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    The EU Clinical Trials Register currently displays   31553   clinical trials with a EudraCT protocol, of which   5083   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2007-006681-15
    Sponsor's Protocol Code Number:ET-B-029-07
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2008-06-20
    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 number2007-006681-15
    A.3Full title of the trial
    Ensayo Clínico de Fase II de Trabectedina tras Progresión a Terapia Antitumoral
    basada en Platino en Pacientes con Cáncer No Microcítico de Pulmón (CNMP)
    Avanzado con Sobreexpresión de XPG y/o ERCC1, y Subexpresión de BRCA1
    A.3.2Name or abbreviated title of the trial where available
    STRACT (Spanish Trabectedin Customized Trial)
    A.4.1Sponsor's protocol code numberET-B-029-07
    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 Yes
    D.2.1.1.1Trade name Yondelis® 0.25 mg and Yondelis® 1 mg
    D.2.1.1.2Name of the Marketing Authorisation holderPharma Mar, S.A.
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameYondelis®
    D.3.2Product code ET-743
    D.3.4Pharmaceutical form Powder for concentrate 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.3.8INN - Proposed INNTrabectedina
    D.3.9.1CAS number 114899-77-3
    D.3.9.2Current sponsor codeET-743
    D.3.9.3Other descriptive nameEcteinascidin 743
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0,05 mg/ml sol. to reconstituida
    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) avanzado
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10059515
    E.1.2Term Non-small cell lung 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 eficacia de trabectedina en pacientes con CNMP y que presenten sobreexpresión de ERCC1 y/o XPG, y baja expresión de BRCA1, después de fallo al tratamiento estándar basado en platino. Para ello, se determinará la tasa de pacientes libres de progresión o muerte a las 12 semanas (tres meses), SLP3.
    E.2.2Secondary objectives of the trial
    Eficacia:
    Tasa de respuesta global (TRG).
    Duración de la respuesta (DR).
    Supervivencia libre de progresión (SLP).
    Supervivencia global (SG).
    Perfil de seguridad:
    Tasa de acontecimiento adversos (AA).
    Perfil farmacogenómico.
    Análisis farmacogenómicos exploratorios generadores de hipótesis para correlacionar los parámetros moleculares en las muestras del paciente con los resultados clínicos al tratamiento.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Consentimientos Informados firmados por el paciente antes de iniciar cualquier
    procedimiento relacionado con el ensayo.
    2. Pacientes de ambos sexos con edad ≥ 18 años.
    3. Diagnóstico histológico o citológico de CNMP localmente avanzado considerado
    irresecable/inoperable o metastásico, y que, además, cumpla las siguientes
    condiciones:
    a. Sobreexprese XPG Y/O ERCC1, Y subexprese BRCA1, de acuerdo a los valores
    de las medianas de expresión en cáncer de pulmón determinadas por qRT-PCR.
    b. Pieza tumoral (bloque de parafina) del diagnóstico del paciente está disponible. En
    su defecto, el RNA o cDNA correspondiente está disponible al haber sido extraído
    de la muestra tumoral para estudios moleculares previos.
    c. CNMP recurrente o persistente tras una línea previa de quimioterapia citotóxica
    basada en platino.
    4. Presencia de al menos una lesión medible uni- o bidimensionalmente por tomografía axial computerizada (TAC), localizada en áreas no irradiadas y medida
    adecuadamente en las cuatro semanas antes del tratamiento.
    5. Función renal, hepática y de médula ósea adecuadas:
    d. Hemoglobina ≥ 9 g/dL.
    e. Recuento de neutrófilos ≥ 1,5 x 109/L.
    f. Recuento de plaquetas ≥ 100 x 109/L.
    g. Aclaramiento de creatinina calculado ≥ 30 mL/min.
    h. Bilirrubina sérica ≤ límite superior de normalidad (LSN).
    i. Fosfatasa alcalina (FA) total ≤ 2,5 x LSN; si el valor es > 2,5 x LSN evaluar la
    isoenzima hepática de la FA y/o gamma-glutamil transferasa (GGT) y/o 5´
    nucleotidasa, cuyos valores deberán estar dentro de los valores del LSN. Esto
    indicaría que la elevación de la FA era de origen óseo.
    j. Aspartato aminotransferasa (AST) y alanina aminotransferasa (ALT) ≤ 2,5 x
    LSN.
    k. Albúmina ≥ 2,5 g/dL.
    l. Creatina fosfoquinasa (CPK) ≤ 2, 5 x LSN.
    6. Estado funcional (ECOG Performance Status) ≤ 1 (Apéndice 1).
    7. Esperanza de vida ≥ 3 meses.
    8. Recuperación completa de cualquier toxicidad por tratamientos previos (excepto
    neuropatía de grado 1 y/o alopecia).
    E.4Principal exclusion criteria
    1. Tratamiento quimioterápico o con agentes biológicos en las cuatro semanas previas a la primera dosis del fármaco del ensayo (seis semanas para nitrosoureas o
    mitomicina C).
    2. Participación en otro ensayo clínico o tratamiento concomitante con cualquier
    medicamento en investigación en los 30 días previos a la inclusión en el ensayo.
    3. Administración concomitante de cualquier otro tratamiento antineoplásico.
    4. Tratamiento previo con > 1 línea de quimioterapia basada en platinos para la
    enfermedad avanzada (se admite un régimen adicional como terapia neoadyuvante o
    adyuvante).
    5. Contraindicaciones al uso de corticoesteroides.
    6. Antecedentes de otra enfermedad neoplásica (excepto cáncer de piel distinto de
    melanoma o carcinoma in situ de cervix, adecuadamente tratados).
    7. Presencia de metástasis cerebrales y/o leptomeníngeas, incluso si están siendo
    tratadas.
    8. Presencia de derrame pleural no controlado.
    9. Otras enfermedades o situaciones clínicas graves y/o relevantes, que a juicio del
    Investigador sean incompatibles con el protocolo (cualquiera de las siguientes):
    a. Antecedentes cardiacos, tales como infarto de miocardio en el año anterior a la
    inclusión en el ensayo, angina pectoris sintomática /no controlada, insuficiencia
    cardiaca congestiva o isquemia cardiaca no controlada, cualquier tipo de arritmia
    no controlada o fracción de eyección ventricular izquierda anormal, o hipertensión
    arterial no controlada (según el estándar de la Organización Mundial de la Salud,
    (OMS)).
    b. Antecedentes de transtornos neurológicos (diferentes a metástasis) o psiquiátricos significativos.
    c. Infección activa que requiera tratamiento antibiótico, antifúngico o antiviral que, en
    opinión del Investigador, pudiera comprometer la capacidad del paciente de tolerar
    el tratamiento.
    d. Enfermedad hepática activa clínicamente relevante.
    e. Cirugía mayor en las dos semanas anteriores a la entrada en el ensayo, o cualquier otra patología concomitante que pudiera comprometer la seguridad del paciente o su compromiso a completar el ensayo.
    10. Mujeres embarazadas o en período de lactancia (se precisa prueba negativa de
    embarazo en los tres días previos a la administración de tratamiento), o bien hombres o mujeres en edad fértil que no utilicen métodos anticonceptivos adecuados.
    11. Incapacidad o negativa a cumplir el protocolo o los procedimientos del ensayo.
    E.5 End points
    E.5.1Primary end point(s)
    Variable primaria:
    • Tasa de pacientes libres de progresión o muerte a las 12
    semanas (SLP3)

    Variables secundarias:
    • Tasa de respuesta global (TRG).
    • Duración de la respuesta (DR).
    • Supervivencia libre de progresión (SLP).
    • Supervivencia global (SG).
    • Perfil de seguridad.
    • Perfil farmacogenómico.
    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 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 No
    E.8.1.2Open Yes
    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) 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 concerned14
    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
    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 months9
    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 2008-06-20. 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 state60
    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 Decision2008-08-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-08-18
    P. End of Trial
    P.End of Trial StatusOngoing
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