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    The EU Clinical Trials Register currently displays   44300   clinical trials with a EudraCT protocol, of which   7354   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2018-003779-36
    Sponsor's Protocol Code Number:ICR-CTSU/2018/10066
    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:2019-09-03
    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 ConcernedUK - MHRA
    A.2EudraCT number2018-003779-36
    A.3Full title of the trial
    ATr inhibitor in combination with olaparib in gynaecological cancers with ARId1A loss or no loss
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    ATr inhibitor in combination with olaparib in gynaecological cancers with ARId1A loss or no loss.
    A.3.2Name or abbreviated title of the trial where available
    ATARI
    A.4.1Sponsor's protocol code numberICR-CTSU/2018/10066
    A.5.4Other Identifiers
    Name:ClinicalTrials.govNumber:NCT04065269
    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 SponsorThe Institute of Cancer Research
    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 supportAstraZeneca UK Limited
    B.4.2CountryUnited Kingdom
    B.4.1Name of organisation providing supportLady Garden Foundation
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationThe Institute of Cancer Research
    B.5.2Functional name of contact pointATARI Trial Manager
    B.5.3 Address:
    B.5.3.1Street AddressICR-CTSU, 15 Cotswold Road
    B.5.3.2Town/ citySutton
    B.5.3.3Post codeSM2 5NG
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number02087224305
    B.5.5Fax number02087707876
    B.5.6E-mailATARI-icrctsu@icr.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 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 nameAZD6738
    D.3.2Product code AZD6738
    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 INNAZD6738
    D.3.9.1CAS number 1352226-88-0
    D.3.9.2Current sponsor codeAZD6738
    D.3.9.4EV Substance CodeAS1
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number20 to 80
    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 Yes
    D.2.1.1.1Trade name Olaparib (Lynparza)
    D.2.1.1.2Name of the Marketing Authorisation holderAstraZeneca AB
    D.2.1.2Country which granted the Marketing AuthorisationSweden
    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 nameOlaparib (Lynparza)
    D.3.2Product code Olaparib (AZD2281)
    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.3.9.2Current sponsor codeOlaparib
    D.3.9.3Other descriptive nameAZD2281
    D.3.9.4EV Substance CodeAS2
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number100 to 150
    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
    Relapsed ovarian and endometrial clear cell carcinoma or relapsed other gynaecological cancers (endometriod (ovarian and endometrial), carcinosarcoma (ovarian and endometrial), cerviacal carcinoma (squamous and adenocarcinoma)
    E.1.1.1Medical condition in easily understood language
    Relapsed gynaecological cancers of rare subtypes, including clear cell (ovarian/uterus) and carcinosarcoma, cervical and endometrioid type.
    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 10073268
    E.1.2Term Ovarian clear cell carcinoma
    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 21.1
    E.1.2Level PT
    E.1.2Classification code 10009252
    E.1.2Term Clear cell endometrial carcinoma
    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 20.0
    E.1.2Level PT
    E.1.2Classification code 10073269
    E.1.2Term Ovarian endometrioid carcinoma
    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 21.1
    E.1.2Level LLT
    E.1.2Classification code 10008224
    E.1.2Term Cervical adenocarcinoma
    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 21.1
    E.1.2Level LLT
    E.1.2Classification code 10062718
    E.1.2Term Endocervical squamous metaplasia
    E.1.2System Organ Class 100000004872
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10052204
    E.1.2Term Ovarian carcinosarcoma
    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 whether AZD6738 has clinical activity as measured by RECIST 1.1 objective response rate as a single agent and in combination with olaparib in patients with ARID1A-deficient (‘loss’) and no loss relapsed gynaecological cancers.
    E.2.2Secondary objectives of the trial
    1. To evaluate the disease control rate using RECIST version 1.1
    2. To evaluate the Progression Free Survival (PFS)
    3. To evaluate the Time to Progression (TTP)
    4. To evaluate the proportion of patients free of progression at 6 months
    5. To assess the safety and tolerability of AZD6738 as monotherapy and in combination with olaparib in ARID1A loss and no loss relapsed gynaecological cancers
    6. To evaluate Overall Survival (OS)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.1. Histologically confirmed progressive or recurrent gynaecological carcinomas of the following histological subtypes:
    • Ovarian and endometrial clear cell (>50% clear cell carcinoma with no serous differentiation)
    • Endometrioid
    • Cervical - adenocarcinomas and squamous
    • Carcinosarcomas
    Note: patients who have an original diagnosis based on cytology only will not be eligible for entry into the study unless a biopsy confirming above histology is performed
    2. Histological tissue specimen (tissue block or 8-10 unstained slides) must be available (specimen can be the sample at diagnosis or taken at relapse). Otherwise, a biopsy must be carried out to obtain sufficient tissue for histological assessment
    3. Evidence of radiological disease progression since last systemic anti-cancer therapy and prior to trial entry
    4. Patients who have progressed after ≥1 prior platinum containing regimen. Platinum-based therapy does not need to be the last treatment prior to study entry. For patients who have disease progression within 6 months of last dose of a platinum-containing regime, no more than two further lines of systemic therapy are permitted prior to trial entry
    5. Measurable disease by RECIST criteria v1.1 which can be accurately assessed at baseline by CT (or MRI where CT is contradicted or unclear). Patients with CA125 progression in the absence of measurable disease will NOT be eligible
    6. ECOG performance status 0 or 1 with no deterioration over the previous 2 weeks
    7. Life expectancy > 16 weeks
    8. Adequate hepatic, bone marrow, coagulation and renal function as defined by the following values within 14 days prior to starting treatment:
    • Haemoglobin ≥10.0 g/dL with no blood transfusion in the past 14 days
    • Absolute neutrophil count (ANC) ≥ 1.5 x 109/L
    • Platelet count ≥ 100 x 109/L with no platelet transfusion in the past 28 days
    • Creatinine clearance ≥51 mL/min (estimated using Cockcroft-Gault equation or EDTA as appropriate);
    • Total bilirubin ≤1.5 x ULN (unless bilirubin rise >1.5 x ULN due to Gilbert’s syndrome a conjugated bilirubin < or = 1.5 x ULN is required)
    • Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≤2.5 x ULN if no demonstrable liver metastases or ≤5 times ULN if patient has documented liver metastases
    9. No significant medical illness which in the opinion of the Investigator would preclude entry to ATARI
    10. Women of child-bearing potential who are confirmed not to be pregnant. This should be evidenced by a negative urine or serum pregnancy test within 72 hours prior to start of trial treatment. Patients will be considered to be not of child-bearing potential if they are:
    • Post-menopausal - defined as aged more than 50 years and amenorrhoeic for at least 12 months following cessation of all exogenous hormonal treatments, OR women under 50 years old who have been amenorrhoeic for at least 12 months following cessation of all exogenous hormonal treatments and have serum follicle-stimulating hormone (FSH), luteinizing hormone (LH) and plasma oestradiol levels in the post-menopausal range for the institution
    • Able to provide documentation of irreversible surgical sterilisation by hysterectomy, bilateral oophorectomy or bilateral salpingectomy but not tubal ligation
    • Radiation or chemotherapy-induced oophorectomy or menopause with > 1 year since last menses
    11. Patients with prior synchronous tumours or history of prior malignancy are eligible provided that there is biopsy evidence that the disease measurable on CT and/or MRI is of the histological subtypes stated in 1
    12. Willingness to commit to scheduled visits, treatments plans, laboratory tests and study procedures
    13. Able to swallow, absorb, retain oral medication
    14. Able to provide written, informed consent
    E.4Principal exclusion criteria
    1. Prior treatment with ATR or PARP inhibitors, including AZD6738 and olaparib
    2. Patients receiving, or having received:
    • cytotoxic treatment for their malignancy within 21 days prior to Cycle1 Day1
    • exposure to a small molecule IP within 30 days or 5 half-lives (whichever is longer) prior to Cycle 1 Day 1. The minimum washout for immunotherapy is 42 days
    • treatment with bevacizumab within 30 days prior to Cycle 1 Day 1
    • palliative radiotherapy within 21 days prior to Cycle 1 Day 1
    3. Treatment with any other investigational medicinal product within the 4 weeks prior to trial entry
    4. Receiving, or having received, concomitant medications, herbal supplements and/or foods that are strong or moderate inhibitors or inducers of CYP3A4, sensitive CYP3A4 substrates or CYP3A4 substrates with a narrow therapeutic index that significantly modulate CYP3A4 or P-gp activity (washout period 5 half-lives or three weeks for St. John’s Wort). Note these include common azole antifungals, macrolide antibiotics and other medications
    5. Pregnant or lactating women
    6. Women of childbearing age and potential who are not willing to use two highly effective forms of contraception as detailed in Section 5.5
    7. Any other malignancy which has been active or treated within the past three years, with the exception of cervical intra-epithelial neoplasia and non-melanoma skin cancer
    8. Clinical/radiological evidence of bowel obstruction (e.g. hospitalisation) or symptoms of sub-acute bowel obstruction within 6 weeks prior to trial entry
    9. Any clinically significant haematuria (as deemed by the investigator)
    10. With the exception of alopecia, any unresolved toxicities from prior therapy should be no greater than CTCAE Grade 2 at trial entry
    11. Clinically significant cardiac disease currently or within the last 6 months including:
    a. Pre-existing arrhythmia:
    i. Mean resting QTc >470 msec obtained from 3 electrocardiograms (ECGs) performed 2-5 minutes apart at study screening (within 14 days prior to Cycle 1 Day 1) using the Fredericia formula
    ii. Clinically important abnormalities in rhythm, conduction or morphology of resting ECG (including complete left bundle-branch block, third degree heart block)
    b. Any factor increasing the risk of QTc prolongation or arrhythmia, including:
    i. Hypokalaemia
    ii. Congenital long QT syndrome
    iii. Immediate family history of long QT syndrome or unexplained sudden death below the age of 40 years
    c. Unstable angina pectoris
    d. Acute myocardial infarction
    e. Unstable cardiac arrhythmias
    f. Cardiac failure
    i. Known reduced LVEF <55%
    ii. New York Heart Association (NYHA) class II, III or IV cardiac failure
    12. Clinically relevant orthostatic hypotension
    13. Patients who have a diagnosis of ataxia telangiectasia
    14. Major surgery within 4 weeks prior to entry to the study (excluding placement of vascular access) or minor surgery (excluding tumour biopsies) within 2 weeks of entry into the study (excluding placement of vascular access)
    15. Spinal cord compression, known leptomeningeal involvement or brain metastases, unless asymptomatic, treated (with no evidence of progression since completion of CNS-directed therapy), presence of disease outside the CNS and stable off steroids for at least 4 weeks prior to registration
    16. Known hypersensitivity to investigational drugs or excipients
    17. Receiving, or having received during the four weeks prior to registration, corticosteroids at a dose >10mg prednisone/day or equivalent for any reason
    18. Any haemopoietic growth factors (e.g., G-CSF, GM-CSF) and blood transfusions within 14 days prior to trial entry. Use of erytropoeitin is not permitted for 4 weeks prior to Cycle 1 Day 1 and for the duration of the study
    19. As judged by the Investigator, any evidence of severe or uncontrolled systemic diseases e.g., severe hepatic impairment, interstitial lung disease [bilateral, diffuse, parenchymal lung disease], uncontrolled chronic renal diseases (glomerulonephritis, nephritic syndrome, Fanconi Syndrome or Renal tubular acidosis), current unstable or uncompensated respiratory or cardiac conditions, active bleeding diatheses or active infection including hepatitis B, hepatitis C, and human immunodeficiency virus (HIV). Screening for chronic conditions is not required
    20. Judgment by the Investigator that the patient is unsuitable to participate in the study and/or the patient is unlikely to comply with study procedures, restrictions and requirements
    21. Refractory nausea and vomiting, chronic gastrointestinal diseases or previous significant bowel resection, with clinically significant sequelae that would preclude adequate absorption of study drug
    22. Patients with uncontrolled seizures
    23. Active infection requiring systemic antibiotics, antifungal or antiviral drugs
    24. Patients with myelodysplastic syndromes (MDS)/acute myeloid leukaemia (AML), or with features suggestive of MDS/AML
    25. Concurrent severe and/
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is confirmed overall objective response rate (complete or partial) as defined by RECIST version 1.1 for each cohort separately.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Analyses of primary endpoint (stage 1 or final) will be triggered after a minimum follow-up of 16 weeks per patient, unless response status can be ascertained earlier e.g. due to progression or confirmed response.
    E.5.2Secondary end point(s)
    1. Disease control rate
    2. Duration of disease control
    3. Progression free survival (PFS)
    4. Time to progression (TTP)
    5. Safety and toxicity
    6. Overall Survival
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. Disease control rate - proportion of patients experiencing complete or partial response, or stable disease lasting at least 16 weeks from start of treatment as assessed radiologically by RECIST v1.1
    2. Duration of disease control - measured from the first documentation of RECIST complete/partial response or stable disease (whichever status recorded first) until first date that progressive disease is objectively documented.
    3. PFS - from start of treatment until the first date of either progressive disease or death
    4. TTP - measured from the date of registration until the date of progressive disease or clinical progression of disease.
    5. Safety and toxicity - throughout treatment period and until 30 days post last dose
    6. OS - from start of treatment until death from any cause
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    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) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    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 concerned6
    E.8.5The trial involves multiple Member States No
    E.8.5.1Number of sites anticipated in the EEA18
    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
    Canada
    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 trial end date is deemed to be the date of last data capture.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days1
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months1
    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: 78
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 38
    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 state44
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 80
    F.4.2.2In the whole clinical trial 116
    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 continued care of patients will be at the discretion of their treating clinician.
    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 Decision2019-10-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-10-11
    P. End of Trial
    P.End of Trial StatusGB - no longer in EU/EEA
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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