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    Summary
    EudraCT Number:2005-001012-41
    Sponsor's Protocol Code Number:ML18523
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2007-02-09
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2005-001012-41
    A.3Full title of the trial
    Phase II Study of the Combination of Bevacizumab (rhuMAb VEGF) and Oxaliplatin plus Capecitabine (XELOX) in Patients with Advanced Colorectal Cancer
    Studio di fase II sulla combinazione di bevacizumab piu` capecitabina e oxaliplatino in pazienti con carcinoma del colon-retto avanzato.
    A.4.1Sponsor's protocol code numberML18523
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorROCHE
    B.1.3.4CountryItaly
    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 Avastin
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Registration Limited
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    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 milligram(s)
    D.3.10.3Concentration number100
    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) No
    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 No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    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 No
    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 typeAnticorpo monoclonale ricombinante umanizzato.
    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 Avastin
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Registration Limited
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    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 milligram(s)
    D.3.10.3Concentration number400
    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) No
    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 No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    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 No
    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 typeAnticorpo monoclonale ricombinante umanizzato.
    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 with inoperable locally advanced or metastatic colorectal cancer, who have not previosly received systemic treatment for metastatic disease.
    Pazienti con carcinoma colorettale primario localmente avanzato non operabile, o metastatico, non pretrattati per malattia metastatica.
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10061451
    E.1.2Term Colorectal cancer
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the preliminary antitumor activity in terms of overall response rate (complete and partial responses) of the combination of bevacizumab and capecitabine plus oxaliplatin in patients with advanced colorectal cancer.
    Determinare il tasso globale di risposte obiettive (complete e parziali) in pazienti con carcinoma colorettale avanzato trattati con bevacizumab e capecitabina piu' oxaliplatino.
    E.2.2Secondary objectives of the trial
    To evaluate toxicity and the safety profile of the combination To evaluate duration of response (DR), time to progression (TTP), time to treatment failure (TTF), and overall survival (OS) at the end of the study.
    Valutare il profilo di tossicita` e di safety di bevacizumab e capecitabina piu` oxaliplatino.Valutare la durata delle risposte (DR),il tempo alla progressione (TTP),il tempo al fallimento terapeutico (TTF),e la sopravvivenza globale fino al termine dello studio.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Histologically or cytologically proven diagnosis of colorectal cancer 2. Locally advanced or metastatic colorectal cancer not previously treated with chemotherapy for metastatic disease 3. Age >= 18 4. ECOG Performance Status 0-1 5. Life expectancy of at least 12 weeks 6. Measurable and/or evaluable lesions according to RECIST criteria 7. Laboratory requirements: Neutrophils >= 1.5 x 109/L and Platelets >= 100 x 109/L Total bilirubin <= 1.5 time the upper-normal limits (UNL) of the Institutional normal values and ASAT (SGOT) and/or ALAT (SGPT) <= 2.5 x UNL, or <= 5 x UNL in case of liver metastases, alkaline phosphatase <= 2.5 x UNL, <= 5 x UNL in case of liver metastases. Creatinine clearance >50 mL/min or serum creatinine <= 1.5 x UNL Urine dipstick of proteinuria <2+. Patients discovered to have >= 2+ proteinuria on dipstick urinalysis at baseline, should undergo a 24-hour urine collection and must demonstrate <= 1 g of protein/24 hr. 8. Written informed consent. 9. Patients must be accessible for treatment and follow up. Patients registered on this trial must be treated and followed at the participating Center.
    1. Pazienti con diagnosi confermata istologicamente o citologicamente di carcinoma colorettale, 2. Pazienti con malattia localmente avanzata, non operabile, o metastatica, non pretrattati con chemioterapia per la malattia metastatica. 3. Eta` &gt;= 18 anni 4. Performance Status ECOG 0-1 5. Attesa di vita di almeno 12 settimane 6. Lesioni misurabili e/o valutabili secondo i criteri RECIST 7. Parametri di Laboratorio: Neutrofili &gt;= 1.5 x 109/L e Piastrine &gt;= 100 x 109/L Bilirubina totale &lt;= 1.5 il limite superiore normale (LSN) del range dei valori normali del Centro e ASAT (SGOT) e/o ALAT (SGPT) &lt;= 2.5 x LSN, o &lt;= 5 x LSN in caso di metastasi epatiche, fosfatasi alcalina &lt;= 2.5 x UNL, &lt;= 5 x LSN in caso di metastasi epatiche, &lt;= 10 x LSN in caso di metastasi ossee. Clearance della Creatinina &gt;50 mL/min o creatinina serica &lt;=1.5 x LSN) Proteinuria (dipstick) &lt;2+. Pazienti con proteinuria &gt;= 2+ al basale, devono sottoporsi a raccolta urine di 24 ore e devono avere &lt;= 1 g di proteine/24 ore. 8. Consenso Informato scritto. 9. Accessibilita` geografica per il trattamento e follow up. Pazienti arruolati in questo studio devono essere trattati e seguiti nel Centro partecipante.
    E.4Principal exclusion criteria
    1. Radiotherapy to any site within 4 weeks before the study. 2. Untreated brain metastases or spinal cord compression or primary brain tumours. 3. History or evidence upon physical examination of CNS disease unless adequately treated (e.g., seizure not controlled with standard medical therapy or history of stroke). 4. History of inflammatory bowel disease and/or acute/subacute bowel occlusion. 5. Serious, non-healing wound, ulcer, or bone fracture. 6. Evidence of bleeding diathesis or coagulopathy. 7. Uncontrolled hypertension. 8. Clinically significant (i.e. active) cardiovascular disease for example cerebrovascular accidents (&#8804;6 months), myocardial infarction (&#8804; 6 months), unstable angina, New York Heart Association (NYHA) grade II or greater congestive heart failure, serious cardiac arrhythmia requiring medication. 9. Current or recent (within 10 days prior to study treatment start) ongoing treatment with anticoagulants for therapeutic purposes. 10. Chronic, daily treatment with high-dose aspirin (>325 mg/day). 11. Treatment with any investigational drug within 30 days prior to enrolment. 12. Patients with known allergy to Chinese hamster ovary cell proteins, or any of the components of the study medications. 13. Other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal and squamous cell carcinoma or cervical cancer in situ. 14. Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to study treatment start, or anticipation of the need for major surgical procedure during the course of the study. 15. Lack of physical integrity of the upper gastrointestinal tract, malabsorption syndrome, or inability to take oral medication. 16. Pregnant or lactating women. Women of childbearing potential with either a positive or no pregnancy test at baseline. Postmenopausal women must have been amenorrheic for at least 12 months to be considered of non-childbearing potential. Sexually active males and females (of childbearing potential) unwilling to practice contraception during the study. 17. Symptomatic peripheral neuropathy &#8805;grade 1 according the NCI Common Toxicity Criteria.
    1. Radioterapia su qualsiasi sede nelle precedenti 4 settimane. 2. Metastasi cerebrali sintomatiche e/o instabili o metastasi leptomeningee che richiedono trattamento. 3. Anamnesi o evidenza clinica di malattia al Sistema Nervoso Centrale (SNC) a meno che non sia adeguatamente trattata (es. crisi non controllata con una terapia medica standard oppure anamnesi di infarto) 4. Storia di malattia infiammatoria intestinale e/o occlusione intestinale acuta/subacuta. 5. Ulcera, ferita non rimarginata grave o frattura ossea. 6. Evidenza di diatesi emorragica o coagulopatia. 7. Ipertensione non controllata. 8. Malattia cardiovascolare clinicamente significativa (attiva): per esempio, accidente cerebrovascolare (&#8804;6 mesi), infarto miocardico (&#8804;6 mesi), angina instabile, insufficienza cardiaca congestizia di grado II o maggiore secondo la New York Heart Association (NYHA), aritmia cardiaca grave che richiede trattamento. 9. Trattamento recente (nei 10 giorni precedenti l`inizio del trattamento) o in corso con anticoagulanti somministrati a scopo terapeutico. 10. Trattamento cronico, giornaliero, con aspirina ad alte dosi (&gt;325 mg/die) o con altri farmaci che possano predisporre all`ulcera gastroinestinale. 11. Trattamento con qualsiasi farmaco sperimentale nei 30 giorni precedenti l`arruolamento. 12. Pazienti con allergia confermata alle proteine delle cellule ovariche di criceto cinese, o a uno qualsiasi dei componenti dei farmaci dello studio. 13. Altre concomitanti patologie neoplastiche diagnosticate negli ultimi 5 anni con l`eccezione del carcinoma basocellulare e del carcinoma cervicale in situ. 14. Intervento di chirurgia maggiore, biopsia a cielo aperto, o lesione traumatica significativa nei 28 giorni precedenti l`inizio del trattamento, o previsione della necessita` di un intervento di chirurgia maggiore durante il corso dello studio. 15. Assenza di integrita` fisica del tratto gastrointestinale superiore, sindrome da malassorbimento, o inabilita` ad assumere farmaci orali. 16. Donna in gravidanza o in allattamento. Donna senza test di gravidanza o con un test di gravidanza positivo al basale. La donna in postmenopausa e` considerata non fertile se amenorroica da almeno 12 mesi. Donne e maschi sessulamente attivi (o potenzialmente fertili) che non praticano un metodo contraccettivo durante lo studio. 17. Neuropatia periferica di grado &#8805;1 secondo i criteri di valutazione della tossicita` del NCI.
    E.5 End points
    E.5.1Primary end point(s)
    - Complete remission (CR): complete disappearance of all previously detectable disease for a period of at least 28 days, and no new lesions. - Adverse events, laboratory parameters. All toxicity will be graded using the NCI common toxicity criteria version 3.0.
    - Remissione completa (CR): scomparsa completa della malattia precedentemente rilevabile per un periodo di almeno 28 giorni e assenza di nuove lesioni. - Eventi avversi, parametri di Laboratorio. Tutti gli eventi avversi saranno classificati usando i criteri di valutazione della tossicita` del NCI, versione 3.0.
    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 No
    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 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 Yes
    E.8.1.7.1Other trial design description
    studio in aperto
    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.8.2.4Number of treatment arms in the trial1
    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 concerned8
    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 No
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    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.1.1Number of subjects for this age range: 0
    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 state49
    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 Decision2005-11-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2005-04-19
    P. End of Trial
    P.End of Trial StatusCompleted
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