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    The EU Clinical Trials Register currently displays   41018   clinical trials with a EudraCT protocol, of which   6709   are clinical trials conducted with subjects less than 18 years old.
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    Phase 1 trials conducted solely in adults and that are not part of an agreed PIP are not public in the EU CTR (refer to European Guidance 2008/C 168/02   Art. 3 par. 2 and   Commission Guideline 2012/C 302/03,   Art. 5) .
     
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    Summary
    EudraCT Number:2007-000557-61
    Sponsor's Protocol Code Number:2/2007/O/Sper
    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:2007-04-03
    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 number2007-000557-61
    A.3Full title of the trial
    PROSPECTIVE RANDOMIZED STUDY ON NEOADJUVANT
    CHEMORADIOTHERAPY PLUS SURGERY VS. SURGERY ALONE IN
    PATIENTS WITH RESECTABLE PANCREATIC ADENOCARCINOMA'
    'STUDIO PROSPETTICO RANDOMIZZATO SULLA CHEMIORADIOTERAPIA NEOADIUVANTE ASSOCIATA ALLA CHIRURGIA VS. CHIRURGIA NEI PAZIENTI CON ADENOCARCINOMA PANCREATICO RESECABILE'
    A.4.1Sponsor's protocol code number2/2007/O/Sper
    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 SponsorAZIENDA OSPEDALIERA DI BOLOGNA POLICLINICO S. ORSOLA M. MALPIGHI
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 GEMZAR*INFUS 1FL 1G POLV
    D.2.1.1.2Name of the Marketing Authorisation holderELI LILLY ITALIA 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 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 INNGemcitabine
    D.3.10 Strength
    D.3.10.1Concentration unit % percent
    D.3.10.3Concentration number1
    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 typeNon Applicabile
    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
    PANCREATIC ADENOCARCINOMA'
    adenocarcinoma pancreatico
    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 PT
    E.1.2Classification code 10052747
    E.1.2Term Adenocarcinoma pancreas
    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
    verify the possibility that the rate of potentially curative
    surgical resection may increase in patients treated with neoadjuvant chemoradiotherapy plus
    surgery.
    Verificare se il tasso di resezioni chirurgiche potenzialmente curative senza residuo di malattia,
    ovvero R0 nei pazienti affetti da adenocarcinoma duttale del pancreas resecabile, trattati con
    radiochemioterapia neoadiuvante, sia significativamente superiore a quello riscontrato in un
    comparabile gruppo di pazienti sottoposti a resezione chirurgica senza trattamento neoadiuvante.
    Viene considerato come successo della terapia, un aumento delle resezioni R0 del 30% nei
    pazienti resecati sottoposti a terapia neoadiuvante rispetto al gruppo di controllo ovvero pazienti
    sottoposti in prima istanza a sola terapia chirurgica.
    E.2.2Secondary objectives of the trial
    Safety and efficacy of neoadjuvant chemoradiotherapy
    Valutare la tossicita' della terapia neoadiuvante,la differenza tra pazienti sottoposti o meno a
    terapia neoadiuvante riguardo allo stadio pTNM della malattia,alla morbilita' ed alla mortalita'
    post&#8208;operatoria.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    PHARMACOGENETIC:
    Vers:Emen08
    Date:2010/12/06
    Title:
    Objectives:

    FARMACOGENETICA:
    Vers:Emen08
    Data:2010/12/06
    Titolo:STUDIO ANCILLARE SUL PROFILO DI ESPRESSIONE GENICA (GENOTYPING) DI PAZIENTI AFFETTI DA ADENOCARCINOMA DEL PANCREAS OPERABILE
    Obiettivi:Obiettivo Primario: 1) verificare o meno l’esistenza di differenti pattern molecolari per adenocarcinomi pancreatici non metastatici alla diagnosi e suscettibili di radicalizzazione chirurgica, mediante l’analisi non-supervisionata dei profili di espressione genica (analisi di cluster e analisi delle componenti principali). Obiettivi Secondari: 1) verificare o meno la correlazione di tali profili genici con il diverso andamento clinico dei pazienti sottoposti al medesimo trattamento, sia chirurgico che chemio-radioterapico, mediante l’analisi supervisionata dei profili di espressione genica e di copy number del gruppo dei responder rispetto ai non-responder alla terapia. 2) Identificare i profili genici predittivi della risposta alla terapia, mediante analisi supervisionata di class prediction (utilizzando approcci di machine-learning quali nearest shrunken centroids, support vector machine..) delle due classi di pazienti. Si precisa che i criteri di inclusione ed esclusione al sottostudio sono gli stessi dello studio principale “Studio prospettico randomizzato sulla chemioterapia neoadiuvante associata alla chirurgia vs. chirurgia nei pazienti con adenocarcinoma pancreatico resecabile”

    E.3Principal inclusion criteria
    Patients with histological proven pancreatic ductal adenocarcinoma
    Patients who have supplied the written informed consent.
    Patients who have completed the staging of the disease
    Pazienti maschi e femmine, di eta' compresa tra i 18 anni e i 75 anni.
    Pazienti con ECOG =0&#8208;1
    Pazienti con anamnesi personale negativa per resezioni pancreatiche, o pregresso
    adenocarcinoma del pancreas.
    Pazienti con funzione epatica, renale, cardiaca, ed ematologica adeguata: in particolare
    saranno inclusi nello studio solo pazienti con conta totale dei granulociti neutrofili &#8805; 1,5 x
    109/l, piastrine &#8805; 100 x 109/l; emoglobina &#8805; 9,0 g/dl , creatinina sierica &#8804; 2,0 mg/dl, albumina &#8805;
    2,5 g/dl; ASAT GOT e/o ALAT GPT &#8804; 2,5 x LSN limite superiore di norma; PT tempo di
    protrombina e PTT tempo di tromboplastina parziale &#8804; 1,5 x LSN.
    Classe ASA &lt;4.
    Pazienti senza evidenza di infezioni in atto o altre condizioni cliniche che possano
    controindicare trattamenti medici e chirurgici e precludere la partecipazione del paziente
    allo studio.
    E.4Principal exclusion criteria
    Cerebral metastases
    HIV infection or AIDS.
    Not agreement or withdrawal of the informed consent.
    Pregnant women
    Chemio e/o radioterapia nei precedenti 6 mesi.
    Trattamento con qualsiasi farmaco sperimentale nei 30 giorni precedenti l'arruolamento.
    Pazienti con allergia confermata ad uno qualsiasi dei componenti dei farmaci dello studio.
    Altre concomitanti patologie neoplastiche diagnosticate negli ultimi 5 anni con l'eccezione
    del carcinoma basocellulare e del carcinoma cervicale in situ.
    Intervento di chirurgia maggiore, biopsia a cielo aperto, o lesione traumatica significativa
    nei 28 giorni precedenti l'inizio del trattamento o previsione della necessita' di un intervento
    di chirurgia maggiore durante il corso dello studio.
    Qualsiasi condizione che, a giudizio del medico, possa pregiudicare la partecipazione del
    soggetto allo studio.
    Qualsiasi condizione che possa pregiudicare la capacita' del paziente di fornire il consenso
    informato scritto.
    E.5 End points
    E.5.1Primary end point(s)
    The end point of the study is that to verify the possibility that the rate of potentially curative
    surgical resection may increase in patients treated with neoadjuvant chemoradiotherapy plus
    surgery.
    L'end point primario di questo studio e' confrontare il tasso di resezioni pancreatiche senza
    residuo di malattia (R0) nei pazienti resecati appartenenti ai due bracci.
    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) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    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
    chemio-radioterapia
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.4.1Number of sites anticipated in Member State concerned1
    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 Information not present in EudraCT
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    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.1.3Elderly (>=65 years) Yes
    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 Yes
    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 state64
    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 Decision2007-02-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-02-06
    P. End of Trial
    P.End of Trial StatusOngoing
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