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    Summary
    EudraCT Number:2012-002841-39
    Sponsor's Protocol Code Number:GINECO-OV-222
    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:2020-12-15
    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 number2012-002841-39
    A.3Full title of the trial
    A randomized, open label, phase II trial of bevacizumab plus weekly
    paclitaxel followed by bevacizumab monotherapy maintenance versus
    weekly paclitaxel followed by observation in patients with relapsed ovarian
    sex-cord stromal tumours
    Studio di fase II, randomizzato, in aperto, con bevacizumab più paclitaxel settimanale, seguito da mantenimento con solo bevacizumab in monoterapia versus il solo paclitaxel in pazienti con recidiva di tumore stromale ovarico dei cordoni sessuali.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Evaluation of efficacy and safety of bevacizumab (Avastin®) combined to
    weekly paclitaxel followed by bevacizumab (Avastin®) alone versus
    weekly paclitaxel followed by observation in patients with relapsed ovarian
    sex-cord stromal tumours
    Valutazione dell'efficacia e della sicurezza di bevacizumab (Avastin®) in combinazione al paclitaxel settimanale seguito dal solo bevacizumab (Avastin®) versus il solo paclitaxel seguito da normale follow up in pazienti con recidiva di tumore stromale ovarico dei cordoni sessuali.
    A.3.2Name or abbreviated title of the trial where available
    ALIENOR
    ALIENOR
    A.4.1Sponsor's protocol code numberGINECO-OV-222
    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 SponsorARCAGY-GINECO
    B.1.3.4CountryFrance
    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 supportFondazione IRCCS Istituto Nazionale Tumori
    B.4.2CountryItaly
    B.4.1Name of organisation providing supportRoche S.p.A.
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFondazione IRCCS Istituto Nazionale Tumori
    B.5.2Functional name of contact pointClinical Trial Center
    B.5.3 Address:
    B.5.3.1Street AddressVia Giacomo Venezian 1
    B.5.3.2Town/ cityMilano
    B.5.3.3Post code20133
    B.5.3.4CountryItaly
    B.5.4Telephone number0223903818
    B.5.5Fax number0223903991
    B.5.6E-mailtrialcenter@istitutotumori.mi.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 AVASTIN - 1 FLACONCINO DA 400 MG DI CONCENTRATO PER SOLUZIONE PER INFUSIONE
    D.2.1.1.2Name of the Marketing Authorisation holderROCHE REGISTRATION LIMITED
    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.3.1Product nameAvastin
    D.3.2Product code [Ro 487-6646]
    D.3.4Pharmaceutical form Concentrate 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 INNBEVACIZUMAB
    D.3.9.1CAS number 216974-75-3
    D.3.9.2Current sponsor codeRo 487-6646
    D.3.9.4EV Substance CodeSUB16402MIG
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Yes
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product Yes
    D.3.11.13.1Other medicinal product typeAnticorpo monoclonale umanizzato 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
    diagnosis of ovarian sex-cord stromal tumor in relapse after a platinum-based chemotherapy.
    diagnosi di tumori stromali dei cordoni sessuali, recidivati dopo chemioterapia a base di platino
    E.1.1.1Medical condition in easily understood language
    rare tumor (ovarian sex-cord stromal tumor) in relapse
    tumori stromali dei cordoni sessuali recidivati
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10065858
    E.1.2Term Ovarian stromal cancer
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the clinical benefit of combining bevacizumab long-term treatment to weekly paclitaxel measured by the non-progression rate after 6 months of treatment
    Valutare il beneficio clinico del trattamento combinato di bevacizumab e paclitaxel settimanale, misurata come percentuale di non- progressione dopo sei mesi dal trattamento.
    E.2.2Secondary objectives of the trial
    •The Progression-Free survival
    •The Overall Survival
    •The Objective Response Rate measured with the number of radiological
    responses defined as PR or CR
    •The duration of response
    •To describe the safety profile of the association paclitaxel + bevacizumab and of bevacizumab long-term maintenance monotherapy.
    The safety profiles will be defined by the number of patients with adverse events (AE) any type and any grade using the NCI-CTC AE scale version 4.0
    •In arm A, to evaluate progression-free survival after introduction of bevacizumab at progression during the surveillance period.
    • Valutare sopravvivenza libera da progressione (PFS);
    • Valutare la sopravvivenza globale (OS);
    • Valutare le risposte radiologiche definite come RP o RC (RR);
    • Valutare la durata della risposta al trattamento per descrivere il profilo di sicurezza dell’associazione fra paclitaxel e bevacizumab e del mantenimento in monoterapia di bevacizumab.
    • Nel braccio A: valutare la sopravvivenza libera da progressione dopo l'introduzione di Bevacizumab alla progressione di malattia, durante il periodo di sorveglianza.
    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 types of substudies
    Specify title, date and version of each substudy with relative objectives: •To analyse the expression pattern of AKT, mTOR, S6rp, 4EBP1, PTEN
    and their related phospho-proteins (p-AKT Ser473 and Thr308, p-mTOR
    Ser2448, p-S6rp Ser 235/236, 4EBP1Thr37/46, PTEN Ser380) by
    immunohistochemistry on archival tumor samples.
    •To determine mutation status of PI3K, AKT, mTOR, PTEN and Forkhead transcription factor (FOX2) genes from archival tumor samples.

    Altre tipologie di sottostudi
    specificare il titolo, la data e la versione di ogni sottostudio con i relativi obiettivi: Sottostudio mandatorio integrato nel protocollo di studio principale ( V.4 del 01.08.2013):
    •Analisi del pattern di espressione di AKT, mTOR, S6rp, 4EBP1, PTEN
    e delle phospho-proteine correlate (p-AKT Ser473 e Thr308, p-mTOR
    Ser2448, p-S6rp Ser 235/236, 4EBP1Thr37/46, PTEN Ser380) attraverso indagine immunoistochimica sui blocchetti tumorali.
    • Determinare lo sto mutazionale dei geni PI3K, AKT, mTOR, PTEN e FOX2 dai blocchetti tumorali collezionati
    E.3Principal inclusion criteria
    1.Female aged >= 18 years at inclusion
    2.Histologically confirmed diagnosis of ovarian SCST including the
    following cell types: granulosa cell tumors (adults and juveniles types),
    granulosa cell theca cell tumor, Sertoli-Leydig cell tumors, malignant
    steroïd cell tumors, gynandroblastoma, unclassified SCST and mixed tumors
    3.Documented relapse of SCST defined by progression of disease
    (radiologic, clinic or biological progression)
    4.At least one measurable site of disease as defined by RECIST 1.1
    -Tumors within a previously irradiated field will be designated as "nontarget"
    lesions unless progression is documented or a biopsy is obtained
    to confirm persistence > 90 days following completion of radiotherapy.
    5.Patients must have been pre-treated with at least 1 prior line of
    platinum based chemotherapy
    6.ECOG Performance status of 0, 1, or 2
    7.Life expectancy = 4 months
    1.Donne di Età = 18 anni;
    2.Diagnosi confermata istologicamente di tumore stromale ovarico dei cordoni sessuali, inclusi i seguenti: tumori a cellule della granulosa (adulti e giovanili), tumore cellulare della teca granulosa dell'ovaio, tumori a cellule di Sertoli-Leydig, cellule a cellule steroidee, ginandroblastoma, tumori stromali ovarici dei cordoni sessuali non classificati e tumori misti;
    3.Recidiva documentata di tumori stromali dei cordoni sessuali definita come progressione di malattia (radiologica, clinica o biologica);
    4.Almeno una lesione misurabile definita come da RECIST 1.1: Lesioni precedentemente irradiate dovranno essere identificata come "non-target", a meno che la progressione sia documentata o sia fatta una biopsia che conferma una persistenza> di 90 giorni dopo il completamento della radioterapia;
    5.Pazienti che hanno ricevuto almeno una precedente linea di trattamento a base di platino;
    6.ECOG - Performance Status 0,1 o 2;
    7.Aspettativa di vita = a 4 mesi;
    E.4Principal exclusion criteria
    1.Prior systemic therapy with bevacizumab
    2.Active peripheral neuropathy = grade 2 (NCI-CTCAE v4.0)
    3.Prior history of other malignancies other than ovarian SCST (except for basal cell or squamous cell carcinoma of the skin or carcinoma in situ
    of the cervix) unless the subjects has been free of the disease for at least 3 years or 5 years for breast cancer
    4.No resolution of specific toxicities related to any prior anti-cancer therapy to grade =1, excluding alopecia, according to the NCI-CTCAE v.4.0
    5.History or evidence of thrombotic or hemorrhagic disorders, including
    cerebro-vascular accident/stroke or transient ischemic attack or subarachnoids'
    haemorrhage within 6 months prior to first dose of study drugs.
    6.Uncontrolled arterial hypertension (systolic = 150 mmHg or diastolic
    = 100 mmHg) despite optimal antihypertensive therapy or clinically
    significant cardiovascular disease
    7.History of bowel obstruction, including sub-occlusive syndrome and history of abdominal fistula, gastro-intestinal perforation or intraabdominal
    abscess during the year prior to inclusion
    8. Prior treatments:
    • Major surgical procedure, open biopsy, or significant traumatic injury
    within 28 days prior to study inclusion. Current or recent treatment with another investigational drug within 30 days of first study treatment dosing or within 6 weeks in case of prior nitrozo-urea and or mitomycin C treatment. In case of hormonotherapy , patients will be eligible if hormonotherapy is discontinued within at least 1 week before treatment initiation
    1.Precedente trattamento con Bevacizumab;
    2.Neuropatia periferica attiva = 3 (NCI-CTCAE v.4.3);
    3.Nessuna altra malignità di rilevanza prognostica, fatta eccezione per carcinoma in situ della cervice o carcinoma basocellulare (pazienti con precedente malignità possono essere arruolati dopo conferma di non evidenza di malattia negli ultimi 3 anni o di 5 per tumore della mammella);
    4.Nessuna risoluzione delle tossicità relative a qualsiasi precedente terapia anti-cancro = grado 1, fatta eccezione per l’ alopecia, secondo NCI-CTCAE v.4.3;
    5.Storia o evidenza di disordini trombotici o emorragici, inclusi ictus, TIA o emorragia sub-aracnidea entro 6 mesi prima dell’inizio del trattamento;
    6.Ipertensione arteriosa non controllata (= 150/100 mmHg) nonostante la terapia antipertensiva o malattia cardiovascolare clinicamente significativa
    7.Metastasi cerebrali evolutive non trattate;
    8.Storia di occlusione intestinale, inclusa la sindrome sub-occlusiva e storia di fistola addominale, perforazione gastrointestinale o ascesso intra-addominale nel corso dell'anno precedente l'inclusione dello studio;
    E.5 End points
    E.5.1Primary end point(s)
    The 6-month non progression rate will be summarized by treatment arm
    by a proportion together with its 95% confidence interval. It will be compared between the two arms using a Fisher exact test.
    Valutare il beneficio clinico del trattamento combinato di bevacizumab e paclitaxel settimanale, misurata come percentuale di non-progressione dopo sei mesi dal trattamento.
    E.5.1.1Timepoint(s) of evaluation of this end point
    After 6 months of chemotherapy +/- bevacizumab
    Dopo 6 mesi di chemioterapia +/- bevacizumab
    E.5.2Secondary end point(s)
    Progression-free survival (PFS) will be measured from the date of randomization to the date of event defined as the first documented
    progression or death due to any cause. Patients with no event at the time of the analysis will be censored at the date of the last adequate
    tumour assessment. PFS will be estimated using the Kaplan-Meier method. ; Overall survival (OS) will be measured from the date of randomization to the date of death or the date of last contact (censored data) and will be
    estimated using the Kaplan-Meier method.
    •Valutare sopravvivenza libera da progressione (PFS) dalla data di randomizzazione alla manifestazione dell'evento (progressione o morteper tutte le cause).
    La PFS verrà stimata utilizzando il metodo Kaplan-Meier . ; •Valutare la sopravvivenza globale (OS) dalla data di randomizzazione alla data di morte o alla data dell'ultimo contatto, stimata attravero il metodo Kaplan-Meier.
    E.5.2.1Timepoint(s) of evaluation of this end point
    In each treatment arm, PFS rate will be evaluated at 6 months
    ; In each treatment arm, OS will be evaluated after 54 months
    In ciascun braccio di trattamento la PFS verrà valutata a 6 mesi.; In ciascun braccio di trattamento l'OS verrà valutata dopo 54 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 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) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Paclitaxe come terapia standard in entrambi i bracci
    Paclitaxel as standard of care given in the 2 arms
    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 Yes
    E.8.5.1Number of sites anticipated in the EEA50
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Australia
    Belgium
    Denmark
    Finland
    France
    Germany
    Italy
    Japan
    Netherlands
    Norway
    Spain
    Sweden
    United Kingdom
    E.8.7Trial has a data monitoring committee Yes
    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 years4
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months6
    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.1.1.1In 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) No
    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 state15
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 45
    F.4.2.2In the whole clinical trial 60
    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)
    The standard of care in prectice at the investigator site
    Lo standard terapeutico usato nella normale pratica clinica
    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 Decision2015-12-01
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-10-28
    P. End of Trial
    P.End of Trial StatusCompleted
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