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    Summary
    EudraCT Number:2016-002041-31
    Sponsor's Protocol Code Number:I4X-MC-JFDA
    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:2021-08-03
    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 number2016-002041-31
    A.3Full title of the trial
    A Single-Arm, Multicenter, Phase 2 Study of Gemcitabine-Carboplatin Chemotherapy Plus Necitumumab in the First-Line Treatment of Patients with Locally Advanced or Metastatic Squamous Non-Small Cell Lung Cancer (NSCLC)
    Studio di Fase 2, Multicentrico a Singolo Braccio di Chemioterapia con Gemcitabina-Carboplatino più Necitumumab come Trattamento di Prima Linea in Pazienti Affetti da Tumore al Polmone non a Piccole Cellule ( NSCLC) ad Istotipo Squamoso in Stadio Localmente Avanzato o Metastatico
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study of Gemcitabine-Carboplatin Chemotherapy Plus Necitumumab in the First-Line Treatment of Patients With Locally Advanced or Metastatic Squamous Non-Small Cell Lung Cancer
    Studio sulla chemioterapia di gemcitabina-carboplatino più necitumumab per
    il trattamento di prima linea di pazienti affetti da Tumore al Polmone non a Piccole Cellule ad istotipo squamoso in stadio localmente avanzato o metastatico
    A.3.2Name or abbreviated title of the trial where available
    na
    na
    A.4.1Sponsor's protocol code numberI4X-MC-JFDA
    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 & COMPANY, LILLY CORPORATE CENTER
    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
    B.5.2Functional name of contact pointClinical Trial Registry Office
    B.5.3 Address:
    B.5.3.1Street AddressLilly Corporate Center, DC 1526
    B.5.3.2Town/ cityIndianapolis
    B.5.3.3Post code46285
    B.5.3.4CountryUnited States
    B.5.4Telephone number+390554257386
    B.5.5Fax number+390554257348
    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 Yes
    D.2.1.1.1Trade name PORTRAZZA
    D.2.1.1.2Name of the Marketing Authorisation holderELI LILLY NEDERLAND B.V.
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 INNNecitumumab
    D.3.9.1CAS number 906805-06-9
    D.3.9.2Current sponsor codena
    D.3.9.4EV Substance CodeSUB33032
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number16
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product 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 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
    D.2.1.1.2Name of the Marketing Authorisation holderELI LILLY AND COMPANY LIMITED
    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 Powder for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNGEMCITABINE
    D.3.9.1CAS number 95058-81-4
    D.3.9.2Current sponsor codeNA
    D.3.9.4EV Substance CodeSUB07892MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/m2 milligram(s)/square meter
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1250
    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 CARBOPLATIN KABI
    D.2.1.1.2Name of the Marketing Authorisation holderFRESENIUS KABI
    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 INNCARBOPLATIN
    D.3.9.2Current sponsor codeNA
    D.3.9.4EV Substance CodeSUB06614MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number750
    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
    Locally Advanced or Metastatic Squamous Non-Small Cell Lung Cancer (NSCLC)
    Tumore al Polmone non a Piccole Cellule ( NSCLC) ad istotipo squamoso in stadio Localmente avanzato o Metastatico
    E.1.1.1Medical condition in easily understood language
    Lung Cancer
    Tumore al Polmone
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10061873
    E.1.2Term Non-small cell lung 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 this study is to evaluate the ORR (CR + PR) associated with gemcitabine-carboplatin plus necitumumab in patients with locally advanced or metastatic EGFR expressing squamous NSCLC who have not received prior chemotherapy for this condition.
    L'obbiettivo primario di questo studio è valutare il tasso di risposta obiettiva (ORR) (risposta completa [CR] + risposta parziale [PR])
    associato a gemcitabina-carboplatino più necitumumab in pazienti
    con NSCLC squamoso esprimente EGFR in stadio avanzato o metastatico
    che non hanno ricevuto una chemioterapia precedente per questa condizione.
    E.2.2Secondary objectives of the trial
    The secondary objectives of this study are:
    • to evaluate OS, PFS, and DCR;
    • to evaluate the safety profile of necitumumab in combination with gemcitabine-carboplatin chemotherapy;
    • to characterize the PK of necitumumab.

    Gli obbiettivi secondari del presente studio sono:
    • valutare OS, PFS e DCR;
    • valutare il profilo di sicurezza di necitumumab associato a
    chemioterapia a base di gemcitabina-carboplatino;
    • caratterizzare la PK di necitumumab.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Have confirmed diagnosis of locally advanced or metastatic NSCLC predominantly squamous histology. Squamous NSCLC diagnosis must be
    confirmed by histology or cytology local pathology report.
    - Has an EGFR protein expressing tumor (defined by local IHC test).
    - Measurable disease at the time of study entry as defined by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) 
    - Has tumor tissue available for biomarker analyses.
    - Has resolution of all clinically significant toxic effects of prior adjuvant and/or neoadjuvant chemotherapy, surgery, radiotherapy (with the exception of alopecia) to Grade =1 by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 4.0.
    - Has an Eastern Cooperative Oncology Group performance status (ECOG PS) score of 0-1 
    - Have discontinued all previous treatments for cancer and recovered from the acute effects of therapy (Biologic agents (for example, antibodies) and Immunotherapy >=4 weeks; Chest radiotherapy >= weeks; Major surgery, excluding biopsy >=4 weeks)
    - Diagnosi confermata di NSCLC localmente avanzato o metastatico
    con istologia prevalentemente squamosa. La diagnosi di NSCLC squamoso deve essere
    confermata da un referto patologico istologico o citologico locale.
    - Presenza di un tumore esprimente la proteina EGFR (definito in base a un'analisi immunoistochimica locale).
    - Malattia misurabile al momento dell'ingresso nello studio definita in base ai Criteri
    di valutazione della risposta nei tumori solidi versione 1.1 (RECIST 1.1)
    - Disponibilità di tessuto tumorale per le analisi dei biomarcatori.
    - Risoluzione di tutti gli effetti tossici clinicamente significativi di precedente terapia
    adiuvante e/o chemioterapia neoadiuvante, intervento chirurgico, radioterapia (ad eccezione
    dell'alopecia) al grado =1 secondo i Criteri comuni della terminologia per gli eventi avversi
    del National Cancer Institute (NCI-CTCAE), versione
    4.0.
    - Punteggio del performance status dell’Eastern Cooperative Oncology Group (PS ECOG) di 0-1
    - Avere interrotto tutti i trattamenti antitumorali precedenti ed essersi ripresi
    dagli effetti acuti della terapia (agenti biologici (ad esempio
    anticorpi) e immunoterapia >=4 settimane; radioterapia toracica >=
    settimane; intervento chirurgico importante >=4 settimane)
    E.4Principal exclusion criteria
    - Has nonsquamous NSCLC
    - Has received prior anticancer therapy targeting the EGFR, vascular
    endothelial growth factor (VEGF), or VEGF receptor
    - Has received previous chemotherapy (including concurrent
    chemoradiation) for advanced NSCLC (patients who have received adjuvant
    and/or neoadjuvant chemotherapy are eligible if the last administration
    occurred at least 1 year prior to start of therapy).
    - Has undergone major surgery or received any investigational
    therapy in the 4 weeks prior to study enrollment.
    - Has undergone chest irradiation within 4 weeks prior to study
    enrollment (except palliative irradiation of bone lesions, which is allowed).
    - Has brain metastases that are symptomatic or require ongoing treatment with steroids or anticonvulsants.
    - Has a bleeding tumor
    - History of arterial or venous thromboembolism within 3 months prior to study enrollment.  
    - Has a history or evidence of current clinically-relevant coronary artery disease of current = Class III as defined by Canadian Cardiovascular Society Angina Grading Scale (Campeau 1976) or congestive heart failure of current = Class III as defined by the New York Heart Association. 
    - Has experienced myocardial infarction within 6 months prior to study enrollment. 
    - Avere NSCLC ad istotipo non squamoso
    - Avere ricevuto una precedente terapia antitumorale mirata contro EGFR, al fattore
    di crescita endoteliale vascolare (VEGF) o al recettore di VEGF
    - Avere ricevuto una precedente chemioterapia (compresa chemioradioterapia
    concomitante) per il NSCLC in stadio avanzato (i pazienti che hanno ricevuto
    una chemioterapia
    adiuvante e/o neoadiuvante sono idonei purché l'ultima somministrazione
    sia avvenuta almeno 1 anno prima dell'avvio della terapia).
    -Aver avuto Intervento chirurgico importante o una terapia sperimentale nelle 4 settimane precedenti all’arruolamento nello studio.
    - Irradiazione toracica nelle 4 settimane precedenti all’arruolamento
    nelllo studio (tranne nel caso di irradiazione palliativa di lesioni ossee,
    che è consentita).
    - Presenza di metastasi cerebrali sintomatiche o che richiedono un trattamento
    continuativo con steroidi o anticonvulsivanti.
    - Presenza di un tumore sanguinante
    - Anamnesi di tromboembolismo arterioso o venoso nei 3 mesi precedenti all'arruolamentoallo studio.
    - Anamnesi o evidenza di coronaropatia attuale clinicamente rilevante
    attualmente = Classe III secondo la definizione della Scala di classificazione dell'angina della
    Canadian Cardiovascular Society (Campeau 1976) o di insufficienza cardiaca
    congestizia attualmente = Classe III secondo la definizione della New York Heart
    Association.
    - Infarto miocardico nei 6 mesi precedenti all'arruolamento
    allo studio.
    E.5 End points
    E.5.1Primary end point(s)
    ORR (CR + PR) based on tumor assessment using RECIST 1.1
    ORR (CR + PR) in base alla valutazione del tumore secondo i criteri RECIST 1.1
    E.5.1.1Timepoint(s) of evaluation of this end point
    Approximately 6 months after enrolment completion.
    Circa 6 mesi dopo il termine dell'arruolamento
    E.5.2Secondary end point(s)
    Secondary efficacy endpoints will include:
    . OS
    . PFS
    . DCR (CR, PR, and SD) based on tumor assessment using RECIST 1.1
    The safety endpoints evaluated will include but are not limited to the
    following:
    . TEAEs, AEs, SAEs, and hospitalizations
    . Clinical laboratory tests, ECGs, vital signs, and physical examinations
    Assess PK parameters for necitumumab
    Gli endpoints di efficacia secondari includeranno:
    . OS
    . PFS
    . DCR (CR, PR e SD) in base alla valutazione del tumore secondo i criteri RECIST 1.1
    Gli endpoints di sicurezza valutati comprenderanno, tra gli
    altri:
    . TEAEs, EAAEs, EAG SAEs e ricoveri ospedalieri
    . Analisi cliniche di laboratorio, ECG, parametri vitali ed esami obbiettivi
    Valutare i parametri di PK per necitumumab
    E.5.2.1Timepoint(s) of evaluation of this end point
    Safety: An interim safety analysis will be performed when at least 15 pts
    have completed at least 2 cycles (or otherwise discontinued study treatment).
    Sicurezza: Un'analisi ad interim della sicurezza verrà eseguita quando almeno 15 pazienti
    avranno completato almeno 2 cicli (o altrimenti interrotto il trattamento dello studio).
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic Yes
    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) 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 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 No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA20
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Russian Federation
    Turkey
    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 study occurs after study completion and when the last patient has discontinued study treatment and completed any applicable continued access follow-up procedures (last patient last visit).
    La fine dello studio avviene dopo il completamento dello studio e quando
    l'ultimo paziente ha interrotto il trattamento dello studio e ha terminato tutte le eventuali
    procedure di follow-up di accesso esteso (ultima visita dell'ultimo paziente).
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months9
    E.8.9.1In the Member State concerned days15
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months9
    E.8.9.2In all countries concerned by the trial days15
    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: 44
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 6
    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 state4
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 32
    F.4.2.2In the whole clinical trial 50
    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)
    None
    None
    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 Decision2016-09-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-11-09
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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