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    Summary
    EudraCT Number:2015-003680-11
    Sponsor's Protocol Code Number:PRESURGY/01/2015
    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:2015-11-25
    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 number2015-003680-11
    A.3Full title of the trial
    Impact of the mitomicin-C (MMC) preoperative administration in patients with primary urothelial
    non-muscle invasive (TVNMI) bladder cancer using electromotive instillation (EMDA). Prospective randomised study.
    Impacto de la administración pre operatoria intravesical con mitomicina-C (MMC) mediante instilación electromotriz (EMDA) en pacientes con tumor vesical no músculo invasivo (TVNMI). Estudio prospectivo aleatorizado.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Evaluation of the mitomicin administration, in patients with non-muscle invasive bladder cancer, using electromotive instillation (EMDA).
    Valoración de la administración pre operatoria de mitomicina, instilada de manera localizada sobre el tumor, en pacientes con tumores vesicales no músculo invasivo.
    A.4.1Sponsor's protocol code numberPRESURGY/01/2015
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorPRESURGY S.L.
    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 supportPRESURGY S.L.
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPRESURGY S.L.
    B.5.2Functional name of contact pointMario Serrano
    B.5.3 Address:
    B.5.3.1Street AddressPollensa 2
    B.5.3.2Town/ cityLas Rozas. Madrid
    B.5.3.3Post code28290
    B.5.3.4CountrySpain
    B.5.4Telephone number0034916402087200
    B.5.5Fax number0034916366610
    B.5.6E-mailcarolina@presurgy.com
    D. IMP Identification
    D.IMP: 1
    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.2.1.1.1Trade name MITOMICINA c
    D.2.1.1.2Name of the Marketing Authorisation holderINIBSA HOSPITAL S.L.U
    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.3.4Pharmaceutical form
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravesical use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNMITOMYCIN
    D.3.9.1CAS number 50-07-7
    D.3.9.4EV Substance CodeSUB09006MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number10 to 40
    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) No
    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 No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    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 No
    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 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 EMDA ( Electromotive instillation ) with Mitomicin-C
    D.2.1.1.2Name of the Marketing Authorisation holderPRESURGY, S,.L
    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 nameMITOMICINA -C
    D.3.4Pharmaceutical form
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravesical use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNMITOMYCIN
    D.3.9.1CAS number 50-07-7
    D.3.9.4EV Substance CodeSUB09006MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number10 to 40
    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) No
    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 No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    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 No
    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
    Impact of the mitomicin-C (MMC) preoperative administration in patients with primary urothelial
    non-muscle invasive bladder cancer (TVNMI) using electromotive instillation (EMDA). Prospective randomised study.
    Impacto de la administración pre operatoria intravesical con mitomicina-C (MMC) mediante instilación electromotriz (EMDA) en pacientes con tumor vesical no músculo invasivo (TVNMI). Estudio prospectivo aleatorizado.
    E.1.1.1Medical condition in easily understood language
    Evaluation of the mitomicin administration, in patients with non-muscle invasive bladder cancer, using electromotive instillation (EMDA).
    Valoración de la administración pre operatoria de mitomicina, instilada de manera localizada sobre el tumor, en pacientes con tumores vesicales no músculo invasivo.
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    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
    Refer to Spanish version below.
    Objetivo principal:
    Evaluar la tasa de recidiva y/o progresión y el tiempo libre hasta el primer evento en los pacientes con TVMNI que reciben MMC+EMDA antes de la RTU en comparación con la instilación tras la RTU.
    E.2.2Secondary objectives of the trial
    Refer to Spanish version below.
    - Analizar la tasa de progresión y el tiempo libre hasta progresión en los pacientes con EMDA antes de la RTU en comparación con la instilación tras la RTU.
    - Evaluar la tolerancia del tratamiento con MMC+EMDA preoperatoria
    - Cuantificar el porcentaje de pacientes en cada grupos que cumplen la totalidad del tratamiento
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    INCLUSION CRITERIA ( Please refer to Spanish version below)
    Criterios de inclusión:
    - Pacientes con carcinoma de células uroteliales Ta o T1
    - Tumor papilar primario alto grado
    - Tumor recurrente único o múltiples de bajo grado
    - Pacientes con reserva de medula ósea (recuento de glóbulos blancos
    ?4000 × 10?/L; recuento de plaquetas ?120×10?/L), función renal conservada (creatinina sérica ?123,76 ?mol / L) y función hepática normal (gamma glutamil transpeptidasa ?51 U/L, alanina aminotransferasa ?50 U/L y bilirrubina total ?22 ?mol/L).
    - Consentimiento informado documentado y firmado.
    E.4Principal exclusion criteria
    EXCLUSION CRITERIA ( Please refer to Spanish version below)
    - Paciente que, a criterio del investigador, sea incapaz de cumplimentar los cuestionarios del estudio o las visitas de seguimiento
    - Pacientes con tumor recurrente de alto grado
    - Pacientes con CIS recurrente
    - Capacidad vesical disminuida (menos de 200 cc)
    - Antecedentes de tumor vesical de alto grado o CIS
    - Antecedentes de infección del tracto urinario sin tratar
    - Infección sistémica grave
    - Tratamiento con radioterapia o quimioterapia
    - Tratamiento con inmunosupresores
    - Otras enfermedades malignas durante los 5 años previos a la inclusión en el estudio (excepto en el caso de cáncer de piel con tratamiento efectivo o en el caso de cáncer cervical localizado)
    - Embarazo
    E.5 End points
    E.5.1Primary end point(s)
    END POINTS ( Please refer to Spanish version below)
    Objetivo principal. Análisis variables de evolución (recurrencia). El análisis estadístico se basará en el principio de intención de tratar. En un primer análisis se comparará el porcentaje de pacientes con recurrencia a 5 años entre los dos grupos de estudio mediante el test de chi cuadrado. En segundo lugar se utilizará el método de Kaplan-Meier para la elaboración de las tablas de supervivencia y mediante la función estadística Log Rango se compararán las curvas de tiempo libre de recurrencia entre todos los grupos. El tiempo libre hasta recurrencia entre el grupos de tratamiento se realizará utilizando para ello un modelo de riesgos proporcionales de Cox crudos y ajustados. En el modelo final se incluirán las variables de interacción y/o confusión que se hayan identificado en el análisis bivariado entre grupos o sean clinicamente relevantes.
    E.5.1.1Timepoint(s) of evaluation of this end point
    60 months
    60 meses
    E.5.2Secondary end point(s)
    Secondary points ( Please refer to Spanish version below)
    Objetivos secundarios: Se realizarán los análisis anteriormente descritos pero como variable dependiente de seguimiento se incluirá la progresion y el tiempo libre hasta progresión. La tolerancia al tratamiento entre grupos se comparará mediante la aparición de efectos secundarios tras la administración de los tratamientos (de estudio o adyugantes). El porcentaje de pacientes que finalizan el tratamiento de estudio se comparará mediante el test de Chi cuadrado.

    Todos los test se realizarán a un nivel de significación a=0.05 y los intervalos de confianza se calcularán al nivel de confianza 1-a = 0.95.
    E.5.2.1Timepoint(s) of evaluation of this end point
    60 months
    60 meses
    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 No
    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 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 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) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    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
    Instilación pasiva de Mitomicina - C después de RTU
    passive instilation of Mitomycin -c after RTU
    E.8.2.4Number of treatment arms in the trial2
    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 concerned2
    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 No
    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
    LAST VISIT: Please refer to Spanish version below
    La finalización del estudio puede producirse en cualquiera de las visitas de estudio que se llevarán a cabo. En cualquiera de los casos en que se produzca, el investigador del estudio deberá recoger la fecha de finalización del paciente, así como el motivo por el cual se produce.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    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 No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 105
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 123
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state228
    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)
    none
    ninguno
    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 Decision2015-12-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-12-09
    P. End of Trial
    P.End of Trial StatusOngoing
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