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    Summary
    EudraCT Number:2005-001919-21
    Sponsor's Protocol Code Number:AIO KRK 0105
    National Competent Authority:Germany - PEI
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2006-07-13
    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 number2005-001919-21
    A.3Full title of the trial
    Phase II-Studie: Standardchemotherapie Capecitabin in Kombination mit Bevacizumab in der Erstlinientherapie beim metastasierten kolorektalen Karzinom
    A.3.2Name or abbreviated title of the trial where available
    AIO KRK 0105
    A.4.1Sponsor's protocol code numberAIO KRK 0105
    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 SponsorMartin-Luther-Universität Halle-Wittenberg, Medizinische Fakultät, endvertreten durch den Dekan
    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 Information not present in EudraCT
    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.3.2Product code RO 487-6646
    D.3.4Pharmaceutical form Intravenous 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 INNBevacizumab
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    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 No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 typemonoclonal antibody
    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.2.5The 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 nameCapecitabine
    D.3.2Product code RO 09-1978
    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 INNCapecitabine
    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 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
    metastasized colorectal cancer
    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
    Progressionsfreie Rate (PFS-Rate) nach 9 Monaten, definiert ab Tag des Therapiebeginns bis zum ersten Auftreten irgendeines der folgenden Ereignisse: Diagnose einer Progression der Erkrankung, eines Zweitmalignoms oder Tod jedweder Ursache
    E.2.2Secondary objectives of the trial
    -Verträglichkeit und Durchführbarkeit der Standardtherapie Capecitabin in Kombination mit Bevacizumab gemessen mittels NCI-CTCAE Version 3.0 unter Berücksichtigung der Inzidenz folgender unerwünschten Arzneimittelwirkungen
    -gastrointestinale Perforation
    -thromboembolische Ereignisse ( arteriell / venös)
    -Wundheilungskomplikationen
    -Hypertonie
    -Proteinurie
    -Blutungen
    -Erfassung der medianen Zeit bis zur Progression
    -Erfassung der objektiven Ansprechrate (CR und PR)
    -Erfassung der Zeit bis zum Therapieversagen
    -Erfassung der Dauer des Ansprechens
    -Erfassung des medianen Überlebens
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    -Patienten mit histologisch gesichertem kolorektalen Karzinom im metastasierten Stadium
    -Erkrankung, die nicht kurativ behandelt werden kann, weder initi-al noch nach Metastasenverkleinerung durch Chemotherapie
    -Mindestens 1 messbare Referenzmetastase > 20 mm oder evaluierbare Erkrankung gemäß RECIST (siehe Abschnitt 7 und Anlage 9)
    -Patienten ≥ 18 Jahre
    -ECOGPerformace Status 0 - 2
    -Adäquate hämatologische, renale und hepatische Funktion mit Bilirubin <= 2 x ONW, ASAT/ALAT <= 2.5 x ONW (<= 5 x ONW bei Lebermetastasen), Kreatinin-Clearance ≥ 30 ml/min
    -Ausreichende Knochenmarksreserve (neutrophile Granulozyten > 1,5/nl, Thrombozyten > 100/ nl)
    -Hämoglobin ≥ 9 g/dl bzw. ≥ 5,59 mmol/l (Transfusion zum Erreichen oder Aufrechterhalten möglich)
    -INR <= 1.5 x ONW
    -Lebenserwartung > 3 Monate
    -Gebärfähige Frauen müssen einen negativen Schwangerschaftstest vorlegen (Erhebung bis eine Woche vor Therapiebeginn möglich), bei postmenopausalen Frauen muss mindestens eine zwölfmonatige Amenorrhöe vorliegen, um als nicht mehr gebärfähig zu gelten. Eine sichere Kontrazeption muss bis 6 Monate nach der letzten Medikation des Bevacizumab sichergestellt sein
    -Einwilligungsfähiger Patient, vorliegen der schriftlichen Einverständniserklärung des Patienten
    E.4Principal exclusion criteria
    -Vorangegangene oder gleichzeitige systemische Immun- oder Chemotherapie ausgenommen:
    -adjuvante oder neo-adjuvante Therapie einer nicht-metastasierten Erkrankung, deren Ende mindestens 6 Monate vor Einschluss in die Studie liegt, bei adjuvanter Therapie zusätzlich ohne Progress innerhalb von 6 Monaten nach Therapieende
    -Zweitmalignome mit Ausnahme eines Basalioms, eines kurativ behandelten in-situ Karzinoms der Cervix uteri oder kurativ behandelten anderen Tumors mit einer Rezidivfreiheit von über 5 Jahren
    -Vorherige große Operation, offene Biopsie oder größere Unfallverletzungen vor weniger als 28 Tagen vor Studienbeginn oder geplante große Operation innerhalb der Studie
    -Chronisch entzündliche Darmerkrankungen oder schwere gastrointestinale Ulzera
    -Größere nicht heilende Wunden, anamnestisch bekannte Blutungsdiathesen oder Koagulopathien oder abgelaufene Thromboembolie oder Hämorrhagie innerhalb der letzten 6 Monate, welche nach Einschätzung des Prüfarztes gegen eine Therapie mit Bevacizumab sprechen
    -Behandlung mit ASS (> 325 mg/Tag) oder anderen bekannten Medikamenten, die eine Entstehung gastrointestinaler Ulzera begünstigen.
    -Anhaltende oder weniger als 10 Tage vor Studienbeginn durchgeführte Therapie mit voller Dosis an Antikoagulantien
    -Schwere Begleiterkrankungen mit Organbeeinträchtigungen, wie
    -schwere ZNS-Erkrankung, ZNS-Metastasierung, cerebrovaskuläre Erkrankung (wie Schlaganfall, etc.) vor weniger als 6 Monaten
    -schwere kardiale oder pulmonale Begleiterkrankung; insb. Symptomatische KHK trotz adäquater Therapie, eine Herzinsuffizienz ab NYHA II, schwere Arrhythmien, instabile Angina pectoris, Myokardinfarkt vor weniger als 6 Monaten, periphere arterielle Verschlusskrankeit ab Stadium II
    -Schwere trotz Medikation nicht kontrollierbare arterielle Hypertonie
    -Proteinurie mit ≥ 2+ im Urin-Stix, solange im 24-Stunden-Sammelurin > 1g Protein im Urin nachweisbar ist
    -Gleichzeitige Behandlung mit Präparaten aus Johanniskraut
    -Teilnahme an einer anderen Studie innerhalb von 4 Wochen vor Einschluss
    -Patienten, die keine Tabletten schlucken können
    -Zurückliegender oder andauernder Drogen-, Medikamenten- oder Alkoholmissbrauch
    -Patienten, die nicht in der Lage oder bereit sind, sich protokollgerecht zu verhalten und behandeln sowie nachuntersuchen zu lassen
    -Bekannter DPD-Mangel
    -Behandlung mit Sorivudin, Brivudin oder Analoga
    -Bekannte Unverträglichkeit gegen eines der eingesetzten Medikamente oder eines deren galenischer Inhaltsstoffe
    -Schwangerschaft oder Stillzeit
    -Sexuell aktive Männer und (gebärfähige) Frauen mit mangelnder Bereitschaft zur Durchführung suffizienter kontrazeptiver Maßnahmen (Pille, Hormonspirale, Depot-Spritze, hormonabgebendes Implantat, Abstinenz oder Vasektomie des Partners)
    E.5 End points
    E.5.1Primary end point(s)
    Es handelt sich um eine Phase II-Studie, mit der die Effektivität einer innovativen Chemo/Immuntherapie-Kombination, bestehend aus Capecitabin und Bevacizumab im Hinblick auf eine zukünftige Erprobung im Rahmen einer umfangreichen Phase III-Studie abgeschätzt werden soll. Als primäres Zielkriterium dient hierbei die progressionsfreie Rate (PFS-Rate) nach 9 Monaten. Diesem Endpunkt wird der Vorzug gegenüber der objektiven Remissionsrate gegeben, da die bisherigen Erfahrungen mit den neuen Wirkstoffen dafür sprechen, dass ihr Potential sich in stärkerem Maße bei der Verzögerung einer Progression bzw. sogar Überlebensverlängerung auswirkt als bei der kurzfristigen Induktion deutlicher Tumorrückbildungen.
    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 Information not present in EudraCT
    E.6.11Pharmacogenomic Yes
    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 No
    E.8.1.2Open No
    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) 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 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 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 years4
    E.8.9.1In the Member State concerned months7
    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 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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2006-07-13. Yes
    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 state80
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 80
    F.4.2.2In the whole clinical trial 80
    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 Decision2006-08-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-08-31
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2010-03-03
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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
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