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    Summary
    EudraCT Number:2008-004908-31
    Sponsor's Protocol Code Number:PM2734-B-001-08
    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:2008-10-06
    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 number2008-004908-31
    A.3Full title of the trial
    Ensayo clínico y farmacocinético de fase II de infusión de 30 minutos de PM02734
    (Irvalec®) cada tres semanas en pacientes con cáncer no microcítico de pulmón
    (CNMP) epidermoide previamente tratado con al menos una línea de quimioterapia
    con platino
    A.4.1Sponsor's protocol code numberPM2734-B-001-08
    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 SponsorPharma Mar 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 namePM02734
    D.3.2Product code PM02734
    D.3.4Pharmaceutical form Powder and solvent for 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 codePM02734
    D.3.10 Strength
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2 to mg
    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 no microcítico de pulmón (CNMP) epidermoide
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level PT
    E.1.2Classification code 10029515
    E.1.2Term Non-small cell lung cancer recurrent
    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 actividad antitumoral de PM02734 administrado como infusión i.v. de 30
    minutos cada tres semanas en pacientes con CPNM tratado previamente con al
    menos una línea de quimioterapia basada en platino.
    E.2.2Secondary objectives of the trial
    • Determinar el perfil de seguridad de esta pauta de administración de PM02734 en
    esta población de pacientes.
    • Determinar el perfil FC de esta pauta de administración de PM02734 en estos
    pacientes.
    • Determinar el perfil FGx de esta pauta de administración de PM02734. Se realizarán
    análisis exploratorios de FGx generadores de hipótesis para correlacionar los parámetros moleculares encontrados en las muestras tumorales de los pacientes con
    los resultados clínicos alcanzados con PM02734. Se evaluarán los siguientes
    parámetros:
    o Marcadores de TEM (E-cadherina, vimentina, claudinas 4 y 7, p-ezrina).
    o Receptores ErbB [receptor del factor de crecimiento epidérmico (EGFR), ErbB2,
    ErbB3] y moléculas de señalización (p-ERK, p-AKT).
    o Genes que participan en la actividad de los lisosomas y en la vía de señalización
    de la beta-catenina.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Subestudio de farmacogenómica (se describe dentro del mismo protocolo):

    Objetivos del subestudio de farmacogenómica:
    Determinar el perfil farmacogenómico de esta pauta de administración de PM02734. Se realizarán análisis exploratorios de farmacogenómica generadores de hipótesis para correlacionar los parámetros moleculares encontrados en las muestras tumorales de los pacientes con los resultados clínicos alcanzados con PM02734.
    E.3Principal inclusion criteria
    1. Consentimiento informado por escrito otorgado voluntariamente por el paciente antes de realizar cualquier procedimiento específico del estudio.
    2. CPNM epidermoide, confirmado histológicamente y con progresión radiológica
    documentada de la enfermedad a la entrada en el estudio.
    3. Tratamiento previo con al menos una línea de quimioterapia basada en platino y no más de dos líneas de quimioterapia (incluidos tratamientos biológicos).
    4. Recuperación completa de los efectos de la radioterapia, si los hubiera y de cualquier acontecimiento adverso (AA) relacionado con un fármaco, derivado de tratamientos previos, excepto la alopecia y cualquier AA de grado 1 de los Criterios comunes de terminología para los acontecimientos adversos del National Cancer Institute (NCICTCAE, versión 3.0).
    5. Al menos una lesión medible [según los Criterios de Evaluación de la Respuesta en
    Tumores Sólidos (RECIST)], localizada en un área no irradiada, medida adecuadamente con métodos adecuados menos de cuatro semanas antes de la entrada en el estudio.
    6. Edad ³ 18 años.
    7. Estado funcional (EF) del Eastern Cooperative Oncology Group (ECOG) R 2.
    8. Esperanza de vida S 3 meses.
    9. Reserva de médula ósea, funciones renales y hepáticas adecuadas.
    a. Recuento de plaquetas S 75 x 109/l, hemoglobina S 10 g/dl y recuento absoluto
    de neutrófilos (RAN) S 1,5 x 109/l.
    b. Fosfatasa alcalina (FA) R 2,5 x límite superior de la normalidad (LSN) (R 5 en
    caso de metástasis óseas o hepáticas).
    c. Alanina-aminotransferasa (ALT), aspartato-aminotransferasa (AST) R 2,5 x LSN
    de los valores del laboratorio de cada centro (o R 5 x LSN en caso de metástasis
    hepáticas).
    d. Bilirrubina total R 1,5 x LSN.
    e. Aclaramiento de creatinina calculado S 30 ml/min.
    10. Las mujeres en edad fértil deberán tener un resultado negativo en una prueba de embarazo antes de la inclusión en el estudio. Tanto las mujeres como los hombres deberán estar conformes en utilizar un método anticonceptivo médicamente
    adecuado a lo largo del período de tratamiento y durante los 3 meses siguientes a la
    suspensión del mismo. Son métodos anticonceptivos aceptables la abstinencia
    completa, los dispositivos intrauterinos (DIU), los anticonceptivos orales, los
    implantes subcutáneos y los métodos de doble barrera (preservativo con esponja
    anticonceptiva u óvulo anticonceptivo).
    E.4Principal exclusion criteria
    1. Tratamiento previo con PM02734 o Kahalalide F.
    2. Mujeres embarazadas o amamantando o cualquier persona que no use un método
    anticonceptivo adecuado.
    3. Transcurso de menos de cuatro semanas desde la radioterapia, el tratamiento
    biológico o la quimioterapia (seis semanas en caso de nitrosourea, mitomicina C o
    altas dosis de quimioterapia).
    4. Más de dos líneas de tratamiento previo para enfermedad metastásica.
    5. Antecedentes de otras neoplasias malignas dentro de los 5 años previos a la entrada en el estudio (excepto cáncer de piel no melanomatoso o carcinoma in situ tratado debidamente).
    6. Evidencia de metástasis progresivas o sintomáticas en sistema nervioso central
    (SNC) o de metástasis leptomeníngeas.
    7. Otras enfermedades o condiciones clínicas adversas relevantes:
    a. Aumento del riesgo cardíaco: insuficiencia cardíaca congestiva, angina pectoris
    inestable, arritmia que precisa tratamiento, hipertensión arterial no controlada o
    infarto de miocardio dentro de los 12 meses previos a la inclusión en el estudio.
    b. Historia de trastorno neurológico o psiquiátrico importantes.
    c. Infección activa.
    d. Hepatopatía no neoplásica importante (p. ej., cirrosis, hepatitis crónica activa).
    e. Pacientes inmunodeprimidos, incluidos aquellos que se sabe que están infectados
    por el virus de la inmunodeficiencia humana (VIH).
    8. Cualquier otra enfermedad importante que, a criterio del Investigador, pueda
    incrementar sustancialmente el riesgo derivado de la participación del paciente en el
    estudio.
    9. Limitación de la capacidad del paciente para cumplir con el tratamiento o el
    seguimiento en un centro participante. Los pacientes registrados en este ensayo
    deberán recibir tratamiento y ser sometidos a seguimiento en un centro participante.
    10. Tratamiento con cualquier producto en fase de investigación en el periodo de los 30 días previos a la inclusión en el estudio.
    11. Hipersensibilidad conocida a cualquier componente de PM02734.
    E.5 End points
    E.5.1Primary end point(s)
    Variable principal:
    La tasa de supervivencia libre de progresión a los tres meses (SLP3), definida como el porcentaje de pacientes sin pruebas de progresión de la enfermedad a los tres meses (esto es, la semana 12 ± 1 semana) después de la primera administración del fármaco del estudio.

    Variables secundarias:
    Eficacia:
    • Tasa de respuesta global (TRG)
    • Duración de la respuesta (DR).
    • Tiempo hasta la progresión (THP).
    • Supervivencia libre de progresión (SLP).
    • Supervivencia global (SG).
    Perfil de seguridad:
    • Acontecimientos adversos (AA).
    Otros:
    • Perfil farmacocinético (FC).
    • Perfil farmacogenómico (FGx).
    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 No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic Yes
    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 No
    E.8.1.1Randomised Information not present in EudraCT
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    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.8.4.1Number of sites anticipated in Member State concerned5
    E.8.5The trial involves multiple Member States No
    E.8.5.1Number of sites anticipated in the EEA5
    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
    3 meses después de la última visita (seguimiento) del último paciente evaluable incluido en el estudio o 9 meses después del reclutamiento del último paciente evaluable (lo qu ocurra antes).
    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 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 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 Yes
    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 2008-10-06. Yes
    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 state20
    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 Decision2008-11-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-11-07
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2010-06-04
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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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