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    The EU Clinical Trials Register currently displays   43851   clinical trials with a EudraCT protocol, of which   7283   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:2004-002908-15
    Sponsor's Protocol Code Number:B9E-XM-O401
    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:2004-11-12
    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 number2004-002908-15
    A.3Full title of the trial
    ENSAYO FASE I/II, MULTICENTRICO DE LA COMBINACIÓN DE CARBOPLATINO Y GEMCITABINA EN EL TRATAMIENTO DE PACIENTES CON CARCINOMA DE OVARIO EN 1ª RECIDIVA TRAS QUIMIOTERAPIA SENSIBLES A PLATINO
    A.4.1Sponsor's protocol code numberB9E-XM-O401
    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 SponsorCarlos Gómez Martín
    B.1.3.4CountrySpain
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    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 Information not present in EudraCT
    D.2.1.1.1Trade name Gemzar
    D.2.1.1.2Name of the Marketing Authorisation holderLilly, S.A.
    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 No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameGemcitabina
    D.3.4Pharmaceutical form Powder for solution for injection
    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 INNGemcitabina
    D.3.10 Strength
    D.3.10.1Concentration unit mg/m2 milligram(s)/square meter
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number2000 to 3000
    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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    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 Information not present in EudraCT
    D.IMP: 2
    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 Information not present in EudraCT
    D.2.1.1.1Trade name Gemzar
    D.2.1.1.2Name of the Marketing Authorisation holderLilly, S.A.
    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 No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameGemcitabina
    D.3.4Pharmaceutical form Powder for solution for injection
    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 INNGemcitabina
    D.3.10 Strength
    D.3.10.1Concentration unit mg/m2 milligram(s)/square meter
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number2000 to 3000
    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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    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 Information not present in EudraCT
    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
    Carcinoma de ovario en primera recidiva tras quimioterapia sensible a platino
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Fase I:
    Determinar la toxicidad limitante de dosis (TLD) así como la máxima dosis tolerada (MDT) de la combinación gemcitabina y carboplatino administrados cada dos semanas en el tratamiento de pacientes con tumores sólidos previamente tratados con una línea previa de quimioterapia.
    Fase II:
    Determinar la tasa de respuestas objetivas al tratamiento con dicha combinación en pacientes con carcinoma de ovario en primera recidiva tras quimioterapia en pacientes sensibles a platino.
    E.2.2Secondary objectives of the trial
    -Valoración de la toxicidad según la escala NCI-CTC (versión 3.0)

    -Estimación de las variables tiempo dependientes según el método actuarial de Kaplan y Meier
    a) Duración de la respuesta
    b) Tiempo a fracaso del tratamiento
    c) Tiempo hasta la progresión
    d) Supervivencia global
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    Fase I:
    · Pacientes con cualquier tumor sólido en recidiva tras un tratamiento previo con quimioterapia.
    · Edad superior a 18 años.
    · Estado funcional 0 ó 1 según la escala de la ECOG.
    · Adecuada función hematológica:
    o Recuento absoluto de neutrófilos ≥ 1.500/mm3,
    o Plaquetas >100.000/mm3
    o Hb >10 g/dL
    · Adecuada función hepática.
    o Bilirrubina ≤ 1,25 x LSN (LSN= límite superior de los valores normales de laboratorio en el centro).
    o Transaminasas (SGOT/SGPT) ≤ 2,5 x LSN
    o Fosfata alcalina ≤ 2.5 x LSN
    · Adecuada función renal: Aclaramiento de creatinina ≥ 50 mL/min (real ó calculado).
    · Los pacientes en edad reproductiva deben de utilizar un método anticonceptivo adecuado.
    · Paciente capaz de realizar el seguimiento y seguir las recomendaciones para el manejo de la toxicidad.
    · Evaluación clínica y de los parámetros de laboratorio en los 8 días anteriores previo al primer ciclo.
    Fase II:
    · Cáncer de ovario avanzado, con confirmación histológica ó citológica, en recidiva tras quimioterapia de 1ª línea. (no se precisa la confirmación histológica de la recidiva).
    · Al menos una lesión mensurable ó no mensurable, según los criterios del RECIST.
    · Edad superior a 18 años.
    · Estado funcional 0 ó 1 según la escala de la ECOG.
    · Expectativa de vida de al menos 12 semanas.
    · Adecuada función hematológica:
    o Recuento absoluto de neutrófilos ≥ 1.500/mm3,
    o Plaquetas >100.000/mm3
    o Hb >10 g/dL
    · Adecuada función hepática:
    o Bilirrubina ≤ 1,25 x LSN (LSN= límite superior de los valores normales de laboratorio en el centro).
    o Transaminasas (SGOT/SGPT) ≤ 2,5 x LSN,
    o Fosfata alcalina ≤ 2.5 x LSN,
    o Tiempo de protrombina > 80%
    · Adecuada función renal: Aclaramiento de creatinina ≥ 50 mL/min (real ó calculado).
    · Las pacientes en edad reproductiva deben de utilizar un método anticonceptivo adecuado.
    · Tratamiento previo con quimioterapia que incluya taxanos y un derivado del platino. Dicho tratamiento debe haber finalizado al menos 6 meses antes de la entrada en este estudio.
    · Estudio de extensión con técnicas de imagen, completado en las 4 semanas previas a la administración del primer ciclo. Evaluación clínica y de los parámetros de laboratorio en los 8 días anteriores previo al primer ciclo.
    · Paciente capaz de realizar el seguimiento y seguir las recomendaciones para el manejo de la toxicidad.
    E.4Principal exclusion criteria
    Fase I:
    · Pacientes que hayan recibido más de 1 línea de quimioterapia previa.
    · Pacientes embarazadas o en periodo de lactancia.
    · Contraindicación para la utilización de quimioterapia (por función hepática o renal inadecuada, enfermedad cardiaca concomitante grave o incapacidad física o psíquica de tolerancia al tratamiento).
    · Infección activa no controlada (que requiere tratamiento con antibióticos).
    · Contraindicación para la utilización de los fármacos en estudio.
    · Otras enfermedades concomitantes severas:
    o Insuficiencia cardiaca congestiva, insuficiencia cardiaca grado > II de la NYHA, enfermedad cardiaca inestable a pesar del tratamiento, infarto de miocardio en los 6 meses previos.
    o Alteraciones psiquiátricas o neurológicas significativas, incluyendo demencia o epilepsia.
    o Otras enfermedades graves como cirrosis, ulcera péptica activa, dibetes mellitus no controlada, hepatitis C.
    · Tratamiento concomitante con otro fármaco en fase de investigación clínica.
    · Pacientes que no puedan seguir las recomendaciones para el tratamiento de la toxicidad o con incapacidad social, psicológica, familiar ó geográfica para realizar el seguimiento.

    Fase II:
    · Pacientes que hayan recibido más de 1 línea de quimioterapia previa.
    · Pacientes con enfermedad realmente no medible teniendo en cuenta los criterios RECIST.
    · Pacientes con metástasis en sistema nervioso central.
    · Segunda malignidad (excepto carcinoma de cérvix in situ o carcinoma cutáneo no melanoma adecuadamente tratados). Se permite malignidad previa tratada hace más de 5 años sin recurrencia antes de la inclusión en el estudio, exceptuando el carcinoma renal o el melanoma.
    · Pacientes embarazadas o en periodo de lactancia.
    · Contraindicación para la utilización de quimioterapia (por función hepática o renal inadecuada, enfermedad cardiaca concomitante grave o incapacidad física o psíquica de tolerancia al tratamiento).
    · Infección activa no controlada (que requiere tratamiento con antibióticos).
    · Contraindicación para la utilización de los fármacos en estudio.
    · Otras enfermedades concomitantes severas:
    o insuficiencia cardiaca congestiva, insuficiencia cardiaca grado > II de la NYHA, enfermedad cardiaca inestable a pesar del tratamiento, infarto de miocardio en los 6 meses previos,
    o alteraciones psiquiátricas o neurológicas significativas, incluyendo demencia o epilepsia,
    o otras enfermedades graves como cirrosis, ulcera péptica activa, dibetes mellitus no controlada, hepatitis C.

    · Tratamiento concomitante con otro fármaco en fase de investigación clínica.
    · Pacientes que no puedan seguir las recomendaciones para el tratamiento de la toxicidad o con incapacidad social, sicológica, familiar ó geográfica para realizar el seguimiento.
    E.5 End points
    E.5.1Primary end point(s)
    La variable principal de valoración es la enfermedad tumoral medible o no medible (se excluirá la realmente no medible) teniendo en cuenta los Criterios RECIST.
    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 Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic Information not present in EudraCT
    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 Yes
    E.7.1.3.1Other trial type description
    DETERMINAR LA TOXICIDAD LIMITANTE DE DOSIS ASÍ COMO LA MÁXIMA DOSIS TOLERADA
    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 No
    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) No
    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.8.5The 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 Information not present in EudraCT
    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 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 Information not present in EudraCT
    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 2004-11-12. Yes
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    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 Information not present in EudraCT
    F.4 Planned number of subjects to be included
    F.4.1In the member state
    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)
    Fase I: dependerá del momento en el que se alcance la máxima dosis tolerada
    Fase II: el número total de pacientes en esta fase será de 36 pacientes evaluables.
    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 Decision2004-12-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2004-07-22
    P. End of Trial
    P.End of Trial StatusOngoing
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