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    Summary
    EudraCT Number:2010-024266-21
    Sponsor's Protocol Code Number:IEOS582/111
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2011-12-19
    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 number2010-024266-21
    A.3Full title of the trial
    A phase II study of metronomic oral chemotherapy with cyclophosphamide plus capecitabine and vinorelbine in metastatic breast cancer patients
    Studio di fase II di terapia orale metronomica con Vinorelbina, Ciclofosfamide e Capecitabina per il trattamento di pazienti con tumore della mammella metastatico
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A phase II study evaluating the role of the combination of Vinorelbine,cyclophosphamide and capecitabine administered metronomically, that means low doses daily orally, in patients with advanced breast cancer
    Studio di fase II che valuta il ruolo della combinazione di tre farmaci chemioterapici Vinorelbina, Ciclofosfamide e Capecitabina, somministrati in modalita' metronomica, ossia a basse dosi date quotidianamente per bocca, alle pazienti affette da carcinoma della mammella metastatico
    A.4.1Sponsor's protocol code numberIEOS582/111
    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 SponsorISTITUTO EUROPEO DI ONCOLOGIA
    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 supportIstituto Europeo Oncologia
    B.4.2CountryItaly
    B.4.1Name of organisation providing supportPIERRE FABRE
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationIstituto Europeo Oncologia
    B.5.2Functional name of contact pointUfficio studi clinici
    B.5.3 Address:
    B.5.3.1Street Addressvia Ramusio 1
    B.5.3.2Town/ cityMilano
    B.5.3.3Post code20141
    B.5.3.4CountryItaly
    B.5.4Telephone number02 57 48 98 48
    B.5.5Fax number02 57 48 97 81
    B.5.6E-mailufficio.studiclinici@ieo.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 Yes
    D.2.1.1.1Trade name ENDOXAN BAXTER*50CPR RIV 50MG
    D.2.1.1.2Name of the Marketing Authorisation holderBAXTER SpA
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 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 INNCYCLOPHOSPHAMIDE MONOHYDRATE
    D.3.9.1CAS number 6055192
    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 Yes
    D.3.11.13.1Other medicinal product typeANTINEOPLASTICI
    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 NAVELBINE*1CPS 30MG
    D.2.1.1.2Name of the Marketing Authorisation holderPIERRE FABRE PHARMA Srl
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 Capsule
    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 INNVINORELBINE DITARTRATE
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number30
    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 Yes
    D.3.11.13.1Other medicinal product typeantineoplastico
    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 NAVELBINE*1CPS 20MG
    D.2.1.1.2Name of the Marketing Authorisation holderPIERRE FABRE PHARMA Srl
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 Capsule
    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 INNVINORELBINE DITARTRATE
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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 Yes
    D.3.11.13.1Other medicinal product typeantineoplastico
    D.IMP: 4
    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 XELODA*120CPR RIV 500MG
    D.2.1.1.2Name of the Marketing Authorisation holderROCHE SpA
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 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 INNCAPECITABINE
    D.3.9.1CAS number 154361-50-9
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number500
    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 Yes
    D.3.11.13.1Other medicinal product typeCHEMIOTERAPICO
    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
    Metastatic breast cancer
    Tumore della mammella metastatico
    E.1.1.1Medical condition in easily understood language
    Metastatic breast cancer
    Tumore della mammella metastatico
    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 10055113
    E.1.2Term Breast cancer metastatic
    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 assess safety and efficacy of the combination
    Valutare l'efficacia e sicurezza della combinazione
    E.2.2Secondary objectives of the trial
    To assess the efficacy of VEX combination in terms of overall clinical benefit, defined as the objective response rate plus the rate of stable disease lasting longer than 24 weeks.
    Valutare l’efficacia in termini di Overall Clinical Benefit definito come Objective Response Rate (ORR) + SD superiori a 24 settimane.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Pre- or post-menopausal women (age ≥18 years) with histologically or citologically (cell block) proven, locally advanced (inoperable) or metastatic breast carcinoma. Immunohistochemical evaluation of ER, PgR, HER2, and EGFR according to EIO (European Institute of oncology) guidelines is mandatory.
    - Patients with ER>1% and/or PgR >1%
    - Patients with HER-2/neu overexpressed tumors, are eligible if they had received previous trastuzumab therapy for advanced disease, and/or a treatment with anti HER2 targeted therapy.
    - Patients fulfilling one of the following criteria:
    - Patients with measurable disease as per RECIST 1.1 criteria. This is defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as ≥ 20 mm with conventional techniques or as ≥ 10 mm with spiral CT scan
    - Patients with bone lesions, lytic or mixed (lytic + sclerotic), in the absence of measurable disease as defined by RECIST 1.1 criteria. Bone lesions must be evaluable by plain CT or MRI. Patients with lesions identified only on radionucleotide bone scan are not eligible.
    - Patients may have received any primary and/or adjuvant therapies, as any previous lines of chemotherapy and endocrine therapy for advanced disease. Patients may have received metronomic capecitabine, methotrexate and cyclophosphamide in adjuvant setting at least 12 months before study entry
    - Previous treatment with capecitabine, cyclophosphamide and vinorelbine not in metronomic schedule for advanced disease is allowed, provided that the patient has progressive disease at study entry and the patients should not be defined as “refractory” to treatments (PR or CR or SD > 6 months).
    - Patients may have had previous hormonal therapy as treatment of metastatic disease provided that the patient has progressive disease at study entry. Hormonal therapy must be discontinued prior to study entry, excluding LH-RH analogue
    - Life expectancy greater than 6 months.
    - ECOG performance status ≤2
    - Patients must have normal organ and marrow function
    Donne in pre o post-menopausa (età ≥ 18 anni) con diagnosi istologica documentata di carcinoma mammario localmente avanzato o metastatico. Valutazione immunoistochimica di ER, PgR, HER2 e EGFR in accordo alle linee guida IEO
    - Pazienti con valori di ER&gt;1% e/o PgR&gt;1%
    - Pazienti con overespressione di HER-2/neu sono eleggibili se hanno ricevuto precedenti trattamenti con trastuzumab per la malattia avanzata, e/o trattamenti anti HER2
    - Pazienti che soddisfino uno dei seguenti criteri:
    - pazienti con malattia misurabile secondo i criteri RECIST 1.1, definita come almeno una lesione accuratamente misurabile in almeno una dimensione (registrare il diametro più lungo) di diametro &gt; 20 mm con tecnica convenzionale o &gt; 10 mm con tac spirale
    - pazienti con lesioni ossee, litiche o miste (litiche + sclerotiche), in assenza di malattia misurabile secondo i criteri RECIST 1.1. Le lesioni ossee devono essere valutate tramite TAC o Risonanza Magnetica. Pazienti con lesioni identificate solo da scintigrafia globale scheletrica non sono eleggibili.
    - Le pazienti possono aver ricevuto qualsiasi terapia in prima linea, in terapia adiuvante e qualsiasi linea di chemioterapia ed endocrino terapia per la malattia avanzata. Le pazienti possono aver ricevuto capecitabina metronomica, metotrexate e ciclofosfamide in setting adiuvante almeno 12 mesi dall’inizio studio.
    - Precedenti trattamenti con capecitabina, ciclofosfamide e vinorelbina in schedula non metronomica per la malattia avanzata sono consentiti a condizione che le pazienti non siano in progressione di malattia all’entrata dello studio e che non siano definite come “refrattarie” al trattamento (PR o CR o SD &gt; 6 mesi).
    - Le pazienti posso essere state trattate con precedenti terapie ormonali per la malattia metastatica a condizione che siano in progressione di malattia all’entrata dello studio. L’ormonoterapia deve essere interrotta all’entrata dello studio, ad esclusione dell’ LH-RH analogo.
    - Aspettativa di vita superiore ai 6 mesi.
    - ECOG performance status ≤ 2
    - Adeguata funzionalità d’organo e midollare
    E.4Principal exclusion criteria
    Previous metronomic chemotherapy for advanced disease with capecitabine, cyclophosphamide and vinorelbine
    - Triple negative subtypes (ER: 0% PgR:0% Her2: negative)
    - Patients defined as “refractory” to capecitabine, cyclophosphamide and vinorelbine (PD or SD < 6 months).
    - Presence of sintomatic cerebral or leptomeningeal involvement.
    - Previous or concomitant other malignancy except basal or squamous cell carcinoma of the skin or adequately treated in situ carcinoma of the cervix.
    - Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
    - Malabsorption syndrome or disease affecting significantly gastrointestinal function or major resection of the stomach or proximal small bowel that could affect absorption of oral vinorelbine
    - Concurrent treatment with any other anti-cancer therapy except LHRH analogue.
    - Patients with pre-existing motor or sensory peripheral neuropathy grade 2 according to NCI criteria
    Precedente chemioterapia metronomica per la malattia avanzata con capecitabina, ciclofosfamide e vinorelbina.
    - Sottotipi triplo negativi (ER: 0% PgR: 0% Her2: negativo)
    - Pazienti definite “refrattarie” alla capecitabina, alla ciclofosfamide ed alla vinorelbina (PD o SD &lt; di 6 mesi)
    - Presenza di sintomatologia cerebrale o leptomeningea
    - Storia di altre neoplasie maligne eccetto per il carcinoma a cellule squamose o basali, o carcinoma in situ della cervice adeguatamente trattati
    - Malattia sistemica severa non controllata in atto incluse, ma non limitate a, infezioni, insufficienza cardiaca congestizia, angina instabile in corso, aritmia cardiaca, o malattie psichiatriche e sociali che possano compromettere la compliance della paziente a partecipare al protocollo di studio
    - Sindrome da malassorbimento, altre patologie che interessano in modo significativo il tratto
    gastroenterico, resezione dello stomaco, resezione prossimale del piccolo intestino che possano compromettere l’assorbimento orale della vinorelbina, capecitabina e ciclofosfamide
    - Concomitante trattamento antitumorale ad eccezione dell’LH-RH analogo
    - Preesistente neuropatia di grado ≥ 2 in accordo ai criteri NCI
    E.5 End points
    E.5.1Primary end point(s)
    Time To Progression
    tempo alla progressione
    E.5.1.1Timepoint(s) of evaluation of this end point
    at 3 and 5 months
    a 3 e 5 mesi
    E.5.2Secondary end point(s)
    To assess the efficacy in terms of overall clinical benefit, defined as the objective response rate plus the rate of stable disease lasting longer than 24 weeks.
    Valutare l’efficacia in termini di Overall Clinical Benefit definito come Objective Response Rate (ORR) + SD (malattia stabile) superiore a 24 settimane.
    E.5.2.1Timepoint(s) of evaluation of this end point
    36 months
    36 mesi
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) 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 Information not present in EudraCT
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    E.8.2.4Number of treatment arms in the trial1
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.4.1Number of sites anticipated in Member State concerned1
    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
    lvls
    lvls
    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 months36
    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 months36
    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 Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 80
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 20
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    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 state100
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 100
    F.4.2.2In the whole clinical trial 100
    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)
    normal medical care
    normale assistenza medica
    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 Decision2011-07-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-06-22
    P. End of Trial
    P.End of Trial StatusOngoing
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