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   44335   clinical trials with a EudraCT protocol, of which   7366   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:2005-004782-41
    Sponsor's Protocol Code Number:MO18660
    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:2006-05-24
    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 number2005-004782-41
    A.3Full title of the trial
    Estudio en grupos paralelos, de fase II de Tarceva® (Erlotinib) en pacientes con cancer de pulmón no microcítico avanzado (estadios IIIB/IV) no tratados previamente con quimioterapia incluyendo una escalada de dosis hasta toxicidad en ex fumadores y fumadores habituales.

    A parallel phase II study of Tarceva® (Erlotinib) in patients with advanced non-small cell lung cancer (Stage IIIB/IV) nt pre-treated by chemotherapy including dose escalation to toxicity in current and former smokers
    A.4.1Sponsor's protocol code numberMO18660
    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 SponsorF. Hoffmann-La Roche Ltd
    B.1.3.4CountrySwitzerland
    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.2.1.1.1Trade name Tarceva
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Registration Limited
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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 nameTarceva
    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 INNerlotinib
    D.3.9.1CAS number 183319-69-9
    D.3.9.2Current sponsor codeRo 50-8231/OSI-774
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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 No
    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 Information not present in EudraCT
    D.2.1.1.1Trade name Tarceva
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Registration Limited
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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 nameTarceva
    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 INNerlotinib
    D.3.9.1CAS number 183319-69-9
    D.3.9.2Current sponsor codeRo 50-8231/OSI-774
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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 No
    D.IMP: 3
    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.2.1.1.1Trade name Tarceva
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Registration Limited
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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 nameTarceva
    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 INNerlotinib
    D.3.9.1CAS number 183319-69-9
    D.3.9.2Current sponsor codeRo 50-8231/OSI-774
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    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 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
    Pacientes con cancer pulmonar no microcítico avanzado no tratados previamente con quimioterapia.

    Patients with advanced NSCLC not previously treated with chemotherapy
    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
    Eficacia de erlotinib administrado como un agente simple en pacientes con CPNM avanzado no tratado previamente con quimioterapia determinado por la Tasa de No Progresión (TNP) a las 8 semanas.
    La evaluación se realizará en el grupo de no fumadores y de fumadores habituales/ex fumadores por separado.
    E.2.2Secondary objectives of the trial
    Variables secundarias de eficacia
    1.Los parámetros de eficacia Secundaria serán determinados por
    · La tasa de respuesta objetiva y la tasa de control de la enfermedad
    · Duración de la respuesta
    · Tiempo hasta la progresión
    · Supervivencia sin progresión
    · Supervivencia global
    2.Se valorarán los datos de los biomarcadores en las muestras tumorales obtenidas antes del tratamiento con erlotinib y correlacionarlos con el resultado del tratamiento con erlotinib
    3.Se evaluarán prospectivamente los parámetros PK que potencialmente influyan la actividad de erlotinib en el grupo de fumadores habituales/ex fumadores y los que nunca han fumado.
    4.Se estudiará la seguridad y la tolerancia de erlotinib en un contexto de tratamiento de primera linea.
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    ·Pacientes con CPNM documentado histológicamente, localmente avanzado ó recurrente (estadío IIIB y no candidato a una modalidad terapéutica combinada) ó metastásico (estadío IV), que no hayan recibido previamente quimioterapia para la enfermedad avanzada

    ·Se facilitarán al investigador coordinador en las 3 semanas siguientes a partir del momento en que el paciente inicie el tratamiento con erlotinib muestras de tejido tumoral pulmonar de diagnóstico primario fijadas en parafina e incluídas en formalina (se prefieren bloques de tejido a láminas) representativas del tumor y obtenidas antes de empezar el tratamiento con erlotinib. Este es un Requisito Imprescindible para Entrar en el Estudio

    ·Que previamente no haya recibido quimioterapia para la enfermedad en estadío avanzado. Se permite que previamente haya recibido tratamiento adyuvante si el paciente ha recidivado > 1 año después de finalizar la quimioterapia.

    ·Enfermedad mesurable según los criterios de respuesta RECIST

    ·Edad igual ó superior a 18 años

    ·Capaz de cumplir los procedimientos del estudio y del seguimiento.

    ·Los pacientes deben ser capaces de tomar medicación por vía oral

    ·Consentimiento Informado por Escrito (CIE) (firmado) para participar en el estudio

    ·Estado funcional ECOG entre 0 – 2.

    ·Expectativa de vida de por lo menos 12 semanas.

    ·Por lo menos 4 semanas sin haberse sometido previamente a cirugía ni radioterapia. Los pacientes deben haberse recuperado (CTC < 1) de toxicidades agudas de cualquier tratamiento previo.

    ·Recuento de granulocitos > 1.500/mm3 y recuento plaquetario > 100.000 / mm3 ; hemoglobina > 9,0 g/dl.

    ·Bilirrubina sérica dentro del límite superior de la normalidad (LSN), SGOT (AST) y SGPT (ALT) < 2,5 x LSN (ó < 5 x LSN en el caso de metástasis hepáticas).

    ·Creatinina sérica < 1,5 LSN ó aclaramiento de creatinina > 60 ml/min.

    ·Para todas las mujeres en edad fértil deberá obtenerse una prueba de embarazo negativa en las 72 horas previas al inicio del tratamiento. Los pacientes con potencial reproductivo deberán utilizar métodos anticonceptivos eficaces.

    ·Pacientes que puedan clasificarse ó bien como que nunca han fumado ó bien como fumadores habituales/ex fumadores según las definiciones del apartado 3.1 (obsérvese que el resto de fumadores (p. ej puro, pipa) serán excluidos de participar en el estudio).


    E.4Principal exclusion criteria
    -Cualquier enfermedad sistémica inestable incluyendo:
    · infección activa ó enfermedad subyacente grave que limite la capacidad del paciente para recibir el tratamiento del protocolo,
    · hipertensión incontrolada
    · angina inestable
    · cardiopatía grave (estadíos de NYHA III y IV, insuficiencia cardíaca, angina inestable, especialmente arritmia incontrolada)
    · insuficiencia cardiaca congestiva
    · antecedentes de infarto de miocardio en el año previo
    · arritmia cardiaca grave que requiera medicación
    · enfermedad hepática, renal ó metabólica
    -Cualquier otra neoplasia en 5 años (exceptuando el carcinoma in situ de cervix ó cáncer de piel de células escamosas ó basal tratados adecuadamente).
    -Se excluirá a los pacientes si existen pruebas clínicas de metástasis cerebral, ó si presentan metástasis cerebrales ó compresión de la médula espinal recién diagnosticada y/ó que aún no se haya tratado definitivamente con cirugía y/ó radiación; también serán una causa de exclusión de pacientes las metástasis en el SNC ó compresión medular previamente diagnosticadas y tratadas sin pruebas de enfermedad estable (clínicamente estable según técnica de diagnóstico por imagen) durante por lo menos 2 meses.
    -Cualquier enfermedad, disfunción metabólica, hallazgo a la exploración física, ó hallazgo en las pruebas de laboratorio que haga sospechar razonablemente que existe una enfermedad ó estado que contraindica el uso de la medicación del estudio.
    -Tratamiento previo con cualquier modalidad terapéutica que actúe en el eje RFCE.
    -Pacientes incapaces de tomar medicación por vía oral, que requieran alimentación intravenosa, con síndrome de malabsorción y cualquier otro estado que afecte la absorción gastrointestinal, ó con una úlcera péptica activa.
    -Mujeres gestantes ó en periodo de lactancia materna.
    -Cualquier cambio inflamatorio de la superficie del ojo
    E.5 End points
    E.5.1Primary end point(s)
    Los dos grupos de tratamiento en este estudio serán evaluados separadamente; no se planea una comparación estadística de los resultados de los dos grupos de tratamiento.
    La variable principal de eficacia se determinará por la Tasa de No Progresión (TNP). La TNP está definida como la proporción de pacientes sin enfermedad progresiva (EP) (basado en el criterio RECIST) a las 8 semanas después de empezar el tratamiento, es decir, todos los pacientes con una respuesta completa (RC) o respuesta parcial (RP), o enfermedad estable (EE) que está documentada durante al menos 8 semanas de la visita Basal.
    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 Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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) 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 No
    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
    El ensayo finalizará cuando el último paciente ha finalizado el tratamiento con erlotinib y completado su visita de tratamiento final (28 días después de la última dosis administrada).
    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 months0
    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 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 2006-05-24. 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 state12
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 44
    F.4.2.2In the whole clinical trial 44
    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)
    Treatment of patients will continue until PD, unacceptable toxicity or death; all patients will be followed every 6 months after end of study medication administration until the end of the study to check their disease and/or survival status.
    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 Decision2006-07-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-06-14
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2009-01-25
    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-Fri May 09 14:17:21 CEST 2025 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA