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    Summary
    EudraCT Number:2010-024107-27
    Sponsor's Protocol Code Number:GlioAvIr1
    National Competent Authority:Germany - PEI
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2011-01-19
    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 ConcernedGermany - PEI
    A.2EudraCT number2010-024107-27
    A.3Full title of the trial
    Monozentrische Randomisierte Phase III Studie zum Vergleich von hoch dosiertem Bevacizumab plus Irinotecan, niedrig dosiertem Bevacizumab plus Irinotecan und CCNU/Procarbacin bei Patienten mit fortschreitendem Glioblastom im Anschluß an zumindest eine Temozolomide enthaltende Therapie
    A.3.2Name or abbreviated title of the trial where available
    GlioAvIr1
    A.4.1Sponsor's protocol code numberGlioAvIr1
    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 SponsorZentrum für Neuro-Onkologie
    B.1.3.4CountryGermany
    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 Avastin
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Registration Limited Welwyn Garden City
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 nameBevacizumab
    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 IMPIntracavernous use
    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 Irinotecan
    D.2.1.1.2Name of the Marketing Authorisation holderActavis Group hf. Island
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 nameIrinotecanhydrochlorid
    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.3.11 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 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 Cecenu
    D.2.1.1.2Name of the Marketing Authorisation holderMedac Hamburg
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 nameLomustin CCNU
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    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 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 Natulan
    D.2.1.1.2Name of the Marketing Authorisation holderSigma-tau Arzneimittel GmbH
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 nameProcarbazinhydrochlorid
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    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
    Patienten, die an einem Glioblastom (Glioblastoma multiforme WHO Grad IV) erkrankt sind
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.1
    E.1.2Level LLT
    E.1.2Classification code 10006153
    E.1.2Term Brain tumor
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Das Ziel dieser Studie ist, die Wirksamkeit des monoklonalen humanisierten Antikörpers Bevacizumab gerichtet gegen Vascular Endothelialen Growth Factor (VEGF) in Kombintion mit Irinotecan (BEV/IRI) in zwei unterschiedlich dosierten Schemata mit der zugelassenen Alternativtherapie bestehend aus CCNU und Procarbacin zu vergleichen und dabei die anzunehmende Überlegenheit der Bevacizumab beinhaltenden Schemata zu belegen. Dabei wird angenommen, dass der niedrig dosierte Arm des Bevacizumab/Irinotecan-Regimes bei vergleichbarer Wirksamkeit besser toleriert wird als das hoch dosierte Regime.
    E.2.2Secondary objectives of the trial
    Nebenziele:
    Gesamtüberleben und ereignisfreies Überleben nach 12, 24 und 60 Monaten ab Beginn der Studienmedikation
    Sowie Nebenwirkungen/Toxizität nach CTCAE3.0
    Lebensqualität
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Glioblastoma multiforme Grad IV histologisch bestätigt
    • Primärtherapie mit Strahlentherapie und begleitender kontinuierlichen Temozolomide-Therapie (EORTC-Protokoll)
    • Plus/minus weiterer Therapie mit Temozolomide konventionell, intensiviert oder metronomisch (= kontinuierlich) dosiert
    • Progressive Erkrankung mit zumindest einer meßbaren Läsion im Kontrastmittel-MRT T1 gewichtet
    • Adäquate Knochenmarkfunktion:
    Leukozyten (WBC)  3x109/L
    Granulocyten >1,5x109/L
    Thrombozyten 100x109/L
    • Patienten-Compliance und geographische Verhältnisse lassen studienkonforme Therapie, Kontrolluntersuchungen und Dokumentation zu
    • Eigenhändig unterschriebene Einverstämdniserklärung
    • Patienten männlichen und weiblichen Geschlechts im Alter von mindestens 18 Jahren.
    • Negativer Schwangerschaftstest und sichergestellte Kontrazeption bei allen Frauen im gebährfähigen Alter
    • Karnofsky Index 70% oder höher, i. e. ECOG Performance Status 2 oder besser
    E.4Principal exclusion criteria
    • Patienten, die irgendeine andere Studienmedikation innerhalb 28 Tagen vor Beginn der Studienmedikation erhalten haben.
    • Jedweder Hinweis auf nicht gegebene Compliance während der Studienmekation oder der anschließenden Nachbeobachtungsphase
    • Aktive Infektion (der Entscheidung des Studienleiters anheimgestellt)
    • Ander aktive bösartige Erkrankungen
    • Inadäquate Leberfunktion (Bilirubin >2facher Normwert); Alanine Transaminase (ALT/SGPT) oder Aspartate Transaminase (AST/SGOT) >3facher Normwert
    • Inadäquate Nierenfunktion (Kreatinine >1.5facher Normwert); Proteinurie >CTCAE Grad 1 innerhalb von 2 Kontrollen (mindestens 1 Woche auseinander), Proteinurie gesamt unter 1.5 g / 24 Stunden
    • Schere Diarrhoen in der Anamnese
    • Bekannte Allergie gegen eine der Studienmedikationen oder ihrer Begleitstoffe
    • Unmöglichkeit zur Durchführung eines MRT
    • Zurückliegende Therapie mit einem der Studienmedikamente
    • Schwangerschaft oder Stillperiode
    • Lebenserwartung unter 3 Monate aus welchem Grund auch immer
    • Nicht kontrollierter arterieller Hypertonus
    • Lungenarterienembolie oder intrakranielle Blutungen in der Anamnese
    • Anamnestisch klinisch relevante Blutungen einschließlich gastrointestinaler Blutungen
    • Chirurgische Eingriffe einschl. Kraniotomie innerhalb von 4 Wochen vor Aufnahme der Studienmedikation
    • Nicht komplett abgeheilte Wunden (ausgenommen Bagatelltraumata)
    • Gleichzeitige Behandlung mit anderen Studienmedikamenten und Teilnahme an Studien mit nicht zugelassenen Medikamenten innerhalb von 30 Tagen vor Einschluss in die Studie
    E.5 End points
    E.5.1Primary end point(s)
    Objektives Ansprechen nach Macdonald´s
    (Macdonald et al.(1990):
    CR (Komplette Remission) = komplette Rückbildung aller
    kontrastmittelaufnehmenden Läsionen im T1 gewichteten MRT
    mit unveränderter oder gebesserter neurologischer Symptomatik
    und unveränderter oder reduzierter Steroid-Dosis
    PR (partielle Remission) = 50%ige Rückbildung aller
    kontrastmittelaufnehmenden Läsionen im T1 gewichteten MRT
    mit unveränderter oder gebesserter neurologischer Symptomatik
    und unveränderter oder reduzierter Steroid-Dosiis
    PD (Progrediente Erkrankung) = 25% Vergrößerung mindestens einer
    kontrastmittelaufnehmenden Läsionen im T1 gewichteten MRT
    oder Nachweis einer neuen Läsion oder neurologische
    Verschlechterung
    SD (Stabile Erkrankung) = alle anderen Situationen)
    Und
    Ereignisfreies Überleben nach 6 Monaten ab Beginn der Studienmedikation (Ereignis = Krankheitsprogression oder Tod oder Beendigung der Studienmedikation aus welchem Grund auch immer)
    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 Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    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
    last subject 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 months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    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.1.3Elderly (>=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 state300
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 0
    F.4.2.2In the whole clinical trial 0
    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)
    Der zuständige Prüfarzt ist für die Organisation und Dokumentation der Nachsorge im Rahmen der Studie verantwortlich. Nach Beendigung der Nachsorgezeit wird generell das weitere Vorgehen mit dem zuständigen Prüfarzt, meist in Zusammenarbeit mit dem Hausarzt, organisiert.
    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 Decision2011-05-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-02-02
    P. End of Trial
    P.End of Trial StatusOngoing
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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