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    The EU Clinical Trials Register currently displays   43865   clinical trials with a EudraCT protocol, of which   7286   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).

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    Summary
    EudraCT Number:2006-002316-10
    Sponsor's Protocol Code Number:H6Q-MC-S019
    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:2010-03-18
    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 number2006-002316-10
    A.3Full title of the trial
    Estudio aleatorizado, en fase 2, controlado con placebo, doble ciego, con o sin enzastaurina en combinación con paclitaxel y carboplatino como tratamiento de primera línea, seguido del tratamiento de mantenimiento, en el cáncer ovárico avanzado



    A Randomized, Phase 2, Placebo-Controlled, Double-Blinded Study With and Without Enzastaurin in Combination With Paclitaxel and Carboplatin as First-Line Treatment, Followed by Maintenance Treatment in Advanced Ovarian Cancer
    A.3.2Name or abbreviated title of the trial where available
    N/A
    A.4.1Sponsor's protocol code numberH6Q-MC-S019
    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 SponsorLilly 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 nameEnzastaurina
    D.3.2Product code LY317615
    D.3.4Pharmaceutical form 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 INNHidrocloruro de Enzastaurina
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number1125 to 500
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboTablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Los pacientes con un diagnostico histologico de carcinoma peritoneal, de trompas de Falopio o carcinoma epitelial invasivo avanzado de ovario en estadío FIGO IIB, IIC, III o IV

    Patients with a histologic diagnosis of FIGO Stage IIB, IIC, III, or IV advanced invasive epithelial ovarian, fallopian tube, or peritoneal carcinoma.
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 8.1
    E.1.2Level LLT
    E.1.2Classification code 10033130
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    El objetivo principal es comparar la actividad antitumoral del tratamiento de primera línea con la asociación paclitaxel-carboplatino más enzastaurina, seguido del tratamiento de mantenimiento con enzastaurina (régimen A), frente a la asociación paclitaxel-carboplatino más placebo seguida del tratamiento de mantenimiento con placebo (régimen B), a juzgar por la supervivencia sin progresión (SSP) de pacientes con cáncer ovárico avanzado (carcinoma epitelial de ovario, trompa uterina o peritoneo en estadio IIB-IV de FIGO).
    E.2.2Secondary objectives of the trial
    •Comparar las tasas de respuesta (TR) según los criterios RECIST (criterios para evaluar la respuesta en los tumores sólidos) y CA-125, conforme a los criterios GCIG, entre los regímenes A y B:
    -Tasa de respuesta completa (RC), respuesta parcial (RP) y enfermedad estable (EE)
    •Comparar los perfiles de seguridad y de los acontecimientos adversos (incluidos los grados CTCAE [Criterios terminológicos comunes de los acontecimientos adversos, versión 3.0, NCI 2003]) de los acontecimientos adversos de laboratorio y de otra índole, entre los regímenes A y B.
    •Evaluar la farmacogenónica y los marcadores biológicos de la enzastaurina (por ejemplo: PKC&#946;, GSK-3&#946;, PI3K/AKT, S6K) y el efecto de la enzastaurina sobre estos marcadores moleculares, en comparación con las pacientes tratadas con placebo.
    •Averiguar si la enzastaurina altera la farmacocinética (FC) del carboplatino y del paclitaxel tras administrarla en combinación con ellos.
    •Caracterizar la farmacocinética de la enzastaurin
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    [1]diagnóstico histológico de carcinoma epitelial invasivo y avanzado de ovario, trompa uterina o peritoneo en estadio IIB, IIC, III o IV de FIGO. Véase el apéndice al protocolo S019.4, Fédération Internationale de Gynécologie et d’Obstétrique: Estadificación del carcinoma ovárico según FIGO (Benedet y cols., 2000).
    [2]cirugía citorreductora óptima (tumor residual de 0 cm) o subóptima (tumor residual >0 cm).
    [3]reclutamiento en las 6 semanas siguientes a la laparotomía, si bien el tratamiento con quimioterapia o enzastaurina/placebo no podrá empezar antes de 3 semanas; y recuperación suficiente de la cirugía para iniciar el tratamiento del estudio.
    [4]consentimiento para la recogida y almacenamiento de la sangre y del tejido tumoral para la investigación traslacional.
    [5]mujeres con una edad mínima de 18 años.
    [6]categoría funcional de ECOG de 0, 1 o 2. Véase el apéndice S019.3, esquema de la categoría funcional ECOG (Oken y cols., 1982).
    [7]función orgánica adecuada, a saber:
    •Reservas adecuadas en la médula ósea: recuento absoluto de neutrófilos (RAN) &#61619;1,5 &#61620; 109/L, plaquetas &#61619;100 &#61620; 109/L y hemoglobina &#61619;9 g/dL.
    •Hígado: bilirrubina total &#61603;1,5 veces el límite superior de la normalidad (&#61620; LSN), fosfatasa alcalina (F. alc.), transaminasa de aspartato (AST) y transaminasa de alanina (ALT) &#61603;2,5 &#61620; LSN (se aceptarán valores de F. alc., AST y ALT &#61603;5 &#61620; LSN si existe una afectación tumoral del hígado).
    •Riñones: aclaramiento calculado de creatinina (CrCl) &#61619;&#61493;&#61488; ml/min según la fórmula convencional de Cockroft y Gault. Véase apéndice al protocolo S019.6, fórmula convencional de Cockcroft y Gault para calcular el aclaramiento de creatinina (Cockcroft y Gault 1976).
    [8]cumplimiento terapéutico y proximidad geográfica que faciliten un seguimiento idóneo.
    [9]firma del consentimiento informado por la paciente o su representante para participar en el estudio.
    [10]la función reproductora de la mujer debe corresponderse con cualquiera de estas: esterilización quirúrgica, estado posmenopáusico o cumplimiento de un régimen anticonceptivo médicamente aprobado (por ejemplo, dispositivo intrauterino [DIU], píldoras anticonceptivas o dispositivo de barrera) durante y hasta 6 meses después del período de tratamiento; las mujeres en edad fértil deberán presentar un resultado negativo de la prueba de embarazo en el suero o en la orina realizada en los 3 días anteriores para el reclutamiento del estudio y no podrán amamantar a sus hijos.
    E.4Principal exclusion criteria
    [1]tratamiento, en los últimos 30 días, con un fármaco que no haya recibido la aprobación de las autoridades sanitarias para ninguna indicación al comienzo del estudio.
    [2]quimioterapia previa u otro tratamiento por vía sistémica del carcinoma de ovario, peritoneo o trompa uterina.
    [3]administración concomitante de cualquier otro tratamiento anticanceroso por vía sistémica, salvo los preparados incluidos en este estudio (paclitaxel, carboplatino o enzastaurina). Administración simultánea de tratamiento hormonal durante el período terapéutico del estudio (se permitirá el tratamiento hormonal sustitutivo y los antieméticos esteroides).
    [4]radioterapia concomitante durante el período de tratamiento del estudio.
    [5]antecedentes de reacción de hipersensibilidad a productos que contengan Cremophor EL (ciclosporina, aceite de ricino o vitamina K) o hipersensibilidad conocida a compuestos químicamente emparentados con el carboplatino, el paclitaxel o la enzastaurina.
    [6]finalización previa o abandono de este estudio o de cualquier otro estudio donde se investigue al enzastaurina.
    [7]imposibilidad para suspender la administración simultánea de carbamazepina, fenobarbital o fenitoína, al menos, 14 días antes del comienzo del estudio.
    [8]infección activa, ya sea de origen bacteriano, micótico o vírico (en opinión del investigador) y otros trastornos sistémicos graves asociados (por ejemplo, infección activa, incluso por el VIH o cardiopatía) que, en opinión del investigador, impidan a la paciente cumplir el protocolo.
    [9]cardiopatía grave, por ejemplo infarto de miocardio en los 6 meses anteriores, angina de pecho o cardiopatía, definida por una categoría III o IV de la New York Heart Association (véase el apéndice al protocolo S019.9, [Bruce 1956]). Se excluirá a las pacientes con una prolongación de QTc >470 ms y a aquellas con antecedentes personales o familiares de un síndrome de prolongación congénita del intervalo QT.
    [10]segunda neoplasia maligna primaria (salvo que se trate de un carcinoma basocelular de la piel adecuadamente tratado) o diagnóstico previo de cualquier neoplasia maligna menos de 5 años antes del comienzo del estudio (con excepción del carcinoma in situ del cuello uterino o del carcinoma basocelular de piel adecuadamente tratado).
    [11]antecedentes de trastornos o metástasis en el sistema nervioso central (SNC) (a menos que la paciente haya finalizado el tratamiento local de metástasis en el SNC y haya permanecido sin esteroides durante, como mínimo, 4 semanas antes de iniciar el tratamiento del estudio). No se solicitará ninguna tomografía computarizada (TC) ni resonancia magnética (RM) de cribado, antes del reclutamiento, si no se tiene la sospecha clínica de metástasis cerebrales.
    [12]imposibilidad para tragar los comprimidos.
    [13]embarazo, lactancia o falta de uso de métodos anticonceptivos adecuados para evitar el embarazo.
    E.5 End points
    E.5.1Primary end point(s)
    La variable principal del estudio es la SSP.
    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 Yes
    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 Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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 Yes
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA10
    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 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 puede encontrar en el protocolo
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    E.8.9.1In the Member State concerned months2
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years5
    E.8.9.2In all countries concerned by the trial months2
    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 No
    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 2010-03-18. 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 state11
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 120
    F.4.2.2In the whole clinical trial 149
    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)
    Se puede encontrar en el protocolo
    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 Decision2007-01-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-12-04
    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
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