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    The EU Clinical Trials Register currently displays   44043   clinical trials with a EudraCT protocol, of which   7319   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:2018-000366-11
    Sponsor's Protocol Code Number:ENGOT-Ov41/GEICO69-O/ANITA
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-06-17
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2018-000366-11
    A.3Full title of the trial
    A phase III randomized, double-blinded trial of platinum-based chemotherapy with or without atezolizumab followed by niraparib maintenance with or without atezolizumab in patients with recurrent ovarian, tubal or peritoneal cancer and platinum treatment-free interval (TFIp) >6 months.
    Studio randomizzato di fase III in doppio cieco sulla chemioterapia a base di platino con e senza l’aggiunta di atezolizumab seguita da terapia di mantenimento con niraparib con e senza l'aggiunta di atezolizumab, nelle pazienti con recidiva di carcinoma ovarico, delle tube di Falloppio o carcinoma peritoneale e intervallo libero da trattamento con il platino (TFIp) > 6 mesi.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Double-blinded trial of platinum-based chemotherapy with or without atezolizumab followed by niraparib maintenance with or without atezolizumab in patients with recurrent ovarian, tubal or peritoneal cancer.
    Studio in doppio cieco sulla chemioterapia a base di platino con e senza l’aggiunta di atezolizumab seguita da terapia di mantenimento con niraparib con e senza l'aggiunta di atezolizumab, nelle pazienti con recidiva di carcinoma ovarico, delle tube di Falloppio o carcinoma peritoneale.
    A.3.2Name or abbreviated title of the trial where available
    ANITA
    ANITA
    A.4.1Sponsor's protocol code numberENGOT-Ov41/GEICO69-O/ANITA
    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 SponsorGrupo Español de Investigación en Cáncer de Ovario (GEICO)
    B.1.3.4CountrySpain
    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
    B.4.2CountrySwitzerland
    B.4.1Name of organisation providing supportTESARO
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGrupo Español de Investigación en Cáncer de Ovario (GEICO)
    B.5.2Functional name of contact pointJavier Sanchez
    B.5.3 Address:
    B.5.3.1Street Addresscalle Velazquez 7
    B.5.3.2Town/ cityMadrid
    B.5.3.3Post code28001
    B.5.3.4CountrySpain
    B.5.4Telephone number0034669528261
    B.5.6E-mailjsanchez@grupogeico.net
    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 TECENTRIQ-1200 MG- CONCENTRATO PER SOLUZIONE PER INFUSIONE- USO ENDOVENOSO- FLACONCINO (VETRO)- 20 ML (60 MG/ML)- 1 FLACONCINO
    D.2.1.1.2Name of the Marketing Authorisation holderROCHE REGISTRATION LIMITED
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 nameAtezolizumab
    D.3.2Product code [RO5541267]
    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 INNAtezolizumab
    D.3.9.1CAS number 1380723-44-3
    D.3.9.2Current sponsor codena
    D.3.9.3Other descriptive nameAtezolizumab
    D.3.9.4EV Substance CodeSUB178312
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1200
    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 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.2.1.2Country which granted the Marketing AuthorisationItaly
    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 nameCarboplatino
    D.3.2Product code [na]
    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 INNCarboplatin
    D.3.9.1CAS number 0041575-94-4
    D.3.9.2Current sponsor codena
    D.3.9.3Other descriptive nameCarboplatin
    D.3.9.4EV Substance CodeSUB06614MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number450
    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 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 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.2.1.2Country which granted the Marketing AuthorisationItaly
    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
    D.3.2Product code [na]
    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
    D.3.9.1CAS number 95058-81-4
    D.3.9.2Current sponsor codena
    D.3.9.3Other descriptive nameGemcitabine
    D.3.9.4EV Substance CodeSUB07892MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1640
    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 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 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.2.1.2Country which granted the Marketing AuthorisationItaly
    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 namePaclitaxel
    D.3.2Product code [na]
    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 INNPaclitaxel
    D.3.9.1CAS number 33069-62-4
    D.3.9.2Current sponsor codena
    D.3.9.3Other descriptive namePaclitaxel
    D.3.9.4EV Substance CodeSUB09583MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number290
    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 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 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: 5
    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.2.1.2Country which granted the Marketing AuthorisationItaly
    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
    D.3.2Product code [na]
    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 INNPegylated Liposomal Doxorubicin
    D.3.9.1CAS number 23214-92-8
    D.3.9.2Current sponsor codena
    D.3.9.3Other descriptive namePegylated Liposomal Doxorubicin
    D.3.9.4EV Substance CodeSUB33393
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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 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: 6
    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.2.1.2Country which granted the Marketing AuthorisationItaly
    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 nameNiraparib
    D.3.2Product code [Niraparib]
    D.3.4Pharmaceutical form Capsule, hard
    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 INNNiraparib
    D.3.9.1CAS number 1038915-60-4
    D.3.9.2Current sponsor codena
    D.3.9.3Other descriptive nameNiraparib
    D.3.9.4EV Substance CodeSUB177208
    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 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 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: 7
    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.2.1.2Country which granted the Marketing AuthorisationItaly
    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
    D.3.2Product code [na]
    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 INNGemcitabine
    D.3.9.1CAS number 95058-81-4
    D.3.9.2Current sponsor codena
    D.3.9.3Other descriptive nameGemcitabine
    D.3.9.4EV Substance CodeSUB07892MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1640
    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 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 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 placeboSolution for infusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Recurrent ovarian, tubal or peritoneal cancer
    Rediciva di carcinoma ovarico, delle tube di Falloppio o peritoneale primario
    E.1.1.1Medical condition in easily understood language
    Ovarian Cancer
    Carcinoma ovarico
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10033131
    E.1.2Term Ovarian carcinoma
    E.1.2System Organ Class 100000004864
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Determine whether the addition of atezolizumab to carboplatin-based chemotherapy followed by maintenance niraparib improves progression-free survival (PFS) compared to placebo combined with carboplatin-based chemotherapy followed by maintenance niraparib, in patients with relapsed epithelial ovarian, fallopian tube, or peritoneal cancer after a platinum treatment free interval (TFIp) of at least 6 months (platinum-sensitive).
    Determinare se l'aggiunta di atezolizumab alla chemioterapia a base di carboplatino, seguita da terapia di mantenimento con niraparib, migliora la sopravvivenza libera da progressione (PFS) rispetto al placebo in combinazione con la chemioterapia a base di carboplatino, seguita da terapia di mantenimento con niraparib, in pazienti con recidiva di carcinoma ovarico, delle tube di Falloppio o peritoneale, dopo un intervallo libero dal trattamento con il platino (TFIp) di almeno 6 mesi (platino-sensibili).
    E.2.2Secondary objectives of the trial
    - Evaluate overall survival
    - Evaluate time from randomization to first subsequent therapy or death (TFST)
    - Evaluate time from randomization to second subsequent therapy or death (TSST)
    - Evaluate time from randomization to second progression or death (PFS2)
    - Assess the safety and tolerability of atezolizumab treatment
    - Determine the impact of atezolizuma on patient-reported abdominal symptoms of ovarian cancer.
    - Evaluate patient-reported outcomes of function and health related quality of life associated with atezolizumab
    - Evaluate the ORR
    - Evaluate the duration of response
    - Evaluate the PFS in patients in complete or partial response
    - Evaluate the efficacy of atezolizumab versus placebo according to BRCA status
    - Characterize the PK of atezolizumab and determine the incidence of ATAs
    - Overall Survival (OS)
    - Il tempo dalla randomizzazione alla prima terapia successiva o alla morte (TFST)
    - Il tempo dalla randomizzazione alla seconda terapia successiva o alla morte (TSST)
    - Il tempo dalla randomizzazione alla seconda progressione o morte (PFS2)
    - Valutare la sicurezza e la tollerabilità del trattamento con atezolizumab
    - Determinare l'impatto di atezolizumab mediante abdominal/GI symptom correlato al carcinoma ovarico
    - Analizzare il Patient Reported outcomes-PRO in merito alla “Health-related Quality of life” (HRQoL), associate all’uso di atezolizumab
    - Valutare L’Objective Response Rate (ORR)
    - Valutare la Duration of Response (DOR)
    - Valutare la PFS nelle pazienti in risposta completa o parziale
    - Valutare l'efficacia di atezolizumab rispetto al placebo in base allo stato mutazionale di BRCA
    -Analizzare il profilo farmacocinetico di atezolizumab e determinare l'incidenza degli anticorpi anti-farmaco ATAs
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Patients = 18 years old
    2. Life expectancy =3 months
    3. Signed informed consent and ability to comply with treatment and follow-up
    4. Histologically confirmed diagnosis (cytology alone excluded) of high- grade serous or endometrioid ovarian, primary peritoneal or tubal carcinoma. In addition, mixed histologies with predominat high grade serous or endometrioid, or undifferentiated adenocarcinoma of the ovary are allowed
    5. BRCA mutational status is known (germline or somatic)
    6. Relapsed disease more than 6 months after the last platinum dose:
    7. No more than 2 prior lines of chemotherapy are allowed, and the last one must contain a platinum-based regimen
    8. At least one measurable lesion to assess response by RECIST v1.1 criteria.
    9. Mandatory de novo tumor biopsy (collected within 3 months prior to randomization) sent to HistoGeneXcentral laboratory as a formalin-fixed, paraffin-embedded (FFPE) sample for PD-L1 status determination for randomization. The inclusion of patients with non informative tissue PD-L1 status will be capped to 10% of the whole study population. In case formalin fixed paraffin embedded (FFPE) blocks are not available at least 5 unstained FFPE slides. Two additional tumour samples are needed: Archival tumor sample must be available for exploratory PD-L1 testing in archival tissue and archival or fresh “de novo” tissue sample for biomarkers must also be available.
    10. Performance status determined by ECOG score of 0-1
    11. Patients must have normal organ and bone marrow function:
    - Haemoglobin =10.0 g/dL
    - Absolute neutrophil count (ANC) =1.5 x 109/L
    - Lymphocyte count =0.5 × 109/L
    - Platelet count =100 x 109/L
    - Total bilirubin =1.5 x institutional upper limit of normal (ULN)
    - Serum albumin =2.5 g/dL
    - Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) =2.5 x ULN, unless liver metastases are present in which case they must be =5 x ULN
    - Serum creatinine =1.5 x institutional ULN or calculated creatinine clearance = 30 mL/min using the Cockcroft-Gault equation
    - Patients not receiving anticoagulant medication must have an International Normalized Ratio (INR) =1.5 and an Activated ProThrombin Time (aPTT) =1.5 x ULN.
    12. Negative Test Results for Hepatitis
    13. Toxicities related to previous treatments must be recovered to < grade 2 (with the exception of alopecia)
    14. Female participants must be postmenopausal (= 12 months of non-therapy-induced amenorrhoea; patients who have been amenorrhoeic for <2 years without history of a hysterectomy and oophorectomy must have a follicle stimulating hormone value in the postmenopausal range upon screening evaluation) or surgically sterile (absence of ovaries and/or uterus, or who received therapeutic radiation to the pelvis) or otherwise have a negative serum pregnancy test within 7 days of the first study treatment and agree to abstain from heterosexual intercourse or use single or combined contraceptive methods that result in a failure rate of <1% per year during the whole treatment period of the study and for at least 180 days after the last dose of study treatment
    15. Participant must agree to not donate blood during the study or for 90 days after the last dose of study treatment.
    16. Participant must agree to not breastfeed during the study or for 180 days after the last dose of study treatment.
    1. Pazienti di età = 18 anni
    2. Aspettativa di vita =3 mesi
    3. Consenso informato firmato e capacità di rispettare il trattamento e il follow-up
    4. Diagnosi confermata istologicamente (esclusa la sola citologia) di carcinoma ovarico sieroso di altro grado o endometroide, carcinoma peritoneale primitivo o tubarico. Inoltre, sono ammessi gli istotipi misti con predominante sieroso di alto grado o endometrioide o adenocarcinoma indifferenziato dell'ovaio
    5. Stato mutazionale BRCA noto (germinale o somatico)
    6. Recidiva di malattia dopo più di 6 mesi dall'ultima dose di terapia a base di platino
    7. Non sono consentite più di 2 linee precedenti di chemioterapia e l'ultima deve contenere un regime a base di platino
    8. Deve essere presente almeno una lesione misurabile per valutare la risposta secondo i criteri RECIST v 1.1. Se l'unica lesione misurabile è limitata a un campo precedentemente irradiato, è necessaria una biopsia per confermare la neoplasia maligna
    9. E’ obbligatorio fornire una biopsia “de novo” di un campione tumorale (ottenuta entro tre mesi dalla randomizzazione) da inviare ad HistoGeneX come blocchetto tumorale paraffinato fissato in formalina (FFPE), per la determinazione dello status del PD-L1, necessario per la randomizzazione. L’inclusione di pazienti con risultato del test PD-L1 non informativo sarà limitata al 10% dell’intera popolazione in studio. Se non sono disponibili blocchetti tumorali paraffinati fissati in formalina (FFPE), è possibile fornire almeno 5 vetrini FFPE. Sono necessari, inoltre, altri due campioni tumorali: uno di archivio per test di tipo esplorativo su PD-L1 e uno di archivio o “de novo” per analisi dei biomarkers.
    10. Performance status determinato dalla scala ECOG di 0-1
    11. Le pazienti devono avere una normale funzionalità organica e del midollo osseo:
    • Emoglobina =10,0 g / dL
    • Conta assoluta dei neutrofili (ANC) = 1,5 x 109 / L
    • Conta dei linfociti =0,5 × 109/L
    • Conta piastrinica =100 x 109/L
    • Bilirubina totale = 1,5 x ULN
    • Albumina sierica = 2,5 g/dL
    • Aspartato aminotransferasi (AST) e Alanina aminotransferasi (ALT) = 2,5 x ULN, a meno che non siano presenti metastasi epatiche, nel qual caso devono essere =5 x ULN
    • Creatinina sierica = 1,5 ULN o clearance della creatinina = 30 ml / min calcolata utilizzando l'equazione di Cockcroft-Gault
    • Le pazienti che non assumono farmaci anticoagulanti devono avere un rapporto internazionale normalizzato (INR) del tempo di protrombina = 1,5 x ULN e un tempo di tromboplastina parziale attivata (aPTT) = 1,5 x ULN.
    12. Risultati negativi dei test per l'epatite:
    13. Le tossicità relative ai trattamenti precedenti devono essere ristabilite ad un grado <2 (ad eccezione dell'alopecia)
    14. Le pazienti partecipanti devono essere in postmenopausa (= 12 mesi di amenorrea indotta da terapia, le pazienti che sono stati amenorroiche per meno di 2 anni senza storia di isterectomia e ovariectomia devono avere al basale un valore di ormone follicolo-stimolante nel range postmenopausale) o chirurgicamente sterili (assenza di ovaie e/o utero, o che hanno ricevuto radioterapia alla pelvi) o altrimenti devono avere un test di gravidanza negativo entro 7 giorni dal primo trattamento di studio e accettare di astenersi dai rapporti sessuali o utilizzare metodi contraccettivi singoli o combinati che comportano un tasso di fallimento <1% all'anno durante l'intero periodo di trattamento dello studio e per almeno 180 giorni dopo l'ultima dose del trattamento di studio
    15. La paziente deve accettare di non donare sangue durante lo studio o per 90 giorni dopo l'ultima dose di trattamento in studio.
    16. La paziente deve accettare di non allattare al seno durante lo studio o per 180 giorni dopo l'ultima dose del trattamento di studio.
    E.4Principal exclusion criteria
    1. Non-epithelial tumor of the ovary, the fallopian tube or the peritoneum
    2. Ovarian tumors of low malignant potential or low grade
    3. Other malignancy within the last 5 years except curatively treated non-melanoma skin cancer, in situ cancer of the cervix and ductal carcinoma in situ (DCIS)
    4. Major surgery or patients who have not completely recovered from the effects of any major surgery at randomization
    5. Core biopsy or other minor surgical procedure.
    6. Administration of other chemotherapy drugs, anticancer therapy or anti-neoplastic hormonal therapy, or treatment with other investigational agents or devices
    7. Palliative radiotherapy
    8. Current or recent chronic use of aspirin or clopidogrel
    9. Clinically significant cardiovascular disease
    10. Resting ECG with QTc >470 msec or family history of long QT syndrome
    11. Left ventricular ejection fraction defined by MUGA/ECHO below the institutional lower limit of normal
    12. History or clinical suspicion of brain metastases or spinal cord compression.
    13. History or evidence upon neurological examination of central nervous system (CNS) disorders
    14. Current, clinically relevant bowel obstruction, including sub-occlusive disease, related to underlying disease
    15. Uncontrolled tumor-related pain
    16. Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures
    17. Uncontrolled hypercalcemia or symptomatic hypercalcemia requiring continued use of bisphosphonate therapy or denosumab
    18. 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
    19. Pregnant or lactating women
    20. Simultaneously receiving therapy in any interventional clinical trial.
    21. Prior treatment with CD137 agonists or immune checkpoint stimulating or blockade therapies, such as anti-PD1, anti-PDL1 or anti-CTLA4 therapeutic antibodies
    22. Treatment with systemic immunostimulatory agents
    23. Treatment with systemic corticosteroids or other systemic immunosuppressive medications
    24. History of autoimmune disease, including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus.
    25. History of idiopathic pulmonary fibrosis, drug-induced pneumonitis, organizing pneumonia, or evidence of active pneumonitis.
    26. Immunocompromised patients, e.g., patients who are known to be serologically positive for human immunodeficiency virus (HIV)
    27. Signs or symptoms of infection within 2 weeks prior to Cycle 1, Day 1
    28. Administration of a live, attenuated vaccine or anticipation that it will be administered at any time during the treatment period of the study
    29. History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins
    30. Known hypersensitivity or allergy to biopharmaceuticals produced in Chinese hamster ovary cells or to any component of the atezolizumab formulation or allergy to any of the other drugs included in the protocol or their solvents (including to Cremophor®)
    31. Patient has received prior treatment with a PARP inhibitor in the recurrent setting. Patients that received PARP inhibitor as front line are eligible for the study. The duration of exposure to PARPi following front line therapy needs to be =18 months for BRCA mutated patients and = 12 months for BRCA wild type patients.
    32. Patient has had any known =Grade 3 hematological toxicity anemia, neutropenia or thrombocytopenia due to prior cancer chemotherapy that persisted >4 weeks and was related to the most recent treatment
    33. Patient has any known history or current diagnosis of MDS or AML
    34. Previous allogeneic bone marrow transplant or previous solid organ transplantation
    35. Participant has any known hypersensitivity to niraparib components or excipients.
    1. Tumore non epiteliale dell'ovaio, della tuba di Falloppio o del peritoneo
    2. Tumori ovarici a basso potenziale di malignità (es tumori borderline) o di basso grado
    3. Altri tumori maligni negli ultimi 5 anni tranne il carcinoma cutaneo non melanoma trattato, carcinoma in situ della cervice e carcinoma duttale in situ (DCIS)
    4. Chirurgia maggiore o pazienti che, alla random, non si sono completamente ristabilite dagli effetti di un intervento chirurgico maggiore
    5. Core biopsy o altra procedura chirurgica minore
    6. Somministrazione di farmaci chemioterapici, terapia antitumorale o terapia ormonale antineoplastica, o trattamento con altri farmaci o dispositivi sperimentali
    7. Radioterapia palliativa
    8. Uso concomitante o recente di aspirina o clopidogrel
    9. Malattia cardiovascolare significativa
    10. ECG a riposo con QTc> 470 msec o storia familiare di sindrome QT lungo
    11. Frazione di eiezione ventricolare sinistra al di sotto del limite normale inferiore
    12. Storia o sospetto clinico di metastasi cerebrali o di compressione del midollo spinale.
    13. Storia o evidenza dall'esame neurologico, di disturbi del sistema nervoso centrale
    14. Ostruzione intestinale concomitante e clinicamente rilevante
    15. Dolore non controllato correlato al tumore
    16. Versamento pleurico incontrollato, versamento pericardico o ascite che richiedono procedure di drenaggio ricorrenti
    17. Ipercalcemia incontrollata o ipercalcemia sintomatica che richiede l'uso continuato di terapia con bifosfonati o denosumab
    18. Evidenze di altra malattia, disfunzione metabolica, risultati di esami fisici di laboratorio che diano il sospetto di una malattia o di una controindicazione per l'uso di un farmaco sperimentale o che pone il paziente ad alto rischio di complicanze correlate al trattamento.
    19. Donne in gravidanza o in allattamento
    20. Pazienti che ricevono contemporaneamente un trattamento in qualsiasi altro studio clinico interventistico.
    21. Precedente trattamento con agonisti del recettore CD137 o terapie di stimolazione o blocco del sistema immunitario, come anti-PD1, anti-PDL1 o con anticorpi anti-CTLA-4.
    22. Trattamento con agenti immunostimolatori sistemici
    23. Trattamento con corticosteroidi sistemici o altri farmaci immunosoppressori sistemici
    24. Storia di malattie autoimmuni, inclusa ma non limitata a miastenia grave, miosite, epatite autoimmune, lupus eritematoso sistemico, artrite reumatoide
    25. Storia di fibrosi polmonare idiopatica (compresa polmonite), polmonite indotta da farmaci
    26. Pazienti immuno-compromesse, ad es. pazienti positive all'HIV
    27. Segni o sintomi di infezione entro 2 settimane prima del ciclo 1, giorno 1
    28. Somministrazione di un vaccino vivo attenuato o sua somministrazione in qualsiasi momento durante il periodo di trattamento dello studio
    29. Storia di gravi reazioni allergiche, anafilattiche o di altre reazioni di ipersensibilità agli anticorpi chimerici, umanizzati o alle proteine di fusione
    30. Ipersensibilità nota o allergia ai prodotti biofarmaceutici o a un componente della formulazione di atezolizumab o allergia a uno degli altri farmaci inclusi nel protocollo oppure ai loro solventi
    31. La paziente ha ricevuto un precedente trattamento con un inibitore di PARP nel setting ricorrente. Le pazienti che hanno ricevuto un trattamento con PARP inibitore in prima linea sono eleggibili per lo studio. La durata della terapia con PARP inibitore deve essere stata di almeno 18 mesi per le pazienti BRCA mutate e di almeno 12 mesi per le pazienti BRCA non mutate.
    32. La paziente ha avuto tossicità ematologiche come anemia, neutropenia o trombocitopenia causate da una precedente chemioterapia antitumorale
    33. La paziente ha una storia nota o diagnosi attuale di leucemia mieloide acuta (AML) o di sindromi mielodisplastiche (MDS).
    34. Precedente trapianto di midollo osseo allogenico o precedente trapianto di organi solidi
    35. La paziente ha una qualsiasi nota ipersensibilità ai componenti o agli eccipienti di niraparib.
    E.5 End points
    E.5.1Primary end point(s)
    Progression-free survival (PFS)
    Sopravvivenza libera da progressione (PFS)
    E.5.1.1Timepoint(s) of evaluation of this end point
    From randomization until progression based on investigator assessment determined by RECIST (version v1.1).
    Dalla randomizzazione fino alla progressione, valutata secondo RECIST (versione 1.1)
    E.5.2Secondary end point(s)
    - Overall survival (OS), defined as the observed length of life from entry into the study (day of randomization) to death from any cause, or the date of last contact
    - Time from randomization to first subsequent therapy or death (TFST)
    - Time from randomization to second subsequent therapy or death (TSST)
    - Time from randomization to second progression or death (PFS2)
    - Frequency and severity of adverse events as assessed by CTCAE version 5.0 for the regimens administered on this study
    - Clinically-meaningful improvement in patient-reported abdominal pain or bloating, defined as a 10-point decrease from the baseline score on either of the two items of the EORTC QLQ-OV28 abdominal/GI symptom scale (items 31 and 32)
    - Clinical improvement, remaining stable, or deterioration in patient-reported function and HRQoL, defined as a 10-point increase, changes within 10 points, and a 10-point decrease, respectively, from the baseline score on each of the functional (physical, role, emotional, and social) and global health status/HRQoL scales of EORTC QLQ-C30
    - Objective Response Rate (ORR) as assessed by RECIST v1.1 during the chemotherapy phase and during the maintenance phase
    - Duration of response (DOR) by RECIST v1.1
    - PFS from start of the maintenance phase (period from start of maintenance treatment until disease progression, death or date of last contact) assessed by the investigator according to RECIST v1.1 criteria, in all patients receiving maintenance treatment as well as in the subgroup of patients with CR/PR of SD after completing chemotherapy
    - Relationship of primary and secondary endpoint outcomes with BRCA mutational status and other stratification factors
    - Serum concentration (Cmin and Cmax) of atezolizumab at specified timepoints. Incidence of ATAs during the study relative to the prevalence of ATAs at baseline
    - Mean and mean changes from the baseline score in disease and/or treatment-related symptoms by cycle and between treatment arms as assessed by all symptom items and/or scales of EORTC QLQ-C30 and QLQ-OV28
    - Proportion of patients reporting each response option at each assessment timepoint by treatment arm for item GP5 from the FACT-G instrument
    - Health utility scores of the EuroQoL 5 Dimension, 5 Level Questionnaire (EQ-5D-5L). European Quality of Life Visual Analogue Scale (EQ-VAS)
    - Relationship between tumour immune-related or disease type-related biomarkers (including but not limited to mutational burden, PD-L1, TILs and cluster of differentiation [CD]8) in tumour tissues or blood samples, and clinical outcomes
    - Relationship between certain exploratory biomarkers (e.g. circulating cell-free DNA, proteins and cytokines) assessed from plasma before and during/after treatment, and clinical outcomes
    - Relationship between ATB use within 2 month before and 1 month after the first study administration with atezolizumab efficacy as measured by PFS and OS.
    -Il tempo dalla randomizzazione alla prima terapia successiva o alla morte (TFST)
    -Il tempo dalla randomizzazione alla seconda terapia successiva o alla morte (TSST)
    -Il tempo dalla randomizzazione alla seconda progressione o morte (PFS2)
    -Frequenza e severità degli eventi avversi inerenti al trattamento in studio, classificati in accordo al National Cancer Institute Common Terminology Criteria for Adverse Events versione 5.0.
    -Miglioramento clinicamente significativo in pazienti che hanno riferito dolore addominale o gonfiore, miglioramento definito da una diminuzione di 10 punti dal punteggio basale, valutata su due items dell’abdominal/GI symptom scale inerente al questionario sulla qualità della vita EORTC QLQ-OV28 (items 31 e 32)
    -Miglioramento clinico, stabilità o deterioramento della funzionalità e della “Health-related Quality of life” (HRQoL) riportato dalle pazienti, definiti rispettivamente come un aumento di 10 punti, cambiamento all’interno dei 10 punti, e una diminuzione di 10 punti rispetto al punteggio basale, in ognuna delle scale funzionali (physical, role, emotional, social) e dello stato di salute generale/HRQoL del questionario EORTC QLQ-C30
    -Overall survival (OS), definita come il tempo dall'ingresso nello studio (giorno della randomizzazione) fino alla morte per qualsiasi causa, o alla data dell'ultimo contatto, se la paziente è in vita.
    -Objective Response Rate (ORR) valutata mediante criteri RECIST v1.1 durante la fase di chemioterapia e durante la fase di mantenimento
    -Duration Of Response (DOR) in accordo ai criteri RECIST v1.1
    -PFS dall'inizio della fase di mantenimento (periodo che va dall'inizio della terapia di mantenimento fino a progressione di malattia, morte o data dell'ultimo contatto) valutata dallo sperimentatore in accordo ai criteri RECIST v1.1, in tutti le pazienti che hanno ricevuto terapia di mantenimento nonché nel sottogruppo di pazienti con risposta CR/PR e SD dopo il completamento della chemioterapia
    -Relazione tra endpoint primari e secondari con lo stato mutazionale di BRCA e di altri fattori di stratificazione
    -Concentrazione sierica (Cmin e Cmax) di atezolizumab a specifici timepoints. Incidenza di ATA durante lo studio in confronto alla prevalenza di ATA al basale
    E.5.2.1Timepoint(s) of evaluation of this end point
    - OS length of life from entry into the study to death
    - TFST from randomization to first subsequent therapy or death
    - TSST from randomization to second subsequent therapy or death
    - PFS2 Time from randomization to second progression or death
    - Averse events assessed every cycle.
    - ORR and DOR assessed during the chemotherapy phase and during the maintenance phase
    - PFS from start of the maintenance phase assessed by the investigator
    - ATAs during the study
    - Mean and mean changes from the baseline score in disease and/or treatment-related symptoms assessed by EORTC QLQ-C30 and QLQ-OV28
    - Assessment of plasma before and during/after treatment, and clinical outcomes
    - Relationship between ATB use within 2 month before and 1 month after the first study administration
    - OS dall'ingresso nello studio fino alla morte
    - TFST dalla randomizzazione alla prima terapia successiva o morte
    - TSST dalla randomizzazione alla seconda terapia successiva o morte
    - PFS2 Tempo dalla randomizzazione alla seconda progressione o morte
    - Eventi avversi ad ogni ciclo.
    - ORR e DOR valutati durante la chemioterapia e la fase di mantenimento
    - PFS dall'inizio della fase di mantenimento valutata dallo sperimentatore
    - Valutazione degli ATA durante lo studio
    - Variazioni medie del punteggio basale nella malattia e /o sintomi correlati al trattamento valutati da EORTC QLQ-C30 e QLQ-OV28
    -Valutazione concentrazione plasmatica prima e durante/dopo il trattamento
    - Relazione tra l'uso di ATB entro 2 mesi prima e 1 mese dopo la prima somministrazione del trattamento in studio
    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 Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic Yes
    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 concerned7
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA74
    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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Israel
    Belgium
    Germany
    Italy
    Poland
    Spain
    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
    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 months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years5
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    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: 124
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 290
    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 state115
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 383
    F.4.2.2In the whole clinical trial 414
    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)
    Normal treatment according to clinical practice
    Trattamento standard in accordo alla normale pratica clinica
    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 Decision2019-12-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-10-16
    P. End of Trial
    P.End of Trial StatusOngoing
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