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    Summary
    EudraCT Number:2012-003866-42
    Sponsor's Protocol Code Number:IRFMN-OVA-6152
    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:2012-11-08
    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 number2012-003866-42
    A.3Full title of the trial
    Multicenter, randomized, non-comparative, open-label phase II trial on the efficacy and safety of the combination of bevacizumab and trabectedin with or without carboplatin in adult women with platinum partially sensitive recurring ovarian cancer.
    Studio italiano multicentrico randomizzato, non comparativo, di fase II, volto a valutare l efficacia e sicurezza della combinazione di bevacizumab e trabectedina con o senza carboplatino nelle pazienti affette da carcinoma ovarico in progressione a 6-12 mesi dal termine della precedente chemioterapia a base di platino
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    multicenter italian study of the combination of bevacizumab and trabectedin with or without carboplatin in advanced ovarian cancer
    studio italiano volto a valutare la combinazione di bevacizumab e trabectedina con o senza carboplatino nel carcinoma ovarico in stadio avanzato
    A.4.1Sponsor's protocol code numberIRFMN-OVA-6152
    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 SponsorIST. DI RICERCHE FARMACOLOG. M. NEGRI
    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 supportRoche
    B.4.2CountryItaly
    B.4.1Name of organisation providing supportPharmaMar
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationIstituto di Ricerche Farmacologiche Mario Negri
    B.5.2Functional name of contact pointunità coordinamento studi clinici
    B.5.3 Address:
    B.5.3.1Street Addressvia la masa,19
    B.5.3.2Town/ citymilano
    B.5.3.3Post code20156
    B.5.3.4CountryItaly
    B.5.4Telephone number0239014649
    B.5.5Fax number0233200231
    B.5.6E-mailchiara.gerardi@marionegri.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 YONDELIS*EV 1FL POLV 1MG
    D.2.1.1.2Name of the Marketing Authorisation holderPHARMA MAR S.A.
    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 Powder for solution for injection
    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 INNtrabectedin
    D.3.9.1CAS number 114899-77-3
    D.3.9.4EV Substance CodeSUB20756
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1000
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product Yes
    D.3.11.13.1Other medicinal product typeagente antineoplastico
    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 AVASTIN*INF 400MG 16ML 25MG/ML
    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 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 INNbevacizumab
    D.3.9.1CAS number 0216974-75-3
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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 typeagente antineoplastico
    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.2.1.2Country 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 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.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number10
    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 typeagente antineoplastico
    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
    adult women with platinum partially sensitive recurring ovarian cancer.
    pazienti con carcinoma ovarico in stadio avanzato che hanno una recidiva a 6-12 mesi dall'ultima terapia a base di platino
    E.1.1.1Medical condition in easily understood language
    advanced ovarian cancer
    carcinoma ovarico in stadio avanzato
    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 10033271
    E.1.2Term Ovarian neoplasia
    E.1.2System Organ Class 100000004864
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    This study is aimed at assessing the efficacy and the safety of the combination of bevacizumab and trabectedin with or without carboplatin in adult women with epithelial ovarian cancer at first recurrence occurred 6-12 months after the end of the first platinum-containing regimen. According to the Bryant and Day design the primary endpoints will be the proportion of progression-free patients at 6 months (PFS-6) for the efficacy, and the proportion of patients with severe toxicity for the safety at the same time-point. Disease progression will be determined using the RECIST criteria, version 1.1.
    valutare in termini di efficacia e sicurezza la combinazione di bevacizumab e trabectedina con o senza carboplatino in pazienti con carcinoma epiteliale dell’ovaio in progressione a 6-12 mesi dal termine della precedente chemioterapia a base di platino. L’endpoint primario per l’efficacia è la percentuale di pazienti libere da progressione a 6 mesi dall’ arruolamento (PFS-6) e per la sicurezza la proporzione di pazienti con gravi tossicità sempre a 6 mesi dall’arruolamento come specificato nel protocollo.
    E.2.2Secondary objectives of the trial
    To evaluate: ­ PFS, defined for each patient as the time from the date of randomization to the date of first progression, second primary malignancy or death for any cause, whichever comes first. Subjects not progressed or died at the time of the analysis will be censored at the last disease assessment date. ­ 12 month overall survival (OS-12), defined as the percentage of patients who are alive at 12 months after the randomization. ­ Clinical benefit, defined as the percentage of patients who are judged by the Investigators to have a complete response, or partial response or stable disease according to the RECIST criteria, version 1.1 after 4 cycles of treatment ­ the treatment compliance. the safety profile, evaluated by the NCI-CTCAE scale, version 4.0 and by the occurrence of serious adverse reactions.
    valutare: la sopravvivenza libera da progressione, la sopravvienza globale a 12 mesi dall'inclusione, beneficio clinici valutati dallo sperimentatore in base a risposta completa parziale o malattia stabile in accordo ai criteri RECIST, compliance al trattamento
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    ­Age≥18years ­ECOG-performance status 0-2 ­Cytological/histological diagnosis of epithelial ovarian cancer ­Progression free interval between 6-12 months (calculated from the first day of the last cycle of the previous last platinum-based chemotherapy until the date of progression confirmation through radiologic imaging). ­Only one previous platinum-based chemotherapy line ­Measurable disease according to RECIST version 1.1 ­Life expectancy ≥ 12 weeks ­Patients must be able to receive dexamethasone or its equivalent, as a premedication for trabectedin ­Written informed consents given before the enrolment according to ICH/GCP.
    Criteri di inclusione: •Donne con età uguale o maggiore di 18 anni •ECOG- Performance Status 0-2 •Pazienti con diagnosi istologica/citologica di carcinoma ovarico epiteliale •Pazienti con intervallo libero da malattia tra i 6 e i 12 mesi calcolato dalla data dell’ultimo ciclo dell’ultima terapia a base di platino fino alla data di progressione radiologicamente confermata. •Pazienti che hanno ricevuto solo una precedente terapia a base di platino •Aspettativa di vita ≥ di 12 settimane •Malattia misurabile in base ai criteri RECIST versione 1.1 •Pazienti che possono ricevere il desametasone o un farmaco equivalente come pre-medicazione prima della trabectedina •Consenso Informato scritto rilasciato dalla paziente prima della randomizzazione
    E.4Principal exclusion criteria
    ­Prior treatment with trabectedin ­Prior progression while on therapy containing bevacizumab or other VEGF pathway–target therapy ­Pre-existing grade > 1 sensitive/motor neurologic disorder ­Current or recent (within 30 days of first study dosing) treatment with another investigational drug ­Surgery (including open biopsy) within 4 weeks prior to the first planned dose of bevacizumab ­Current or recent (within 10 days prior to the first study drug dose) use of full-dose oral or parenteral anticoagulant or thrombolytic agent for therapeutic purposes (except for line patency, in which case international normalized ratio [INR] must be maintained below 1.5). Post operative prophylaxis with low molecular weight heparin sc is allowed ­Inadequate bone marrow function: absolute neutrophil count (ANC): <1.5 x 109/l, or platelet count <100 x 109/l or haemoglobin <9 g/dl. Patients may be transfused to maintain haemoglobin values ≥9 g/dl ­Inadequate coagulation parameters: activated partial thromboplastin time (APTT) >1.5 x upper limit of normal (ULN) or INR >1.5 ­Inadequate liver function, defined as: serum (total) bilirubin > ULN for the institution AST/SGOT or ALT/SGPT >2.5 x ULN ­Inadequate renal function: serum creatinine >1.5 mg/dL or >132 mol/L and urine dipstick for proteinuria 2+ and >1g of protein in their 24-hour urine collection ­History or evidence of brain metastases or spinal cord compression ­ Pregnant, breastfeeding women and women of child bearing potential, who do not agree to use a medically acceptable method of contraception through the treatment period and for 6 months after discontinuation of treatment ­History or evidence of thrombotic or hemorrhagic disorders; including cerebrovascular accident, stroke or transient ischemic attack or sub-arachnoid haemorrhage within 6 months prior to the first study treatment ­Uncontrolled hypertension (sustained systolic >150 mmHg and/or diastolic >100 mmHg despite antihypertensive therapy) or clinically significant (i.e. active) cardiovascular disease, including: myocardial infarction or unstable angina within 6 months prior to the first study treatment, New York Heart Association grade II or greater congestive heart failure, serious cardiac arrhythmia requiring medication ­History of bowel obstruction, including subocclusive disease, related to the underlying disease and history of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess. Evidence of recto-sigmoid involvement by pelvic examination or bowel involvement on CT scan or clinical symptoms of bowel obstruction ­Non-healing wound, ulcer or bone fracture ­HCV positivity ­Other malignancy within the last 5 years, except for adequately treated carcinoma in situ of the cervix or squamous carcinoma of the skin, or adequately controlled limited basal cell skin cancer
    Criteri di esclusione: •Pazienti precedentemente esposte a trabectedina •Pazienti che hanno dimostrato progressione durante una terapia con bevacizumab o altre terapie target (VEGF pahtway – target therapy) •Pre-esistente patologia neurologica sensitivo/motoria NCI-CTCAE grado &gt; 1 •Recente (30 giorni antecedenti la prima somministrazione) o concomitante trattamento con altri farmaci sperimentali •Chirurgia (biopsia inclusa) nelle 4 settimane antecedenti alla prima somministrazione di bevacizumab •Recente (nei 10 giorni antecedenti la prima somministrazione dei farmaci sperimentali) o concomitante utilizzo di anticoagulanti orali o parenterali o agenti trombolitici a scopo terapeutico (fanno eccezione le procedure per mantenere la pervietà degli accessi venosi in questi casi l’indice di normalizzazione deve essere sotto l’1.5); è ammessa la somministrazione di eparina a basso peso molecolare come profilassi post-operatoria •Inadeguata funzionalità del midollo osseo definita con i seguenti valori: i. Neutrofili &lt; 1.5 x 109/l ii. Piastrine &lt;100 x 109/l iii. Emoglobina &lt;9 g/dl E’ ammessa la possibilità di trasfusione per mantenere il valore dell’Emoglobina &gt;9 g/dl •Parametri non adeguati relativi alla coagulazione: APTT &gt; 1.5 x ULN o INR &gt; 1.5 •Funzionalità epatica inadeguata definita come: bilirubina sierica (totale)&gt;ULN, AST/SGOT e ALT/SGPT &gt;2,5 x ULN •Funzionalità renale inadeguata definita come creatinina sierica &gt; 1.5 mg/dL o 132 µmol/L. Proteinuria confermato da stick diagnostico per le urine con un valore ≥ 2 e &gt; 1g di proteine nelle 24 ore di raccolta •Diagnosi precedente o attuale di metastasi cerebrali o compressione del midollo spinale •Pazienti in gravidanza, pazienti in allattamento o in età fertile che non accettino di utilizzare metodi contraccettivi durante il trattamento e nei 6 mesi successivi dal termine dello stesso •Precedente o attuale evidenza di malattie trombotiche o emorragiche, inclusi ictus, attacco ischemico transitorio, angina instabile, emorragia sub aracnoidea nei 6 mesi che precedono la prima somministrazione dei farmaci sperimentali. •Ipertensione arteriosa non controllata (pressione arteriosa sistolica attuale &gt; 150 mm Hg e/o pressione arteriosa diastolica &gt; 100 mm Hg nonostante terapia anti-ipertensiva) o malattie cardiovascolari clinicamente rilevanti, includendo: infarto del miocardio o angina instabile a meno dei 6 mesi precedenti la prima somministrazione del farmaco sperimentale, di grado &gt; II della New York Medical Association, insufficienza cardiaca congestizia, o grave aritmia cardiaca che richieda un trattamento •Anamnesi positiva per occlusione intestinale, inclusa sindrome sub-occlusiva, correlata a una patologia sottostante, fistula addominale, perforazione gastrointestinale o ascesso intra-addominale. Evidenza di coinvolgimento retto-sigma all’esame pelvico o coinvolgimento intestinale alla TAC o sintomi clinici di occlusione intestinale •Ferite non guarite, ulcere o frattura ossea •Positività per HCV •Altre patologie maligne negli ultimi 5 anni ad esclusione del carcinoma in situ della cervice o carcinoma squamoso basocellulare della pelle adeguatamente trattati.
    E.5 End points
    E.5.1Primary end point(s)
    the proportion of progression-free patients at 6 months (PFS-6) for the efficacy, and the proportion of patients with severe toxicity for the safety at the same time-point. Disease progression will be determined using the RECIST criteria, version 1.1. The following conditions will be considered as severe toxicity: 1. absolute neutrophil count (ANC) < 0.5x109/L lasting > 7 days and/or with fever 2. platelets < 25x109/L 3. any other grade 3-4 (evaluated by the NCI-CTCAE scale, version 4.0) non-hematological toxicities except for reversible nausea/vomiting, diarrhea, hypersensitivity reactions, and ALT or AST elevation reversible to grade 1 by day 28 4. any toxicity causing a delay of >14 days in the following cycle
    percentuale di pazienti con sopravvivenza libera da progressione a 6 mesi e sicurezza come percentuale di pazienti con tossicità gravi definite come segue: 1. absolute neutrophil count (ANC) < 0.5x109/L lasting > 7 days and/or with fever 2. platelets < 25x109/L 3. any other grade 3-4 (evaluated by the NCI-CTCAE scale, version 4.0) non-hematological toxicities except for reversible nausea/vomiting, diarrhea, hypersensitivity reactions, and ALT or AST elevation reversible to grade 1 by day 28 4. any toxicity causing a delay of >14 days in the following cycle
    E.5.1.1Timepoint(s) of evaluation of this end point
    PFS-6 and safety will be evalueted at 6 months from randomization
    per l'efficacia:6 mesi per la sopravvivenza libera da progressione e per la sicurezza: 6 mesi per le tossicità gravi
    E.5.2Secondary end point(s)
    Efficacy endpoints: ­The PFS, defined for each patient as the time from the date of randomization to the date of first progression, second primary malignancy or death for any cause, whichever comes first. Subjects not progressed or died at the time of the analysis will be censored at the last disease assessment date. Disease progression will be determined using the RECIST criteria, version 1.1. ­The 12 month overall survival (OS-12), defined as the percentage of patients who are alive at 12 months after the randomization. ­the clinical benefit (CB), defined as the percentage of patients who are judged by the Investigators to have a complete response (CR), or partial response (PR) or stable disease (SD) according to the RECIST criteria, version 1.1 after 12 weeks from the date of randomization. Compliance endpoints ­Percentage of patients with dose and/or time modifications ­Percentage of premature withdrawals. Safety endpoints ­Incidence, nature, severity and seriousness of AEs, according to NCI-CTCAE, version 4.0 ­Maximum toxicity grade experienced by each patient for each specific toxicity ­Percentage of patients experiencing grade 3-4 toxicity for each specific toxicity ­Patients with at least a SAE ­Patients with at least a serious adverse drug reaction (SADR) ­Patients with at least a suspect unexpected serious adverse reaction (SUSAR).
    sopravvivenza libera da progressione, percentuale di pazienti vivi a 12 mesi dalla randomizzazione, percentuale di pazienti che si sono ritirati dallo studio, percentuale di pazienti che hanno avuto una modifica di dosi e/o tempi, beneficio clinico, pazienti che hanno avuto almeno un SAE,incidenza natura e gravità di un AE,pazienti che hanno avuto almeno un SAE, pazienti che hanno avuto alemeno un SADR, pazienti che hanno avuto almeno un SUSAR,percentuale di pazienti ai quai compare una tossicità di grado 3-4, massimo grado di tossicità avuta da ciascun paziente per ciascuna tossicità
    E.5.2.1Timepoint(s) of evaluation of this end point
    12 months
    12 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 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 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 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 concerned6
    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 months30
    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: 60
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 14
    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 state74
    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)
    patients will be evalueted according to clinical practice guideline for advanced ovarian cancer
    le pazienti verrano seguite da pratica clinica secondo le linee guida per il carcinoma ovarico in stadio avanzato
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation Mario Negri Gynecologic Oncology group
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2012-12-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-10-25
    P. End of Trial
    P.End of Trial StatusOngoing
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