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    Summary
    EudraCT Number:2009-011400-33
    Sponsor's Protocol Code Number:MO22224
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2009-10-08
    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 ConcernedFrance - ANSM
    A.2EudraCT number2009-011400-33
    A.3Full title of the trial
    A multi-centre, open-label, randomised, two-arm Phase III trial of bevacizumab plus chemotherapy versus chemotherapy alone in patients with platinum-resistant, epithelial ovarian, fallopian tube or primary peritoneal cancer.
    A.3.2Name or abbreviated title of the trial where available
    AURELIA
    A.4.1Sponsor's protocol code numberMO22224
    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 Limited
    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 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 codeRO4876646
    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
    Platinum-resistant, epithelial ovarian, fallopian tube or primary peritoneal cancer
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10033128
    E.1.2Term Ovarian cancer
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10016180
    E.1.2Term Fallopian tube cancer
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10061344
    E.1.2Term Peritoneal neoplasm
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To compare progression-free survival (PFS) of patients randomised to selected chemotherapy only or to selected chemotherapy plus bevacizumab
    E.2.2Secondary objectives of the trial
    • Objective response rate (ORR)
    - by RECIST and CA-125 response criteria (“responders”)
    - by RECIST only (“RECIST responders”)
    - by CA-125 response criteria only (“CA-125 responders”).
    • Biological progression-free interval (PFIBIO)
    - by serum CA-125 and assessed according to the GCIG criteria
    • Overall survival (OS)
    • Quality of life (QOL)
    - QOL and symptom control will be assessed using EORTC QLQ-C30, QLQ-OV28,
    Hospital Anxiety Depression Scale (HADS), FACT/NCCN Ovarian Symptom Index
    (FOSI) and symptom questionnaires.
    • Safety and tolerability
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    . Signed informed consent obtained prior to initiation of any study-specific
    procedures and treatment as confirmation of the patient’s awareness and
    willingness to comply with the study requirements.
    . Patients ≥18 years of age
    . Histologically confirmed and documented disease. The following histological types are eligible:
    • adenocarcinoma NOS
    • clear cell adenocarcinoma
    • endometriod adenocarcinoma
    • malignant Brenner's tumour
    • mixed epithelial carcinoma
    • mucinous adenocarcinoma
    • serous adenocarcinoma
    • transitional cell carcinoma
    • undifferentiated carcinoma.
    . Patients must have platinum-resistant disease, (defined as progression within <6
    months of platinum therapy)
    . Patients must have disease that is measurable according to RECIST or assessable
    according to the GCIG CA-125 criteria and require chemotherapy treatment.
    . ECOG PS 0–2.
    . Life expectancy of greater than or equal to 12 weeks.
    E.4Principal exclusion criteria
    . Non-epithelial, including malignant mixed Müllerian tumours.
    . Ovarian tumours with low malignant potential.
    . Other malignancy within the last 5 years
    . Minor surgical procedures within 24 hours prior to first study treatment.
    . Previous exposure to murine CA-125 Ab (only applicable to those patients
    with non-measurable disease by RECIST).
    . Current or recent treatment with another investigational drug and/or
    participation in another investigational study within 30 days of first study
    treatment dosing or earlier participation in this study.
    . Chronic daily treatment with corticosteroids, excluding inhaled steroids.
    . Inadequate bone marrow function: ANC: <1.5 x 10E9/l, or platelet count <100 x
    10E9/l, or haemoglobin <9 g/dl. Patients may be transfused to maintain
    haemoglobin values >9 g/dl.
    . Inadequate coagulation parameters: aPTT >1.5 x ULN (patients on heparin
    treatment must have an aPTT between 1.5 - 2.5 x ULN), or INR >1.5.
    . Inadequate liver function, defined as: serum (total) bilirubin >1.5 x ULN for the
    institution; alkaline phosphatase, AST/SGOT or ALT/SGPT >2.5 x ULN (or 5 x ULN
    in the presence of liver metastases).
    . Inadequate renal function, defined as serum creatinine >2.0 mg/dl or >177
    µmol/l or calculated creatinine clearance <40ml/min for patients intended to be
    treated with topotecan. urine dipstick for proteinuria >2+. Patients with greater
    than or equal to 2+ proteinuria on baseline dipstick analysis should undergo
    a 24-hour urine collection and must demonstrate ≤1 g of protein in the 24-hour
    urine. Alternatively, proteinuria testing can be performed according to local
    standards.
    . Pre-existing peripheral neuropathy ≥CTC grade 2.
    . Pregnant or lactating females. Serum pregnancy test to be assessed within 7
    days prior to study treatment start, or within 14 days (with a confirmatory urine
    pregnancy test within 7 days prior to study treatment start).
    . Women of childbearing potential not using highly-effective, non-hormonal means
    of contraception (intrauterine contraceptive device or barrier method of
    contraception in conjunction with spermicidal jelly) during the study and for 6
    months after the last dose of study medication.
    . LVEF defined by MUGA/ECHO below the institutional lower limit of normal (only
    applicable for patients intended to be treated with PLD).
    . Serious active infection requiring i.v. antibiotics and/or hospitalisation at study
    entry.
    . Known hypersensitivity to any of the study drugs or excipients.
    . Evidence of any other medical conditions, physical examination or laboratory
    findings that may interfere with the planned treatment, affect patient compliance
    or place the patient at high risk from treatment-related complications.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy variable is progression-free survival (PFS). It is defined as the time from the date of randomisation to the first documented disease progression or death, whichever occurs first.
    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 Yes
    E.6.13.1Other scope of the trial description
    Tolerability; Biomarker (CA-125) analysis; QoL
    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 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) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    bevacizumab + selected standard chemotherapy vs selected standard chemotherapy
    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 concerned50
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA111
    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
    End of study is defined as the date of the last visit of the last patient. The primary analysis will be performed once at least 228 events of disease progression or death have been observed, or at the end of study, which ever occurs first. Patients are anticipated to be followed for a minimum of 4 months for PFS. Follow-up for survival will continue until the last patient has completed 12 months of follow-up and the trial will end at this point.
    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 months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years4
    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 No
    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 state70
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 272
    F.4.2.2In the whole clinical trial 300
    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)
    In the event of confirmed disease progression, study therapy should be discontinued permanently. However, it may be possible on a case-by case basis (and where the investigator has made a careful risk benefit assessment), for some patients initially randomized to the control arm to continue to receive bevacizumab. Such patients would be treated as part of the MO22224 AURELIA protocol post-study Phase. .
    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 Decision2009-11-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-10-08
    P. End of Trial
    P.End of Trial StatusCompleted
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