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    Summary
    EudraCT Number:2012-004125-24
    Sponsor's Protocol Code Number:AGO-OVAR2.21/ENGOT-ov18
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:GB - no longer in EU/EEA
    Date on which this record was first entered in the EudraCT database:2014-09-01
    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 ConcernedUK - MHRA
    A.2EudraCT number2012-004125-24
    A.3Full title of the trial
    A prospective randomized Phase III trial of carboplatin/gemcitabing/bevacizumab vs caboplatin/pegylated lipsomal doxorubicin/bevacizumab in patients with platinum-sensitive recurrent ovarian cancer
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    OPSROC: Optimal therapy for women with Platinum Sensitive Ovariance Cancer.
    A randomised trial comparing two different chemotherapy regiments in combination with bevacizumab in women with ovarian cancer relapsing over 6 months from first line therapy.
    A.3.2Name or abbreviated title of the trial where available
    OPSROC (AGO-OVAR 2.21 / ENGOT-ov 18)
    A.4.1Sponsor's protocol code numberAGO-OVAR2.21/ENGOT-ov18
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01837251
    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 SponsorGreater Glasgow Health Board
    B.1.3.4CountryUnited Kingdom
    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
    B.4.2CountryGermany
    B.4.1Name of organisation providing supportRoche
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCRUK Clinical Trials Unit
    B.5.2Functional name of contact pointLiz-Anne Lewsley
    B.5.3 Address:
    B.5.3.1Street AddressBeatson West of Scotland Cancer
    B.5.3.2Town/ cityCentre, 1053 Gt Western Rd
    B.5.3.3Post codeG120YN
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number01413017193
    B.5.5Fax number01413017244
    B.5.6E-mailliz-anne.lewsley@glasgow.ac.uk
    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 AuthorisationUnited Kingdom
    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.3.4Pharmaceutical 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.3.9.4EV Substance CodeAS3
    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) No
    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 No
    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 carboplatin
    D.2.1.1.2Name of the Marketing Authorisation holderAccord Healthcare Limited
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 namecarboplatin
    D.3.4Pharmaceutical form 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 INNcarboplatin
    D.3.9.1CAS number 41575-94-4
    D.3.9.4EV Substance CodeAS5
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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 No
    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 No
    D.IMP: 3
    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 gemcitabine hydrochloride
    D.2.1.1.2Name of the Marketing Authorisation holderEli Lilly and Company Limited
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 namegemcitabine hydrochloride
    D.3.4Pharmaceutical form Powder 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 INNgemcitabine hydrochloride
    D.3.9.1CAS number 122111-03-9
    D.3.9.4EV Substance CodeAS6
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1000
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNgemcitabine hydrochloride
    D.3.9.1CAS number 122111-03-9
    D.3.9.4EV Substance CodeAS7
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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 No
    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 No
    D.IMP: 4
    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 pegylated liposomal doxorubicin hydrochloride
    D.2.1.1.2Name of the Marketing Authorisation holderJanssen-Cilag International NV
    D.2.1.2Country which granted the Marketing AuthorisationBelgium
    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 namepegylated liposomal doxorubicin hydrochloride
    D.3.4Pharmaceutical form Concentrate for solution for injection
    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 INNpegylated liposomal doxorubicin
    D.3.9.1CAS number 25316-40-9
    D.3.9.4EV Substance CodeAS8
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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 No
    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 No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Patients with platinum-sensitive recurrent ovarian cancer
    E.1.1.1Medical condition in easily understood language
    Patients with recurrent ovarian cancer which has returned more than six months after treatment with a platinum containing chemotherapy
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.0
    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 17.0
    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
    The primary efficacy outcome measure for this clinical trial is investigator-determined progression-free survival
    E.2.2Secondary objectives of the trial
    (1) Overall survival
    (2) Biological Progression-free Survival (PFSbio) by serum CA125 assessed according to GCIG criteria
    (3) Quality of Life (QoL) assessed by EORTC QLQ-C30 and QLQ-OV28
    (4) Safety and tolerability
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    (1) Written informed consent
    (2) Females >= 18 years
    (3) Histologically confirmed diagnosis of:
    - epithelial ovarian carcinoma (including mixed Mullerian tumours) or
    - fallopian tube carcinoma or
    - primary peritoneal carcinoma
    All FIGO stages, histological grades and types are allowed
    (4) First disease recurrence > 6 months after first-line platinum-based chemotherapy, no prior chemotherapy in the recurrent setting is allowed.
    (5) Patient with measurable or non-measurable disease (according to RECIST v1.1) or CA125 assessable disease (according to GCIG criteria) or histological proven diagnosis or relapse
    (6) In case of cytoreductive surgery for recurrent, patients must be able to commence cytotoxic chemotherapy within 8 weeks after cytoreductive surgery. The first dose of bevacizumab can be omitted in both arms if the investigator decides to start chemotherapy within 4 weeks after debulking surgery for recurrent disease.
    (7) ECOG performance status (PS) 0-2
    (8) Life expectancy > 3 months
    (9) Adequate bone marrow function (within 28 days prior to randomisation):
    - ANC >= 1.5 x 109
    - Platelets >= 100 x 109
    - Haemoglobin >= 9.5 g/dL
    (10) Adequate coagulation parameters (within 28 days prior to randomisation:

    - Patients not receiving anticoagulant medication who have an INR <=1.5 and an aPTT <= 1.5 x ULN
    (11) Adequate liver function (within 28 days prior to randomisation):
    - serum bilirubin (BR) <= 2 x ULN
    - serum transaminases <= 2.5 x ULN (<= 5 x ULN in the presence of liver metastasis)
    (12) Adequate renal function (within 28 days prior to randomisation):
    - serum creatinine < 1.6 mg/dL or creatiine clearance >= 40 mL/min
    - Glomerular filtration rate > 40 ml/min based on the Cockcroft-Gault or Jelliffe formula are sufficient)
    - Urine dipstick for proteinuria < 2+
    (13) Normal blood pressure or adequately treatment and controlled hypertension (systolic BP <= 140mmHg and/or diastolic BP <= 90mmHg)

    Please see protocol for full details on inclusion criteria.
    E.4Principal exclusion criteria
    (1) Non-epithelial origin of the ovary, the fallopian tube or the peritoneum (i.e. germ cell tumors).
    (2) Ovarian tumors of low malignant potential (i.e. borderline tumors)
    (3) 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
    - and/or carcinoma in situ of the breast
    - and/or endometrial carcinoma (FIGO stage <= 1A)
    Patients may have received previous adjuvant chemotherapy for other malignancies e.g. breast or colorectal carcinoma if diagnosed over 5 years ago before randomisation with no evidence of subsequent recurrence
    (4) Administration of other simultaneous chemotherapy drugs, any other anticancer therapy or anti-neoplastic hormonal therapy, or simultaneous radiotherapy during the trial treatment period (hormone replacement therapy is permitted as are steroidal antiemetics)
    (5) Any previous radiotherapy to the abdomen or pelvis
    (6) Treatment with any other investigational agent, or participation in another clinical trial testing a drug within the past 30 days before randomisation
    (7) Known hypersensitivity to used chemotherapeutic agents in this trial and bevacizumab and its excipients, chinese hamster ovary cell products or other recombinant hum or humanised antibodies
    (8) Current or recent (within 10 days prior to randomisation) chronic use of aspirin >325 mg/day
    (9) Surgery (including open biopsy) within 4 weeks prior to anticipated first dose of bevacizumab (allowed for the fact that bevacizumab can be omitted for 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.
    (10) Any planned surgery during the treatment period plus 4 additional weeks to allow for bevacizumab clearance
    (11) History of VEGF therapy related abdominal fistula or gastrointestinal perforation
    (12) Current, clinically relevant bowel obstruction, including sub-occlusive disease, related to underlying disease
    (13) Patients with evidence of abdominal free air not explained by paracentesis or recent surgical procedure
    (14) Previous Cerebro-Vascular Accident (CVA), Transient Ischaemic Attack (TIA) or Sub-Arachnoid Haemorrhage (SAH) within 6 months prior to randomisation
    (15) Prior history of hypertensive crisis or hypertensive encephalopathy. Uncontrolled hypertension (sustained elevation of systolic blood pressure > 140 mmHg and/or diastolic >90 mmHg despite antihypertensive therapy).
    (16) Clinically significant (i.e. active) cardiovascular disease, including:
    - myocardial infarction or unstable anginal within <= 6 months of randomisation
    - 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)
    - peripheral vascular disease grade >= 3 (i.e. symptomatic and interfering with activities of daily living (ADL) requiring repair or revision)
    (17) Left ventricular ejection fraction (LVEF) defined by ECHO/MUGA below the institutional lower limit of normal
    (18) Significant traumatic injury during 4 weeks prior to randomisation
    (19) Current brain metastases or spinal cord compression. CT/MRI of the brain is mandatory (within 4 weeks prior to randomisation) in case of suspected brain metastases. Spinal MRI is mandatory (within 4 weeks prior to randomisation) in case of suspected spinal cord compression
    (20) History or evidence upon neurological examination of central nervous system (CNS) disease, unless adequately treated with standard medical therapy, e.g. uncontrolled seizures
    (21) 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.
    (22) History or evidence of thrombotic or haemorrhagic disorders within 6 months prior to randomisation
    (23) Evidence of bleeding diathesis or significant coagulatopathy (in the absence of therapeutic coagulation)
    (24) 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 duration of the trial and at least 6 months afterwards
    (25) Pregnant or lactating women
    (26) 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.
    (27) Requirements of therapeutic coagulation using marcumar, warfarin or PTT-prolonging heparin.
    E.5 End points
    E.5.1Primary end point(s)
    The primary outcome measure is Progression-free survival (PFS)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Tumor assessments will include gynecological examination and cross sectional imaging (by CT, or MRI in case of contrast allergy) of the pelvis and abdomen and (by X-ray or CT scan,) of the chest every 12 weeks. Evaluation will be based on RECIST v.
    E.5.2Secondary end point(s)
    (1)Overall Survival (OS)
    (2)Biological Progression-free survival (PFSBIO) by serum CA125 assessed according to the GCIG criteria
    (3)Quality of Life (QoL) assessed by EORTC QLQ-C30 and QLQ-OV28
    (4)Safety and Tolerability
    E.5.2.1Timepoint(s) of evaluation of this end point
    Overall survival (OS) is defined as the time from the date of randomization to the date of death.

    CA 125 will be measured at baseline, day 1 of each cycle (i.e. every 3 or 4 weeks depending on treatment arm) during study treatment, and every 3 months until a minimum of 30 months or disease progression or occurrence of unacceptable toxicity.

    Toxicity: The National Cancer Institute’s Cancer Toxicity Criteria for Adverse Events (NCI-CTCAE) version 4.03 will be used to evaluate the clinical safety of the treatment.

    Quality of Life (EORTC QLQ-C30 and QLQ-OV28 questionnaires will be assessed every 12 weeks starting on day 1 of cycle 1 until
    disease progression or the occurrence of an unacceptable toxicity (whichever occurs first) and at the safety follow up visit.
    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) 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 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) Yes
    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 concerned7
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA177
    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
    Australia
    Austria
    France
    Germany
    United Kingdom
    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
    The definition of the end of the trial will be last vist of the last subject
    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 months0
    E.8.9.1In the Member State concerned days1
    E.8.9.2In all countries concerned by the trial years7
    E.8.9.2In all countries concerned by the trial months5
    E.8.9.2In all countries concerned by the trial days1
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 45
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 20
    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 No
    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 state65
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 489
    F.4.2.2In the whole clinical trial 654
    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)
    The clinical trial will end when all patients have been followed for up at least 30 months after the last patient has started study treatment. As a result a small number of patients could potentially still be receiving bevacizumab at the time the study finishes. The AGO have confirmed that they will negotiate supply of Bevacizumab with Roche as the study approaches its end and it is clear how many patients might be involved and for how long treatment might be required.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2014-10-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-10-09
    P. End of Trial
    P.End of Trial StatusGB - no longer in EU/EEA
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