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    Summary
    EudraCT Number:2014-004027-52
    Sponsor's Protocol Code Number:GINECO-OV125b
    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:2016-02-29
    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 number2014-004027-52
    A.3Full title of the trial
    Randomized, Double-Blind, Phase III Trial of Olaparib vs. Placebo in Patients with Advanced FIGO Stage IIIB – IV High Grade Serous or Endometrioid Ovarian, Fallopian Tube, or Peritoneal Cancer treated with standard First-Line Treatment, Combining Platinum-Taxane Chemotherapy and Bevacizumab Concurrent with Chemotherapy and in Maintenance
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Randomized, Double-Blind, Phase III Trial of Olaparib vs. Placebo added to Bevacizumab in Maintenance in Patients with Advanced Ovarian, Fallopian Tube, or Peritoneal Cancer after treatment with standard First-Line Treatment, Combining Platinum-Taxane Chemotherapy and concurrent Bevacizumab.
    A.3.2Name or abbreviated title of the trial where available
    PAOLA-1
    A.4.1Sponsor's protocol code numberGINECO-OV125b
    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 SponsorARCAGY-GINECO
    B.1.3.4CountryFrance
    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 supportARCAGY-GINECO
    B.4.2CountryFrance
    B.4.1Name of organisation providing supportAstra Zeneca
    B.4.2CountryUnited Kingdom
    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 organisationARCAGY-GINECO
    B.5.2Functional name of contact pointStudy project management
    B.5.3 Address:
    B.5.3.1Street Address1, place du Parvis Notre-Dame – Place Jean-Paul II
    B.5.3.2Town/ cityParis
    B.5.3.3Post code75181 CEDEX 04
    B.5.3.4CountryFrance
    B.5.6E-mailsmijonnet@arcagy.org
    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 No
    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 nameOlaparip
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNOlaparib
    D.3.9.1CAS number 763113-22-0
    D.3.9.3Other descriptive nameOLAPARIB
    D.3.9.4EV Substance CodeSUB32234
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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: 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 No
    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 nameOlaparip
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNOlaparib
    D.3.9.1CAS number 763113-22-0
    D.3.9.3Other descriptive nameOLAPARIB
    D.3.9.4EV Substance CodeSUB32234
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    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
    D.8.3Pharmaceutical form of the placeboFilm-coated tablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Patients with advanced FIGO stage IIIB – IV high grade serous or endometrioid ovarian, fallopian tube, or peritoneal cancer treated with standard first-line treatment, combining platinum-taxane chemotherapy and bevacizumab concurrent with chemotherapy and in maintenance
    E.1.1.1Medical condition in easily understood language
    Patients with advanced ovarian, fallopian tube, or peritoneal cancer after standard first-line treatment
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.1
    E.1.2Level PT
    E.1.2Classification code 10070908
    E.1.2Term Ovarian cancer stage IV
    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 18.1
    E.1.2Level PT
    E.1.2Classification code 10070907
    E.1.2Term Ovarian cancer stage III
    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 18.1
    E.1.2Level PT
    E.1.2Classification code 10016187
    E.1.2Term Fallopian tube cancer stage IV
    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 18.1
    E.1.2Level PT
    E.1.2Classification code 10016186
    E.1.2Term Fallopian tube cancer stage III
    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 18.1
    E.1.2Level PT
    E.1.2Classification code 10016182
    E.1.2Term Fallopian tube cancer metastatic
    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 18.1
    E.1.2Level PT
    E.1.2Classification code 10057529
    E.1.2Term Ovarian cancer metastatic
    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 18.1
    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 18.1
    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 determine the efficacy by progression free survival (PFS1) investigator based according to modified Response Evaluation Criteria in Solid Tumors (RECIST version 1.1) of olaparib maintenance compared to placebo in high grade epithelial ovarian, fallopian tube, or peritoneal cancer that are in clinical complete response or partial response following first line platinumtaxane based chemotherapy plus bevacizumab, and planned to pursue bevacizumab in the maintenance phase up to a total of 15 months.
    E.2.2Secondary objectives of the trial
    1. To determine :
    · time to earliest progression by RECIST or Cancer Antigen-125 (CA-125) or death
    · time from randomization to first subsequent therapy or death (TFST)
    · time from randomization to second progression (PFS2)
    · time from randomization to second subsequent therapy or death (TSST)
    · overall survival (OS)
    2. To assess the safety and tolerability of olaparib maintenance compared to placebo.
    3. To compare the effects of olaparib maintenance compared to placebo on
    Health-Related Quality of Life (HRQoL) and patient reported outcomes (PROs), with consideration of patient preference.
    4. To evaluate the impact of treatment and disease on resource use.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    I-1. Female Patient must be ≥18 years of age.
    I-2. Signed informed consent and ability to comply with treatment and follow-up.
    I-3. Patient with newly diagnosed
    I-3-1 Ovarian cancer, primary peritoneal cancer and/or fallopian-tube cancer,
    I-3-2 Histologically confirmed (based on local histopathological findings):
    · high grade serous (see appendix 2) or
    · high grade endometrioid (see appendix 2) or
    · other epithelial non mucinous ovarian cancer in a patient with germline BRCA 1 or 2 deleterious mutation
    I-3-3 at an advanced stage: FIGO stage IIIB, IIIC, or IV of the 1988 FIGO classification
    I-4. Patient who has completed prior to randomization first line platinum-taxane
    chemotherapy:
    a. Platinum-taxane based regimen must have consisted of a minimum of 6 treatment cycles and a maximum of 9. However if platinum based therapy must be discontinued early as a result of non hematological toxicity specifically related to the platinum regimen, (i.e. neurotoxicity, hypersensitivity etc.), patient must have received a minimum of 4 cycles of the platinum regimen.
    b. Intravenous, intraperitoneal, or neoadjuvant platinum based chemotherapy is allowed; for weekly therapy, three weeks are considered one cycle. Interval debulking is allowed.
    I-5. Patient must have received prior to randomization a minimum of 3 cycles of
    bevacizumab in combination with the 3 last cycles of platinum-based chemotherapy. Bevacizumab treatment should be administered at a dose 15mg/kg q3 weeks up to a total of 15 months.
    I-6. Patient must be prior to randomization without evidence of disease (NED) or in complete response (CR) or partial response (PR) from her first line treatment. There should be no clinical evidence of disease progression (physical exam, imagery, CA 125) throughout her first line treatment and prior to study randomization.
    I-7. Patient must be randomized at least 3 weeks and no more than 9 weeks after her last dose of chemotherapy (last dose is the day of the last infusion) and all major toxicities from the previous chemotherapy must have resolved to CTC AE grade 1 or better (except alopecia and peripheral neuropathy).
    I-8. Patient must have normal organ and bone marrow function:
    a. Hemoglobin ≥ 10.0 g/dL.
    b. Absolute neutrophil count (ANC) ≥ 1.5 x 109/L.
    c. Platelet count ≥ 100 x 109/L.
    d. Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN).
    e. Aspartate aminotransferase /Serum Glutamic Oxaloacetic Transaminase
    (ASAT/SGOT)) and Alanine aminotransferase /Serum Glutamic Pyruvate Transaminase (ALAT/SGPT)) ≤ 2.5 x ULN, unless liver metastases are present in
    which case they must be ≤ 5 x ULN.
    f. Serum creatinine ≤ 1.25 x institutional ULN and creatinine clearance > 50 mL/min.
    g. Patient not receiving anticoagulant medication who has an International
    Normalized 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 site medical standard) and if the patient is on a stable dose of anticoagulants for at least two weeks at thetime of randomization.
    h. Urine dipstick for proteinuria < 2+. If urine dipstick is ≥2+, 24-hour urine must demonstrate <1 g of protein in 24 hours.
    i. Normal blood pressure or adequately treated and controlled hypertension
    (systolic BP ≤ 140 mmHg and/or diastolic BP ≤ 90 mmHg).
    I-9. Eastern Cooperative Oncology Group (ECOG) performance status 0-1
    I-10. Formalin fixed, paraffin embedded (FFPE) tumor sample from the primary cancer must be available for central BRCA testing and test result must be available for stratification.
    I-11. Postmenopausal or evidence of non-childbearing status for women of childbearing potential prior to the first dose of study treatment.
    I-12. For France only: In France, a subject will be eligible for randomization in this study only if either affiliated to, or a beneficiary of, a social security category.
    E.4Principal exclusion criteria
    E-1. Non-epithelial origin of the ovary, the fallopian tube or the peritoneum (i.e. germ cell tumors).
    E-2. Ovarian tumors of low malignant potential (e.g. borderline tumors), or mucinous carcinoma.
    E-3. Patient with synchronous primary endometrial cancer unless both of the following criteria are met:
    a. stage < II,
    b. Less than 60 years old at the time of diagnosis of endometrial cancer with stage IA or IB grade 1 or 2, or stage IA grade III endometrioid adenocarcinoma
    OR ≥ 60 years old at the time of diagnosis of endometrial cancer with stage IA
    grade 1 or 2 endometrioid adenocarcinoma.
    Patient with serous or clear cell adenocarcinoma or carcinosarcoma of the endometrium is not eligible.
    E-4. Other malignancy within the last 5 years except: adequately treated non-melanoma skin cancer curatively treated in situ cancer of the cervix, DCIS.
    E-5. Patient with myelodysplastic syndrome/acute myeloid leukemia history.
    E-6. Patient having experienced for at least one cycle, a delay > 2 weeks due to prolonged hematological recovery during the first line chemotherapy.
    E-7. Patient receiving radiotherapy within 6 weeks prior to study treatment.
    E-8. Major surgery within 4 weeks of starting study treatment and patient must have recovered from any effects of any major surgery.
    E-9. Previous allergenic bone marrow transplant.
    E-10. Any previous treatment with PARP inhibitor, including olaparib.
    E-11. Administration of other simultaneous chemotherapy drugs, any other anticancer therapy or anti-neoplastic hormonal therapy, or simultaneous radiotherapy during the trial treatment period (hormonal replacement therapy is permitted as are steroidal antiemetics).
    E-12. Current or recent (within 10 days prior to randomization) chronic use of aspirin > 325 mg/day.
    E-13. Concomitant use of known potent CYP3A4 inhibitors such as ketoconazole, itraconazole, ritonavir, indinavir, saquinavir, telithromycin, clarithromycin and nelfinavir.
    E-14. Prior history of hypertensive crisis (CTC-AE grade 4) or hypertensive encephalopathy.
    E-15. Clinically significant (e.g. active) cardiovascular disease, including:
    a. Myocardial infarction or unstable angina within ≤ 6 months of randomization,
    b. NYHA ≥ grade 2 congestive heart failure.
    c. Poorly controlled cardiac arrhythmia despite medication (patient with rate
    controlled atrial fibrillation are eligible), or any clinically significant abnormal
    finding on resting ECG,
    d. Peripheral vascular disease grade ≥ 3 (e.g. symptomatic and interfering with
    ADL requiring repair or revision).
    E-16. Previous Cerebro-Vascular Accident, Transient Ischemic Attack or Sub-
    Arachnoids Hemorrhage within 6 months prior to randomization.
    E-17. History or evidence of hemorrhagic disorders within 6 months prior to randomization.
    E-18. Evidence of bleeding diathesis or significant coagulopathy (in the absence of coagulation).
    E-19. History or clinical suspicion of brain metastases or spinal cord compression. CT/MRI of the brain is mandatory in case of suspected brain
    metastases. Spinal MRI is mandatory in case of suspected spinal cord compression.
    E-20. History or evidence upon neurological examination of central nervous system disease, unless adequately treated with standard medical therapy (e.g. uncontrolled seizures).
    E-21. Significant traumatic injury during 4 weeks prior to randomization.
    E-22. Non-healing wound, active ulcer or bone fracture. Patient with granulating incisions healing by secondary intention with no evidence of facial dehiscence or infection is eligible but require 3 weekly wound examinations.
    E-23. History of VEGF therapy related abdominal fistula or gastrointestinal perforation or active gastrointestinal bleeding within 6 months prior to the first study treatment.
    E-24. Current, clinically relevant bowel obstruction, including sub-occlusive disease, related to underlying disease.
    E-25. Patient with evidence of abdominal free air not explained by paracentesis or recent surgical procedure.
    E-26. Evidence of any other disease, metabolic dysfunction, physical examination finding or laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or puts the patient at high risk for treatment related complications.
    E-27. Pregnant or lactating women.
    E-28. Participation in another clinical study with an investigational product during her chemotherapy course immediately prior to randomization.
    E-29. Patient unable to swallow orally administered medication and patient with
    gastrointestinal disorders likely to interfere with absorption of the study medication.
    E-30. Patient with a known hypersensitivity to olaparib or any of the recipients of the product.
    E-31. Immunocompromised patient, e.g., with known active hepatitis (i.e. Hepatitis B or C) due to risk of transmitting the infection through blood or other body fluids or patient who is known to be serologically positive for HIV.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is progression-free survival (PFS1) defined as the time from the date of randomization to the first documented disease progression (according to RECIST v1.1) or death from any cause, whichever occurs first.
    E.5.1.1Timepoint(s) of evaluation of this end point
    An interim analysis of PFS1 will be performed when approximately 50% (187 events) of the final number of PFS1 events has been reached.
    Final analysis will be performed when 372 PFS1 events have occurred
    E.5.2Secondary end point(s)
    1 Time from randomization to second progression (PFS2) and overall survival
    2 Time to earliest progression or death, TFST, TSST
    3 Patient reported outcome (QoL)
    4 Pharmaco-economic analysis
    5 Safety; The assessment of safety will be based mainly on the frequency of adverse events (AE).
    E.5.2.1Timepoint(s) of evaluation of this end point
    1 An interim analysis of PFS2 and OS will be performed at the time of the final PFS1 analysis. A further analysis of PFS2 and OS will be performed when the PFS2 data are approximately 54% mature (approximately 329 events); A final update of overall survival results will be performed when the OS data are approximately 60% mature.
    2-4 same as for primary endpoint
    5 continously; The period of safety analysis will be defined from the first dose of any study treatment to 30 days after end of last study treatment.
    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 Yes
    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 Yes
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA200
    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
    Austria
    Belgium
    Denmark
    Finland
    France
    Germany
    Japan
    Spain
    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
    LPLV
    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 months6
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years6
    E.8.9.2In all countries concerned by the trial months5
    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: 636
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 636
    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 state12
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 612
    F.4.2.2In the whole clinical trial 636
    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)
    There are no post trial treatment plans. Patient should be treated for their disease is at the discretion of the investigator and as per local and international guidelines.
    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 ENGOT
    G.4.3.4Network Country European Union
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2016-04-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-04-20
    P. End of Trial
    P.End of Trial StatusOngoing
    The status of studies in GB is no longer updated from 1.1.2021
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