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    The EU Clinical Trials Register currently displays   42330   clinical trials with a EudraCT protocol, of which   6971   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2009-014445-80
    Sponsor's Protocol Code Number:CP4055-306
    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:2010-05-03
    Trial 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 number2009-014445-80
    A.3Full title of the trial
    A Randomised Phase III Study of Elacytarabine vs. Investigator´s Choice in Patients
    with Late Stage Acute Myeloid Leukaemia

    Estudio aleatorizado fase III de elacitarabina comparada con la elección del investigador en pacientes con leucemia mieloide aguda en estadio avanzado
    A.4.1Sponsor's protocol code numberCP4055-306
    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 SponsorClavis Pharma
    B.1.3.4CountryNorway
    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 Yes
    D.2.5.1Orphan drug designation numberOD 476 (ref EU/3/07/476)
    D.3 Description of the IMP
    D.3.1Product nameElacitarabina
    D.3.2Product code CP-4055
    D.3.4Pharmaceutical form Intravenous 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 INNelacitarabina
    D.3.9.1CAS number 188181-42-2
    D.3.9.3Other descriptive name5'O-(trans-9'-octadencenoyl1)1-beta-D arabinofuranosyl cytosine
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number7.5
    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
    Late Stage Acute Myeloid Leukaemia

    Pacientes con leucemia mieloide aguda en estadio avanzado
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 11
    E.1.2Level LLT
    E.1.2Classification code 10066764
    E.1.2Term Progresión de leucemia mieloide aguda
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Comparar la eficacia, medida como supervivencia global (SG), de la elacitarabina y la elección del investigador en pacientes con LMA en estadio avanzado
    E.2.2Secondary objectives of the trial
    -Comparar la tasa y la duración de la respuesta a la elacitarabina con la elección del investigador en pacientes con LMA en estadio avanzado.
    -Comparar el perfil de seguridad de la elacitarabina con el de la elección del investigador.
    -Caracterizar las relaciones entre exposición y respuesta para determinar la eficacia y la toxicidad.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Tener 18 o más años de edad.
    2. Pacientes con un diagnóstico confirmado de LMA de acuerdo con la clasificación de la OMS (excluida la leucemia promielocítica aguda) y haber recibido dos o tres regímenes previos de inducción o reinducción. Uno de los regímenes de (re)inducción puede ser trasplante de células madre (TCM) para lograr la remisión. Pueden haberse administrado regímenes de mantenimiento y consolidación (incluido el TCM), pero no se contarán como regímenes previos.
    3. Las biopsias y/o aspirados medulares deben contener > 5 % de células blásticas leucémicas o bien el paciente debe presentar LMA extramedular demostrada con biopsia o detectarse células blásticas leucémicas en su sangre periférica.
    4. Los pacientes deben:
    a. no haber alcanzado nunca la RC ni la RCi (resistencia primaria); o
    b. haber fracasado con la terapia de inducción inicial y haber alcanzado la RC o la RCi tras tratamiento(s) de rescate y haber recidivado en un plazo < 6 meses; o
    c. haber alcanzado la RC o la RCi tras la terapia de inducción inicial y haber recidivado en un plazo < 12 meses, sin responder al o a los tratamientos de rescate; o
    d. haber recidivado tras la última RC o RCi en un plazo < 6 meses.
    5. Los pacientes menores de 65 años deben haber sido tratados previamente con citarabina.
    6. Los pacientes deben haberse recuperado de un trasplante previo de médula ósea y/o de células madre para ser capaces de tolerar el tratamiento del estudio. No hay ninguna restricción respecto al número de regímenes ni al tipo de tratamiento administrado para el mantenimiento o la consolidación durante las fases previas de la enfermedad.
    7. Los pacientes deben presentar un grado de actividad (GA) ECOG de 0 a 2.
    8. Las mujeres potencialmente fértiles deben presentar un resultado negativo en una prueba de embarazo en suero u orina dentro de las dos semanas previas al inicio del tratamiento.
    9. Los y las pacientes deberán utilizar métodos anticonceptivos aceptables durante su participación en el estudio. En el caso de los varones, este plazo se prolongará hasta 3 meses después de haber recibido la última dosis de elacitarabina.
    10. Los pacientes deben ser capaces de comprender y cumplir los requisitos del protocolo así como de ser capaces y estar dispuestos a firmar un formulario de consentimiento informado.
    E.4Principal exclusion criteria
    1. Historia de reacciones alérgicas al huevo. Historia de reacciones alérgicas a la citarabina de grado 3 ó 4 (CTCAE).
    2. Toxicidad clínicamente relevante y persistente de quimioterapia previa.
    3. Historia de cáncer que, en opinión del investigador, pueda afectar a la evaluación de los criterios de valoración del estudio.
    4. Resultado positivo en prueba del virus de la inmunodeficiencia humana (VIH).
    5. Pacientes embarazadas o en fase de lactancia.
    6. Enfermedad concomitante e incontrolada, incluidas, pero no limitadas a, infecciones incontroladas o enfermedades psiquiátricas o situaciones sociales que limiten el cumplimiento de los requisitos del estudio.
    7. Trastorno hepático o de la función renal que, en opinión del investigador, haga que el paciente se exponga a un riesgo excesivo si participa en este estudio clínico.
    8. Cardiopatía activa, incluido el infarto de miocardio durante los 3 meses anteriores, arteriopatía coronaria sintomática, arritmias no controladas con medicación o insuficiencia cardíaca congestiva no controlada. Cualquier insuficiencia cardíaca de grado 3 ó 4 (NYHA).
    9. Aplicable solamente a pacientes en los que la antraciclina forme parte del tratamiento de control seleccionado:
    La fracción de eyección ventricular izquierda (FEVI) debe ser >= 45 % según el resultado de una exploración MUGA o ecocardiografía bidimensional realizada dentro de los 14 días anteriores al inicio del tratamiento. Ambosmétodos se consideran aceptables para medir la FEVI.
    10. Aplicable solamente a pacientes en los que la antraciclina forme parte del tratamiento de control seleccionado:
    Pacientes tratados previamente con una dosis acumulada de daunorubicina o equivalente superior a 370 mg/m2. El paciente debe tolerar como mínimo un curso de terapia combinada.
    11. Pacientes que hayan recibido agentes antileucémicos durante las últimas 4 semanas. Sin embargo, la hidroxiurea se permite hasta 12 horas antes de recibir el tratamiento del estudio.
    12. Pacientes que hayan recibido cualquier tratamiento en investigación durante los últimos 14 días.
    13. Cualquier enfermedad o trastorno médico que, en opinión del investigador, exponga al paciente a un riesgo inaceptablemente elevado de toxicidad.
    E.5 End points
    E.5.1Primary end point(s)
    Número de muertes por cualquier causa
    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 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 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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Investigators´choice (There is no standard therapy for second salvage treatment of AML)
    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 EEA43
    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 Yes
    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 years1
    E.8.9.1In the Member State concerned months8
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months8
    E.8.9.2In all countries concerned by the trial days0
    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 No
    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
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 230
    F.4.2.2In the whole clinical trial 350
    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 Decision2010-06-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-06-07
    P. End of Trial
    P.End of Trial StatusOngoing
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