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    The EU Clinical Trials Register currently displays   42567   clinical trials with a EudraCT protocol, of which   7008   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2011-001015-32
    Sponsor's Protocol Code Number:AGO-OVAR17
    National Competent Authority:Germany - PEI
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2011-06-17
    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 ConcernedGermany - PEI
    A.2EudraCT number2011-001015-32
    A.3Full title of the trial
    A prospective randomised 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
    Evaluation of optimal initial treatment duration of bevacizumab in combination with carboplatin and paclitaxel in patients with ovarian cancer.
    A.3.2Name or abbreviated title of the trial where available
    The BOOST (Bevacizumab Ovarian Optimal Standard Treatment) Trial
    A.4.1Sponsor's protocol code numberAGO-OVAR17
    A.5.4Other Identifiers
    Name:GINECO OV118Number:ENGOT Ov-15 Trial
    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
    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 supportRoche Pharma AG
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAGO Research GmbH
    B.5.2Functional name of contact pointStudy Office
    B.5.3 Address:
    B.5.3.1Street AddressKaiser-Friedrich-Ring 71
    B.5.3.2Town/ cityWiesbaden
    B.5.3.3Post code65185
    B.5.3.4CountryGermany
    B.5.4Telephone number00496118804 670
    B.5.5Fax number00496118804 6767
    B.5.6E-mailoffice-wiesbaden@ago-ovar.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 GmbH (RRG), Grenzach, Germany
    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 nameBevacizumab
    D.3.2Product code Ro 487-6646
    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 codeRo 487-6646
    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 number100mg/4ml
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    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 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.IMP: 2
    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 GmbH (RRG), Grenzach, Germany
    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 nameBevacizumab
    D.3.2Product code Ro 487-6646
    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 codeRo 487-6646
    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 number400mg/16ml
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    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 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, fallopian tube carcinoma or primary peritoneal carcinomas with indication for a platin/paclitaxel chemotherapy
    E.1.1.1Medical condition in easily understood language
    After operation of primary tumor, patients with newly diagnosed FIGO stage IIB - IV (all grades and all histological types) ovarian cancer with indication for a platin/paclitaxel chemotherapy
    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 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) (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
    - Objective response rate by RECIST v1.1
    - Overall survival
    - Health related Quality of life 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 Qestionnaires
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Germany:
    Improved utilisation of resources and optimisation of quality of care through internet-based second opinion pathology - standardized in an optimized ovarian cancer network (AGO VISION-1).
    The aim of the VISION protocol is to establish a new infrastructure that may provide a high throughput second opinion pathology for ovarian carcinoma with a time necessary of only 10 days.

    Storage and collection of data and human biological specimens in the Clinical Repository of the AGO Research GmbH and further genetic research using the collected data and human biological specimens.
    The aim is to identify through genetic association studies
    - prognostic and predictive genetic markers for progression free survival and for toxicity after therapy with bevacizumab and paclitaxel/carboplatin
    - predictive genetic markers for toxicity in patients treated with bevacizumab

    France:
    Second opinion pathology - optional

    Pharmacogenomic sub-study
    Tumor tissue block for Germany:
    Analyzing of the tumor tissue and the genetic information of the tumor (DNA/RNA) in view of existence of specific structures and molecules which could be of importance for diagnosis, assessment of prognosis and new treatment possibilities.

    Tumor tissue block for France - optional:
    Paraffin-embedded sections of primary tumor specimens will be collected. It is planned to analyze the tumor tissue and the genetic information of the tumor (DNA/RNA) in view of existence of specific structures and molecules which could be of importance for diagnosis, assessment of prognosis and new treatment possibilities.
    Among the markers, which are aimed to be assessed, are the following:
    - To assess the mutational status of the PIK3CA, KiRAS et B-Raf genes in archival tumor material.
    - To assess the expression of the Ki67, cycline E, p53, HER2, EGF-R, IGF-R, MAPK, P-MAPK, PIK3CA, AKT, P-AKT, mTOR, P-mTOR, pTEN, PDGF-R in archival tumor material using IHC.
    - To assess the amplified genes (including e.g. AKT, HER2 genes) in archival tumor
    material using array comparative hybridization.

    Complementary and Alternative Treatment Questionnaires
    This sub-study will be identify the relationship between progress of the disease and physical activity, quality of life and physical activity as well as quality of life and the use of complementary and alternative treatment.
    E.3Principal inclusion criteria
    - Written informed consent and patients awareness
    and willingness to comply with the study
    requirements
    - Primary diagnosis is confirmed by specialized
    pathology review (Germany only)
    - Age ≥ 18 years
    - Histologically confirmed, newly diagnosed epithelial ovarian carcinoma, fallopian tube carcinoma or primary peritoneal carcinoma and FIGO stage IIB - IV (all grades and all histological types)
    - Patients should have already undergone surgical debulking and 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 are eligible providing other criteria are fulfilled
    - Patients able to commence cytotoxic
    chemotherapy within 8 weeks of cytoreductive surgery
    - ECOG performance status 0-2
    - Life expectancy > 3 months
    - Adequate bone marrow function, coagulation parameters, liver function, postoperative glomerulare filtration rate (based on the Cockroft-Gault or Jelliffe formula)
    - 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
    - Non-epithelial origin of the ovary, the fallopian
    tube or the peritoneum
    - Borderline tumours and FIGO stage IA – IIA
    - Planned intraperitoneal cytotoxic chemotherapy
    - Surgery (including open biopsy) within 4 weeks prior to anticipated first dose of bevacizumab or anticipation of interval cytoreductive surgery during study treatment
    - Uncontrolled hypertension
    - Any previous radiotherapy to the abdomen or pelvis
    - Previous Cerebro-Vascular Accident, Transient Ischaemic Attack or Sub-Arachnoid Haemorrhage within 6 months prior to randomisation
    - Malignancies other than ovarian cancer within 5 years prior to randomisation, 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
    - Patients with synchronous primary endometrial carcinoma, or a past history of primary endometrial carcinoma, are excluded unless the given single criterion is met
    - Non healing wound, active ulcer or bone fracture
    - History or evidence of thrombotic or hemorrhagic disorders
    - Clinically significant cardiovascular disease, including Myocardial infarction or unstable angina within 6 months of randomisation, NYHA ≥ Grade 2, poorly controlled cardiac arrhythmia despite medication, Grade ≥ 3 peripheral vascular disease
    - Current or recent (within 10 days prior to randomisation) chronic use of aspirin > 325 mg/day or use of any other inhibitor of platelet aggregation.
    E.5 End points
    E.5.1Primary end point(s)
    Progression-free survival (PFS)
    E.5.1.1Timepoint(s) of evaluation of this end point
    At least 697 PFS events have been observed or after data base closure on 30th of November 2020, which ever comes first.
    E.5.2Secondary end point(s)
    - Objective response rate (ORR)
    - Overall survival (OS)
    - Quality of life (QoL)
    - Safety and tolerability

    Further exploratory outcome measures on ancillary studies will include:
    - Translational Sub Studies
    - Complementary and Alternative Treatment Questionnaires
    E.5.2.1Timepoint(s) of evaluation of this end point
    OS: 7.5 years appr.
    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 Yes
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Quality of life, Translational Research, Complementary and Alternative Treatment Questionnaires
    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 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) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    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 concerned100
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA150
    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
    Denmark
    Finland
    France
    Germany
    Norway
    Sweden
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    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 years5
    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 No
    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 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 Information not present in EudraCT
    F.4 Planned number of subjects to be included
    F.4.1In the member state700
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 900
    F.4.2.2In the whole clinical trial 900
    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 Decision2011-09-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-11-15
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2020-11-26
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