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    Summary
    EudraCT Number:2005-003493-19
    Sponsor's Protocol Code Number:BO17929
    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:2006-01-03
    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 number2005-003493-19
    A.3Full title of the trial
    An exploratory phase II, single arm, multicenter study to evaluate the efficacy and safety of the combination of pertuzumab and Herceptin (trastuzumab) in patients with HER2-positive metastatic breast cancer
    Studio esplorativo, di fase II, a singolo braccio, multicentrico, per valutare l`efficacia e la sicurezza dell associazione di pertuzumab ed Herceptin (trastuzumab) in pazienti affette da carcinoma della mammella metastatico HER2-positivo
    A.4.1Sponsor's protocol code numberBO17929
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorF.Hoffmann-La Roche Ltd
    B.1.3.4CountrySwitzerland
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportF.Hoffmann-La Roche Ltd
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationRoche S.p.A.
    B.5.2Functional name of contact pointHead of Clin.Ops. - Italy
    B.5.3 Address:
    B.5.3.1Street AddressViale G.B. Stucchi 110
    B.5.3.2Town/ cityMonza (MB)
    B.5.3.3Post code20900
    B.5.3.4CountryItaly
    B.5.4Telephone number039-2475070
    B.5.5Fax number039-2475084
    B.5.6E-mailsergio.scaccabarozzi@roche.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation 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 namePertuzumab
    D.3.2Product code RO4368451
    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 INNPertuzumab
    D.3.9.2Current sponsor codeRO 4368451
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.3Concentration number175
    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 typeAnticorpo monoclonale umanizzato
    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 Herceptin
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Registration Ltd.
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form 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 INNTrastuzumab
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.3Concentration number150
    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 typeAnticorpo monoclonale umanizzato
    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 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 namePertuzumab
    D.3.2Product code RO4368451
    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 INNPertuzumab
    D.3.9.2Current sponsor codeRO 4368451
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.3Concentration number420
    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 typeAnticorpo monoclonale umanizzato
    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 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 namePertuzumab
    D.3.2Product code RO4368451
    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 INNPertuzumab
    D.3.9.2Current sponsor codeRO 4368451
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.3Concentration number175
    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 typeAnticorpo monoclonale umanizzato
    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
    Patients with HER2-positive metastatic breast cancer after progression on treatment with Herceptin
    Pazienti con carcinoma della mammella metastatico HER2-positivo, nelle quali la malattia sia progredita durante il trattamento con Herceptin
    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 10027475
    E.1.2Term Metastatic breast cancer
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    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 make a preliminary assessment of the efficacy of pertuzumab in patients who have progressed during Herceptin-based therapy as determined by the objective response rate and/or the clinical benefit response rate (total of the number of responses and the number > 6 month stable disease).
    Effettuare una valutazione preliminare dell efficacia di pertuzumab in pazienti che abbiano sviluppato progressione della malattia durante la terapia con Herceptin, sulla base del tasso di risposte obiettive e/o del tasso di risposte del beneficio clinico (totale del numero di risposte e del numero di pazienti con malattia stabile di durata &gt;6 mesi).
    E.2.2Secondary objectives of the trial
    To make a preliminary assessment of the efficacy of single agent pertuzumab. To assess the safety profile of the combination of pertuzumab and Herceptin and pertuzumab as single agent. To determine the duration of response, time to response, time to progression, progression-free survival and overall survival. To evaluate biomarkers that may be associated with clinical benefit due to pertuzumab in combination with Herceptin and due to single agent use of pertuzumab.
    Effettuare una valutazione preliminare dell efficacia del trattamento con solo pertuzumab.Valutare il profilo di sicurezza dell associazione pertuzumab e Herceptin e di pertuzumab come singolo trattamento.Determinare la durata della risposta,il tempo alla risposta,il tempo alla progressione e la sopravvivenza libera da progressione e la sopravvivenza globale.Valutare i marcatori biologici che possono essere correlati al beneficio clinico di pertuzumab in associazione ad Herceptin e di pertuzumab come singolo trattamento.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Histologically confirmed breast cancer. 2. HER2-positive tumors. HER2 status must be reconfirmed in a central lab before study entry. 3. Availability of a FFPE tumor tissue sample from primary tumor for eligibility (HER2-status) testing and biomarker assessment. 4. Patients with metastatic breast cancer, who have progressed on Herceptin-based therapy as last treatment for metastatic disease. 5. Patients with &#8804; 3 chemotherapy regimens prior to study entry. 6. The last Herceptin dose must be &#8804; 9 weeks before study day 1 for patients in cohorts 1 and 2 and &#8805; 4 weeks before study day 1 for patients in cohort 3. 7. At least one measurable lesion according to RECIST. A measurable lesion in a previously irradiated area has to reveal clear signs of progression (increase in size of &#8805; 50% or new lesions) 8. At least 4 weeks since prior radiotherapy, with full recovery. 9. At least 4 weeks since major surgery, with full recovery 10. LVEF of &#8805; 55 % or local parameter for &#8805; LLN by echocardiography or MUGA. 11. Performance status ECOG &#8804; 2. 12. Age &#8805; 18 years 13. Signed informed consent.
    1. Carcinoma della mammella confermato istologicamente. 2. Tumori HER2-positivi. Lo stato recettoriale di HER2 deve essere riconfermato da un laboratorio centrale prima dell`ingresso nello studio. 3. Disponibilita` di un campione di tessuto tumorale fissato in formalina e incluso in paraffina prelevato dal tumore primario, per effettuare un test di elegibilita` allo studio (stato HER2) e per la valutazione dei marcatori biologici. 4. Pazienti con carcinoma della mammella metastatico, che abbiano sviluppato progressione della malattia durante la terapia con Herceptin, ricevuta come ultimo trattamento per la malattia metastatica. 5. Pazienti che hanno ricevuto &#8804; 3 regimi chemioterapici prima dell ingresso nello studio. 6. Somministrazione dell ultima dose di Herceptin &#8804; 9 settimane prima del giorno 1 dello studio per le pazienti nella coorte 3. 7. Presenza di almeno una lesione misurabile secondo i criteri RECIST. Una lesione misurabile in un area precedentemente trattata con radioterapia deve presentare segni evidenti di progressione (aumento della massa tumorale &gt; 50% o sviluppo di nuove lesioni). 8. Almeno 4 settimane intercorse dalla precedente radioterapia, con ristabilizzazione completa. 9. Almeno 4 settimane intercorse da un precedente intervento chirurgico maggiore, con ristabilizzazione completa. 10. Frazione di eiezione ventricolare sinistra &#8805; 55 % o un parametro locale &#8805; ULN (limite superiore di normalita`) rilevato mediante ecocardiografia o MUGA. 11. Performance status secondo l ECOG &#8804; 2. 12. Eta` &#8805; 18 anni. 13. Firma del modulo di Consenso informato.
    E.4Principal exclusion criteria
    1. Prior treatment with any targeted therapy other than Herceptin, such as cetuximab, bevacizumab, gefitinib or with anticancer vaccine. 2. Prior exposure to the following cumulative doses of anthracyclines: doxorubicin or liposomal doxorubicine > 360 mg/m2, epirubicin > 720 mg/m2, mitoxantrone > 120 mg/m2, idarubicin > 90 mg/m2 3. Known asymptomatic decreases in LVEF to below 50% absolute value during Herceptin treatment. 4. Patients with known history of any cardiac adverse event which according to the criteria of the investigator was related to Herceptin therapy. 5. History of congestive heart failure (any NYHA grading),unstable angina, evidence of transmural infarction on ECG, poorly controlled hypertension (systolic > 180 mm Hg and/or diastolic > 100 mm Hg), or hemodynamically significant valvular disease. 6. Other malignancy within the last 5 years, except for carcinoma in situ of the cervix or basal cell carcinoma 7. Absolute Neutrophil Count (ANC) < 1.5 x 109/L, Platelet count < 100 x 109/L or Hb < 10 g/dL. 8. Impaired liver function: serum [total] bilirubin > 1.5 x ULN, AST, ALT > 2.5 x ULN, (> 5 x ULN in patients with liver metastases). 9. Serum creatinine > 2 x ULN 10. History or clinical evidence of brain metastases. 11. Severe uncontrolled systemic disease (e.g. hypertension, clinically significant cardiovascular, pulmonary, metabolic, wound-healing, ulcer, or bone fracture). 12. Patients with severe dyspnea at rest requiring supplementary oxygen therapy due to complications of advanced malignancy. 13. Positive pregnancy test in women of childbearing potential 14. Patients with reproductive potential not willing to use effective method of contraception. 15. Pregnant or lactating women. 16. Patients with known infection with HIV, HBV, HCV. 17. Known hypersensitivity to Herceptin, murine proteins, or to any of its excipients. 18. Treatment with any investigational drug within 28 days prior to the start of the study. 19. Patients assessed by the investigator to be unable or unwilling to comply with the requirements of the protocol.
    1.Precedente trattamento con una terapia trageted diversa da Herceptin, come cetuximab, bevacizumab, gefitinib o con vaccino antitumorale. 2. Precedente esposizione alle dosi cumulative di antracicline di seguito riportate: doxorubicina o doxorubicina liposomiale &gt; 360 mg/m2, epirubicina &gt; 720 mg/m2, mitoxantrone &gt;120 mg/m2, idarubicina &gt; 90 mg/m2. 3. Diminuzioni asintomatiche note della frazione di eiezione ventricolare sinistra &#8805; 15% rispetto al valore basale e/o sotto il 50% come valore assoluto durante il trattamento con Herceptin. 4. Pazienti con storia nota di qualsiasi evento avverso cardiaco, correlato alla terapia con Herceptin a giudizio dello sperimentatore. 5. Storia di scompenso cardiaco congestizio (secondo qualsiasi classificazione della New York Heart Association [NYHA]), angina instabile, evidenza di infarto transmurale all ECG, ipertensione scarsamente controllata (pressione arteriosa sistolica &gt; 180 mmHg e/o pressione arteriosa diastolica &gt; 100 mmHg), o valvulopatia emodinamicamente significativa. 6. Presenza di altre formazioni neoplastiche maligne negli ultimi 5 anni, ad esclusione del carcinoma in situ della cervice o del carcinoma basocellulare della cute. 7. Conteggio totale dei neutrofili (ANC, Absolute Neutrophil Count) &lt; 1.5 x 109/L, conteggio delle piastrine &lt; 100 x 109/L o Hb &lt; 10 g/dL. 8. Compromissione della funzionalita` epatica: bilirubina [totale] nel siero &gt; 1.5 x ULN, AST, ALT &gt; 2.5 x ULN, (&gt; 5 x ULN nelle pazienti con metastasi epatiche). 9. Creatinina sierica &gt; 2 x ULN 10. Storia o evidenza clinica di metastasi cerebrali. 11. Malattia sistemica grave non controllata (ad es., ipertensione, malattia cardiovascolare clinicamente significativa, polmonare, metabolica, presenza di una ferita in corso di cicatrizzazione, ulcera o fratture ossee). 12. Pazienti con dispnea grave a riposo richiedente terapia aggiuntiva con ossigeno, a causa di complicazioni della neoplasia maligna in stadio avanzato. 13. Test di gravidanza positivo nelle donne in eta` fertile. 14. Pazienti in grado di riprodursi che si rifiutino di utilizzare metodi anticoncezionali efficaci. 15. Donne in gravidanza o allattamento. 16. Pazienti con infezione nota da HIV, HBV, HCV. 17. Ipersensibilita` accertata a Herceptin, alle proteine muriniche o a uno qualsiasi dei suoi eccipienti. 18. Trattamento con farmaci sperimentali nei 28 giorni precedenti l`inizio dello studio. 19. Pazienti giudicati dallo sperimentatore non in grado o non disposti ad aderire al protocollo.
    E.5 End points
    E.5.1Primary end point(s)
    Primary: Objective response and clinical benefit response according to RECIST.
    Risposta obiettiva e risposta del beneficio clinico secondo i criteri RECIST.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Valutazione di biomarcatori per l`efficacia clinica.
    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 No
    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) 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 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 concerned3
    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
    Fine dello studio alla morte di tutti i pazienti coinvolti, o ritiro del consenso o abbandono al follow up o dopo tre anni dall`ultima dose somministrata all`ultimo paziente (quale di questi eventi si verifichi per primo).
    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 months18
    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 months18
    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.1.3Elderly (>=65 years) Yes
    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 state12
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 46
    F.4.2.2In the whole clinical trial 62
    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 Decision2006-03-01
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2005-12-05
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-09-01
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