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    Summary
    EudraCT Number:2013-003839-30
    Sponsor's Protocol Code Number:D081CC00006
    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:2014-04-15
    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 number2013-003839-30
    A.3Full title of the trial
    A randomised, double-blind, parallel group, placebo-controlled multi-centre Phase III study to assess the efficacy and safety of olaparib versus placebo as adjuvant treatment in patients with germline BRCA1/2 mutations and high risk HER2 negative primary breast cancer who have completed definitive local treatment and neoadjuvant or adjuvant chemotherapy.
    Studio randomizzato, in doppio cieco, a gruppi paralleli, controllato con placebo, multicentrico, di fase III per la valutazione dell'efficacia e della sicurezza di olaparib rispetto a placebo come trattamento adiuvante in pazienti con mutazioni germline del gene BRCA1/2, affetti da carcinoma mammario primitivo HER2 negativo ad alto rischio, che hanno completato il trattamento locale definitivo e la chemioterapia neoadiuvante o adiuvante
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Olaparib as adjuvant treatment in patients with germline BRCA mutated high risk HER2 negative primary breast cancer.
    Olaparib come trattamento adiuvante in pazienti con mutazioni germline del gene BRCA1/2, affetti da carcinoma mammario primitivo HER2 negativo ad alto rischio.
    A.3.2Name or abbreviated title of the trial where available
    Olympia
    Olympia
    A.4.1Sponsor's protocol code numberD081CC00006
    A.5.4Other Identifiers
    Name:Protocol Study CodeNumber:BIG 6-13
    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 SponsorAstraZeneca AB
    B.1.3.4CountrySweden
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportAstraZeneca AB
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAstraZeneca
    B.5.2Functional name of contact pointInformation Center
    B.5.3 Address:
    B.5.3.1Street AddressNot Applicable
    B.5.3.2Town/ cityNot Applicable
    B.5.3.3Post codeNot Applicable
    B.5.3.4CountryUnited States
    B.5.6E-mailinformation.center@astrazeneca.com
    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 nameolaparib
    D.3.2Product code 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.3.9.1CAS number 763113-22-0
    D.3.9.3Other descriptive nameOLAPARIB
    D.3.9.4EV Substance CodeSUB32234
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameolaparib
    D.3.2Product code 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.3.9.1CAS number 763113-22-0
    D.3.9.3Other descriptive nameOLAPARIB
    D.3.9.4EV Substance CodeSUB32234
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboFilm-coated tablet
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboFilm-coated tablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Adjuvant breast cancer
    carcinoma mammario avanzato
    E.1.1.1Medical condition in easily understood language
    Breast cancer
    carcinoma mammario
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.1
    E.1.2Level PT
    E.1.2Classification code 10006187
    E.1.2Term Breast 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
    Efficacy of adjuvant treatment with olaparib on Invasive Disease Free Survival (IDFS).
    efficacia del trattamento adiuvante con olaparib sulla sopravvivenza libera da malattia invasiva (IDFS, Invasive Disease Free Survival)
    E.2.2Secondary objectives of the trial
    - Efficacy of adjuvant treatment with olaparib on overall survival (OS).
    - Efficacy of adjuvant treatment with olaparib on Distant Disease Free Survival (DDFS)
    - Efficacy of adjuvant treatment with olaparib on the incidence of new invasive breast primary cancer and/or new epithelial ovarian cancer.
    - Efficacy of olaparib on patient reported outcomes using the FACIT fatigue scale and EORTC QLQ-C30 QoL scale.
    - Efficacy of olaparib in patients identified as having a deleterious or suspected deleterious variant in either of the BRCA genes using variants identified with current and future BRCA mutation assays (gene sequencing and large rearrangement analysis).
    1.efficacia del trattamento adiuvante con olaparib sulla sopravvivenza globale (OS)
    2.efficacia del trattamento adiuvante con olaparib sulla sopravvivenza libera da malattia a distanza (DDFS)
    3.efficacia del trattamento adiuvante con olaparib sull'incidenza di nuovo carcinoma mammario invasivo primitivo e/o nuovo carcinoma ovarico epiteliale
    4.efficacia di olaparib sugli esiti riferiti dai pazienti utilizzando la scala di valutazione dell'affaticamento FACIT e la scala di valutazione della qualità della vita QLQ-C30 dell'EORTC
    5.efficacia di olaparib in pazienti nei quali è stata identificata una variante deleteria o sospetta deleteria in uno dei geni BRCA utilizzando varianti identificate con dosaggi attuali e futuri di determinazione della mutazione germline del gene BRCA (sequenziamento genico e analisi di riarrangiamento esteso)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Histologically confirmed non-metastatic primary triple negative invasive adenocarcinoma of the breast.
    -Invasive TNBC
    -Documented mutation in BRCA1 or BRCA2 that is predicted to be deleterious or suspected deleterious (known or predicted to be detrimental/lead to loss of function).
    - Completed adequate breast and axilla surgery. Completed at least 6 cycles neoadjuvant or adjuvant chemotherapy containing anthracyclines, taxanes or the combination of both. Prior platinum as potentially curative treatment for prior cancer (e.g. ovarian) or as adjuvant or neoadjuvant treatment for breast cancer is allowed.
    -ECOG 0-1.
    •Pazienti con diagnosi istologica di adenocarcinoma della mammella triplo negativo non metastatico.
    •Tumore della mammella triplo negativo invasivo
    •Mutazione documentata in BRCA1 or BRCA2 che si prevede sia, o si sospetta essere, deleteria (nota per essere o prevista essere dannosa/che porta a perdita di funzione).
    •Intervento chirurgico completo della mammella comprensivo dei linfonodi ascellari
    •Precedente trattamento di almeno 6 cicli chemioterapia neoadiuvanti o adiuvanti a base di antraci cline, taxani o la combinazione di entrambi. Pazienti che hanno ricevuto platino come trattamento potenzialmente curativo per precedenti tumori (es. tumore all’ovaio) o come trattamento adiuvante/neoadiuvante per il carcinoma della mammella.
    •ECOG 0-1
    E.4Principal exclusion criteria
    - Any previous treatment with a PARP inhibitor, including olaparib and/or known hypersensitivity to any of the
    excipients of study treatment.
    - Patients with second primary cancer, EXCEPTIONS: adequately treated non-melanoma skin cancer, curatively treated in situ cancer of the cervix, Ductal Carcinoma in situ (DCIS) of the breast, stage 1 grade 1 endometrial carcinoma, or other solid tumours including lymphomas (without bone marrow involvement) curatively treated with no evidence of disease for ≥ 5 years prior to randomization. More than one course of chemotherapy for previous malignancies.
    -Resting ECG with QTc > 470 msec detected on 2 or more time points within a 24 hour period or family history of long QT syndrome. If ECG demonstrates QTc >470 msec, patient will be eligible only if repeat ECG demonstrates QTc ≤470 msec.
    - Concomitant use of known potent CYP3A4 inhibitors such as ketoconazole, itraconazole, ritonavir, indinavir, saquinavir, telithromycin, clarithromycin and nelfinavir.-Whole blood transfusions in the last 120 days prior to entry to the study which may interfere with gBRCA testing
    •Precedente trattamento con inibitori PARP, incluso Olaparib e/o nota ipersensibilità a qualsiasi eccipiente del prodotto.
    •Pazienti con un secondo tumore primario, ECCEZIONI: tumore della pelle che non sia melanoma, adeguatamente trattato, cancro della cervice trattato in-situ in modo curativo, Carcinoma Duttale in Situ (DCIS), carcinoma endometriale stadio 1 grado 1, o altri tumori solidi inclusi i linfomi (senza coinvolgimento del midollo osseo) trattati in modo curativo senza evidenza di malattia per ≥ 5 anni prima dell’ingresso nello studio. Più di un trattamento chemioterapico per tumori precedenti.
    •ECG a riposo con QTc > 470 msec rilevato in 2 o più tempi entro un periodo di 24 ore o storia familiare di sindrome del QT lungo. Se ECG mostra QTc > 470 msec, il paziente sarà eleggibile solo se ECG ripetuti mostrano QTc ≤ 470 msec.
    •Uso concomitante di potenti inibitori del CYP3A4 noti come ketoconazolo, itraconazolo, ritonavir indinavir, saquinavir, telitromicina, claritromicina e nelfinavir.
    •Trasfusioni di sangue intero nei 120 giorni precedenti all’arruolamento nello studio, che potrebbero interferire con il test gBRCA .
    E.5 End points
    E.5.1Primary end point(s)
    Invasive Disease Free Survival (IDFS)
    Sopravvivenza libera da malattia invasiva (IDFS)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Recurrent/new cancers assessments will be performed at day 1, weeks 12, 24, 38, 52. In follow-up period in year 2 every 3 months, in year 3, 4,5 every 6 months and year 6 to 10 every 12 months. MRI to be performed every 12 months after the 6 months scan.
    Valutazioni di nuovi/ ricorrenti tumori verranno effettuate al giorno 1, settimane 12, 24, 38, 52.
    Durante il periodo di follow up del secondo anno, verranno effettuate ogni 3 mesi, nel terzo, quarto e quinto anno ogni 6mesi, e dal sesto al decimo anno di follow up ogni 12 mesi.
    La risonanza magnetica (MRI) verrà effettuata ogni 12 mesi, ad una distanza di 6 mesi dalla TAC.
    E.5.2Secondary end point(s)
    1. Efficacy of adjuvant treatment with olaparib on overall survival (OS).
    2. Efficacy of adjuvant treatment with olaparib on Distant Disease Free Survival (DDFS)
    3. Efficacy of adjuvant treatment with olaparib on the incidence of new invasive breast primary cancer and/or new epithelial ovarian cancer.
    4. Efficacy of olaparib on patient reported outcomes using the FACIT fatigue scale and EORTC QLQ-C30 QoL scale.
    5. Efficacy of olaparib in patients identified as having a deleterious or suspected deleterious variant in either of the BRCA genes using variants identified with current and future BRCA mutation assays (gene sequencing and large rearrangement analysis).
    1.efficacia del trattamento adiuvante con olaparib sulla sopravvivenza
    globale (OS)
    2.efficacia del trattamento adiuvante con olaparib sulla sopravvivenza
    libera da malattia a distanza (DDFS)
    3.efficacia del trattamento adiuvante con olaparib sull'incidenza di nuovo
    carcinoma mammario invasivo primitivo e/o nuovo carcinoma ovarico
    epiteliale
    4.efficacia di olaparib sugli esiti riferiti dai pazienti utilizzando la scala di
    valutazione dell'affaticamento FACIT e la scala di valutazione della
    qualità della vita QLQ-C30 dell'EORTC
    5.efficacia di olaparib in pazienti nei quali è stata identificata una variante deleteria o sospetta deleteria in uno dei geni BRCA utilizzando
    varianti identificate con dosaggi attuali e futuri di determinazione della
    mutazione germline del gene BRCA (sequenziamento genico e analisi di
    riarrangiamento esteso)
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. Day 1, 15, 29 week 8,12,16,20,24,38,52, 30 days after last dose of study medication, in year 2 every 3 months, in year 3, 4,5 every 6 months and above year 6 every 12 months
    2 & 3.Physical examination will be performed at day 1, weeks 12, 24, 38, 52. In follow-up period in year 2 every 3 months, in year 3, 4,5 every 6 months and year 6 to 10 every 12 months. MRI to be performed every 12 months after the 6 months scan
    4.EORTC QLQ-C30 and FACIT-Fatigue scale will be collected prior randomization, at weeks 24 and 52 and also every 6 months during the 2nd year post randomisation (months 18 and 24 only).
    5. Within 15 years from last subject last visit
    1. gg 1, 15, 29 settimana 8,12,16,20,24,38,52, 30 giorni dopo l’ultima dose di farmaco, nel second anno ogni 3 mesi, negli anni 3, 4,5 ogni 6
    Mesi e oltre il sesto anno ogni 12 mesi.
    2 & 3.GLi esami fisicisaranno effettuati al giorno 1, settimana 12, 24, 38,
    52. Durante il periodo di follow up del secondo anno, verranno effettuate ogni 3 mesi, nel terzo, quarto e quinto anno ogni 6mesi, e dal sesto al decimo anno di follow up ogni 12 mesi.La risonanza magnetica (MRI) verrà effettuata ogni 12 mesi, ad una distanza di 6 mesi dalla TAC.4.Il questionario EORTC QLQ-C30e la scala FACIT-Fatigue saranno raccolti prima della randomizzazione, e alla settimana 24 e 52 e anche ogni 6 mesi durante il secondo anno succesivo alla randomizzazione (solo ai mesi 18 e 24).
    5. Entro 15 anni dal LSLV
    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 No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned17
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA224
    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
    Argentina
    Australia
    Austria
    Belgium
    Canada
    China
    France
    Germany
    Israel
    Italy
    Japan
    Korea, Republic of
    Netherlands
    Poland
    Portugal
    Spain
    Sweden
    Switzerland
    Taiwan
    United Kingdom
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    Last subject last visit
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years15
    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 years15
    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: 660
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 660
    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 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 state40
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 873
    F.4.2.2In the whole clinical trial 1320
    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)
    Standard of care
    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 Decision2014-06-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-11-05
    P. End of Trial
    P.End of Trial StatusOngoing
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