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    Summary
    EudraCT Number:2009-012090-36
    Sponsor's Protocol Code Number:ML22519
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2009-06-25
    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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2009-012090-36
    A.3Full title of the trial
    A single-arm, open-label phase II study: Treatment beyond progression by adding Bevacizumab to XELOX or FOLFOX chemotherapy in patients with metastatic colorectal cancer and disease progression, under first-line FOLFIRI + bevacizumab combination
    A.3.2Name or abbreviated title of the trial where available
    AVASTAY
    A.4.1Sponsor's protocol code numberML22519
    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 SponsorN.V. Roche S.A.
    B.1.3.4CountryBelgium
    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 25 mg/ml concentrate for solution for infusion
    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.3.4Pharmaceutical form Concentrate for solution for injection
    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 codeRo 4876646
    D.3.9.3Other descriptive namerhuMab VEGF, 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 humanized 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
    Metastatic colorectal cancer with disease progression under first-line FOLFIRI + Bevacizumab combination (Patients no candidates for primary metastectomy)
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10052358
    E.1.2Term Colorectal cancer metastatic
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10052362
    E.1.2Term Metastatic 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 Progression Free Survival (PFS) of treatment beyond progression therapy
    E.2.2Secondary objectives of the trial
    - To assess PFS from time of starting first line therapy
    - To evaluate the Response rate (RECIST version 1.1)
    - To evaluate the safety profile
    - To study the relationship between the levels of proangiogenic cytokines and progression (only in selected qualified centers)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Patients with histological onfirmed diagnosis of metastatic CRC and disease progression (according to RECIST assessed by investigator, documented by CT or MRI) previously treated with first-line therapy (FOLFIRI + Bevacizumab) until progression and who are no candidates for primary metastectomy.
    - At least one measurable lesion according to RECIST version 1.1
    - Disease Progression ≤ 8 weeks after last bevacizumab administration.
    - No more than 8 weeks between last administration 1st line treatment with FOLFIRI + bevacizumab and start 2nd line XELOX or FOLFOX + Bevacizumab
    - Evaluation of tumor disease according to RECIST by investigator, 4 weeks or less prior inclusion.
    - No major surgery within 4 weeks prior to inclusion
    - Wound healing completed
    - Age ≥ 18 years
    - Life expectancy > 3 months
    - ECOG ≤ 2
    - Neutrophils ≥ 1.500/µL
    - Platelets ≥ 100.000/µL
    - Hemoglobin > 9 g/dL
    - Creatinine clearance > 30mL/min (Dosage modification for Capecitabine 1250 mg/m² bid if creatinine clearance < 30-50 mL/min), serum creatinine < 1,25 x upper normal limit
    - Serum bilirubin < 1,25 x upper normal limit, AST/ALT < 2.5 x ULN
    - In case of liver metastasis, serum bilirubin < 1,5 x upper normal limit, AST/ALT < 5 x ULN
    - Signed written informed consent
    - Fertile women (< 2 years after last menstruation) and men of childbearing potential must use effective means of contraception (oral contraceptives, intrauterine contraceptive device, barrier method of contraception in conjunction with spermicidal jelly or surgically sterile)
    E.4Principal exclusion criteria
    - Diagnosis of progression of disease more than 8 weeks after last Bevacizumab administration
    - Current and/or previous treatment with any other investigational agent or other biological agent (e.g. cetuximab)
    - Participation in another clinical trial (except for the non-interventiolal trial ML22517 - Avastart) within 30 days prior to entering this study
    - Inadequately controlled hypertension (definded as systolic blood pressure > 150 mmHg and/or diastolic blood pressure > 100 mmHg)
    - Prior history of hypertensive crisis or hypertensive encephalopathy
    - NYHA Class II or greater CHF
    - History of myocardial infarction or unstable angina within 6 months prior to Day 1
    - Known CNS disease, except for treated brain metastasis (treated brain metastasis are defined as having no evidence of progression or hemorrhage after treatment and no ongoing requirement for dexamethasone, as ascertained by clinical examination and brain imaging (MRI or CT) during the screening period. Anticonvultants (stable dose) are allowed. Treatment for brain metastases may include whole brain radiotherapy (WBRT), radio surgery (RS; Gamma Knife; LINAC; or equivalent) or a combination as deemed appropriate by the treating physician. Patients with CNS metastases treated by neurosurgical resection or brain biopsy performed within 3 months of start of study therapy will be excluded).
    - Significant vascular disease (e.g. aortic aneurysm requiring surgical intervention, pulmonary embolism or recent peripheral arterial thrombosis) within 6 months prior start of study treatment.
    - History of haemoptysis (≥ ½ teaspoon of bright red blood per episode) within 1 month prior to start of study treatment
    - Evidence of bleeding diathesis or significant coagulopathy (in absence of therapeutic anticoagulation)
    - Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to start of study therapy, or anticipation of need for major surgical procedure during the course of the study
    - Core biopsy or other minor surgical procedure, excluding placement of vascular access device, within 7 days prior start of study therapy
    - History of abdominal fistula or gastrointestinal perforation within 6 months prior to start of study therapy
    - Serious, non healing wound, active ulcer, or untreated bone fracture
    - History or evidence upon physical/neurological examination of CNS disease (unrelated to cancer) (unless adequately treated with standard medical therapy) e.g. uncontrolled seizures
    - Past or current history (within the last 2 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)
    - Known hypersensitivity to any of the study drugs
    - Acute intra abdominal inflammatory process
    - 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
    - Patients with contraindication for oxaliplatin containing chemotherapy (e.g. patients with serious polyneuropathy > grade 1, not feasible for oxaliplatin based treatment beyond progression).
    - Previous radiotherapy: Patients must have recovered from any radiotherapy toxicity prior to enrolment
    - Contraindication for CTX regimen as indicated in relevant SmPC (oxaliplatinum/capecitabine/5-FU/LV)
    - Life expectancy less than 3 months
    - Inability or unwillingness to comply with the protocol
    - Inadequate haematological function: ANC < 1.5 x 109/L; platelets < 100 x 109/L, Hemoglobin (Hb) < 9 g/dL (may be transfused prior to enrolment)
    - INR >1.5 within 7 days prior to starting study treatment. aPTT > 1.5 x ULN within 7 days prior to starting study treatment. EXEMPTION: patients on full anticoagulation due to VTE must have an in-range INR [usually between 2-3]. Any anticoagulation therapy must be at stable dosing prior to enrolment.
    - Liver function: Serum bilirubin > 1.5 x ULN; alkaline phosphatase and transaminases > 5 x ULN (liver metastases)
    - Urine dipstick for proteinuria ≥ 2+. If urine dipstick is ≥ 2+, 24-hours urine must demonstrate ≤ 1 g of protein in 24 hours for patient to be eligible. Rescreening for proteinuria is possible but must be confirmed before study entry by the result of 24 hours collection.
    - Pregnancy or lactation.
    - Fertile women (< 2 years after last menstruation) and men of childbearing potential unwilling or unable to use effective means of contraception (oral contraceptives, intrauterine contraceptive device, barrier method of contraception in conjunction with spermicidal jelly or surgically sterile).
    E.5 End points
    E.5.1Primary end point(s)
    Assessment of efficacy through:
    - PFS of treatment beyond progression therapy
    - PFS from time of starting first-line therapy
    - Overall Response rate (RECIST)

    Assessment of safety through:
    incidence of serious and non-serious adverse events will be investigated. The NCI CTCAE criteria (version 3.0) will be used to score intensity of these events
    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 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) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    E.8.3 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 concerned27
    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
    End of trial is last patient last visit
    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 months9
    E.8.9.1In the Member State concerned days5
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months9
    E.8.9.2In all countries concerned by the trial days5
    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 state100
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 100
    F.4.2.2In the whole clinical trial 100
    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)
    No treatment is provided by the sponsor after the subject has ended his/her participation in the trial.
    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 Decision2009-07-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-06-30
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2012-01-16
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