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    Summary
    EudraCT Number:2011-001015-32
    Sponsor's Protocol Code Number:AGO-OVAR17/BOOST
    National Competent Authority:Sweden - MPA
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2012-11-09
    Trial 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 ConcernedSweden - MPA
    A.2EudraCT number2011-001015-32
    A.3Full title of the trial
    A multi-centre, open-label, randomised, twoarm Phase III trial to evaluate optimal treatment duration of first-line bevacizumab in combination with carboplatin and paclitaxel in patients with primary epithelial ovarian, fallopian tube or peritoneal cancer.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A multi-centre, open-label, randomised, twoarm Phase III trial to evaluate optimal treatment duration of first-line bevacizumab in combination with carboplatin and paclitaxel in patients with primary epithelial ovarian, fallopian tube or peritoneal cancer.
    A.3.2Name or abbreviated title of the trial where available
    BOOST/OVAR-17
    A.4.1Sponsor's protocol code numberAGO-OVAR17/BOOST
    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 SponsorAGO Research GmbH, AGO Study Group
    B.1.3.4CountryGermany
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportAGO Research GmbH, AGO Study Group
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationStädt. Klinikum Solingen gGmbH, Frauenklinik
    B.5.2Functional name of contact pointProf. Dr. med. J. Pfisterer
    B.5.3 Address:
    B.5.3.1Street AddressGotenstr. 1
    B.5.3.2Town/ citySolingen
    B.5.3.3Post codeD-42653
    B.5.3.4CountryGermany
    B.5.4Telephone number+49212 547-2371
    B.5.6E-mailgynaekologie@klinikumsolingen.de
    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.3.1Product nameAvastin
    D.3.4Pharmaceutical form Concentrate and solvent 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 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
    Following primary cytoreductive surgery, patients with newly diagnosed FIGO stage IIb -
    IV (all grades and all histological types) epithelial ovarian cancer (EOC), fallopian tube
    carcinoma (FTC) or primary peritoneal carcinomas (PPC) with indication for a platin/paclitaxel chemotherapy.
    E.1.1.1Medical condition in easily understood language
    Ovarian cancer, fallopian tube carcinoma or primary peritoneal carcinomas
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10016412
    E.1.2Term Female reproductive neoplasm NOS
    E.1.2System Organ Class 100000004864
    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) (by RECIST v1.1, clinical or symptomatic) of
    patients randomized to front-line paclitaxel/carboplatin with bevacizumab for 15 months
    or 30 months.
    E.2.2Secondary objectives of the trial
    To compare
    • Objective response rate (ORR) by RECIST v1.1)
    • Overall survival (OS)
    • Quality of life (QoL)
    o QOL and symptom control will be assessed using EORTC QLQ-C30 and QLQ-OV28 questionnaires
    • Safety and tolerability
    Further exploratory outcome measures on ancillary studies will include:
    - Translational Sub Studies
    - Complementary and Alternative Treatment Questionnaires
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Signed written informed consent obtained prior to initiation of any studyspecific
    procedures and treatment as confirmation of the patients awareness and willingness to comply with the study requirements.
    2. Primary diagnosis is confirmed by specialized pathology review (Germany only)
    3. Females aged ≥ 18 years
    4. Histologically confirmed, newly diagnosed
    • Epithelial ovarian carcinoma
    • Fallopian tube carcinoma
    • Primary peritoneal carcinoma
    AND FIGO stage IIb - IV (all grades and all histological types)
    5. Patients should have already undergone surgical debulking, by a surgeon experienced
    in the management of ovarian cancer, with the aim of maximal surgical cytoreduction according to the GCIG Conference Consensus Statement. There must be no planned surgical debulking prior to disease progression. Patients with stage III and IV disease in
    whom initial surgical debulking was not appropriate or possible will still be eligible providing
    • the patient has a histological diagnosis and
    • debulking surgery prior to disease progression is not foreseen
    6. Patients must be able to commence cytotoxic chemotherapy within 8 weeks of cytoreductive surgery. The first dose of bevacizumab can be omitted in both arms if the investigator decides to start chemotherapy within 4 weeks of surgery
    7. ECOG performance status (PS) 0-2
    8. Life expectancy > 3 months
    9. Adequate bone marrow functiona (within 14 days prior to randomization)
    • Absolute Neutrophil Count (ANC) ≥ 1.5 x 109/L
    • Platelets (PLT) ≥ 100 x 109/L
    • Hemoglobin (Hb) ≥ 9 g/dL (can be post-transfusion)
    10. Adequate coagulation parametersa (within 14 days prior to randomization)
    • Patients not receiving anticoagulant medication who have an International Normalised Ratio (INR) ≤ 1.5 and an Activated ProThrombin Time (aPTT) ≤ 1.5 x ULN
    • The use of full-dose oral or parenteral anticoagulants is permitted as long as the INR or aPTT is within therapeutic limits (according to institution medical standard) and the patient has been on a stable dose of anticoagulants for at least two weeks at the time of randomization
    11. Adequate liver functiona (within 14 days prior to randomization)
    • Serum bilirubin ≤ 1.5 x ULN
    • Serum transaminases ≤ 2.5 x ULN
    12. Urine dipstick for proteinuria < 2+. If urine dipstick is ≥ 2+, 24 hour urine must
    demonstrate ≤ 1 g of protein in 24 hours
    13. Adequate postoperative glomerulare filtration rate > 40 ml/min (estimates based on the Cockroft-Gault or Jelliffe formula are sufficient)
    E.4Principal exclusion criteria
    1. Non-epithelial origin of the ovary, the fallopian tube or the peritoneum
    2. Borderline tumours (tumours of low malignant potential) and FIGO stage Ia – IIa
    tumours
    3. Planned intraperitoneal cytotoxic chemotherapy
    4. Prior systemic anti-cancer therapy for ovarian cancer (for example chemotherapy,
    monoclonal antibody therapy, tyrosine kinase inhibitor therapy or hormonal therapy)
    5. Surgery (including open biopsy) within 4 weeks prior to anticipated first dose of bevacizumab (allowing for the fact that bevacizumab can be omitted from the first cycle of chemotherapy).
    It is strongly recommended that an interval of 7 days is left between the insertion of any central venous access devices (CVADs) and the onset of bevacizumab treatment.
    6. Any planned surgery during the study treatment period plus 4 additional weeks to allow for bevacizumab clearance
    7. Uncontrolled hypertensionb (sustained elevation of BP systolic > 150mmHg and/or diastolic > 100mmHg despite antihypertensive therapy)
    8. Any previous radiotherapy to the abdomen or pelvis
    9. Significant traumatic injury during 4 weeks preceding the potential first dose of bevacizumab
    10. History or clinical suspicion of brain metastases or spinal cord compression. CT/MRI of the brain is mandatory (within 4 weeks prior to randomization) in case of suspected brain metastases. Spinal MRI is mandatory (within 4 weeks prior to randomization) in case of suspected spinal cord compression
    11. History or evidence upon neurological examination of central nervous system (CNS) disease, unless adequately treated with standard medical therapy e.g. uncontrolled seizures
    12. Previous Cerebro-Vascular Accident (CVA), Transient Ischaemic Attack (TIA) or Sub-Arachnoid Haemorrhage (SAH) within 6 months prior to randomization
    13. Fertile woman of childbearing potential not willing to use adequate contraception
    (oral contraceptives, intrauterine device or barrier method of contraception in conjunction with spermicidal jelly or surgically sterile) for the study duration and at least 6 months afterwards
    14. Pregnant or lactating women
    15. Treatment with other investigational agents, or participation in another clinical
    trial testing a drug within the past 4 weeks before start of therapy concomitantly with this trial
    16. Malignancies other than ovarian cancer within 5 years prior to randomization, except
    for adequately treated
    - carcinoma in situ of the cervix
    - and/or basal cell skin cancer
    - and/or non-melanomatous skin cancer
    - carcinoma in situ of the breast
    - and/or early endometrial carcinoma
    as specified below. Patients may have received previous adjuvant chemotherapy for other malignancies e.g. breast or colorectal carcinoma if diagnosed over 5 years ago with no evidence of subsequent recurrence
    17. Patients with synchronous primary endometrial carcinoma, or a past history of primary endometrial carcinoma, are excluded unless ALL of the following criteria for describing the endometrial carcinoma are met
    • Disease stage FIGO stage ≤ IA (tumour invades less than one half of the myometrium)
    18. Known hypersensitivity to bevacizumab and its excipients, Chinese hamster ovary
    cell products or other recombinant human or humanised antibodies
    19. Non healing wound, active ulcer or bone fracture. Patients with granulating incisions
    healing by secondary intention with no evidence of facial dehiscence or infection are eligible but require 3 weekly wound examinations
    20. History or evidence of thrombotic or hemorrhagic disorders within 6 months prior to randomization
    21. Clinically significant cardiovascular disease, including
    • Myocardial infarction or unstable angina within 6 months of randomization
    • New York Heart Association (NYHA) ≥ Grade 2 Congestive Heart Failure (CHF)
    • Poorly controlled cardiac arrhythmia despite medication (patients with rate-controlled atrial fibrillation are eligible)
    • Grade ≥ 3 peripheral vascular disease (i.e. symptomatic and interfering with activities of daily living [ADL] requiring repair or revision)
    22. Current or recent (within 10 days prior to randomization) chronic use of aspirin > 325 mg/dayc
    23. Pre-existing sensory or motor neuropathy ≥ Grade 2
    24. Evidence of any other disease, metabolic dysfunction, physical examination finding or laboratory finding giving reasonable suspicion of a disease or condition that contra-indicates the use of an investigational drug or puts the patient at high risk for treatment-related complications
    E.5 End points
    E.5.1Primary end point(s)
    PFS: 4.5 years appr. (at least 523 PFS events have occured)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Each patient will be followed for the primary PFS and for the secondary endpoint OS every 6 months for at least 5 years after study treatment start.

    See protocol Table 1A: FLOWCHART: Schedule of Assessments
    E.5.2Secondary end point(s)
    OS: 7.5 years appr.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Each patient will be followed for the primary PFS and for the secondary endpoint OS every 6 months for at least 5 years after study treatment start.

    See protocol Table 1A: FLOWCHART: Schedule of Assessments
    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
    Quality of Life
    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
    Different treatment duration with bevacizumab (15 months vs 30 months)
    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 Yes
    E.8.4.1Number of sites anticipated in Member State concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA30
    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 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
    Last patient last visit
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years7
    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 years7
    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 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: 900
    F.1.3Elderly (>=65 years) No
    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 state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 900
    F.4.2.2In the whole clinical trial 900
    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 who end their participation in the trial will be treated according to the sites standard of care. Follow up visits will be done regardles of disease status every 6 months for at least 5 years after study treatment start.
    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 Decision2013-01-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-03-05
    P. End of Trial
    P.End of Trial StatusOngoing
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