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    Summary
    EudraCT Number:2011-002009-31
    Sponsor's Protocol Code Number:MO25757
    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:2012-08-31
    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 number2011-002009-31
    A.3Full title of the trial
    A single arm open label multicentre extension study of bevacizumab in patients with solid tumours on study treatment with bevacizumab at the end of a F. Hoffmann-La Roche and/or Genentech sponsored study.
    Studio di estensione multicentrico, in aperto e a braccio singolo sull'uso di bevacizumab in pazienti con neoplasie solide trattati con bevacizumab sperimentale, al termine di uno studio sponsorizzato da F. Hoffmann-La Roche e/o Genentech.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A multicentre extension study of bevacizumab in patients with solid tumours on study treatment with bevacizumab, at the end of a F. Hoffmann-La Roche and/or Genentech sponsored study.
    Studio multicentrico di estensione con bevacizumab, in pazienti con neoplasie solide trattati con bevacizumab sperimentale, al termine di uno studio sponsorizzato da F. Hoffmann-La Roche.
    A.4.1Sponsor's protocol code numberMO25757
    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 CLINICAL OPERATIONS
    B.5.3 Address:
    B.5.3.1Street AddressVIALE G.B. STUCCHI 110
    B.5.3.2Town/ cityMONZA
    B.5.3.3Post code20900
    B.5.3.4CountryItaly
    B.5.4Telephone number039-2475070
    B.5.5Fax number039-2475085
    B.5.6E-mailitaly.info_cta@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 Yes
    D.2.1.1.1Trade name AVASTIN
    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 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.3.9.2Current sponsor codeRO4876646
    D.3.9.4EV Substance CodeSUB16402MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number400
    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 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 ricombinante 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
    Solid tumours.
    Tumori solidi.
    E.1.1.1Medical condition in easily understood language
    Cancer.
    Cancro.
    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 LLT
    E.1.2Classification code 10049280
    E.1.2Term Solid tumour
    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 15.0
    E.1.2Level LLT
    E.1.2Classification code 10065143
    E.1.2Term Malignant solid tumour
    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 provide continued bevacizumab therapy as single agent or in combination with an anti-cancer drug to patients with cancer, who were previously enrolled in a F. Hoffmann-La Roche (Roche)/ Genentech sponsored bevacizumab study (i.e. the Parent, P-trial) and who derived benefit from the therapy administered in the P-trial - To collect safety data with regard to long-term administration of bevacizumab
    - Fornire il trattamento continuativo con bevacizumab in monoterapia o in associazione a un farmaco antitumorale a pazienti oncologici precedentemente arruolati in uno studio su bevacizumab sponsorizzato da F. Hoffmann-La Roche (Roche) e/o Genentech (lo studio capostipite o “studio P” dall'inglese Parent) e che hanno tratto beneficio dalla terapia somministrata nello studio P. - Raccogliere dati sulla sicurezza della somministrazione a lungo termine di bevacizumab.
    E.2.2Secondary objectives of the trial
    -
    -
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Written informed consent prior to any study-specific procedure. 2. Patient is treated with bevacizumab at the end of the Roche/Genentech sponsored P-trial and continues to have benefit as judged by the investigator 3. Eligible for continuation of bevacizumab treatment at the end of the Parent-trial, according to Parent-trial protocol 4. Able to comply with the Extension-trial protocol MO25757 5. Female patients should not be pregnant or breastfeeding. 6. Female patients of childbearing potential/fertile male patients must use a highly effective contraceptive method during the Extension-trial and for a period of at least 6 months following the last administration of Extension-trial drug(s).
    1. Prima di effettuare qualunque procedura prevista dallo studio si dovrà ottenere la firma del modulo di consenso informato 2. Il paziente è in trattamento con bevacizumab al termine dello studio P sponsorizzato da Roche/Genentech e continua a trarne beneficio secondo il parere dello sperimentatore 3. È idoneo a proseguire il trattamento con bevacizumab al termine dello studio P, ai sensi del protocollo dello studio P 4. È in grado di rispettare i requisiti del protocollo dello studio E (MO25757) 5. Le pazienti di sesso femminile non devono essere in gravidanza o in allattamento. Le pazienti di sesso femminile potenzialmente fertili (&lt; 2 anni dall'ultima mestruazione o non sottoposte a sterilizzazione chirurgica) devono utilizzare un metodo contraccettivo altamente efficace (metodi di controllo delle nascite consentiti, con un tasso di insuccesso inferiore all'1% all'anno sono contraccettivi impiantabili, iniettabili, contraccettivi orali combinati, IUD [solo spirali ormonali], astinenza sessuale o partner vasectomizzato) durante lo studio E e per un periodo di almeno 6 mesi dopo l'ultima somministrazione del/i farmaco/i dello studio E. Le pazienti di sesso femminile con utero intatto (se non amenorreiche da almeno 24 mesi) devono presentare un test di gravidanza sul siero negativo prima di ricevere il primo trattamento in studio (vedere paragrafo 5.4.1). 6. I pazienti di sesso maschile potenzialmente fertili devono utilizzare un metodo contraccettivo altamente efficace (metodi di controllo delle nascite consentiti, con un tasso di insuccesso inferiore all'1% all'anno: partner femminili che utilizzano contraccettivi impiantabili, iniettabili, orali combinati, IUD [solo spirali ormonali], astinenza sessuale o precedente vasectomia) durante lo studio E e per un periodo di almeno 6 mesi dopo l'ultima somministrazione del/i farmaco/i dello studio E.
    E.4Principal exclusion criteria
    1. Evidence of disease progression assessed according to Parent-trial protocol during the screening phase for this Extension-trial 2. Evidence of any adverse event potentially attributable to bevacizumab, for which the local label recommends permanent discontinuation. 3. A treatment interruption with bevacizumab of more than 42 days since the last administration of bevacizumab in the Parent-trial. 4. Evidence of any other disease, neurological or metabolic dysfunction, physical examination finding or laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of the investigational drug(s) or puts the patient at high risk for treatment related complications.
    1. Evidenza di progressione della malattia, determinata in base al protocollo dello studio P durante la fase di screening per questo studio E. 2. Evidenza di qualsiasi evento avverso potenzialmente attribuibile a bevacizumab, per cui l'etichettatura locale raccomandi la sospensione permanente. 3. Interruzione del trattamento con bevacizumab superiore ai 42 giorni dall'ultima somministrazione di bevacizumab nello studio P. 4. Evidenza di qualsiasi altra malattia, disfunzione neurologica o metabolica, riscontro all’esame obiettivo o riscontro negli esami di laboratorio che facciano ragionevolmente sospettare una malattia o una condizione patologica che controindichi l’impiego di un farmaco in fase di sperimentazione, o che ponga il paziente ad alto rischio di sviluppare complicanze correlate al trattamento.
    E.5 End points
    E.5.1Primary end point(s)
    Safety data (AE grade ≥3 related to bevacizumab, SAEs, cause of deaths)
    Dati sulla sicurezza (AE di grado >=3 correlati a bevacizumab, SAEs, causa di morte).
    E.5.1.1Timepoint(s) of evaluation of this end point
    There will be a safety interim analysis approximately 3 years after the enrolment of the first patient in this Extension-trial. A final analyses will be done at the trial end.
    Sarà effettuata una interim analisi sulla sicurezza circa tre anni dopo l'arruolamento del primo paziente in questo studio di estensione. L'analisi finale verrà effettuata alla conclusione della sperimentazione.
    E.5.2Secondary end point(s)
    -
    -
    E.5.2.1Timepoint(s) of evaluation of this end point
    -
    -
    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) 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 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 Yes
    E.8.5.1Number of sites anticipated in the EEA85
    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 No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Argentina
    Australia
    Canada
    China
    Hong Kong
    Israel
    Korea, Republic of
    Mexico
    Russian Federation
    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
    Study MO25757 will end 30 days after the last patient stops bevacizumab treatment.
    Lo studio MO25757 terminera' 30 giorni dopo l'interruzione del trattamento con bevacizumab dell'ulitmo paziente.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years6
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years6
    E.8.9.2In all countries concerned by the trial months0
    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.1.2.1Number of subjects for this age range: 250
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 250
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 250
    F.4.2.2In the whole clinical trial 500
    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)
    MO25757 is an extension trial designed to allow benefitting patients to continue treatment with bevacizumab. All patients will have stopped bevacizumab treatment at the end of study MO25757. Decisions concerning the care of the patient will be left with the patients' treating physician after completion of this extension trial.
    MO25757 e' uno studio di estensione disegnato per permettere, ai pazienti che ne hanno beneficio, di continuare il trattamento con bevacizumab. Tutti i pazienti avranno terminato il trattamento con bevacizumab alla fine dello studio MO25757. Le decisioni circa le terapie dei pazienti al completamento della sperimentazione saranno lasciate al medico che ha in cura il paziente.
    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 Decision2012-04-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-04-05
    P. End of Trial
    P.End of Trial StatusOngoing
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