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    Summary
    EudraCT Number:2011-000211-64
    Sponsor's Protocol Code Number:H9H-MC-JBAJ
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2012-08-09
    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 number2011-000211-64
    A.3Full title of the trial
    A Phase 1b/2 Study with Gemcitabine and LY2157299 for
    Patients with Metastatic Cancer (Phase 1b) and Advanced
    or Metastatic Unresectable Pancreatic Cancer (Phase 2)
    Studio di fase 1b/2 sull'™uso di gemcitabina e LY2157299 in pazienti affetti da cancro metastatico (fase 1b) e cancro pancreatico metastatico non resecabile o in stadio avanzato (fase 2)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    This is an open-label, multicenter, nonrandomized Phase 1b study of oral
    administration of LY2157299 in combination with gemcitabine followed
    by a randomized, double-blind, Phase 2 study of oral administration of
    LY2157299 monohydrate in combination with gemcitabine versus gemcitabine plus placebo
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    A.4.1Sponsor's protocol code numberH9H-MC-JBAJ
    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 SponsorELI LILLY AND COMPANY
    B.1.3.4CountryUnited States
    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 supportEli Lilly and Company
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationEli Lilly and Company
    B.5.2Functional name of contact pointClinical Trial Information
    B.5.3 Address:
    B.5.3.1Street AddressLilly Corporate Center
    B.5.3.2Town/ cityIndianapolis, Indiana
    B.5.3.3Post code46285
    B.5.3.4CountryUnited States
    B.5.4Telephone number+ 1 317 277 6494
    B.5.5Fax number+ 1 317 276 9666
    B.5.6E-mailEU_Lilly_Clinical_Trials@lilly.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 nameLY2157299 monohydrate
    D.3.2Product code LY2157299
    D.3.4Pharmaceutical form Coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNLY2157299 monohydrate
    D.3.9.1CAS number 924898-09-9
    D.3.9.2Current sponsor codeLY2157299
    D.3.9.3Other descriptive nameLY2157299 monohydrate
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNLY2157299 monohydrate
    D.3.9.1CAS number 924898-09-9
    D.3.9.2Current sponsor codeLY2157299
    D.3.9.3Other descriptive nameLY2157299 monohydrate
    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 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 RoleComparator
    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 1000 mg
    D.2.1.1.2Name of the Marketing Authorisation holderEli Lilly and Company Limited
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    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 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 HYDROCHLORIDE
    D.3.9.1CAS number 122111-03-9
    D.3.9.4EV Substance CodeSUB02324MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    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 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 placeboTablet
    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
    Advanced or Metastatic Unresectable Pancreatic Cancer
    Cancro pancreatico metastatico non resecabile o in stadio avanzato
    E.1.1.1Medical condition in easily understood language
    Advanced (pancreatic) cancer that has failed standard treatment or for whom no standard treatment exists and/or is suitable for gemcitabine therapy (which cannot be treated by surgery)
    Carcinoma (pancreatico) avanzato che ha fallito il trattamento standard o privo di un trattamento standard e/o adatto per la terapia con gemcitabina (non trattabile chirurgicamente
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10033606
    E.1.2Term Pancreatic cancer non-resectable
    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 compare the overall survival (OS) of patients with Stage II to IV
    unresectable pancreatic cancer when treated with a combination of LY2157299 monohydrate and gemcitabine with that of gemcitabine plus placebo.
    Confronto tra la sopravvivenza totale (OS) dei pazienti affetti da cancro pancreatico non resecabile, di stadio da II a IV, trattati con LY2157299 monoidrato in combinazione con gemcitabina rispetto alla OS dei pazienti trattati con gemcitabina più placebo.
    E.2.2Secondary objectives of the trial
    - To compare LY2157299 monohydrate combined with gemcitabine to gemcitabine plus placebo;
    - To evaluate tolerability profile of LY2157299 monhydrate when administered in combination with gemcitabine
    • To evaluate the PK profile of LY2157299 monohydrate
    • To compare of LY2157299 monohydrate plus gemcitabine to gemcitabine plus placebo with regard to biomarker responses.
    PLEASE REFER TO THE PROTOCOL FOR FULL DESCRIPTION OF SECONDARY OBJECTIVES OF THE TRIAL
    • confronto tra LY2157299 monoidrato più gemcitabina e gemcitabina più placebo
    • valutazione del profilo di tollerabilità di LY2157299 monoidrato, quando somministrato in combinazione con gemcitabina;
    • valutazione del profilo PK di LY2157299 monoidrato;
    • confronto delle risposte dei biomarcatori associate alla somministrazione di LY2157299 monoidrato più gemcitabina rispetto a quelle associate alla somministrazione di gemcitabina più placebo.
    Fare riferimento al protocollo per il dettaglio completo degli obiettivi dello studio.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Have histological or cytological diagnosis of adenocarcinoma of the
    pancreas that is locally advanced (Stage II, III) or metastatic (Stage IV)and not amenable to resection with curative intent. Patients with
    previous radical surgery for pancreatic cancer are eligible after
    progression is documented. If they received adjuvant chemotherapy or
    chemoradiotherapy with gemcitabine, they can be enrolled if the
    treatment was completed 3 months before or longer.
    -Tumor tissue or unstained slides are available from original biopsy
    or resection or other tumor biopsies.
    Have measurable disease or non-measurable disease, defined according
    to RECIST
    - Males or females at least 18 years of age.
    - Have given written informed consent prior to any study-specific procedures
    - Have adequate organ function
    - Have a performance status of ≤2 on the Eastern Cooperative Oncology
    Group
    -Patients may have received previous adjuvant treatment with gemcitabine with or without radiotherapy for pancreatic cancer
    Adjuvant treatment must have finished at least 6 months before enrolling
    - patients must have recovered from any Grade 3/4 toxicities of previous therapies
    Are reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures
    Prior radiation therapy for treatment of cancer is allowed to <25% of the
    bone marrow (Cristy and Eckerman 1987), and patients must have
    recovered from the acute toxic effects of their treatment prior to study
    enrollment. Prior radiation to the whole pelvis is not allowed. Prior
    radiotherapy must be completed at least 4 weeks before study entry.
    Male and female patients with reproductive potential must use an
    approved contraceptive method, if appropriate, during and for 3 months
    after discontinuation of study treatment.
    Women of childbearing potential must have a negative beta-human
    chorionic gonadotropin pregnancy test documented within 14 days prior
    to treatment. If condoms are used as a barrier contraceptive, a
    spermicidal agent should be added to ensure that pregnancy does not
    occur. Should a woman become pregnant or suspect she is pregnant
    while participating in this study, she should inform her treating
    physician immediately.
    - diagnosi istologica o citologica di adenocarcinoma pancreatico, localmente avanzato (stadio II, III) o metastatico (stadio IV) e non adatto alla resezione a scopo curativo. I pazienti con pregresso intervento chirurgico radicale per il cancro pancreatico sono eleggibili dopo progressione documentata. Se hanno ricevuto chemioterapia adiuvante o chemioradioterapia con gemcitabina, possono essere arruolati se il trattamento è stato completato almeno 3 mesi prima.
    •Disponibilità di tessuto tumorale o di vetrini non colorati da originale biopsia o resezione o altre biopsie.
    •Presentano patologia misurabile o non misurabile, definita in base ai criteri RECIST;
    •Pazienti di sesso maschile o femminile di età pari o superiore a 18 anni.
    •firma del consenso informato scritto PRIMA di qualunque procedura di studio
    •Funzionalità degli organi adeguata
    •Performance status &lt;2 secondo la scala ECOG (Eastern Cooperative Oncology Group).
    •I pazienti possono aver ricevuto un precedente trattamento adiuvante con gemcitabina con o senza radioterapia per il cancro del pancreas
    Il trattamento adiuvante deve essere cessato da almeno 6 mesi prima dell' arruolamento nello studio
    •I pazienti devono essere recuperati da qualsiasi tossicità di grado 3/4 delle terapie precedenti
    • pazienti affidabili e disposti a rendersi disponibili per tutta la durata dello studio e a seguire le procedure di studio.
    •Precedente radioterapia per il trattamento del cancro è consentito su &lt;25% del midollo osseo (Cristy e Eckerman 1987) , ed i pazienti devono avere recuperato dagli effetti tossici acuti del loro trattamento prima dell'arruolamento nello studio.
    Precedente radiazioni di tutto il bacino non è permesso. La radioterapia precedente deve essere stata completata almeno 4 settimane prima dell'inizio dello studio.
    •Pazienti di sesso maschile e femminile in età fertile devono utilizzare un metodo contraccettivo accettabili per tutta la durata dello studio e per 3 mesi dopo l'interruzione del trattamento in studio.
    Le donne in età fertile devono avere un test di gravidanza negativo gonadotropina corionica beta-umana
    entro 14 giorni prima dell' inizio del trattamento. Se vengono utilizzati preservativi come metodo contraccettivo, deve essere aggiunto per assicurare uno agente spermicida per assicurarsi che non intervenga una gravidanza. Qualora una donna intraprenda una gravidanza o sospetti di essere incinta nel corso della partecipazione a questo studio, dovrebbe informare immediatamente il medico curante.
    E.4Principal exclusion criteria
    Patients will be excluded from the study if they meet any of the
    following criteria:
    Are currently enrolled in, or discontinued within the last 30 days from, a clinical trial involving an investigational product or nonapproved use of a drug or device (other than the investigational product used in this study), or concurrently enrolled in any other type of medical research
    judged not to be scientifically or medically compatible with this study.
    Have moderate or severe cardiac disease
    Are unable to swallow tablets or capsules.
    Are pregnant or breastfeeding.
    Have any significant medical illnesses that, in the investigator's opinion,
    cannot be adequately controlled with appropriate therapy or would
    compromise the patient?s ability to tolerate this therapy.
    Have a history of any other cancer (except non-melanoma skin cancer or
    carcinoma in-situ), unless in complete remission and off of all therapy
    for that disease for a minimum of 3 years.
    Have active infection that would interfere with the study objectives or
    influence study compliance.
    Endocrine pancreatic tumors or ampullary cancer.
    Patients with acute or chronic leukemia or with any other disease likely to have a significant bone marrow infiltration (screening not required).
    Have previously completed or withdrawn from this study or any other
    study investigating LY2157299 monohydrate or any other TGF-ß
    inhibitor.
    Have known allergy to LY2157299 monohydrate or gemcitabine or any
    ingredient of LY2157299 monohydrate or gemcitabine formulations.
    Are investigator site personnel directly affiliated with this study and/or their immediate families. Immediate family is defined as a spouse,parent, child, or sibling, whether biological or legally adopted.
    Saranno esclusi dallo studio pazienti che presentano uno delle seguenti condizioni:
    sono attualmente arruolati, o hanno interrotto la partecipazione negli ultimi 30 giorni, in uno studio clinico con un prodotto sperimentale o sull'uso non ancora approvato di un farmaco o un dispositivo (diverso dal prodotto sperimentale utilizzato in questo studio), o contemporaneamente arruolati in un qualsiasi altro tipo di ricerca medica giudicato non essere scientificamente o clinicamente compatibile con questo studio.
    - presenza di malattia cardiaca moderata o grave
    - non sono in grado di deglutire compresse o capsule.
    - donne in stato di gravidanza o l'allattamento.
    - presenza di qualunque condizione clinica significativa che, a giudizio del ricercatore, non può essere adeguatamente controllata con una terapia appropriata o potrebbe compromettere la capacità del paziente a tollerare questa terapia.
    - storia di qualsiasi altro cancro (eccetto il cancro non-melanoma della pelle o carcinoma in situ), se non in remissione completa ed è stata completamente conclusa ogni terapia
    per tale malattia per un minimo di 3 anni.
    - infezione attiva che potrebbe interferire con gli obiettivi di studio o influenzare la compliance dello studio.
    - Tumori endocrini del pancreas o cancro ampollare.
    - pazienti con leucemia acuta o cronica o con qualsiasi altra malattia che può avere una significativa infiltrazione del midollo osseo (screening non richiesto).
    - pazienti che hanno già completato o hanno interrotto questo studio o qualsiasi altro studio che ha valutato LY2157299 monoidrato o qualsiasi altro TGF-ß inibitore.
    - Allergia nota a LY2157299 monoidrato o gemcitabina o a qualsiasi ingrediente di LY2157299 monoidrato o formulazioni gemcitabina.
    - siano personale del centro direttamente collegata con questo studio / o loro nucleo familiare. Nucleo familiare è definito come coniuge, genitore, figlio, fratello o sorella, biologici o legalmente adottati.
    E.5 End points
    E.5.1Primary end point(s)
    Overall survival
    Sopravvivenza globale (OS)
    E.5.1.1Timepoint(s) of evaluation of this end point
    patient death (study anticipates Phase 2 patients will be in the
    study @ 6 months)
    decesso del paziente (lo studio prevede che i pazienti arruolati nella Fase 2 resteranno in studio circa 6 mesi)
    E.5.2Secondary end point(s)
    define LY2157299 monohydrate pharmacokinetics, investigate efficacy
    definire farmacocinetica di LY2157299 monoidrato, verificare l 'efficacia
    E.5.2.1Timepoint(s) of evaluation of this end point
    PK 4weeks efficacy - 8 weeks or until pt withdraws
    PK 4 settimane efficacia 8 settimane o fino a quando il pat resta 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 No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    explore biomarker response assoc.with LY2157299;eval. tolerability profile
    esplorare risposte biomarcatori associate a somministraz.di LY2157299 valutare tollerabil. LY215729
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled 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) Yes
    E.8.2.2Placebo No
    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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA25
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Canada
    United States
    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
    This Phase 1b/2 study will be considered complete following the completion of all data analyses (including any possible long-term follow-up survival analysis). The Lilly Clinical Research Physician will notify investigators in the event of study closure and the decision to stop collecting data
    Lo studio sarà considerato completo dopo completamento analisi dei dati (inclusi eventuali effetti a lungo termine follow-up analisi di sopravvivenza)Lilly notificherà gli sperimentatori dell'eventuale chiusura studio e interruzione raccolta dati
    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 months24
    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 months24
    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: 150
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 150
    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 125
    F.4.2.2In the whole clinical trial 150
    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)
    Not applicable as it is similar to the expected normal treatment
    Non applicabile in quanto è simile al normale trattamento previsto
    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 Decision2012-08-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-08-01
    P. End of Trial
    P.End of Trial StatusCompleted
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