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    Summary
    EudraCT Number:2005-003767-23
    Sponsor's Protocol Code Number:EGF105884
    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:2007-08-09
    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 number2005-003767-23
    A.3Full title of the trial
    A Randomized, Double-Blind, Placebo-Controlled, Multicentre,
    Phase II Study of Oral Lapatinib in combination with Concurrent
    Radiotherapy and Cisplatin versus Radiotherapy and Cisplatin
    alone, in Subjects with Stage III and IVA,B Squamous Cell
    Carcinoma of the Head and Neck (SCCHN)

    Estudio de fase II, multicéntrico, aleatorizado, doble ciego, controlado con placebo, de lapatinib oral en combinación con radioterapia concomitante y cisplatino frente a radioterapia y cisplatino solo, en pacientes con carcinoma epidermoide de cabeza y cuello (SCCHN) de estadio III y IVA,B.
    A.4.1Sponsor's protocol code numberEGF105884
    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 S.A.
    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 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 nameLapatinib
    D.3.2Product code GW572016
    D.3.4Pharmaceutical form 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 nameTykerb
    D.3.10 Strength
    D.3.10.1Concentration unit mg/g milligram(s)/gram
    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 placeboTablet
    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
    Stage III, IVa, IVb Squamous Cell Carcinoma of the Head & Neck

    Carcinoma epidermoide de cabeza y cuello estadíos III,IVa,IVb.
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 8.1
    E.1.2Level LLT
    E.1.2Classification code 10041823
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate and explore the activity of lapatinib or placebo in the two treatment groups with respect to the complete response rate (per RECIST) at six months (24 weeks) from chemoradiation completion in subjects with locally advanced SCCHN.

    Evaluar e investigar la actividad de lapatinib o placebo en los dos grupos de tratamiento respecto al índice de respuesta completa (según RECIST) a los 6 meses (24 semanas) desde la finalización de la quimiorradioterapia en pacientes con SCCHN localmente avanzado.
    E.2.2Secondary objectives of the trial
    To evaluate PFS at 6-months and 1-year, OS, disease-specific survival, loco-regional control & distant relapse, evaluate volumetric tumour responses, determine tolerabilty of the proposed regimen, assess serum concentrations of ErbB1, potentially perform proteomic analysis, determination of intra-tumoural expression of ErbB1, ErbB2, ligands for ErbB receptors and downstream biomarkers

    Evaluar y comparar los dos grupos de tratamiento respecto a lo siguiente: supervivencia sin progresión a los 6 meses y al año, supervivencia global, supervivencia específica de la enfermedad, control locorregional y recaídas a distancia.Evaluar las respuestas volumétricas del tumor.Determinar la toxicidad asociada a los tratamientos propuestos.Evaluar y comparar las concentraciones séricas de ErbB1, realizar un posible análisis proteómico.Determinación de la expresión intratumoral de ErbB1, ErbB2, ligandos de los receptores de ErbB y marcadores biológicos a lo largo de la cascada de señalización.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Willing and able to sign a written informed consent;
    2. Histologically confirmed diagnosis of SCCHN of one or more of the following sites: oral cavity, oropharynx, hypopharynx and larynx;
    Multiple primary tumours will:
    • Have to be histologically proven;
    • Have to be anatomically distant and surrounded by normal tissue;
    • Exclude distant metastasis.
    3. Prior to enrolment subjects must have ErbB1 over-expression determined by immunohistochemistry (IHC) 3+ as assessed by a central laboratory;
    4. Subjects with stage III and IVA/IVB disease, who are to receive cisplatin chemotherapy and radiation therapy as primary treatment (total dose 65 - 70 Gy);
    • Subjects with any T1 and T2 disease, stage N1, are excluded.
    • Subjects with distant metastases, ie Stage IVC, are excluded.
    5. Willing and able to have a tumour biopsy taken at screening; For patients who have had prior tumour biopsy, an adequate archived specimen must be available.
    6. Male or female greater than or equal to 18 years of age;
    Additional criteria for female subjects or female partners of male subjects are outlined in the protocol.
    7. ECOG performance status 0, 1 or 2;
    8. Subjects must have adequate haematological, renal and hepatic function as defined in the protcol.
    9. Left ventricular ejection fraction (LVEF) within the institutional normal ranges as measured by echocardiogram (ECHO) or Multigated Acquisition (MUGA) scan;
    10. Able to swallow tablets whole or swallow a suspension of tablets dissolved in water at study inclusion;
    •The use and timing of feeding tube is optional. If necessary, the suspension may be administered via percutaneous endoscopic gastrostomy (PEG), percutaneous jejunostomy tube (J- Tube), or a nasogastric tube (NG or Dobhoff type tube).
    11. Life expectancy of at least 6 months in the best judgment of the investigator.

    1.que el paciente acepte y sea capaz de dar su consentimiento informado por escrito;
    2.que el paciente presente un diagnóstico de SCCHN confirmado mediante histología en una o más de las siguientes localizaciones: cavidad oral, orofarínge, hipofaringe y laringe;
    Los tumores primarios múltiples tendrán:
    •que estar confirmados mediante histología;
    •que encontrarse anatómicamente distantes y rodeados de tejido normal;
    •que excluir metástasis distantes.
    3.antes del reclutamiento los pacientes deben presentar una sobreexpresión de ErbB1 determinada mediante inmunohistoquímica (IHC) 3+ según la evaluación de un laboratorio central;
    4.pacientes con enfermedad en estadios III y IVA/IVB, que vayan a recibir quimioterapia con cisplatino y radioterapia como tratamiento principal (dosis total 65 - 70 Gy);
    •están excluidos los pacientes con enfermedad T1 y T2, estadio N1.
    •están excluidos los pacientes con metástasis distantes, es decir estadio IVC.
    5.Pacientes que acepten que se les realice una biopsia tumorales durante la selección; Para los pacientes que dispongan de una biopsia tumoral previa, deberá estar disponible un muestra almacenada adecuada.
    6.hombre o mujer >=18 años de edad; se recogen en el protocolo criterios adicionales para mujeres y parejas femeninas de pacientes
    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 >=60 ml/min determinado según el método de Cockcroft y Gault modificado.
    •Recuento absoluto de neutrófilos >=1.500/microl, plaquetas >=100.000/microl.
    •Hemoglobina >=9gm/dL (5mmol/L).
    •Aspartato (AST) y alanina transaminasas (ALT) inferiores a 4 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;
    •El uso de un tubo de alimentación es opcional, así como el plazo de tiempo de su uso. 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 el mejor criterio del investigador.
    E.4Principal exclusion criteria
    1. Nasopharyngeal, paranasal sinuses or nasal cavity tumours;
    2. Any prior or current treatment for invasive head and neck cancer of any kind. This will include but is not limited to: prior tyrosine kinase inhibitors, prior neoadjuvant therapy, prior surgical resection, or use of any investigational agent;
    3. Concurrent use of CYP3A4 inducers or inhibitors. A standard 3-day course of dexamethasone for the prevention of cisplatin-induced nausea and vomiting is permitted;
    4. Subjects with known history of uncontrolled or symptomatic angina, arrhythmias, or congestive heart failure;
    5. History of another malignancy within the last 5 years, with the exception of completely resected basal or squamous cell skin cancer, or successfully treated in-situ carcinoma. History of non-invasive lesion or in-situ carcinoma, including in the head and neck region that was successfully treated with surgery, photodynamics or laser, will be permitted;
    6. Peripheral neuropathy greater than or equal to grade 2;
    7. Pregnant or lactating females (female subjects of child-bearing potential will undertake pregnancy testing at screening and during study completion/withdrawal visits);
    8. Malabsorption syndrome, disease significantly affecting GI function, that could affect absorption of lapatinib;
    9. History of allergic reactions to appropriate antiemetics (e.g. 5-HT3 antagonists) to be administered with platinum chemotherapy;
    10. The investigator considers the subject unfit for the study as a result of the medical interview, physical examinations, or screening investigations;

    1.Pacientes con tumor nasofaríngeo, en los senos nasales y paranasales;
    2.Pacientes que hayan recibido con anterioridad o reciban actualmente tratamiento de cualquier clase para el cáncer de cabeza y cuello invasivo. Entre otros se incluyen los siguientes: inhibidores de la tirosina cinasa previos, terapia neoadyuvante previa, resección quirúrgica previa, o uso de cualquier producto en investigación;
    3.Pacientes que hagan uso concomitante de inductores o inhibidores del CYP3A4. Se permite el uso de un ciclo estándar de 3 días de dexametasona para la prevención de las nauseas y los vómitos inducidos por cisplatino;
    4.Pacientes con historia conocida de angina de pecho, arritmias o insuficiencia cardiaca congestiva no controladas o sintomáticas;
    5.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, incluso en la región de la cabeza y cuello, que haya sido tratado con éxito con cirugía, tratamiento fotodinámico o con láser;
    6.Pacientes con neuropatía periférica de grado 2 o superior;
    7.Pacientes que sean mujeres gestantes o en periodo de lactancia (a las pacientes mujeres en edad fértil se les realizará la prueba de embarazo en la selección y durante las visitas de finalización/retirada del estudio) ;
    8.Pacientes con síndrome de malabsorción, enfermedad que afecte significativamente a la función GI, que pudiera alterar la absorción de lapatinib;
    9.Pacientes con historia de reacciones alérgicas a los correspondientes antieméticos (por ejemplo antagonistas 5HT3) que serán administrados junto con la quimioterapia basada en cisplatino;
    10.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;
    E.5 End points
    E.5.1Primary end point(s)
    Complete response rate (per RECIST) at six months (24 weeks) from chemoradiation completion.

    Evaluar e investigar la actividad de lapatinib o placebo en los dos grupos de tratamiento respecto al índice de respuesta completa (según RECIST) a los 6 meses (24 semanas) desde la finalización de la quimiorradioterapia en pacientes con SCCHN localmente avanzado.
    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 No
    E.6.4Safety No
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    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 Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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.8.4.1Number of sites anticipated in Member State concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA13
    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 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
    LSLV as defined in Section 9 of the protocol
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years5
    E.8.9.2In all countries concerned by the trial months0
    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 2007-08-09. 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 state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 40
    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)
    At this time, no treatment with investigational product, after the end of this study is planned.
    En este momento, no está planeado el tratamiento con el producto en investigación después de que finalice el ensayo.
    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 Decision2007-10-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-10-08
    P. End of Trial
    P.End of Trial StatusCompleted
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