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    The EU Clinical Trials Register currently displays   42572   clinical trials with a EudraCT protocol, of which   7010   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2009-011400-33
    Sponsor's Protocol Code Number:MO22224
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2009-11-03
    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 ConcernedDenmark - DHMA
    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.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study of bevacizumab plus chemotherapy versus chemotherapy alone in patients with ovarian cancer.
    A.3.2Name or abbreviated title of the trial where available
    AURELIA
    A.4.1Sponsor's protocol code numberMO22224
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT00976911
    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 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 supportF. Hoffmann-La Roche Ltd
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationF.Hoffmann-La Roche Ltd
    B.5.2Functional name of contact pointTrial Information Support Line-TISL
    B.5.3 Address:
    B.5.3.1Street AddressGrenzacherstrasse 124
    B.5.3.2Town/ cityBasel
    B.5.3.3Post code4070
    B.5.3.4CountrySwitzerland
    B.5.6E-mailglobal.rochegenentechtrials@roche.com
    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 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.3.9.1CAS number 216974-75-3
    D.3.9.2Current sponsor codeRO4876646
    D.3.9.3Other descriptive namerhuMAb VEGF, anti-VEGF
    D.3.9.4EV Substance CodeSUB16402MIG
    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) 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 Yes
    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
    Platinum-resistant, epithelial ovarian, fallopian tube or primary peritoneal cancer
    E.1.1.1Medical condition in easily understood language
    ovarian cancer
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.1
    E.1.2Level PT
    E.1.2Classification code 10061344
    E.1.2Term Peritoneal neoplasm
    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 16.1
    E.1.2Level PT
    E.1.2Classification code 10016180
    E.1.2Term Fallopian tube cancer
    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 16.1
    E.1.2Level PT
    E.1.2Classification code 10033128
    E.1.2Term Ovarian 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 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
    1. 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.
    2. Patients ≥18 years of age with 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.
    3. Patients must have platinum-resistant disease (defined as progression within <6
    months from completion of a minimum of 4 platinum therapy cycles. The date should be calculated from the last administered dose of platinum therapy).
    4. Patients must have disease that is measurable according to RECIST or assessable according to the GCIG CA-125 criteria and require chemotherapy treatment.
    5. ECOG PS 0–2.
    6. Life expectancy of greater than or equal to 12 weeks.
    E.4Principal exclusion criteria
    1. Patients whose disease was refractory to their previous platinum treatment.
    2. Non-epithelial, including malignant mixed Müllerian tumours.
    3. Ovarian tumours with low malignant potential.
    4. History of other clinically active malignancy within 5 years of enrollment
    5. Previous treatment with >2 anticancer regimens.
    6. Any prior radiotherapy to the pelvis or abdomen.
    7. Surgery (incl. open biopsy) within 4 wks prior to the start of study, or anticipation of the need for major surgery during study treatment.
    8. Minor surgical procedures within 24 hours prior to first study treatment.
    9. Previous exposure to murine CA-125 Ab (only applicable to those patients with non-measurable disease by RECIST).
    10. Current or recent chronic daily treatment with aspirin (>325 mg/day).
    11. Current or recent treatment with another investigational drug within 30 days of first study treatment dosing or earlier participation in this study.
    12. Chronic daily treatment with corticosteroids, excluding inhaled steroids.
    13. Inadequate bone marrow function: ANC: <1.5x10E9/l, or platelet count <100x10E9/l, or haemoglobin <9 g/dl. Patients may be transfused to maintain haemoglobin values >9 g/dl.
    14. 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.
    15. 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).
    16. Inadequate renal function, defined as serum creatinine >2.0mg/dl or >177μmol/l or calculated creatinine clearance <40ml/min for patients intended to be treated with topotecan. urine dipstick for proteinuria >2+. Patients with ≥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.
    17. History or evidence upon physical/ neurological examination of CNS disease unrelated to cancer, unless adequately treated with standard medical therapy (e.g. uncontrolled seizures).
    18. Symptomatic CNS metastasis
    19. Pre-existing peripheral neuropathy ≥CTC grade 2 for those patients planned to receive paclitaxel.
    20. 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).
    21. Women of childbearing potential not using highly-effective, hormonal or nonhormonal means of contraception (i.e. intrauterine contraceptive device) during
    the study and for 6 months after the last dose of study medication.
    22. History or evidence of thrombotic or hemorrhagic disorders; including CVA/stroke or TIA or sub-arachnoid haemorrhage within ≤6 months prior to the first study treatment.
    23. Uncontrolled hypertension (sustained systolic >150 mmHg and/or diastolic >100
    mmHg despite antihypertensive therapy) or clinically significant (i.e. active cardiovascular disease, including: myocardial infarction or unstable angina within ≤6 months prior to the first study treatment; NYHA grade II or greater CHF;
    serious cardiac arrhythmia requiring medication (with the exception of atrial
    fibrillation or paroxysmal supraventricular tachycardia); peripheral vascular disease >grade 3.
    24. LVEF defined by MUGA/ECHO below the institutional lower limit of normal (only
    applicable for patients intended to be treated with PLD).
    25. History of bowel obstruction, including sub-occlusive disease, related to the
    underlying disease and history of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess. Evidence of recto-sigmoid involvement by pelvic examination or bowel involvement on CT scan or clinical symptoms of bowel obstruction.
    26. Non-healing wound, ulcer or bone fracture.
    27. Serious active infection requiring i.v. antibiotics and/or hospitalisation at study
    entry.
    28. Known hypersensitivity to any of the study drugs or excipients.
    29. 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.5.1.1Timepoint(s) of evaluation of this end point
    Disease progression, death, or 6 month after the first dose of study treatment, whichever occurs first.
    E.5.2Secondary end point(s)
    • Objective response rate (ORR)
    • Overall survival (OS)
    E.5.2.1Timepoint(s) of evaluation of this end point
    For Objective response rate, the timepoint is disease progression, death, or 6 month after the first dose of study treatment, whichever occurs first.
    For overall survival, the timepoint is death or 12 month after the last patient last dose of study treatment, 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
    selected standard chemotherapy
    E.8.2.4Number of treatment arms in the trial2
    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 Information not present in EudraCT
    E.8.4.1Number of sites anticipated in Member State concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA90
    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 No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Belgium
    Bosnia and Herzegovina
    Denmark
    Finland
    France
    Germany
    Greece
    Italy
    Netherlands
    Norway
    Portugal
    Spain
    Sweden
    Turkey
    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
    LPLV. The study will be closed as soon as the protocol amendment 5 is approved by CAs and ECs. The primary analysis will be performed once at least 247 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 6 months for PFS. Survival follow-up will continue until protocol amendment 5 is approved by Competent Authorities and Ethics Committees.
    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 months10
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months10
    E.8.9.2In all countries concerned by the trial days0
    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.1.2.1Number of subjects for this age range: 228
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 133
    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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 341
    F.4.2.2In the whole clinical trial 361
    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 receiving bevacizumab at the time of study end will be offered participation in the Avastin Long Term Extension study (MO25757). In countries where MO25757 protocol is not approved, patients may be offered continued bevacizumab treatment with sponsored commercial drug until PD, toxicity or patient request for discontinuation.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation PAREXEL International GmbH
    G.4.3.4Network Country Germany
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2009-12-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-11-19
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2014-07-09
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