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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:2007-005706-44
    Sponsor's Protocol Code Number:TOPO-LAPA/CFB/2007-05
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2007-11-26
    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 ConcernedFrance - ANSM
    A.2EudraCT number2007-005706-44
    A.3Full title of the trial
    Etude de phase II évaluant l'association topotécan-lapatinib chez des patientes en rechute moins de 12 mois après une première ligne de chimiothérapie à base de platine pour un cancer de l'ovaire, de la trompe ou du péritoine
    A.3.2Name or abbreviated title of the trial where available
    TOPO-LAPA
    A.4.1Sponsor's protocol code numberTOPO-LAPA/CFB/2007-05
    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 SponsorCentre François Baclesse
    B.1.3.4CountryFrance
    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 Yes
    D.2.1.1.1Trade name HYCAMTIN (Topotécan)
    D.2.1.1.2Name of the Marketing Authorisation holderGlaxoSmithKline
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameTOPOTECAN
    D.3.4Pharmaceutical form Powder for 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 INNHYCAMTIN
    D.3.10 Strength
    D.3.10.1Concentration unit mg/m2 milligram(s)/square meter
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number3.2
    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.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 TYVERB
    D.2.1.1.2Name of the Marketing Authorisation holderGlaxoSmithKline
    D.2.1.2Country which granted the Marketing AuthorisationSwitzerland
    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 nameLAPATINIB
    D.3.4Pharmaceutical form Coated 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 INNTYKERB
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1250
    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
    Patientes atteintes d'un cancer de l'ovaire, ou de la trompe ou du péritoine en rechute moins de 12 mois après une première ligne de chimiothérapie à base de sels de platine.
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10066697
    E.1.2Term Ovarian cancer recurrent
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Evaluer le taux de réponse globale (réponse complète, réponse partielle et stabilisation) de l’association topotécan-lapatinib.
    E.2.2Secondary objectives of the trial
    •Cliniques
    Evaluer :
    o Le taux de survie globale
    o Le taux de survie sans progression
    o La durée de la réponse
    o Le temps sans progression
    •De tolérance
    o La survenue de toxicité
    o La qualité de vie
    •Biologiques : Etude translationnelle
    Caractériser le profil de la réponse tumorale au traitement à partir d’échantillons :
    o De la tumeur initiale
    o D’ascite
    o De sérum
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Age > ou = à 18 ans.
    - Adénocarcinome ovarien primitif histologiquement vérifié.
    - Ou adénocarcinome du péritoine ou de la trompe histologiquement vérifié.
    - Progression ou récidive dans les 12 mois après la fin d’une première ligne de chimiothérapie par sels de platine.
    - Une association en première ligne d’un sel de platine avec un autre agent anticancéreux est autorisée (taxanes, antracyclines, alkylants ou gemcitabine) de même qu’avec un traitement anti-angiogénique (bevacizumab, sunitinib).
    - Une chimiothérapie intra-péritonéale en 1ère ligne est possible.
    - Patientes n’ayant pas reçu en première ligne des traitements inhibiteurs de la famille HER (ex : gefitinib).
    - Population non sélectionnée sur le statut HER : aucun screening de l’amplification de ERB1 ou ERB2 n'est demandé pour l’inclusion.
    - Patientes avec des lésions mesurables (critères de réponse RECIST).
    et/ou un taux de CA125 supérieur à 2 fois la normale (si normalisé après une première ligne de chimiothérapie) ou Ca 125 supérieur à 2 fois le nadir (si non normalisé) vérifié par deux prélèvements espacés d’au moins un mois.
    - Patientes ayant un état de performance OMS < ou =2.
    - Patientes présentant un bilan biologique satisfaisant :
    - Créatininémie ≤ 150 µmol/L ou clairance ≥ 50 mL/min.
    - Bilirubinémie ≤ 1,5 fois la limite supérieure de la normale.
    - Taux de transaminases et/ou de phosphatases alcalines ≤ 2 fois la limite supérieure de la normale en l’absence de métastases hépatiques ou ≤ 3 fois la limite supérieure de la normale en cas de métastases hépatiques.
    - Taux de polynucléaires neutrophiles ≥ 1,5.109/L.
    - Taux de plaquettes ≥ 100.109/L.
    - FEV normale.
    - Absence de traitement par chimiothérapie, hormonothérapie, immunothérapie ou radiothérapie dans les 4 semaines précédant l'entrée dans l'étude.
    - Absence de corticothérapie à l’inclusion et pendant le traitement (autorisé seulement si doses : prednisone ≤ 10 mg, méthylprednisone ≤ 8 mg et dexaméthasone ≤1.5 mg).
    - Patientes ayant donné leur consentement éclairé signé.
    E.4Principal exclusion criteria
    - Traitement antérieur avec au moins un de ces items :
    • une chimiothérapie intensive ayant nécessité une autogreffe de moelle ou des cellules souches périphériques,
    • deux lignes de chimiothérapie (y compris avec le même protocole),
    • une irradiation antérieure abdominale totale,
    • une chimiothérapie antérieure associée à un traitement anti-HER
    - Antécédents de métastases cérébrales ou méningées non contrôlées.
    - Antécédents d'autre tumeur maligne, à l'exception d'un carcinome baso-cellulaire ou spino-cellulaire de la peau ou d'un carcinome in situ du col utérin, traité et guéri.
    - Pathologie infectieuse non contrôlée.
    - Pathologie cardio-vasculaire non contrôlée.
    - Patientes en occlusion intestinale non levée par un traitement médicamenteux spécifique et ne permettant pas la prise d’un traitement oral.
    - Patientes présentant une hypersensibilité connue au topotécan ou à l’un de ses excipients
    - Patientes enceintes ou allaitant ou, en âge de procréer et n'utilisant pas une contraception adéquate.
    - Patientes privées de liberté.
    E.5 End points
    E.5.1Primary end point(s)
    Critère principal :
    Le critère principal de cette étude sera l’évaluation de la réponse tumorale globale selon les critères RECIST pour les maladies mesurables et/ou la réponse biologique selon les critères Rustin pour les maladies non mesurables.

    Critères secondaires :
    Les critères secondaires seront :
    - Le taux de survie globale
    - Le taux de survie sans progression
    - La durée de la réponse
    - Le temps sans progression
    - La survenue de toxicité
    - La qualité de vie
    - Etude translationnelle : caractériser le profil de la réponse tumorale au traitement
    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 No
    E.6.5Efficacy No
    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) 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 Information not present in EudraCT
    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) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    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 concerned19
    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 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 years2
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned 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 No
    F.3.3.1Women of childbearing potential not using contraception Information not present in EudraCT
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    F.3.3.3Pregnant women Information not present in EudraCT
    F.3.3.4Nursing women Information not present in EudraCT
    F.3.3.5Emergency situation Information not present in EudraCT
    F.3.3.6Subjects incapable of giving consent personally Information not present in EudraCT
    F.3.3.7Others Information not present in EudraCT
    F.4 Planned number of subjects to be included
    F.4.1In the member state54
    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 Decision2008-01-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-01-11
    P. End of Trial
    P.End of Trial StatusOngoing
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