. ej., fenitoína, fenobarbital o carbamazepina), rifampizina y rifabutina y hierba de San Juan ≤ 14 días antes de la aleatorización.
    •Ketoconazol ≤ 7 días antes de la aleatorización (itraconazol debe utilizarse con precaución).
    •Cualquier agente o tratamiento en investigación ≤ 30 días antes de la aleatorización.
    •Enfermedad cardiovascular clínicamente significativa (incluyendo el infarto de miocardio, angina inestable, insuficiencia cardiaca congestiva sintomática, arritmia cardiaca incontrolada grave) ≤ 1 año antes de la aleatorización
    •Alergia o hipersensibilidad conocida a irinotecán, 5-FU o leucovorina.
    •Antecedentes de enfermedad pulmonar intersticial (p. ej., neumonitis o fibrosis pulmonar) o evidencia de enfermedad pulmonar intersticial en la TC de tórax basal.
    •Enfermedad inflamatoria intestinal activa u otra enfermedad intestinal que cause diarrea crónica (definida como ≥ grado 2 de CTC [CTCAE versión 3.0]).
    •Prueba(s) positivas conocidas de infección por el virus de la inmunodeficiencia humana (VIH), el virus de la hepatitis C, infección activa por hepatitis B aguda o crónica.
    •Cualquier enfermedad comórbida o condición que pudiera aumentar el riesgo de toxicidad (p. ej., deficiencias de dihidropirimidina, ascitis significativa o derrame pleural).
    •Cualquier enfermedad concomitante incontrolada o antecedentes de cualquier enfermedad que pudiera interferir con la interpretación de los resultados del estudio.
    •Procedimiento quirúrgico mayor (que requiera anestesia general) ≤ 28 días antes o procedimiento quirúrgico menor (excluida la colocación de un catéter venoso central) ≤ 14 días antes de la aleatorización. Los pacientes deben haberse recuperado de las toxicidades relacionadas con la cirugía
    •Mujer que está embarazada o en periodo de lactancia.
    •Mujer u hombre en edad fértil que no esté de acuerdo con tomar precauciones anticonceptivas adecuadas, es decir, métodos anticonceptivos de barrera doble (p. ej., diafragma más condón) o abstinencia durante el transcurso del estudio y durante 6 meses después de la última administración del fármaco del estudio para las mujeres y 1 mes para los hombres.
    •El sujeto no desea o es incapaz de cumplir los requisitos del estudio.
    •Aleatorizado previamente al protocolo de este estudio.
    E.5 End points
    E.5.1Primary end point(s)
    Eficacia: Supervivencia global (OS) y supervivencia libre de progresión (SLP).
    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 Information not present in EudraCT
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Information not present in EudraCT
    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) Information not present in EudraCT
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) Information not present in EudraCT
    E.8 Design of the trial
    E.8.1Controlled No
    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) 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 Yes
    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
    Los sujetos con evidencia de progresión de la enfermedad interrumpirán el tratamiento y se les hará un seguimiento de seguridad (30 días ± 3 días después de la última administración del tratamiento del estudio) y de la supervivencia (cada 3 meses ± 28 días hasta 30 meses después de haberse aleatorizado el último sujeto).
    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 months2
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months2
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Information not present in EudraCT
    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 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 state60
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 635
    F.4.2.2In the whole clinical trial 1100
    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 Decision2006-06-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-06-13
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2010-09-13
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    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
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