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    Summary
    EudraCT Number:2007-005684-10
    Sponsor's Protocol Code Number:1247.3
    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:2008-05-27
    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 number2007-005684-10
    A.3Full title of the trial
    Ensayo clínico abierto de fase I/IIa para evaluar la dosis máxima tolerada, eficacia, seguridad y farmacocinética de BI 811283 en combinación con citarabina en pacientes con leucemia mieloide aguda no tratados previamente y que no sean elegibles para tratamiento intensivo

    An open Phase I/IIa trial to investigate the maximum tolerated dose, safety, efficacy and pharmacokinetics of BI 811283 in combination with cytarabine in patients with previously untreated acute myeloid leukaemia ineligible for intensive treatment
    A.4.1Sponsor's protocol code number1247.3
    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 SponsorBoehringer Ingelheim España 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.3.2Product code BI 811283
    D.3.4Pharmaceutical form 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.3.9.2Current sponsor codeBI 811283 BS
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    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.2.1.2Country which granted the Marketing AuthorisationSpain
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community Information not present in EudraCT
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product namecytarabine
    D.3.4Pharmaceutical form Injection*
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNcytarabine
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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) Information not present in EudraCT
    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
    Pacientes con leucemia mieloide aguda no tratados previamente y que no sean elegibles para tratamiento intensivo

    Previously untreated acute myeloid leukaemia in adult patients that are not eligible
    for intensive treatment
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10000886
    E.1.2Term Acute myeloid leukemia
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    El ensayo se realizará en dos partes, una parte de Fase I y una de Fase II. En la parte e Fase I sólo participa Alemania, y se evaluaran dos pautas de tratamiento de BI 811283 en combinación con dosis bajas de citarabina (LD-Ara-C). En la Fase I se escalará la dosis de BI 811283 para determinar la dosis máxima tolerada (MTD).
    En la parte de Fase IIa, en que participa España, se evaluaran las dos pautas de tratamiento de BI 811283 a la MTD determinada en la fase I en asociación con LD-Ara-C y una pauta de tratamiento se LD-Ara-C en monoterapia, para determinar la eficacia (remisión completa, remisión completa con con recuperación incompleta del hemograma) de las dos pautas de tratamiento combinado en comparación con el LD-Ara-c en monoterapia en paciente con leucemia mieloide aguda no tratados previamente.
    E.2.2Secondary objectives of the trial
    - Incidencia e intensidad de los acontecimientos adversos clasificados según los CTCAE (versión 3.0)
    - Incidencia de toxicidad limitante de la dosis (TLD)
    - Remisión parcial (RP)
    - Supervivencia sin acontecimientos (SSA)
    - Supervivencia sin recidiva
    - Duración de la remisión
    - Supervivencia global (SG)
    - Necesidades de tratamiento complementario (hemoderivados, uso de antibióticos, hospitalización).
    - Vigilancia de la farmacodinamia: efecto del fármaco en las células leucémicas (p. ej., poliploidia, fosforilación de la histona H3, cambios morfológicos)
    - Farmacocinética de citarabina tras una dosis única y en estado estacionario cuando se administra sola y en combinación con BI 811283 BS (base libre de BI 811283)
    - Farmacocinética de BI 811283 BS en presencia de citarabina
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    ● Hombre o mujeres adultos con LMA no tratada previamente.
    ● Diagnóstico confirmado de LMA según la definición de la OMS (excepto en el caso de leucemia promielocítica aguda, LPA).
    ● Se considera que el paciente no cumple los requisitos para recibir tratamiento intensivo.
    ● El paciente cumple los requisitos para recibir tratamiento con LD-Ara-C.
    ● Esperanza de vida ≥ 3 meses.
    ● Puntuación del estado funcional del Eastern Co-operative Oncology Group (ECOG, R01-0787) ≤ 2 en la selección.
    ● Firma del consentimiento informado por escrito de acuerdo con las directrices de la Buena Práctica Clínica de la Conferencia Internacional de Armonización (ICH-GCP) y la legislación local.
    E.4Principal exclusion criteria
    ● Paciente con LPA [subtipo M3 de LMA según la clasificación francesa-americana-británica (FAB)].
    ● Recidiva de LMA o LMA resistente al tratamiento.
    ● Hipersensibilidad a uno de los fármacos del ensayo o a los excipientes.
    ● Otro proceso maligno que requiera tratamiento.
    ● Afectación comprobada del sistema nervioso central.
    ● Aspartato amino transferasa (AST) o alanina amino transferasa (ALT) mayor de 2,5 veces el límite superior de la normalidad.
    ● INR > 1,5 x LSN en pacientes que no estén recibiendo tratamiento con antagonistas de la vitamina K (fenprocoumon, warfarina).
    ● Bilirrubina superior a 1,5 mg/dl (> 26 µmol/l, unidad equivalente del SI).
    ● Creatinina sérica superior a 2,0 mg/dl.
    ● FEVI (fracción de eyección del ventrículo izquierdo) < 50% en ecocardiografía o insuficiencia cardíaca congestiva de grado III-IV de la New York Heart Association (NYHA).
    ● Enfermedad concomitante, que afectaría la evaluación de la eficacia o la seguridad del fármaco del estudio, p. ej., infección grave activa, angina de pecho inestable o arritmia cardíaca.
    ● Enfermedad psiquiátrica o situación social que limitaría el cumplimiento con los requisitos del ensayo.
    ● Tratamiento concomitante, que se considere importante para la evaluación de la eficacia o seguridad del fármaco del estudio (es decir, otra quimioterapia o inmunoterapia, véase también el apartado 4.2.2)
    ● Contraindicaciones al tratamiento con citarabina según la ficha técnica.
    ● Pacientes sexualmente activos y no dispuestos a utilizar un método anticonceptivo médicamente aceptable durante el ensayo (anticoncepción hormonal, dispositivo intrauterino, preservativo con espermicida, etc.).
    ● Pacientes embarazadas o en período de lactancia.
    ● Pacientes que no sean capaces de cumplir el protocolo.
    E.5 End points
    E.5.1Primary end point(s)
    Fase I: Dosis Máxima Tolerada de dos pautas de tratamiento de BI 811283 en combinación con LD-Ara-C

    Fase IIa: Respuesta (remisión completa, RC; remisión completa con recuperación incompleta del hemograma, RCi)
    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 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) Yes
    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 Yes
    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) Yes
    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.8.4.1Number of sites anticipated in Member State concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA20
    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
    Se dará por concluido el ensayo en cuanto el último paciente incluido finalice la última evaluación de seguimiento.
    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 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 2008-05-27. 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 state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 169
    F.4.2.2In the whole clinical trial 169
    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 Decision2008-08-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-07-09
    P. End of Trial
    P.End of Trial StatusCompleted
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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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