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    Summary
    EudraCT Number:2012-004301-27
    Sponsor's Protocol Code Number:NIBIT-M2
    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:2012-10-30
    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 number2012-004301-27
    A.3Full title of the trial
    A randomized, Phase III study of Fotemustine versus the Combination of Fotemustine and Ipilimumab in Patients with Metastatic Melanoma with brain metastasis
    Studio randomizzato di fase III di confronto tra Fotemustina e la combinazione di Fotemustina e Ipilimumab in pazienti con Melanoma metastatico con metastasi cerebrali
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A randomized, Phase III study of Fotemustine versus the Combination of Fotemustine and Ipilimumab in Patients with Metastatic Melanoma with brain metastasis
    Studio randomizzato di fase III di confronto tra Fotemustina e la combinazione di Fotemustina e Ipilimumab in pazienti con Melanoma metastatico con metastasi cerebrali
    A.3.2Name or abbreviated title of the trial where available
    NIBIT-M2
    NIBIT-M2
    A.4.1Sponsor's protocol code numberNIBIT-M2
    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 SponsorFONDAZIONE NIBIT
    B.1.3.4CountryItaly
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportBristol Myers Squibb
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAzienda Ospedaliera Universitaria Senese
    B.5.2Functional name of contact pointMedical Oncology and Immunotherapy
    B.5.3 Address:
    B.5.3.1Street AddressViale Bracci, 14
    B.5.3.2Town/ citySiena
    B.5.3.3Post code53100
    B.5.3.4CountryItaly
    B.5.4Telephone number0577-586069
    B.5.5Fax number0577-586303
    B.5.6E-maila.digiacomo@ao-siena.toscana.it
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation 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 nameIpilimumab
    D.3.2Product code BMS-734016
    D.3.4Pharmaceutical form 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 INNIPILIMUMAB
    D.3.9.1CAS number 477202009
    D.3.9.2Current sponsor codeBMS734016
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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 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 Yes
    D.3.11.13.1Other medicinal product typeProteina ricombinante
    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
    Subjects (men and women) 18 years old presenting with Stage IV melanoma with presence of brain metastasis
    Soggetti (uomini e donne) ≥ 18 anni con melanoma di stadio IV con presenza di metastasi cerebrali
    E.1.1.1Medical condition in easily understood language
    Patients with melanoma (presence of brain metastasis)
    Pazienti con melanoma con prezenza di metastasi al cervello
    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 PT
    E.1.2Classification code 10025671
    E.1.2Term Malignant melanoma stage IV
    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 efficacy of the combination of ipilimumab and fotemustine versus fotemustine in terms of overall survival (OS) in patients with metastatic melanoma with brain metastasis
    Paragonare l’efficacia della combinazione ipilimumab più fotemustna vs fotemustina da sola in termini di sopravvivenza globale (OS) in pazienti con melanoma metastatico con metastasi cerebrali
    E.2.2Secondary objectives of the trial
    To assess safety, tolerability and feasibility of the combination.

    To further describe efficacy using the following tumor response indicators and clinical endpoints (with modified WHO – mWHO - tumor response criteria and with immune-related response criteria - irRC):
    a) Disease Control rate (DCR) in and outside the brain;
    b) Progression-Free Survival (PFS); three- and 6-months brain PFS rates;
    c) Objective Response Rate, Duration of response, Time to response;
    To evaluate HRQoL

    To assess the pharmacodynamic effects of ipilimumab and fotemustine in combination on Absolute Lymphocyte Count (ALC).

    To assess associations between ALC and anti-tumor activity of ipilimumab and fotemustine in combination.

    Translational studies
    a) To investigate changes in melanoma-specific humoral immune responses
    Valutare la sicurezza, la tollerabilità e la fattibilità della combinazione
    Descrivere ulteriormente l’efficacia utilizzando i seguenti indicatori di risposta tumorale ed endpoint clinici (con criteri WHO modificati – mWHO – e con criteri di risposta immunocorrelati – irRC):
    a) Tasso di controllo della malattia (DCR) all’interno e al di fuori del cervello
    b)Sopravvivenza libera da progressione (PFS); tassi di PFS a 3 e a 6 mesi;
    c)Tasso di risposta obiettivo, durata della risposta, tempo di risposta;
     Valutare l’HRQoL
     Valutare gli effetti farmacodinamici di ipilimumab e fotemustina in combinazione sulla Conta Assoluta dei Linfociti (ALC)
     Valutare le associazioni tra ALC e l’attività antitumorale di ipilimumab e fotemustina in combinazione
     Studi traslazionali
    a)Investigare i cambiamenti nelle risposte immunitarie umorali specifiche del melanoma
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    OTHER SUBSTUDIES:
    A) changes in melanoma-specific humoral immune responses
    B) changes in the phenotypic profile of PBMC and the frequency of selected PBMC subsets
    C) changes in T cell subpopulations within PBMC
    ALTRI SOTTOSTUDI:
    A) cambiamenti nelle risposte umorali melanoma-specifici
    B) modificazioni del profilo fenotipico di PBMC e la frequenza di determinati sottoinsiemi PBMC
    C) variazioni sottopolazione cell. T in PBMC
    E.3Principal inclusion criteria
    1) Signed Written Informed Consent
    a) Willing and able to give written informed consent.
    2) Target Population
    a) Histologic diagnosis of malignant melanoma;
    b) Stage IV melanoma;
    c) No prior therapy for advanced (unresectable Stage III or Stage IV) disease;
    d) No previous systemic corticosteroid therapy within 7 days; steroids for symptoms related to brain disease, developed during treatment are allowed;
    e) Prior adjuvant treatment with IFN or other immunotherapy allowed with exception of anti-CTLA-4;
    f) Presence of asymptomatic brain metastases: patients must have measurable metastases in the brain, defined as lesions that can be accurately measured in 2 dimensions as ≥ 0.5 cm (maximum 2 cm) in the brain MRI with contrast;
    g) Pts who have been previously treated with brain stereotactic radiotherapy (SRT), whole-brain radiotherapy (WBRT) and/or surgery, must have developed new measurable brain lesions;
    h) Have a full set of baseline (i.e., Screening) digital images of cutaneous lesions and radiographic images, including, but not limited to: MRI of brain, CT of chest, abdomen, pelvis and soft tissue. All images must be of adequate quality as detailed in Section 6.4.1 of the protocol;
    i) Life expectancy 12 weeks;
    j) ECOG performance status of 0 or 1;
    k) Required values for initial laboratory tests:
    i) WBC >=3500/uL
    ii) ANC >=2000/uL
    iii) Platelets >=100 x 103/uL
    iv) Hemoglobin >=9 g/dL
    v) Creatinine <=2.5 x ULN
    vi) AST <=2.5 x ULN for patients without liver metastasis
    <= 5 x ULN for patients with liver metastasis
    vii) Bilirubin <= 1.5 x ULN for patients without liver metastasis
    <= 3 x ULN for patients with liver metastasis
    < 3.0 mg/mL for patients with Gilbert’s Syndrome
    Negative screening tests for HIV, Hepatitis B, and Hepatitis C. If positive results are not indicative of true active or chronic infection, the patient can enter the study after discussion and agreement between the Investigator and clinical monitor.
    3) Age and Sex
    a) Men and women, of and over 18 years old.
    Women of childbearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study and for up to 8 weeks after the study in such a manner that the risk of pregnancy is minimized.
    WOCBP include any female who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or is not postmenopausal. Post menopause is defined as:
    (1) Amenorrhea >=12 consecutive months without another cause or
    (2) For women with irregular menstrual periods and on hormone replacement therapy (HRT), a documented serum follicle stimulating hormone (FSH) level > 35 mIU/mL
    a) Consenso informato scritto firmato dal paziente prima di qualsiasi procedura dello studio;
    b) Pazienti maschi o femmine di età ≥ 18 anni al momento della sottoscrizione del modulo di consenso informato;
    c) Pazienti con diagnosi di melanoma in stadio IV, confermato istologicamente;
    d) Non è permessa alcuna terapia precedente per il melanoma di stadio III non resecabile o stadio IV
    e) Non è consentita nessuna terapia sistemica con corticosteroidi nei 7 giorni precedenti
    f) Pazienti in trattamento adiuvante con IFN o altra immunoterapia altro ad eccezione degli anti-CTLA-4;
    g) Presenza di metastasi cerebrali asintomatiche: i pazienti devono avere metastasi misurabili nel cervello, definito come lesioni che possono essere accuratamente misurate in 2 dimensioni come ≥ 0,5 cm (massimo 2 cm) utilizzando la risonanza magnetica(brain MRI) con mezzo di contrasto;
    h) Pazienti che sono stati precedentemente trattati con radioterapia stereotassica cerebrale (SRT), radioterapia panencefalica (whole-brain radiotherapy WBRT) e / o un intervento chirurgico, e che hanno sviluppato nuove lesioni cerebrali misurabili
    i) La serie completa di immagini radiografiche e digitali di lesioni cutanee al basale (MRI del cervello, CT del torace, addome, pelvi e dei tessuti molli.). Tutte le immagini devono essere di qualità adeguata come descritto nella sezione 6.4.1 del protocollo;
    j) Aspettativa di vita ≥ 12 settimane
    k) Performance status secondo Eastern Cooperative Oncology Group (ECOG) pari a 0 o 1;
    l) Adeguata funzionalità ematologica, renale ed epatica, come definita in base ai valori di laboratorio sotto indicati:
    i) Conta dei globuli bianchi  3500/uL
    ii) Conta dei globuli rossi  2000/uL
    iii) Conta piastrinica  100 x 103/uL
    iv) Emoglobina  9 g/dL
    v) Creatinina sierica  2.5 volte il limite superiore di normalità (ULN)
    vi) Aspartato aminotrasferasi  2.5 volte l’ULN per pazienti senza metastasi epatiche
     5 volte l’ ULN per pazienti con metastasi epatiche
    vii) Bilirubina totale  1.5 volte l’ ULN per pazienti senza metastasi epatiche
     3 volte l’ULN per pazienti con metastasi epatiche
    &lt; 3.0 mg/mL per pazienti con Gilbert’s Syndrome
    viii) Test negativi per HIV, HBV e HCV. Se i test risultano positivi, ma non indicativi di infezione acuta o cronica, il paziente può entrare nello studio, dopo discussione con il Principal investigator.
    ix) Donne potenzialmente fertili devono adottare un metodo contraccettivo adeguato per l’intero periodo dello studio e fino a 8 settimane dopo l’ultima somministrazione, in modo tale da ridurre il rischio di gravidanza.
    E.4Principal exclusion criteria
    1) Sex and Reproductive Status
    a) WOCBP who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for up to 8 weeks after the study;
    b) Women who are pregnant or breastfeeding;
    c) Women with a positive pregnancy test on enrollment or prior to investigational product administration;
    d) Sexually active fertile men not using effective birth control if their partners are WOCBP.
    2) Target Disease Exceptions
    a) Any malignancy from which the patient has been disease-free for less than 5 years, with the exception of adequately treated and cured basal or squamous cell skin cancer, superficial bladder cancer, carcinoma in situ of the cervix;
    b) Primary ocular or mucosal melanoma.
    3) Medical History and Concurrent Diseases
    a) Symptomatic brain metastases requiring immediate local intervention (radiotherapy (RT) and/or surgery);
    b) Leptominingeal involvement by disease;
    c) Autoimmune disease: Patients with a documented history of Inflammatory Bowel Disease, including ulcerative colitis and Crohn’s disease are excluded from this study as are patients with a documented history of symptomatic autoimmune disease (eg, rheumatoid arthritis, systemic progressive sclerosis [scleroderma], Systemic Lupus Erythematosus, autoimmune vasculitis [eg, Wegener’s Granulomatosis] and autoimmune hepatitis. Subjects with motor neuropathy considered of autoimmune origin (eg, Guillain-Barre Syndrom) are also excluded from this study;
    d) Any underlying medical condition, which in the opinion of the investigator, will make the administration of study drug hazardous or obscure the interpretation of adverse events, such as a condition associated with frequent diarrhea.
    4) Prohibited Treatments and/or Therapies
    a) Concomitant therapy with any anti-cancer agent; immunosuppressive agents; any non-oncology vaccine therapy used for prevention of infectious diseases (for up to 1 month prior to or after any dose of study drug); surgery or radiotherapy (except as described in Sections 5.5.1 and 5.5.2); other investigational anti-cancer therapies; or chronic use of systemic corticosteroids (used in the management of cancer or non-cancer-related illnesses);
    b) Previous treatment with other investigational products, including cancer immunotherapy, within 30 days;
    c) Prior treatment with anti-CTLA-4 and/or fotemustine.
    5) Other Exclusion Criteria
    a) Prisoners or subjects who are involuntarily incarcerated;
    b) Subjects who are compulsorily detained for treatment of either a psychiatric or physical (eg, infectious disease) illness.
    a) Non sono ammessi al presente studio: le donne in età riproduttiva che non vogliono, o non possono, adottare un metodo accettabile per prevenire la gravidanza durante l'intero periodo dello studio e fino a 8 settimane dopo l'ultima somministrazione dell'infusione; le donne in stato di gravidanza, le donne che allattano, le donne con test di gravidanza positivo al momento dell'arruolamento nello studio o prima della somministrazione del farmaco in studio ed i maschi fertili sessualmente attivi le cui partner sono in età riproduttiva, a meno che non adottino un metodo adeguato di controllo delle nascite;
    b) Nessuna neoplasia secondaria negli ultimi 5 anni, ad eccezione del carcinoma in situ della cervice e del carcinoma basocellulare o squamoso della pelle risolti con la chirurgia;
    c) Pazienti con melanoma oculare e mucoso;
    d) Metastasi cerebrali sintomatiche che richiedono un immediato intervento locale (radioterapia e/o chirurgia);
    e) Assenza di patologia autoimmune: i pazienti con anamnesi documentata di malattia intestinale infiammatoria, compresi colite ulcerosa e morbo di Crohn sono esclusi dal presente studio; sono inoltre esclusi i pazienti con anamnesi di malattia sintomatica (ad esempio, artrite reumatoide, sclerosi progressiva sistemica [sclerodermia], lupus eritematoso sistemico, vasculite autoimmune [granulomatosi di Wegener]), e epatite autoimmune. Pazienti con neuropatia motoria considerata di origine autoimmune (Sindrome Guillain-Barrè) sono esclusi dallo studio
    f) I pazienti non devono presentare una patologia medica o psichiatrica di base che, a parere dello Sperimentatore, renderebbe pericolosa la somministrazione del farmaco in studio o renderebbe incerta l'interpretazione degli eventi avversi o dell'efficacia, ad esempio una condizione associata a diarrea frequente;
    g) Nessuna terapia precedente o concomitante con antitumorali, immunosoppressivi; altre terapie vaccinali non oncologiche per la prevenzione delle malattie infettive (fino ad 1 mese prima o dopo qualsiasi dose del farmaco in studio); chirurgia o radioterapia (ad eccezione di quanto descritto nelle Sezioni 5.5.1 e 5.5.2 del protocollo); altre terapie antitumorali sperimentali od uso cronico di corticosteroidi sistemici (utilizzati per la gestione del tumore o di patologie non tumorali);
    h) Il trattamento precedente con altri farmaci sperimentali, inclusa l’immunoterapia, a meno che l’ultima dose sia stata somministrata almeno 30 giorni prima della registrazione nello studio;
    i) Nessun precedente trattamento con anti- CTLA-4 e/o fotemustina;
    j) Nel presente studio non devono essere arruolati detenuti o pazienti in ricovero coatto (internamento involontario) per il trattamento di una patologia psichiatrica o fisica (ad esempio, malattia infettiva).
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint in this study will be overall survival (OS) of fotemustine versus the combination of ipilimumab and fotemustine in patients with metastatic melanoma with brain metastasis.
    L'endpoint primario di questo studio sarà la sopravvivenza globale (OS) della fotemustina rispetto alla combinazione di ipilimumab e fotemustina nei pazienti con melanoma metastatico con metastasi al cervello.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Tumor assessment with radiographic imaging (e.g. MRI of brain, CT of chest, abdomen, pelvis, other soft tissues) and digital photographs of skin lesions will be performed for all subjects at Screening, week 12, then every 8 weeks at weeks 20, 28, 36 and every 12 weeks from week 36 onwards, for all non-progressing subjects.
    At each evaluation investigators will assess the overall response (complete response (CR), partial response (PR), stable disease (SD) or Progressive Disease (PD) (as categorized by mWHO and irRC).
    la valutazione del tumore sarà effettuata con esami radiologici (ad es. RMN del cervello, TAC di torace, addome, pelvi, altri tessuti molli) e foto digitali delle lesioni cutanee allo Screening, alla settimana 12 e poi ogni 8 settimane alle settimane 20, 28, 36 e ogni 12 settimane dalla settimana 36 in poi per tutti i soggetti senza progressione di malattia.
    Ad ogni valutazione gli sperimentatori stimeranno la risposta globale (risposta completa (CR), risposta parziale (PR), stabilità della malattia (SD) o progressione della malattia (PD) come sono classificate dalle mWHO e dall’irRC).
    E.5.2Secondary end point(s)
    Secondary endpoints include: To assess safety, tolerability and feasibility of the combination: all subjects who receive at least 1 dose of study treatment will be evaluated for safety parameters To further describe efficacy using the following tumor response indicators and clinical endpoints (with modified WHO – mWHO - tumor response criteria and with immune-related response criteria - irRC):
    a) Disease Control Rate (DCR) in and outside the brain;
    b) Progression-free Survival; three- and 6-months brain progression-free survival rates;
    c) Objective Response Rate, Duration of response, Time to response; To evaluate HRQoL
    Sopravvivenza libera da progressione, e velocità di progressione delle metastasi al cervello a tre e 6 mesi.

    Tasso di risposta obiettiva, durata della risposta, tempo di risposta

    Valutazione HRQoL
    Gli endpoint secondari includono:
    Valutare la sicurezza, la tollerabilità e la fattibilità della combinazione: tutti i soggetti che ricevono almeno 1 dose del trattamento in studio saranno valutati per i parametri di sicurezza

    Per descrivere ulteriormente l'efficacia utilizzando i seguenti indicatori di risposta del tumore e gli endpoint clinici (con modifica OMS - mWHO - i criteri di risposta del tumore e con immuno-correlati criteri di risposta - IRRC):
    Malattia Rate Control (DCR) e al di fuori del cervello;
    E.5.2.1Timepoint(s) of evaluation of this end point
    Tumor assessment with radiographic imaging (e.g. MRI of brain, CT of chest, abdomen, pelvis, other soft tissues) and digital photographs of skin lesions will be performed for all subjects at Screening, week 12, then every 8 weeks at weeks 20, 28, 36 and every 12 weeks from week 36 onwards, for all non-progressing subjects.
    At each evaluation investigators will assess the overall response (complete response (CR), partial response (PR), stable disease (SD) or Progressive Disease (PD) (as categorized by mWHO and irRC).
    la valutazione del tumore sarà effettuata con esami radiologici (ad es. RMN del cervello, TAC di torace, addome, pelvi, altri tessuti molli) e foto digitali delle lesioni cutanee allo Screening, alla settimana 12 e poi ogni 8 settimane alle settimane 20, 28, 36 e ogni 12 settimane dalla settimana 36 in poi per tutti i soggetti senza progressione di malattia.
    Ad ogni valutazione gli sperimentatori stimeranno la risposta globale (risposta completa (CR), risposta parziale (PR), stabilità della malattia (SD) o progressione della malattia (PD) come sono classificate dalle mWHO e dall’irRC).
    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 Yes
    E.6.13.1Other scope of the trial description
    feasibility 'of the combination
    fattibilita' della combinazione
    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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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 concerned10
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    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
    ND
    ND
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned 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: 160
    F.1.3Elderly (>=65 years) No
    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 state160
    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)
    ND
    ND
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2012-11-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-10-29
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2023-09-27
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