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    Summary
    EudraCT Number:2012-003043-29
    Sponsor's Protocol Code Number:MITO-16/MaNGO-OV2
    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:2012-09-14
    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 number2012-003043-29
    A.3Full title of the trial
    A multicenter study in patients with stage III-IV epithelial ovarian cancer treated with carboplatin/paclitaxel with bevacizumab: clinical and biological prognostic factors
    Studio multicentrico in pazienti affette da carcinoma ovarico stadio III-IV trattate con carboplatino-paclitaxel e bevacizumab in prima linea: valutazione di marcatori prognostici clinici e molecolari
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Clinical trial of first line treatment with carboplatin and paclitaxel plus bevacizumab for advanced ovarian cancer patients.
    STUDIO CLINICO DI TRATTAMENTO IN PRIMA LINEA DI PAZIENTI CON CARCINOMA OVARICO AVANZATO CON CARBOPLATINO PACLITAXEL E BEVACIZUMAB
    A.4.1Sponsor's protocol code numberMITO-16/MaNGO-OV2
    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 NAZIONALE PER LO STUDIO E LA CURA DEI TUMORI - FONDAZIONE "G. PASCALE"
    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.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationISTITUTO NAZIONALE PER LO STUDIO E LA CURA DEI TUMORI - FONDAZIONE
    B.5.2Functional name of contact pointUnità Sperimentazioni Cliniche
    B.5.3 Address:
    B.5.3.1Street AddressVia M. Semmola, 3
    B.5.3.2Town/ cityNAPOLI
    B.5.3.3Post code80131
    B.5.3.4CountryItaly
    B.5.4Telephone number0815903571
    B.5.5Fax number081 7702938
    B.5.6E-mailfrancesco.perrone@usc-intnapoli.net
    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 nameNA
    D.3.2Product code NA
    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 216974-75-3
    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 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) Yes
    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 No
    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.2.1.2Country 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.3.9.1CAS number 41575-94-4
    D.3.9.4EV Substance CodeSUB06614MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    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 No
    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 INNPACLITAXEL
    D.3.9.1CAS number 33069-62-4
    D.3.9.4EV Substance CodeSUB09583MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number6
    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 No
    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
    advanced ovarian cancer
    tumore ovarico avanzato
    E.1.1.1Medical condition in easily understood language
    advanced ovarian cancer
    tumore dell'ovaio avanzato
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 15.0
    E.1.2Level PT
    E.1.2Classification code 10033128
    E.1.2Term Ovarian 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 No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    • To explore whether clinical and biological factors, as detailed below, are able to identify a subset of patients with better prognosis in term of progression free survival (PFS) and overall survival (OS) after combined therapy with chemotherapy and bevacizumab.
    Verificare il ruolo potenziale che taluni fattori, clinici e molecolari, possono avere nell’identificare, nell’ambito di pazienti trattate con bevacizumab associato ad un regime chemioterapico, un sottogruppo a prognosi migliore, sia in termini di sopravvivenza libera da progressione (PFS) che di sopravvivenza globale (OS).
    E.2.2Secondary objectives of the trial
    • To describe the safety of bevacizumab added to carboplatin-paclitaxel chemotherapy in first line treatment of epithelial ovarian, fallopian tube and primary peritoneal cancer patients in the clinical routine practice • To investigate the prognostic value for hypertension, circulating and in-situ biomarkers for advanced epithelial ovarian, fallopian tube and primary peritoneal cancer patients treated with carboplatin-paclitaxel and bevacizumab • To describe the prevalence of use of oral antidiabetic therapy and antithrombotic therapy among the patients enrolled in the trial.
    Obiettivi secondari dello studio sono: • descrivere la sicurezza, nella comune pratica clinica, di un trattamento che combini bevacizumab e chemioterapia a base di carboplatino-paclitaxel, per la terapia di prima linea delle pazienti con carcinoma epiteliale dell’ovaio oppure carcinoma delle tube di Falloppio o per neoplasie a primitività peritoneale; • valutare il valore prognostico di ipertensione, biomarcatori circolanti e locali, per le pazienti con carcinoma epiteliale avanzato dell’ovaio oppure delle tube di Falloppio o anche neoplasie a primitività peritoneale trattate con carboplatino-paclitaxel bevacizumab; • descrivere la prevalenza dell’uso delle terapie antidiabetiche orali ed antitrombotiche fra le pazienti arruolate nello studio.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Female patients ≥18 years of age. • Patients with histologically confirmed epithelial ovarian carcinoma, fallopian tube carcinoma or primary peritoneal carcinoma, including mixed Mullerian Tumours Or Recurrent early stage epithelial ovarian or fallopian tube carcinoma treated with surgery alone. • FIGO stage IIIB & C or IV • ECOG Performance Status of 0–2. • Life expectancy of at least 12 weeks. • Signed informed consent obtained prior to initiation of any study-specific procedures and treatment as confirmation of the patient’s awareness and willingness to comply with the study requirements. • Availability of tumour samples for molecular analyses
    • Pazienti di sesso femminile con età ≥18 anni. • Diagnosi istologica di carcinoma epiteliale dell’ovaio oppure delle tube di Falloppio o carcinoma primitivo del peritoneo, inclusi i tumori Mulleriani misti oppure • Recidiva in stadio precoce di carcinoma epiteliale dell’ovaio o delle tube di Falloppio trattata con sola chirurgia. • FIGO stadio IIIB & C o IV • Performance Status 0–2 secondo ECOG. • Aspettativa di vita di almeno 12 settimane. • Consenso informato firmato ottenuto prima dell’inizio di qualsiasi procedura studio specifica e del trattamento quale conferma della volontà della paziente di partecipare allo studio e della consapevolezza da parte della paziente di dover rispettare le procedure previste dal protocollo. • Disponibilità di campioni di tessuto tumorale per analisi molecolari.
    E.4Principal exclusion criteria
    • Ovarian tumours with low malignant potential (i.e. borderline tumours) • Previous systemic anti-cancer therapy for advanced ovarian cancer. • History or evidence of brain metastases or spinal cord compression. • History or evidence of synchronous primary endometrial carcinoma, unless all of the following criteria related to the endometrial carcinoma are met: o stage ≤Ia o no more than superficial myometrial invasion o no lymphovascular invasion o not poorly differentiated (grade 3 or papillary serous or clear cell carcinoma). • 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.
    • Tumori ovarici a basso potenziale di malignità (i.e. tumori borderline) • Precedente terapia antineoplastica sistemica per cancro dell’ovaio avanzato. • Storia o evidenza di metastasi cerebrali o di compressione midollare. • Storia o evidenza di carcinoma endometriale primitivo sincrono a meno che tutti i seguenti criteri per il carcinoma endometriale siano rispettati: o stadio ≤Ia o invasione miometrale solo superficiale o nessuna invasione linfovascolare o assenza di forme scarsamente differenziate (grado 3 oppure carcinoma sieroso papillare o a cellule chiare). • Altre patologie neoplastiche negli ultimi 5 anni, ad eccezione del carcinoma in situ della cervice o del carcinoma cutaneo spinocellulare o basocellulare in stadio iniziale, purché adeguatamente trattati.
    E.5 End points
    E.5.1Primary end point(s)
    PFS and OS
    PFS and OS
    E.5.1.1Timepoint(s) of evaluation of this end point
    at disease progression or patient death
    data della progressione o del decesso
    E.5.2Secondary end point(s)
    overall toxicity
    tossicità globale
    E.5.2.1Timepoint(s) of evaluation of this end point
    at the end of each cycle
    alla fine di ogni ciclo
    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 Yes
    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) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    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 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 concerned2
    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 years4
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 320
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 80
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state400
    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)
    further chemotherapy, if applicable, including other trial treatments
    Se adeguato, successive linee di chemioterapia inclusa la partecipazione a successivi trial sperimentali
    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 MITO group
    G.4 Investigator Network to be involved in the Trial: 2
    G.4.1Name of Organisation MaNGO
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2012-09-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-07-18
    P. End of Trial
    P.End of Trial StatusOngoing
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