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   43865   clinical trials with a EudraCT protocol, of which   7286   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:2006-006363-24
    Sponsor's Protocol Code Number:TTD-06-04
    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:2007-01-30
    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 number2006-006363-24
    A.3Full title of the trial
    An Phase 2 Clinical Trial of Panitumumab in Conbination vith Irinotecan chemotherapy as 2nd line Therapy in subjects with Metastatic Colorectal Cancer.

    Ensayo Clínico fase II de Panitumumab combinado con quimioterapia de Irinotecan como tratamiento de segunda linea en sujetos con cáncer colorectal metastásico.
    A.4.1Sponsor's protocol code numberTTD-06-04
    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 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 namePANITUMUMAB
    D.3.4Pharmaceutical form Intravenous 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.3.10 Strength
    D.3.10.1Concentration unit mg/kg milligram(s)/kilogram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number9
    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 IgG2 (IgG2 monoclonal antibody)
    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.2.5The 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 nameIRINOTECAN
    D.3.4Pharmaceutical form Intravenous 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.3.9.1CAS number 100286-90-6
    D.3.10 Strength
    D.3.10.1Concentration unit mg/m2 milligram(s)/square meter
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number300 to 350
    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 colorectal metastásico.
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 8.1
    E.1.2Level PT
    E.1.2Classification code 10052358
    E.1.2Term Colorectal cancer metastatic
    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 resuesta objetiva cuando se administra Panitumumab combinado con Irinotecan como tratmiento de segunda linea en sujetos con cancer colorectal matastásico (CCRm)
    E.2.2Secondary objectives of the trial
    Evaluar la terapia combinada de panitumumab más irinotecán con otras medidas de eficacia: tasa de control de la enfermedad (TCE), duración de la respuesta (DR), tiempo hasta la respuesta (THR), supervivencia libre de progresión (SLP), tiempo hasta la progresión (THP), tiempo hasta el fracaso del tratamiento (THF), duración de la enfermedad estable (DEE).
    Evaluar la eficacia y la seguridad de la estrategia terapéutica de terapia combinada de panitumumab más irinotecán, seguida de panitumumab solo para sujetos que interrumpen irinotecán como tratamiento de segunda línea de un cáncer colorrectal metastásico previamente tratado.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Hombre o mujer > 18 años de edad.
    - Capaz de comprender, firmar y fechar un formulario de consentimiento informado aprobado por el CEI.
    - Adenocarcinoma de colon o recto confirmado histológicamente o citológicamente por el investigador en sujetos que presentan enfermedad metastásica.
    - Progresión de la enfermedad documentada radiológicamente, según los criterios RECIST modificados, mientras recibe la última dosis de quimioterapia para el CCRm o 6 meses después de la misma.
    - Al menos una lesión medible en una dimensión, de al menos 20 mm , según los criterios RECIST modificados (deben evaluarse todas las localizaciones de la enfermedad ≤ 28 días antes de la inclusión).
     Si un sujeto tiene antecedentes de un cáncer diferente al carcinoma colorrectal, carcinoma de células basales o carcinoma cervical in situ, no debe haber recibido tratamiento ni presentado enfermedad activa en los últimos 5 años.
    - La radioterapia previa es aceptable. Deben haber pasado al menos 14 días desde la administración de la radioterapia y deben haber remitido todos los signos de toxicidad.
    - Uno y sólo un régimen previo de quimioterapia para el CCRm que consiste en una quimioterapia de primera línea basada en fluoropirimidina (se permite quimioterapia previa adyuvante basada en fluoropirimidina).
    - Estado de actividad de 0, 1 ó 2 según el Eastern Cooperative Oncology Group (ECOG)
    - Esperanza de vida ≥ 3 meses
    - Función hematológica adecuada (dentro de los 7 días del inicio del tratamiento en estudio):
    - Función renal adecuada (dentro de los 7 días del inicio del tratamiento en estudio):
    - Función hepática adecuada (dentro de los 7 días del inicio del tratamiento en estudio).
    E.4Principal exclusion criteria
    - No más de un régimen previo de quimioterapia para el CCRm que consista en una quimioterapia de primera línea basada en fluoropirimidina (se permite quimioterapia previa adyuvante basada en fluoropirimidina).
    - Quimioterapia sistémica, tratamiento hormonal, inmunoterapia o anticuerpos/proteínas experimentales o aprobados (p. ej., bevacizumab) ≤ 30 días antes de la inclusión.
    - Toxicidades no resueltas de un tratamiento sistémico previo que, según la opinión del investigador, hacen que el paciente no sea apto para la inclusión.
    - Metástasis en el cerebro/sistema nervioso central (excepción: son elegibles los sujetos que se hayan tratado, tengan metástasis asintomáticas en el sistema nervioso central y no hayan estado recibiendo esteroides durante al menos los 30 días previos a la inclusión en el estudio).
    - Enfermedad cardiovascular significativa, incluida la angina de pecho inestable o el infarto de miocardio dentro de los 6 meses previos al inicio del tratamiento de estudio o antecedentes de arritmia ventricular.
    - Tratamiento previo con anticuerpos anti-EGFr (p. ej., cetuximab) o tratamiento con inhibidores de la tirosina cinasa del EGFr de molécula pequeña (p. ej., erlotinib).
    - Antecedentes de neumonitis intersticial o fibrosis pulmonar o indicios de neumonitis intersticial o fibrosis pulmonar en la TC de tórax de basal.
    - Tratamiento por infección sistémica dentro de los 14 días previos al inicio del tratamiento en estudio.
     Radioterapia ≤ 14 días antes de la inclusión. Los pacientes deben haberse recuperado de todas las toxicidades relacionadas con la radioterapia
    - Enfermedad intestinal inflamatoria activa u otra enfermedad intestinal que cause diarrea crónica (definida como > 4 deposiciones sueltas al día).
    - Antecedentes de síndrome de Gilbert o de deficiencia de dihidropirimidina.
    - Antecedentes de cualquier enfermedad que pueda aumentar los riesgos asociados a la participación en el estudio o pueda interferir en la interpretación de los resultados del estudio.
    - Prueba positiva conocida de infección por el virus de la inmunodeficiencia humana, el virus de la hepatitis C, infección por hepatitis B activa crónica.
    - Sujeto alérgico a los ingredientes de la medicación en estudio o a la proteína A de Staphylococcus.
    - Cualquier enfermedad comórbida que pueda aumentar el riesgo de toxicidad.
    - El sujeto presenta un trastorno de cualquier tipo que compromete su capacidad de proporcionar el consentimiento informado escrito y/o cumplir con los procedimientos del estudio
    - Cualquier agente en investigación dentro de los 30 días anteriores a la inclusión.
    - No deben haberse sometido a un procedimiento de cirugía mayor dentro de los 28 días previos a la aleatorización.
    - 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, utilizar 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 en estudio para las mujeres y 1 mes para los hombres.
    - El sujeto no desea o es incapaz de cumplir los requisitos del estudio.
    E.5 End points
    E.5.1Primary end point(s)
    Tasa de respuesta objetiva (TRO) durante la fase de tratamiento combinado.
    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 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 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.8.5The 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
    Ultima visita del último paciente.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months
    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 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.1.3Elderly (>=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 state80
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 80
    F.4.2.2In the whole clinical trial 80
    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 Decision2007-04-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-01-12
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2010-03-30
    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-Mon Apr 29 17:18:49 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA