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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:2005-002485-11
    Sponsor's Protocol Code Number:EGF104334
    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:2005-11-11
    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 number2005-002485-11
    A.3Full title of the trial
    Estudio fase II, multicéntrico, aleatorizado, simple ciego y controlado con placebo, de Lapatinib en pacientes con carcinoma epidermoide de cabeza y cuello locamente avanzado
    A Randomized, Single Blind, Placebo-controlled, Multi-centre, Phase II Study of Lapatinib in Patients with Locally Advanced Squamous Cell Carcinoma of the Head and Neck
    A.4.1Sponsor's protocol code numberEGF104334
    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 SponsorGlaxoSmithKline
    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 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 nameLapatinib
    D.3.2Product code GW572016
    D.3.4Pharmaceutical form Film-coated 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 INNLapatinib
    D.3.9.1CAS number 388082-78-8
    D.3.9.2Current sponsor codeGW572016
    D.3.9.3Other descriptive nameLapatinib ditosilato monohidrato
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number250
    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 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 Information not present in EudraCT
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboFilm-coated tablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Carcinoma epidermoide de cabeza y cuello
    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
    Explorar los efectos de la monoterapia con lapatinib en la apoptosis/necrosis, en muestras de tejido tumoral tomadas antes (pre-) y después (pos-) del tratamiento en pacientes con SCCHN localmente avanzado.
    E.2.2Secondary objectives of the trial
    Investigar los efectos de la monoterapia con lapatinib en la proliferación celular, en muestras de tejido tumoral tomadas pre- y postratamiento en pacientes con SCCHN localmente avanzado.
    Evaluar la actividad clínica inicial y la seguridad de lapatinib administrado en pacientes con SCCHN no tratados con anterioridad.
    Correlacionar las respuestas tumorales radiológicas tempranas con los marcadores biológicos.
    Investigar los efectos de lapatinib en los mediadores intracelulares que regulan el crecimiento de células tumorales y la supervivencia en muestras de tejido tumoral pretratamiento y postratamiento.
    Evaluar los efectos de la terapia con lapatinib en el perfil proteómico en sangre periférica.
    Examinar el perfil molecular de los tumores para localizar factores que puedan influir en las respuestas biológica y clínica a lapatinib.
    Presencia de células tumorales circulantes (CTCs) y su potencial correlación con la respuesta tumoral al tratamiento.
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    1. Pacientes que acepten y sean capaces de dar su consentimiento informado por escrito
    2. Con diagnóstico de SCCHN confirmado mediante histología o citología
    3. Pacientes con enfermedad de estadio III y IVA, que han de recibir quimiorradioterapia como tratamiento primario (dosis total ≥ 66 Gy). Se excluirá a los pacientes con metástasis distantes (estadio IVB).
    4. Pacientes que acepten que se les realice dos biopsias tumorales, una durante la selección y otra tomada durante la administración de lapatinib o placebo.
    5. Hombres o mujeres 18 años de edad:
    6. Criterios para pacientes mujeres o parejas femeninas de pacientes masculinos:
    No potencialmente fértiles (es decir, mujeres con ovarios funcionales con ligadura de trompas o histerectomía documentadas, o mujeres postmenopáusicas); o
    Potencialmente fértiles (es decir, mujeres con ovarios funcionales y sin alteración documentada de la función ovárica, tubárica o uterina que pudiera causar esterilidad). Esta categoría incluye mujeres con oligomenorrea (intensa), mujeres perimenopáusicas, y mujeres jóvenes que han comenzado a menstruar). Las pacientes deben tener una prueba de embarazo en suero negativa en la selección y estar de acuerdo en una de las siguientes opciones:
    • Abstinencia completa de relaciones sexuales durante 2 semanas antes de la administración de la primera dosis de la medicación de estudio y hasta 28 días después de la dosis final de la misma; o

    • Seguimiento habitual y correcto de uno de los siguientes métodos anticonceptivos aceptables:
    • Pareja sexual masculina estéril y única antes de la inclusión de la paciente en el estudio;
    • Implantes de levonorgestrel; o
    • Progestágeno inyectable
    • Cualquier dispositivo intrauterino (DIU) con una tasa documentada de fracasos inferior al 1% anual; o
    • Anticonceptivos orales (combinados o sólo progestágeno); o
    • Métodos de barrera incluidos: diafragma o preservativo con espermicida.
    7. Pacientes con puntuación 0, 1 o 2 en la escala del estado funcional ECOG.
    8. Pacientes que tengan un adecuado control de la función hematológica, renal y hepática.
    • Aclaramiento calculado de creatinina de 40 ml/min determinado según el método de Cockcroft y Gault o por el método del EDTA.
    • Recuento absoluto de neutrófilos 1,500/l, plaquetas 100,000/l.
    • Hemoglobina 9gm/dL (5mmol/L).
    • Aspartato (AST) y alanina transaminasas (ALT) inferiores a tres veces el límite superior normal (LSN).
    • Bilirrubina total 2.0 mg/dL.
    9. Pacientes con fracción de eyección ventricular izquierda (FEVI) que esté dentro de los rangos de normalidad del centro determinada mediante imágenes mediante ecocardiograma o ventriculografía nuclear (MUGA).
    10. Paciente capaz de tragar un comprimido completo o la suspensión obtenida a partir del comprimido disuelto en agua en el momento de la inclusión en el estudio. Si fuera necesario, la suspensión se podrá administrar vía gastrostomía endoscópica percutánea (PEG), tubo de yeyunostomía percútanea, o por vía nasogástrica (tubo NG o tipo Dobhoff).
    11. Pacientes con expectativa de vida de al menos 6 meses bajo criterio del investigador
    E.4Principal exclusion criteria
    1. Pacientes con tumor en los senos nasales y paranasales;
    2. Pacientes que hayan recibido quimioterapia sistémica con intenciones curativas con anterioridad;
    3. Pacientes que hayan recibido radioterapia con anterioridad;
    4. Pacientes que hayan recibido tratamiento previo o concomitante con inhibidores de la tirosina cinasa;
    5. Pacientes que hayan utilizado un fármaco en investigación en los 30 días o 5 semividas, lo que sea más largo, anteriores a la primera dosis de lapatinib;
    6. Pacientes que hagan uso concomitante de inductores o inhibidores del CYP3A4;
    7. Pacientes con historia conocida de angina de pecho, arritmias o insuficiencia cardiaca congestiva no controladas o sintomáticas;
    8. Pacientes con antecedentes de otra enfermedad maligna durante los últimos 5 años, a excepción de carcinoma cutáneo epidermoide o basal completamente resecado, o en carcinoma tratado con éxito in situ. Se permitirá la inclusión de pacientes con historia de lesión no invasiva o carcinoma in situ de cabeza y cuello que haya sido tratado con éxito con cirugía, tratamiento fotodinámico o con láser;
    9. Pacientes con metástasis a distancia, es decir de estadio IVB;
    10. Pacientes que sean mujeres u hombres potencialmente fértiles con actividad sexual, que no acepten practicar un método anticonceptivo efectivo. (por ejemplo anticonceptivos orales, DIU o diafragma junto con un espermicida )
    11. Pacientes que sean mujeres gestantes o en periodo de lactancia (A las pacientes potencialmente fértiles se les realizará una prueba de embarazo en la selección y durante las visitas de finalización o retirada del estudio);
    12. Pacientes con síndrome de malabsorción, enfermedad que afecte significativamente a la función GI, que podría alterar la absorción de lapatinib;
    13. Pacientes con historia de reacciones alérgicas a los correspondientes diuréticos o antieméticos (por ejemplo antagonistas 5HT3) que serán administrados junto con la quimioterapia basada en platino;
    14. Pacientes que el investigador considere que no son adecuados para el estudio, como resultado de la entrevista clínica, las exploraciones físicas o las pruebas de selección.
    15. Pacientes que tomen cualquier medicación prohibida
    E.5 End points
    E.5.1Primary end point(s)
    • Calcular el porcentaje de apoptosis/necrosis en muestras de biopsia tumoral de pacientes con SCCHN después de recibir tratamiento de dos a seis semanas con lapatinib o placebo
    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 Information not present in EudraCT
    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 Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind Yes
    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 Yes
    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 Yes
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    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
    Según se define en la sección 12 del protocolo, el fin del ensayo será la última visita del último sujeto incluido en el ensayo
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    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 years1
    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 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 Information not present in EudraCT
    F.3.3.1Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2005-11-11. Yes
    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 state7
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 45
    F.4.2.2In the whole clinical trial 90
    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)
    No se prevé ningún tratamiento tras el final del 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 Decision2005-11-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2005-11-09
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2007-12-27
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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
    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.

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