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    The EU Clinical Trials Register currently displays   35467   clinical trials with a EudraCT protocol, of which   5825   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2005-002943-23
    Sponsor's Protocol Code Number:TT11EU
    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:2005-09-20
    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 number2005-002943-23
    A.3Full title of the trial
    Ensayo clínico en fase I-II de Topotect (dexrazoxano) y dosis altas de etopósido en el tratamiento de pacientes adultos con tumores cerebrales sólidos, primarios o secundarios.
    A.3.2Name or abbreviated title of the trial where available
    TT11
    A.4.1Sponsor's protocol code numberTT11EU
    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 SponsorTopoTarget A/S
    B.1.3.4CountryDenmark
    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 Information not present in EudraCT
    D.2.1.1.1Trade name Cardioxane
    D.2.1.1.2Name of the Marketing Authorisation holderChiron
    D.2.1.2Country which granted the Marketing AuthorisationDenmark
    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 nameTopotect, dexrazoxano (DOE), dexrazoxane (INN), ICRF-187, ADR 529, Zinecard
    D.3.4Pharmaceutical form Powder 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.3.8INN - Proposed INNdexrazoxano
    D.3.9.1CAS number 0024584-09-6
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number500
    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 Yes
    D.3.11.13.1Other medicinal product typeDerivado del EDTA autorizado como cardioprotector frente a las antraciclinas. En fase III como protector en el extravasamiento de antraciclinas y en fase I-II en la toxicidad sistémica del etopósido.
    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 VePesid
    D.2.1.1.2Name of the Marketing Authorisation holderBristol-Myers Squibb
    D.2.1.2Country which granted the Marketing AuthorisationDenmark
    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 nameetopósido (DOE), etoposide (INN), VP16, VP16213
    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.3.8INN - Proposed INNetopósido
    D.3.9.1CAS number 0033419-42-0
    D.3.10 Strength
    D.3.10.1Concentration unit mg/l milligram(s)/litre
    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 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 Yes
    D.3.11.13.1Other medicinal product typeDerivado semisintético de la podofilotoxina que inhibe la Topoisomerasa II, autorizado en numerosos países como tratamiento antineoplásico y comercializado en España bajo varias marcas.
    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
    Tumores primarios y secundarios del Sistema Nervioso Central y de sus membranas.

    En MedDRA versión 7.1, dicha indicación está clasificada con el código MedDRA 10029104, correspondiente al SOC 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)'.
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 7.1
    E.1.2Level SOC
    E.1.2Classification code 10029104
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Determinar la dosis máxima tolerada de Topotect (dexrazoxano) y etopósido en combinación, definiendo su perfil de seguridad y toxicidad.

    La toxicidad se evaluará a través de la variable principal 1
    La seguridad se evaluará a través de la variable principal 2

    Al afectar un producto la toxicidad del otro, se determinará la toxicidad y dosis máxima tolerada de la combinación de ambos mediante el escalado de dosis alterno de cada fármaco:

    En la Parte I del ensayo se determinará la dosis máxima tolerada de etopósido (DMT25) asociada a una dosis fija inicial de Topotect 25mg/m2.

    En la Parte II se determinará la dosis de Topotect que ofrezca la máxima protección (MDP) frente a la dosis fija de etopósido DMT25.

    En la Parte III se determinará la dosis máxima tolerada de etopósido (DMTmdp) frente a la dosis fija de Topotect MDP.



    E.2.2Secondary objectives of the trial
    -Determinación preliminar de la actividad antineoplásica del tratamiento combinado de Topotect con etopósido aplicando los criterios de eficacia RECIST.

    -Estudiar la farmacocinética de Topotect y etopósido combinados.

    -Determinar la actividad antineoplásica presente en el plasma de pacientes tratados con Topotect y etopósido, mediante una batería de ensayos biológicos.
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    1. Tumor sólido maligno confirmado histológicamente, primario o secundario, y localizado en el cerebro o membranas del sistema nervioso central, con la enfermedad del sistema nervioso central como condición clínicamente más relevante.
    2. Puntuación inferior o igual a 2 en la escala ECOG.
    3. Esperanza de vida estimada superior a 3 meses.
    4. Parámetros hematológicos, renales y hepáticos acordes con los siguientes límites: leucocitos > 3,0x109/L; plaquetas > 100x109/L; bilirrubina total < límite normal superior; ASAT < 2x límite normal superior (o < 5x dicho límite en caso de metástasis hepáticas); creatinina y BUN < límite normal superior; albúmina sérica ≥ 85% del límite normal inferior.
    5. Edad ≥ 18 años.
    E.4Principal exclusion criteria
    1. Quimioterapia menos de 3 semanas antes de entrar en el estudio.
    2. Radioterapia cerebral de campo grande menos de 3 meses antes, o radioterapia cerebral de campo pequeño menos de 3 semanas antes, o radioterapia cerebral total menos de 2 meses antes de entrar en el estudio.
    3. Infección activa concomitante así como toda otra condición concomitante que posiblemente interfiera con los procedimientos del estudio.
    4. Cualquier otra enfermedad maligna, incompatible con el protocolo.
    5. Historia de alcoholismo, de drogodependencia o de psicosis que impide el seguimiento adecuado.
    6. Mujer embarazada o lactante.
    7. Mujer potencialmente fértil que no usa ningún método anticonceptivo eficiente.
    E.5 End points
    E.5.1Primary end point(s)
    1. Toxicidad hematológica y no hematológica según criterios NCI CTC (Criterios Comunes de Toxicidad del Instituto Nacional del Cáncer de Estados Unidos).

    Para la determinación de DMT25, MDP y DMTmdp, se define la dosis máxima tolerada o DMT como el nivel de dosis inmediatamente inferior al que cause una Toxicidad Limitante de Dosis (TLD) en al menos 2 pacientes. TLD consistirá en una toxicidad hematológica de grado IV o toxicidad no hematológica de grado III o superior (con las restricciones que se mencionan en la sección 7 del protocolo).

    2. Frecuencia y severidad de los Acontecimientos Adversos y de los Acontecimientos Adversos Graves durante el tratamiento y período de seguimiento del tratamiento con Topotect y con etopósido.
    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 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 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 No
    E.8.1.1Randomised No
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    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 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 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 years
    E.8.9.1In the Member State concerned months24
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months36
    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 No
    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 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 30
    F.4.2.2In the whole clinical trial 40
    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)
    Los investigadores tendrán la posibilidad de ofrecer una continuación del tratamiento (hasta un máximo de 6 ciclos) como uso compasivo.
    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 Decision2005-10-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2005-10-06
    P. End of Trial
    P.End of Trial StatusOngoing
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