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    Summary
    EudraCT Number:2006-003293-10
    Sponsor's Protocol Code Number:MO19286 (AVEX)
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2007-03-14
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2006-003293-10
    A.3Full title of the trial
    A randomized, open-label Phase III study to assess efficacy and safety of bevacizumab in combination with capecitabine as first line treatment for elderly patients with metastatic colorectal cancer
    ESTUDIO ALEATORIZADO Y ABIERTO FASE III PARA VALORAR LA EFICACIA Y SEGURIDAD DE BEVACIZUMAB ASOCIADO CON CAPECITABINA COMO TRATAMIENTO DE PRIMERA LÍNEA EN ANCIANOS CON CÁNCER COLORECTAL METÁSTASICO
    A.3.2Name or abbreviated title of the trial where available
    AVEX: Avastin in Elderly with Xeloda
    A.4.1Sponsor's protocol code numberMO19286 (AVEX)
    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 SponsorF. Hoffmann-La Roche Ltd.
    B.1.3.4CountrySwitzerland
    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 Ltd.
    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 nameAvastin
    D.3.2Product code RO4876646
    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.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNBevacizumab
    D.3.9.1CAS number 216974-75-3
    D.3.9.2Current sponsor codeRO487664
    D.3.9.3Other descriptive namerhuMAb, VEGT, anti-VEGF
    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 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 Yes
    D.3.11.13.1Other medicinal product typeRecombinant humanised monoclonal antibody
    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
    First line metastatic colorectal carcinoma

    Tratamiento de primera línea en cáncer colorrectal metastásico.
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 8.1
    E.1.2Level LLT
    E.1.2Classification code 10052358
    E.1.2Term Colorectal cancer metastatic
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To determine the efficacy of bevacizumab in combination with capecitabine, based on progression free survival (PFS).
    E.2.2Secondary objectives of the trial
    •To evaluate the safety profile of bevacizumab in combination with capecitabine
    •To determine the overall response rate (RR), time to response, duration of response and overall survival (OS) of bevacizumab in combination with capecitabine
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1) Written informed consent (approved by the Institutional Review Board [IRB] / Independent Ethics Committee [IEC]) obtained prior to any study specific screening procedures
    2) Age >= 70 years
    3) Patient must be able to comply with the protocol
    4) Histologically or cytologically confirmed carcinoma of the colon and/or rectum with evidence of metastases (new confirmation of metastatic disease is required in case the time interval from last histological/cytological diagnosis to enrolment exceeds 3 years)
    5) Diagnosis of metastatic disease not more than 6 months prior to enrolment
    6) At least one measurable metastatic lesion, measurable or at least evaluable disease (as per RECIST criteria)
    7) Prior adjuvant (or neo-adjuvant for rectal cancer patients) chemotherapy allowed if completed more than 6 months before inclusion
    8) ECOG performance score of 0 – 2
    9) Life Expectancy of at least 3 months
    10) Adequate haematological function: ANC >= 1.5 x 10Exp9/L; platelets >= 100 x 10Exp9/L, Hb >= 9 g/dL
    11) INR <= 1.5; PTT <= 1.5 × ULN within 7 days prior to starting study treatment
    12) Adequate liver function: Serum bilirubin <= 1.5 x ULN; AST / ALP <= 2.5 x ULN (in case of liver metastases < 5 × ULN)
    13) Calculated creatinine clearance >= 50 mL/min
    14) Urine dipstick for proteinuria < 2+. If urine dipstick is >= 2+, 24-hour urine must demonstrate <= 1 g of protein in 24 hours
    E.4Principal exclusion criteria
    1) Patients who received adjuvant antiVEGF treatment
    2) Prior chemotherapeutic treatment for metastatic CRC
    3) Clinical evidence of brain metastases or 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) or psychiatric disability judged by the investigator to be clinically significant precluding informed consent or interfering with compliance for oral drug intake
    4) Past or current history (within the last 5 years prior to treatment start) of other malignancies except metastatic colorectal cancer (Patients with curatively treated basal and squamous cell carcinoma of the skin or in situ carcinoma of the cervix are eligible)

    5) Clinically significant cardiovascular disease, for example CVA (<= 6 months before treatment start), myocardial infarction (<= 6 months before treatment start), unstable angina, NYHA >= grade 2 CHF, arrhythmia requiring medication, or uncontrolled hypertension
    6) Treatment with any other investigational agent, or participation in another clinical trial within 30 days prior to entering this study
    7) Known hypersensitivity to any of the study drugs
    8) Current or recent (within 10 days of first dose of study treatment) daily use of aspirin (> 325 mg/day) or other NSAID
    9) Current or recent (within 10 days prior to study treatment start) use of full-dose oral or parenteral anticoagulants or thrombolytic agent for therapeutic (as opposed to prophylactic) purposes. Patients receiving (or considered candidate to receive) anticoagulants agents as prophylaxis of cardiovascular risk, should continue (or start) the appropriate treatment at study entry
    10) History of thromboembolic or haemorrhagic events within 6 months prior to treatment
    11) History of abdominal fistula, gastrointestinal perforation or intraabdominal abscess within 6 month prior to enrolment
    12) Evidence of bleeding diathesis or coagulopathy
    13) Serious, non healing wound, ulcer, or bone fracture
    14) Major surgical procedure, open biopsy or significant traumatic injury within 28 days prior to treatment
    15) Evidence of any other disease, metabolic dysfunction, physical examination finding or laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or puts the patient at high risk for treatment-related complications (e.g. serious intercurrent infections, other serious uncontrolled concomitant disease)
    16) Patients who don’t have an intact GI (e.g. clinically significant malabsorption syndrome) and those who are unable to take oral medication (e.g. swallowing difficulty)
    17) Men of childbearing potential not willing to use effective means of contraception
    18) Requirement for concurrent use of the antiviral agent sorivudine or chemically related analogues, such as brivudine
    19) Organ allografts requiring immunosuppressive therapy
    E.5 End points
    E.5.1Primary end point(s)
    Progression free survival (PFS), defined as the time period from the date of randomisation to disease progression or death from any cause, whichever occurs first. Patients without an event will be censored at the date of last assessment, last documented tumor assessment, or in case none of this is available, at the date of randomisation. Disease progression will be based on investigator’s assessment; evaluation of target lesions and non target lesions will be in accordance with the RECIST criteria.
    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 Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    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 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) Yes
    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.8.4.1Number of sites anticipated in Member State concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA37
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    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
    The end of the study is defined as the follow up visit following the observation of the 401st event (disease progression or death) or 18 months after randomisation of last patient, whichever is reached first.
    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 months6
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months6
    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) No
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state50
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 295
    F.4.2.2In the whole clinical trial 430
    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)
    Patients still on treatment with bevacizumab without progression of disease at the time of study closure may continue bevacizumab within an extension protocol.

    Patients who want to switch to an alternative treatment before experiencing progressive disease (PD) will be followed up until PD and censored as Event at the time of treatment discontinuation.
    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 Decision2007-05-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-05-03
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2013-03-08
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