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    Summary
    EudraCT Number:2016-004118-84
    Sponsor's Protocol Code Number:ONC-2016-001
    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:2018-09-17
    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 number2016-004118-84
    A.3Full title of the trial
    A multicenter, phase I-II trial of gemcitabine plus oxaliplatin and nbb-paclitaxel in subjects with advanced (unresectable or metastatic) biliary tract cancer (gallbladder cancer, cancer of the extrahepatic bile duct, intrahepatic cholangiocarcinoma and ampullary carcinoma).
    STUDIO MULTICENTRICO DI FASE I-II DI GEMCITABINA IN ASSOCIAZIONE A OXALIPLATINO E nab-PACLITAXEL IN SOGGETTI CON NEOPLASIA AVANZATA (non operabile o metastatica) DELLE VIE BILIARI (tumore della colecisti, tumore del dotto biliare extraepatico, colangiocarcinoma intraepatico e carcinoma ampollare)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A multicenter, phase I-II trial of gemcitabine plus oxaliplatin and nbb-paclitaxel in subjects with advanced (unresectable or metastatic) biliary tract cancer
    STUDIO MULTICENTRICO DI FASE I-II DI GEMCITABINA IN ASSOCIAZIONE A OXALIPLATINO E nab-PACLITAXEL IN SOGGETTI CON NEOPLASIA AVANZATA (non operabile o metastatica) DELLE VIE BILIARI
    A.3.2Name or abbreviated title of the trial where available
    A multicenter, phase I-II trial of gemcitabine plus oxaliplatin and nbb-paclitaxel in subjects with
    STUDIO MULTICENTRICO DI FASE I-II DI GEMCITABINA IN ASSOCIAZIONE A OXALIPLATINO E nab-PACLITAXEL IN
    A.4.1Sponsor's protocol code numberONC-2016-001
    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 SponsorIRCCS ISTITUTO CLINICO HUMANITAS
    B.1.3.4CountryItaly
    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 supportCelgene International II Sarl
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCD Pharma Group S.r.l.
    B.5.2Functional name of contact pointCRO
    B.5.3 Address:
    B.5.3.1Street AddressPiazza De Angeli, 7
    B.5.3.2Town/ cityMilano
    B.5.3.3Post code20146
    B.5.3.4CountryItaly
    B.5.4Telephone number+39 0289051076
    B.5.5Fax number+39 0289051088
    B.5.6E-mailsimona.manzi@cdpharma.it
    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 ABRAXANE - 5 MG/ML - POLVERE PER SOSPENSIONE PER INFUSIONE - USO ENDOVENOSO- 100 MG - FLACONCINO(VETRO) 1 FLACONCINO
    D.2.1.1.2Name of the Marketing Authorisation holderCELGENE EUROPE 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 nameAbraxane
    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 INNPACLITAXEL ALBUMINA
    D.3.9.1CAS number 33069-62-4
    D.3.9.2Current sponsor codeNab-paclitaxel
    D.3.9.3Other descriptive namePACLITAXEL ALBUMINA
    D.3.10 Strength
    D.3.10.1Concentration unit mg/m2 milligram(s)/square meter
    D.3.10.2Concentration typeup to
    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) 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 Yes
    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 GEMZAR - 1 G POLVERE PER SOLUZIONE PER INFUSIONE 1 FLACONECINO DA 1 G
    D.2.1.1.2Name of the Marketing Authorisation holderELI LILLY ITALIA S.P.A.
    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 nameGemcitabina
    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 INNGEMCITABINA CLORIDRATO
    D.3.9.1CAS number 122111-03-9
    D.3.9.2Current sponsor codeGemcitabina
    D.3.9.3Other descriptive nameGEMCITABINA CLORIDRATO
    D.3.10 Strength
    D.3.10.1Concentration unit mg/m2 milligram(s)/square meter
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number1000
    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.2.1.1.1Trade name OXALIPLATINO TEVA - 5 MG/ML CONCENTRATO PER SOLUZIONE PER INFUSIONE 1 FLACONCINO DI VETRO DA 4 ML
    D.2.1.1.2Name of the Marketing Authorisation holderTEVA ITALIA S.R.L.
    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 nameOxaliplatino
    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 INNOXALIPLATINO
    D.3.9.1CAS number 63121-00-6
    D.3.9.2Current sponsor codeOxaliplatino
    D.3.9.3Other descriptive nameOXALIPLATINO
    D.3.10 Strength
    D.3.10.1Concentration unit mg/m2 milligram(s)/square meter
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number80
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Advanced (unresectable or metastatic) biliary tract cancer
    neoplasia avanzata (non operabile o metastatica) delle vie biliari.
    E.1.1.1Medical condition in easily understood language
    Advanced (unresectable or metastatic) biliary tract cancer
    neoplasia avanzata (non operabile o metastatica) delle vie biliari.
    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 10073073
    E.1.2Term Hepatobiliary cancer
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of the phase I part of the study is to determine the maximum tolerated dose (MTD) of the combination gemcitabine plus oxaliplatin plus nab-paclitaxel, established in the first cycle of therapy, in order to determine the recommended phase II dose (RP2D).
    The primary objective of the phase II is to determine activity of GEMOX plus nab-paclitaxel.
    L’obiettivo primario della fase I dello studio è determinare la dose massima tollerata della combinazione di gemcitabina con oxaliplatino e nab-paclitaxel, stabilita nel primo ciclo di terapia, per determinare la dose raccomandata per la fase II (RP2D)
    L’obiettivo primario della fase II dello studio è determinare l’attivita di GemOx in associazione a nab-paclitaxel.
    E.2.2Secondary objectives of the trial
    The secondary objectives of the study consist in to better define the safety profile and the outcome of the study treated population.
    L’obiettivo secondario dello studio (Fase I e Fase II) consiste nel definire meglio il profilo di safety e l’outcome della popolazione di studio trattata.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Written, signed informed consent
    2. Male or female aged 18 years or older
    3. Histologically or citologically-confirmed advanced (unresectable or metastatic) BTC (gallbladder cancer, cancer of the extrahepatic bile duct, intrahepatic cholangiocarcinoma and ampullary carcinoma)
    4. Measurable or evaluable but non-measurable disease according to RECIST v. 1.1
    5. Chemotherapy-naïve (prior chemotherapy in the adjuvant setting completed more than 6 months before the trial entry is accepted)
    6. Adequate bone marrow, liver, and renal function
    7. ECOG PS 0-1
    8. Life expectancy of at least 12 weeks
    9. Negative serum pregnancy test for women of childbearing potential;
    10. Adoption of adequate contraceptive methods when applicable :
     Women of child-bearing potential must use the following adequate contraceptive methods during all the study and for 1 month after completion of study treatment: abstinence, tubal ligation, oral contraception or transdermal contraceptives, copper intrauterine device, vasectomy of the partner. It is unknown whether the experimental drugs interact or have effect on the hormonal contraceptives functioning: if patients are using hormonal contraceptives, must be associated a barrier method of contraception.
     For male patients with female partners of childbearing potential, agreement to use a barrier method of contraception from the first dose of treatment and for 6 months after completion of study treatment.
    11. Male patients mustn’t donate sperm during the treatment with nab-paclitexel and for 6 months after completion of study treatment.
    12. Agreement not to donate blood during the study.
    Criteri di inclusione:
    1. Firma del consenso informato scritto
    2. Maschi e femmine di età ≥ 18 anni
    3. Neoplasia avanzata (non operabile o metastatica) delle vie biliari (tumore della colecisti, tumore del dotto biliare extraepatico,colangiocarcinoma intraepatico e carcinoma ampollare) istologicamente e citologicamente confermata
    4. Malattia non misurabile o valutabile ma misurabile in accordo a RECIST v. 1.1
    5. Pazienti naive alla chemioterapia (è accettata precedente chemioterapia in trattamento adiuvante completata più di 6 mesi prima dell’arruolamento nel trial)
    6. Adeguata funzione del midollo osseo, renale, ed epatica
    7. ECOG PS 0-1
    8. Aspettativa di vita di almeno 12 settimane
    9. Per donne in età fertile, è necessario un test di gravidanza su siero negativo;
    10. Adozione di adeguati metodi contraccettivi, quando applicabile:
    Le donne in età fertile devono usare metodi contraccettivi adeguati durante lo studio e per 1 mese dopo il completamento del trattamento in studio, quali: astinenza, legatura delle tube, contraccezione orale o contraccettivi transdermici, dispositivi intrauterini in rame, vasectomia del partner. Non è noto se i farmaci sperimentali interagiscano o abbiano effetto sul funzionamento dei contraccettivi ormonali: se le pazienti stanno utilizzando contraccettivi ormonali, dovrà essere associato un metodo contraccettivo di barriera.
    I pazienti di sesso maschile con partner di sesso femminile in età fertile, dovranno utilizzare un metodo contraccettivo di barriera dalla prima dose di trattamento fino a 6 mesi dopo il completamento del trattamento in studio.
    11. Pazienti di sesso maschile non devono donare sperma durante il trattamento con nab-paclitexel e fino a 6 mesi dopo il completamento del trattamento in studio.
    12. Accordo a non donare sangue durante lo studio.
    E.4Principal exclusion criteria
    1. Peripheral neuropathy of grade 2 or greater by Common Terminology Criteria for Adverse Events (CTCAE) 4.0. In CTCAE version 4.0 grade 2 sensory neuropathy is defined as "moderate symptoms; limiting instrumental activities of daily living (ADLs)"
    2. Previous systemic treatment for advanced disease
    3. Known symptomatic brain metastases or carcinomatous meningitis
    4. Severe or uncontrolled systemic disease and/or active or uncontrolled infection
    5. Women who are currently pregnant or breast feeding
    6. Previous or current malignancies of other histologies within the last 3 years, with the exception of cervical carcinoma in situ and adequately treated basal cell or squamous cell carcinoma of the skin
    7. Known hypersensitivity to nab-paclitaxel, gemcitabine, oxaliplatin or any of the excipients
    1. Neuropatia periferica di grado 2 o superiore secondo CTCAE (Common Terminology Criteria for Adverse Events) 4.0.
    Nel CTCAE versione 4.0 il grado 2 di neuropatia periferica è definita come “sintomi moderati; limitanti le attività strumentali della vita quotidiana (ADLs)”
    2. Precedente trattamento sistemico per malattia avanzata
    3. Note metastasi cerebrali sintomatiche o meningite carcinomatosa
    4. Malattie sistemiche severe o non controllate e/o attive o infezioni non controllate
    5. Gravidanza o allattamento
    6. Precedenti o attuali neoplasie di altre istologie entro gli ultimi 3 anni, ad eccezione del carcinoma cervicale in situ e carcinoma basocellulare o carcinoma delle cellule squamose della pelle adeguatamente trattati
    7. Ipersensibilità nota a nab-paclitexel, gemcitabina, oxaliplatino o ad uno qualsiasi degli eccipienti.
    E.5 End points
    E.5.1Primary end point(s)
    Phase I : MTD established in the first cycle of therapy
    Phase II: PFS at 6 months
    Fase I: MTD stabilita durante il primo ciclo di terapia
    Fase II: PFS a 6 mesi
    E.5.1.1Timepoint(s) of evaluation of this end point
    Phase I: first cycle
    Phase II: 6 months
    Fase I: primo ciclo
    Fase II: 6 mesi
    E.5.2Secondary end point(s)
    Safety and Tolerability;
    PFS;
    OS;
    Objective response rate (ORR);
    Duration of response
    Sicurezza e tollerabilità;
    PFS;
    OS;
    Risposta (ORR);
    Durata della risposta
    E.5.2.1Timepoint(s) of evaluation of this end point
    at each visit
    a ciascuna visita
    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 Yes
    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) Yes
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    E.7.1.3.1Other trial type description
    maximum tolerated dose of the combination gemcitabine plus oxaliplatin plus nab-paclitaxel
    massima dose tollerata della nuova combinazione di gemcitabina, oxaliplatino e nab-paclitaxel
    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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial4
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.4.1Number of sites anticipated in Member State concerned1
    E.8.5The trial involves multiple Member States No
    E.8.5.1Number of sites anticipated in the EEA1
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.7Trial has a data monitoring committee No
    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 years0
    E.8.9.1In the Member State concerned months36
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months36
    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.1.1Number of subjects for this age range: 1
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 35
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 50
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    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 Yes
    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 state85
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 85
    F.4.2.2In the whole clinical trial 85
    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 subjects, at the end of the partecipation in the trial, will be followed according to the normal clinical practice.
    I pazienti al termine della Sperimentazione saranno seguiti 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 Decision2017-04-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-03-14
    P. End of Trial
    P.End of Trial StatusOngoing
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