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    Summary
    EudraCT Number:2011-005335-97
    Sponsor's Protocol Code Number:GO25632
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2012-08-31
    Trial results View 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 number2011-005335-97
    A.3Full title of the trial
    A phase III, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy and safety of bevacizumab, and associated biomarkers, in combination with paclitaxel compared with paclitaxel plus placebo as first-line treatment of patients with HER2-negative metastatic breast cancer
    Studio di fase III, randomizzato, in doppio cieco, controllato con placebo, multicentrico, per valutare l'efficacie e la sicurezza di Bevacizumab, e biomarcatori associati, in combinazione con paclitaxel, rispetto a Paclitaxel piu' placebo come trattamento di prima linea di pazienti con cancro alla mammella metastatico HER2-negativo
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to evaluate the efficacy and safety of bevacizumab in combination with chemotherapy in patients with breast cancer that spread to other tissues.
    Studio per valutare l'efficacia e la sicurezza di bevacizumab in combinazione con chemioterapia in pazienti con cancro alla mammella metastatico
    A.3.2Name or abbreviated title of the trial where available
    MERIDIAN
    MERIDIAN
    A.4.1Sponsor's protocol code numberGO25632
    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 SponsorF. HOFFMANN - LA ROCHE LTD.
    B.1.3.4CountrySwitzerland
    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 supportF. Hoffmann-La Roche Ltd
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationRoche SpA
    B.5.2Functional name of contact pointCountry Head Clin. Ops. Italy
    B.5.3 Address:
    B.5.3.1Street AddressVial G.B. Stucchi 110
    B.5.3.2Town/ cityMonza
    B.5.3.3Post code20900
    B.5.3.4CountryItaly
    B.5.4Telephone number039 2475070
    B.5.5Fax number039 2475084
    B.5.6E-mailsergio.scaccabarozzi@roche.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 Yes
    D.2.1.1.1Trade name Avastin
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Registration Ltd.
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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.3.4Pharmaceutical 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 INNBEVACIZUMAB
    D.3.9.1CAS number 216974-75-3
    D.3.9.2Current sponsor codeRO4876646/F02
    D.3.9.4EV Substance CodeSUB16402MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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 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 Yes
    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 Yes
    D.3.11.13.1Other medicinal product typeanticorpo monoclonale ricombinante umanizzato
    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 placeboConcentrate for solution 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
    HER2-negative metastatic breast cancer.
    Carcinoma mammario metastatico HER-2 negativo
    E.1.1.1Medical condition in easily understood language
    Breast cancer that spread to other tissues
    Tumore mammario diffuso ad altri tessuti
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 15.0
    E.1.2Level LLT
    E.1.2Classification code 10027475
    E.1.2Term Metastatic 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
    To evaluate the efficacy of bevacizumab + paclitaxel compared with placebo + paclitaxel as first-line treatment in patients with HER2- negative metastatic breast cancer as measured by: - PFS based on investigator tumor assessment in the intent-to treat (ITT) patient population - PFS based on investigator tumor assessment in ITT patients with high plasma VEGF-A levels
    Valutare l’efficacia di bevacizumab + paclitaxel rispetto al placebo + paclitaxel come trattamento di prima linea in pazienti con carcinoma mammario metastatico (Metastatic Breast Cancer, MBC) negativo per il recettore 2 del fattore di crescita dell’epidermide umano (Human Epidermal growth factor Receptor 2, HER2) in base a: Sopravvivenza libera da progressione (Progression-Free Survival, PFS) basata sulla valutazione del tumore da parte dello sperimentatore nella popolazione di pazienti Intent-To-Treat (ITT). PFS basata sulla valutazione del tumore da parte dello sperimentatore nei pazienti ITT con elevati livelli plasmatici di fattore di crescita dell’endotelio vascolare A (Vascular Endothelial Growth Factor, VEGF-A).
    E.2.2Secondary objectives of the trial
    To evaluate on the ITT population and the VEGF-A high subset the efficacy of bevacizumab + paclitaxel compared with placebo + paclitaxel as first-line treatment in patients with HER2-negative MBC as measured by: - OS - Objective response rate for patients with measurable disease at baseline, as assessed by investigator -Duration of objective response for patients with measurable disease at baseline - One-year survival To evaluate on the ITT population and the VEGF-A high subset the safety of bevacizumab + paclitaxel compared with placebo + paclitaxel as firstline treatment in patients with HER2-negative MBC, focusing on National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (NCI CTCAE v4.0) all-grade treatment-emergent adverse events.
    I seguenti obiettivi secondari saranno valutati all’interno della popolazione ITT e del sottoinsieme con elevato VEGF-A:valutare l’efficacia di bevacizumab + paclitaxel rispetto al placebo + paclitaxel come trattamento di prima linea in pazienti con MBC HER2-negativo in base a: Sopravvivenza complessiva (Overall Survival, OS). Tasso di risposta obiettiva per i pazienti con malattia misurabile al basale, come valutato dallo sperimentatore. Durata della risposta obiettiva per i pazienti con malattia misurabile al basale. Sopravvivenza a un anno. Valutare la sicurezza di bevacizumab + paclitaxel rispetto al placebo + paclitaxel come trattamento di prima linea in pazienti con MBC HER2-negativo, concentrandosi sui Criteri Terminologici Comuni per gli Eventi Avversi del National Cancer Institute, V.4.0 (NCI CTCAE v4.0) per gli eventi avversi emergenti dal trattamento di qualsiasi grado
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Histologically or cytologically confirmed, HER2 negative adenocarcinoma of the breast, with measurable or non-measurable locally recurrent or metastatic disease. Locally recurrent disease must not be amenable to resection with curative intent. 2. Signed Informed Consent Form 3. Age ≥ 18 years 4. ECOG performance status of 0 or 1 5. Ability and capacity to comply with study and follow up procedures 6. For women of childbearing potential, use of an acceptable and effective method of non-hormonal contraception 7. For patients who have received recent radiotherapy, recovery prior to randomization from any significant (Grade ≥ 3) acute toxicity, and radiation treatments have to be completed more than 3 weeks from randomization
    -Adenocarcinoma della mammella HER2-negativo con conferma istologica o citologica, con malattia localmente recidivante o metastatica misurabile o non misurabile. -Modulo di consenso informato firmato -Età &gt;=18 anni -Stato di validità dell’Eastern Cooperative Oncology Group (ECOG) di 0 o 1 (vedi Appendice 3) -Capacità e attitudine a rispettare le procedure di studio e di follow-up. -Per le donne potenzialmente fertili, uso di un metodo contraccettivo non ormonale accettabile ed efficace. -Per i pazienti recentemente sottoposti a radioterapia, recupero prima della randomizzazione da eventuale tossicità acuta significativa (Grado 3), e completamento dei trattamenti radioterapici più di 3 settimane prima della randomizzazione.
    E.4Principal exclusion criteria
    Disease-Specific Exclusions 1. HER2-positive status. 2. Prior chemotherapy for locally recurrent or metastatic disease 3. Prior hormonal therapy < 2 weeks prior to randomization. 4. Prior adjuvant or neo-adjuvant chemotherapy is allowed, provided its conclusion has been for at least 12 months prior to randomization. 5. Investigational therapy within 28 days of randomization General Medical Exclusions 6. Life expectancy of < 12 weeks 7. Inadequate organ function 8. Persistent Grade ≥ 3 sensory neuropathy 9. Uncontrolled serious medical or psychiatric illness 10. Active infection requiring intravenous (IV) antibiotics at screening 11. Pregnancy (positive pregnancy test) or lactation. Patients of reproductive potential must use an effective means of contraception (men and women). 12. History of other malignancies within 5 years prior to screening, except for tumors with a negligible risk for metastasis or death, such as adequately controlled basal cell carcinoma or squamous cell carcinoma of the skin or carcinoma in situ of the cervix. Patients with a history of bilateral breast cancer or history of breast cancer are not eligible. Bevacizumab-Specific Exclusions 13. Inadequately controlled hypertension (defined as systolic blood pressure > 150 mmHg and/or diastolic blood pressure > 100 mmHg) 14. Prior history of hypertensive crisis or hypertensive encephalopathy 15. New York Heart Association Class II or greater CHF/left ventricular ejection fraction 16. History of myocardial infarction or unstable angina within 6 months prior to randomization 17. History of stroke or transient ischemic attack within 6 months prior to randomization 18. Known CNS disease except for treated brain metastasis. 19. Significant vascular disease 20. History of hemoptysis 21. Evidence of bleeding diathesis or significant coagulopathy (in the absence of therapeutic anticoagulation) 22. Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to randomization or anticipation of need for major surgical procedure during the course of the study 23. Core biopsy or other minor surgical procedure, excluding placement of a vascular access device, within 7 days prior to randomization 24. History of abdominal fistula or gastrointestinal (GI) perforation within 6 months prior to randomization 25. Serious, non-healing wound, active ulcer, or untreated bone fracture 26. Proteinuria at screening 27. Known hypersensitivity to any component of bevacizumab 28. Prior therapy with bevacizumab, sorafenib, sunitinib, or other VEGF pathway–targeted therapy
    1.Esclusioni dovute in modo specifico alla malattia Stato HER2-positivo;precedente chemioterapia per malattia metastatica o localmente recidivante;precedente terapia ormonale &lt; 2 settimane prima della randomizzazione; la precedente terapia ormonale per malattia metastatica o localmente recidivante è consentita a condizione che il trattamento sia stato interrotto più di 2 settimane prima della randomizzazione nello studio GO25632.La chemioterapia adiuvante o neoadiuvante precedente è permessa, a condizione che si sia conclusa almeno 12 mesi prima della randomizzazione; terapia sperimentale entro 28 giorni dalla randomizzazione. 2.Esclusioni dovute a condizioni mediche generali Aspettativa di vita &lt; 12 settimane; funzionalità organica inadeguata; neuropatia sensoriale di Grado 3 persistente;grave patologia medica o psichiatrica non controllata;infezione attiva che richiede antibiotici per via endovenosa (EV) al momento dello screening; gravidanza (test di gravidanza positivo) oppure allattamento;anamnesi di altre neoplasie maligne nei 5 anni precedenti lo screening, eccetto tumori con rischio trascurabile di metastasi o decesso, come carcinoma cutaneo basocellulare o squamocellulare adeguatamente controllato oppure carcinoma in situ della cervice. 3.Esclusioni dovute in modo specifico a bevacizumab Ipertensione non adeguatamente controllata (cioè pressione arteriosa sistolica &gt; 150 mmHg e/o pressione arteriosa diastolica &gt; 100 mmHg);anamnesi di precedenti crisi ipertensive o encefalopatia ipertensiva;insufficienza cardiaca congestizia (ICC)/frazione di eiezione ventricolare sinistra di Classe II o superiore secondo la New York Heart Association (vedi Appendice 4); anamnesi di infarto miocardico o angina instabile nei 6 mesi precedenti la randomizzazione; anamnesi di ictus o attacco ischemico transitorio nei 6 mesi precedenti la randomizzazione; patologia del sistema nervoso centrale (SNC) nota, eccetto metastasi cerebrali trattate;patologia vascolare significativa (es. aneurisma aortico che richiede riparazione chirurgica, oppure trombosi arteriosa periferica recente nei 6 mesi precedenti la randomizzazione);anamnesi di emottisi (mezzo cucchiaino di sangue rosso vivo per episodio) nel mese precedente la randomizzazione; evidenza di diatesi emorragica o coagulopatia significativa (in assenza di anticoagulazione terapeutica); intervento chirurgico maggiore, biopsia a cielo aperto o lesione traumatica significativa nei 28 giorni precedenti la randomizzazione, oppure previsione della necessità di un intervento chirurgico maggiore durante lo svolgimento dello studio; biopsia percutanea o altro intervento chirurgico minore, escluso il posizionamento di un dispositivo di accesso vascolare, nei 7 giorni precedenti la randomizzazione; anamnesi di fistola addominale o perforazione gastrointestinale (GI) nei 6 mesi precedenti la randomizzazione; ferita grave che non guarisce, ulcera attiva oppure frattura ossea non trattata; proteinuria allo screening, dimostrata da test diagnostico delle urine su stick oppure proteine nelle urine delle 24 ore &gt; 1,0 grammi; ipersensibilità nota ad uno qualsiasi dei componenti di bevacizumab; terapia precedente con bevacizumab, sorafenib, sunitinib oppure altre terapie mirate alla via di segnalazione del VEGF.
    E.5 End points
    E.5.1Primary end point(s)
    Coprimary endpoints: 1) PFS in the intention-to-treat population (all randomized patients) 2) PFS in the patients with high VEGF-A levels
    L’endpoint primario è la PFS della popolazione ITT, definita come il tempo trascorso dalla randomizzazione alla prima comparsa di progressione della malattia in base alla valutazione dello sperimentatore, determinata utilizzando i criteri RECIST v1.1, oppure al decesso per qualunque causa, a seconda dell’evento che si verifica per primo. L’endpoint co-primario è la PFS dei pazienti ITT con elevati livelli plasmatici di VEGF-A.
    E.5.1.1Timepoint(s) of evaluation of this end point
    The primary analysis of PFS will occur when both (I) 326 PFS events in all patients and (II) 146 PFS events in the VEGF-A high subgroup have been observed.
    L'analisi primaria di PFS verrà fatta quando si saranno osservati 326 eventi di PFS in tutti i pazienti e 146 eventi PFS nel sottogruppo con elevati livelli plasmatici di VEGF-A.
    E.5.2Secondary end point(s)
    1) Objective Response Rate 2) Duration of Objective Response 3) 1-year Survival Rate 4) Overall Survival
    1)Tasso di risposta obiettiva nei pazienti con malattia misurabile al basale, definita come risposta completa o parziale valutata dallo sperimentatore in base ai criteri RECIST v1.1. 2) Durata della risposta obiettiva per i pazienti con malattia misurabile al basale 3) Tasso di sopravvivenza a un anno 4) sopravvivenza complessiva
    E.5.2.1Timepoint(s) of evaluation of this end point
    1) Objective response, 2)duration of response, first IA of OS, AEs will be analyzed at the same time with final PFS. 3) Primary 1-year survival rate will be analyzed when OS crosses the boundary or at the time of final OS event maturity. 4) Final OS will also be conducted when both (I) 309 deaths in all patients and (II) 170 deaths in the VEGF-A high subgroup have been observed.
    Il tasso di risposta obiettiva, la durata della risposta obiettiva, la prima Analisi ad Interim di sopravvivvenza complessiva e gli ebventi avversi verranno valutati in contemporanea con la sopravvivenza libera da progressione; il tasso di sopravvivenza ad un anno sarà valutato quando la sopravvivenza complessiva supererà il valore limite o al completamento dell'vento di sopravvivenza complessiva. La valutazione finale della sopravvivenza complessiva sarà inoltre fatta quando si saranno verificate 309 morti tra tutti i pazienti e 170 morti nel sottogruppo con VEGF-A elevati
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Biomarker assessment
    misurazione dei biomarcatori
    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 No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    paclitaxel
    paclitaxel
    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 EEA38
    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
    Brazil
    Chile
    China
    Japan
    Korea, Republic of
    Panama
    Russian Federation
    Ukraine
    United States
    Vietnam
    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
    The end of the study is defined as the date when 309 deaths in the ITT population and 170 deaths in the VEGF-A high subgroup have been observed. The final OS data are expected to mature approximately 6.5 years after the first patient is randomized.
    la fine dello studio è definita la data in cui si osservano 309 morti tra la popolazione ITT e 170 morti nella popolazione VEGF-A high. Si prevede che lo studio durerà circa 6.5 anni dall'arruolamento del primo paziente
    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 months83
    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 months83
    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: 0
    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: 384
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 96
    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 state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 93
    F.4.2.2In the whole clinical trial 480
    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 sponsor will evaluate the appropriateness of continuing to provide bevacizumab to study patients after evaluating the primary efficacy outcome measures and gathering safety data in the study; these analyses may be conducted prior to completion of the study.
    lo sponsor valuterà la possibilità di continuare a fornire Bevacizumab ai pazienti dopo aver valutato l'esito di efficacia primaria e i dati di sicurezza dello studio. queste valutazioni verranno fatte prima del termine dello studio
    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 Decision2012-08-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-07-12
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2017-11-21
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