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    Summary
    EudraCT Number:2007-002403-41
    Sponsor's Protocol Code Number:ML20829
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2007-07-23
    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 ConcernedFrance - ANSM
    A.2EudraCT number2007-002403-41
    A.3Full title of the trial
    Etude clinique ouverte randomisée évaluant le traitement préventif par doxycycline sur la survenue d’éruption type folliculite lors du traitement par erlotinib chez les patients atteints d’un cancer bronchique non à petites cellules localement avancé ou métastatique en rechute après une première ligne de chimiothérapie
    A.3.2Name or abbreviated title of the trial where available
    CYTAR
    A.4.1Sponsor's protocol code numberML20829
    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 SponsorROCHE SAS
    B.1.3.4CountryFrance
    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 Yes
    D.2.1.1.1Trade name TARCEVA
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Registration Limited
    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.3.4Pharmaceutical form Film-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 INNerlotinib
    D.3.9.2Current sponsor code183321-74-6
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    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 Tolexine
    D.2.1.1.2Name of the Marketing Authorisation holderlaboratoires BIORGA
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    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 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 INNdoxycycline
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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: 3
    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 TARCEVA
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Registration Limited
    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.3.4Pharmaceutical form Film-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 INNerlotinib
    D.3.9.2Current sponsor code183321-74-6
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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: 4
    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 TARCEVA
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Registration Limited
    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.3.4Pharmaceutical form Film-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 INNerlotinib
    D.3.9.2Current sponsor code183321-74-6
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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
    patients atteints de cancer bronchique non à petite cellule
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10025044
    E.1.2Term Lung cancer
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Evaluer l’efficacité du traitement préventif par la doxycycline sur la survenue d’éruptions de type folliculite lors du traitement par erlotinib
    E.2.2Secondary objectives of the trial
    •Evaluer la tolérance générale de l’association doxycycline – erlotinib.
    •Evaluer l’impact du traitement préventif sur l’intensité de l’éruption cutanée type folliculite.
    •Evaluer l’observance au traitement par erlotinib.
    •Evaluer l’observance à la doxycycline.
    •Evaluer l’efficacité du traitement par erlotinib dans les deux bras (survie sans progression, survie à 1 an).
    •Evaluer les autres lésions cutanées.
    •Evaluer la qualité de vie.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Relatifs à la population :
    •Patient ayant délivré un consentement de participation écrit avant le début de l’étude.
    •Patient apte selon l'investigateur à se plier aux impératifs de l'étude.
    •Patient affilié à un régime de sécurité sociale ou bénéficiaire d'un tel régime.
    •Age ≥ 18 ans.
    •Test de grossesse négatif pour les femmes en âge de procréer (48 h avant randomisation).
    Relatifs à la pathologie
    •CBNPC avec confirmation histologique ou cytologique diagnostiqué par biopsie, cytologie ou ponction trans-thoracique, avec une maladie mesurable ou évaluable (RECIST).
    •Ayant déjà été traité par une ligne de chimiothérapie pour la maladie localement avancée ou métastatique (stades III B et IV) et candidat à un traitement de seconde ligne par erlotinib.
    •Espérance de vie estimée > 12 semaines.
    •Performance status ≤ 2.
    •Neutrophiles > 1 000/mm3 et plaquettes > 100 000/mm3.
    •Fonction hépatique normale :
    ASAT et ALAT < 1,5 x LSN sauf si attribuable aux métastases hépatiques, dans ce cas < 5 x LSN sera accepté.
    bilirubine < 1,5 limite supérieure de la normale (LSN).
    phosphatases alcalines < 2,5 x LSN (sauf si attribuable à lésion métastatique osseuse sans lésion hépatique associée).
    •Fonction rénale normale (créatinémie < 1,5 x LSN ou clairance ≥60ml/min).
    •Calcémie dans les limites de la normale.
    E.4Principal exclusion criteria
    Relatifs à la population:
    •Femme enceinte ou allaitant.
    •Femme en période d’activité génitale sans contraception efficace.
    •Patient atteint d’une déficience ne lui permettant pas une bonne compréhension des impératifs de l’essai.
    •Patient ayant déjà été sélectionné dans le présent essai (consentement signé).
    •Patient participant ou ayant participé à un essai clinique dans les 30 jours précédant la randomisation.
    •Patient présentant une éruption cutanée en cours, quelle qu’en soit l’origine.
    Relatifs à la pathologie
    •Cancer bronchique à petites cellules ou tumeur neuro endocrine.
    •Absence de traitement antérieur par une première ligne de chimiothérapie pour le CBNPC avancé ou métastatique.
    •Maladie cardiaque significative (ex: hypertension non contrôlée, angine de poitrine instable, insuffisance cardiaque congestive, arythmie ventriculaire nécessitant un traitement ou infarctus du myocarde de moins de 12 mois).
    •Présence d’autres pathologies malignes concomitantes ou diagnostiquées dans les cinq dernières années, excepté les carcinomes baso-cellulaires ou les cancers du col de l’utérus in situ traités.
    •Patient présentant une fonction hépatique altérée définie comme:
    - ASAT et ALAT ≥ 1,5 x LSN sauf si attribuable aux métastases hépatiques, dans ce cas ≥ 5 x LSN ne sera pas éligible.
    - bilirubine ≥ 1,5 limite supérieure de la normale (LSN),
    - phosphatases alcalines ≥ 2,5 x LSN (sauf si attribuable à lésion métastatique osseuse sans lésion hépatique associée).
    Relatif aux traitements à l’essai
    •Maladie ophtalmologique cliniquement significative, (inflammatoire ou infectieuse).
    •Maladie gastro-intestinale cliniquement significative.
    •Patient inapte à prendre une médication orale ou nécessitant une alimentation parentérale.
    •Hypersensibilité à l’erlotinib ou un de ses excipients (dont le lactose).
    •Traitement en cours par une cycline (voie locale ou générale).
    •Contre indication au traitement par doxycycline ; allergie aux antibiotiques de la famille des tétracyclines et allergie croisée (réactions d’hypersensibilité à la doxycycline ou ses excipients et association aux rétinoïdes).
    •Traitement antérieur par un agent ciblant la voie EGFR (gefitinib, cetuximab ou autre).
    E.5 End points
    E.5.1Primary end point(s)
    CRITERE PRINCIPAL :
    - Proportion de patients ayant présenté une éruption cutanée de type folliculite, de tout grade, pendant les quatre premiers mois de traitement.
    CRITERES SECONDAIRES :
    - Nombre d’événements, intensité et proportion de patients avec éruption type folliculite selon l’échelle CTC AE version 3 pendant les 4 premiers mois de traitement.
    - Nombre d’événements, intensité et proportion de patients avec éruption type folliculite selon l’échelle CTC AE version 3 au-delà des quatre premiers mois de traitement.
    - Délai sans éruption de type folliculite.
    - Durée des éruptions de type folliculite.
    - Proportion de patients avec diminution de posologie, interruption ou arrêt de traitement par erlotinib.
    - Proportion de patients avec diminution de posologie, interruption ou arrêt de traitement par doxycycline.
    - Tolérance de l’association doxycycline – erlotinib (échelle CTC AE V3).
    - Nombre d’événements, intensité et proportion de patients avec autres lésions cutanées selon l’échelle CTC AE pendant les 4 premiers mois de traitement.
    - Efficacité du traitement dans les deux bras : taux de réponse et de contrôle de la maladie (critères RECIST), survie sans progression et survie à 1 an.
    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 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 Yes
    E.6.13.1Other scope of the trial description
    qualité de vie
    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 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
    Tolexine vs aucun traitement préventif
    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 concerned30
    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 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 patient last visit
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months10
    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 Yes
    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 No
    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 state146
    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)
    NA
    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 Decision2007-07-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-07-27
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2010-02-23
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