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    Summary
    EudraCT Number:2014-002876-10
    Sponsor's Protocol Code Number:ONC-2014-002
    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:2014-09-11
    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 number2014-002876-10
    A.3Full title of the trial
    A PHASE II STUDY OF THE COMBINATION OF GEMCITABINE AND IMATINIB
    MESYLATE IN PEMETREXED-PRETREATED PATIENTS WITH MALIGNANT
    PLEURAL MESOTHELIOMA
    STUDIO DI FASE II DELLA COMBINAZIONE DI GEMCITABINA E IMANTINIB MESILATO IN PAZIENTI CON MESOTELIOMA PLEURICO MALIGNO PRETRATTATI CON PEMETREXED
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A PHASE II STUDY OF THE COMBINATION OF GEMCITABINE AND IMATINIB
    MESYLATE IN PRETREATED PATIENTS WITH MALIGNANT
    PLEURAL MESOTHELIOMA
    STUDIO DI FASE II DELLA COMBINAZIONE DI GEMCITABINA E IMANTINIB MESILATO IN PAZIENTI CON MESOTELIOMA PLEURICO MALIGNO PRETRATTATI
    A.4.1Sponsor's protocol code numberONC-2014-002
    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 Clinico Humanitas
    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 supportIstituto Clinico Humanitas
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationEMMEDI Srl Divisione Solaris
    B.5.2Functional name of contact pointCRO
    B.5.3 Address:
    B.5.3.1Street AddressVia C. Poma 1
    B.5.3.2Town/ cityMilano
    B.5.3.3Post code20129
    B.5.3.4CountryItaly
    B.5.4Telephone number00390276114280
    B.5.5Fax number00390276118026
    B.5.6E-mailsolaris@solariscro.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 Glivec
    D.2.1.1.2Name of the Marketing Authorisation holderNovartis
    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 nameimatinib mesylate
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPBuccal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNIMATINIB MESYLATE
    D.3.9.1CAS number 220127-57-1
    D.3.9.4EV Substance CodeSUB12517MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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: 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 Gemzar
    D.2.1.1.2Name of the Marketing Authorisation holderEli-Lilly
    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 nameGemcitabine
    D.3.4Pharmaceutical form Powder 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.3.9.1CAS number 95058-81-4
    D.3.9.4EV Substance CodeSUB07892MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(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 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
    Malignant Pleural Mesothelioma
    Mesotelioma Pleurico Maligno
    E.1.1.1Medical condition in easily understood language
    Malignant Pleural Mesothelioma
    Mesotelioma Pleurico Maligno
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.0
    E.1.2Level PT
    E.1.2Classification code 10059518
    E.1.2Term Pleural mesothelioma malignant
    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 assess the anti-tumor activity of IM in combination
    with GEM, in terms of 3-months progression-free
    survival (PFS) rate.
    -Valutare l'attività anti-tumorale della combinazione
    IM/GEM, in termini di tasso di sopravvivenza libera da
    progressione a 3 mesi.
    E.2.2Secondary objectives of the trial
    - To assess anti-tumor activity of IM in combination Protocol ONC-2014-002
    Version/Date: 1.0/ 03 Sep 2014 11
    with GEM, in terms of objective response rate
    according to RECIST criteria (Modified RECIST
    criteria for Malignant Pleural Mesothelioma), and
    duration of response.
    - To assess anti-tumor activity of IM in combination
    with GEM, in terms of PFS and overall survival (OS)
    - To determine the safety profile of IM in combination
    with GEM.
    - To evaluate the molecular profile of patients enrolled
    with Ion PGM Torrent Next-generation Sequencing
    platform correlating the molecular profiles identified
    with clinical characteristics and survival data of
    patients.
    -Valutare l'attività antitumorale di IM in combinazione
    con GEM in termini di tasso di risposta obiettiva
    secondo i criteri RECIST (criteri RECIST modificati per
    mesotelioma pleurico maligno) ed in termini di durata
    della risposta.
    -Valutare l'attività antitumorale di IM in combinazione
    con GEM in termini di sopravvivenza globale (OS)
    - Valutare il profile di sicurezza della combinazione
    IM/GEM.
    -Valutare il profilo molecolare dei pazienti arruolati con
    la piattaforma di sequenziamento di nuova
    generazione Ion PGM Torrent correlando I profile
    identificati con le caratteristiche cliniche ed i dati di
    risposta e sopravvivenza dei pazienti.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1) Age of > 18 years.
    2) Patients with a histologically proven malignant
    mesothelioma of the pleura, expressing PDFGR-beta
    and/or C-Kit by immunochemistry (ICH).
    3) Locally advanced disease, unsuitable for curative surgical
    resection, or metastatic disease.
    4) Confirmed progression of the disease according to
    modified RECIST-criteria, documented after a
    pemetrexed-based chemotherapy.
    5) ECOG Performance Status of 0, 1 or 2.
    6) Life expectancy of at least 3 months.
    7) Written informed consent.
    1) Età > 18 anni.
    2) Pazienti con diagnosi di mesotelioma pleurico maligno
    confermato istologicamente, che esprime PDGFR-beta
    e/o C-kit in immunoistochimica (ICH).
    3) Malattia localmente avanzata, non suscettibile di
    resezione chirurgica completa, o malattia metastatica
    4) Malattia in progressione secondo i criteri RECIST
    modificati, documentati dopo una chemioterapia a base
    di pemetrexed.
    5) ECOG Performance Status 0-2.
    6) Aspettativa di vita di almeno 3 mesi.
    7) Consenso informato scritto.
    E.4Principal exclusion criteria
    1) Co-existing tumors of different histologic origin, except
    non melanomatous localized skin cancer and/or in situ
    cervical carcinoma.
    2) A history of earlier tumors of different histologic origin
    being in complete remission since less than 5 years.
    3) Unresolved toxicity from prior antitumor treatment(s).
    4) Primary peritoneal mesothelioma.
    5) Any of the following abnormal baseline hematological
    values:
    a. Hb < 9 g/dL
    b. WBC < 3 x 10^9/L
    c. Neutrophils < 1.5 x 10^9/L
    d. Platelets < 100 x 10^9/L
    e. Serum bilirubin > 2.5 mg/dL
    f. ALAT and ASAT > 3 x UNL (unless due to liver
    metastases)
    g. Serum creatinine > 1.5 mg/dL.
    6) Symptomatic and/or unstable pre-existing brain
    metastases. To be enrolled in the study, subjects must
    have confirmation of stable disease by MRI or computer tomography (CT) scan within 4 weeks from day 1 of cycle 1 of treatment and have CNS metastases well controlled by steroids, anti – epileptics or other symtom-relieving medications.
    7) Clinically relevant cardiovascular disease, i.e., myocardial infarction or other severe coronary artery diseases within the prior 6 months, cardiac arrythmia requiring medication, uncontrolled hypertension, overt cardiac failure or non compensated chronic heart disease in NYHA class II or more.
    8) History of psychiatric disabilities, potentially interfering with the capability of giving adequate informed consent.
    9) Pregnant or lactating women or inability/unwillingness to practice a medically approved method of contraception during study period (including 3 months following the end of treatment)
    10) Uncontrolled active infections.
    11) Any condition which, in the judgement of the Investigator, would place the patient at undue risk or interfere with the results of the study.
    1) Tumori co-esistenti di diversa origine istologica, ad
    eccezione di tumore localizzato della pelle non
    melanomatoso e/o di carcinoma cervicale in situ.
    2) Una storia di tumori precedenti di diversa origine
    istologica in remissione completa da meno di 5 anni.
    3) Tossicità non risolta di un trattamento precedente.
    4) Mesotelioma primitivo del peritoneo.
    5) Uno dei seguenti valori ematologici basali anomali:
    a. Hb < 9 g/dL
    b. WBC < 3 x 10^9/L
    c. Neutrofili < 1.5 x 10^9/L
    d. Piastrine < 100 x 10^9/L
    e. Bilirubina sierica > 2.5 mg/dL
    f. ALT e AST > 3x (in assenza di metastasi epatiche)
    g. Creatinina sierica > 1.5 mg/dL.
    6) Metastasi cerebrali preesistenti sintomatiche e / o
    instabili. Per essere arruolati nello studio, i soggetti
    devono avere la conferma di malattia cerebrale stabile
    alla risonanza magnetica o alla tomografia
    computerizzata (TC) entro 4 settimane dal giorno 1 del
    ciclo 1 del trattamento e devono avere la conferma che
    le metastasi del sistema nervoso centrale siano ben
    controllate dagli steroidi e/o dagli anti - epilettici e/o da
    altri farmaci sintomatici.
    7) Malattia cardiovascolare clinicamente rilevante, vale a
    dire, infarto del miocardio o altre gravi malattie
    coronariche nei precedenti sei mesi, aritmia cardiaca che
    richiede farmaci, ipertensione non controllata,
    insufficienza cardiaca manifesta o malattia cardiaca
    cronica non compensata in classe NYHA II o superiore.
    8) Storia di disabilità psichiatrica, potenzialmente
    interferente con la capacità di dare adeguato consenso
    informato.
    9) Donne in gravidanza o in fase di allattamento o con
    l'incapacità / non volontà di praticare un metodo
    contraccettivo clinicamente approvato durante il periodo
    di studio (compresi i tre mesi successivi alla fine del
    trattamento).
    10) Infezioni attive non controllate.
    11) Qualsiasi condizione che, a giudizio dello
    sperimentatore, potrebbe esporre il paziente a rischi
    inutili o che potrebbe interferire con i risultati dello studio.
    E.5 End points
    E.5.1Primary end point(s)
    - To assess the anti-tumor activity of IM in combination
    with GEM, in terms of 3-months progression-free
    survival (PFS) rate.
    -Valutare l'attività anti-tumorale della combinazione
    IM/GEM, in termini di tasso di sopravvivenza libera da
    progressione a 3 mesi.
    E.5.1.1Timepoint(s) of evaluation of this end point
    March 2018
    Marzo 2018
    E.5.2Secondary end point(s)
    •- To assess anti-tumor activity of IM in combination with GEM, in terms of objective response rate according to RECIST criteria (Modified RECIST criteria for Malignant Pleural Mesothelioma), and duration of response.
    •- To assess anti-tumor activity of IM in combination with GEM, in terms of PFS and overall survival (OS)
    •- To determine the safety profile of IM in combination with GEM.
    •- To evaluate the molecular profile of patients enrolled with Ion PGM Torrent Next-generation Sequencing platform correlating the molecular profiles identified with clinical characteristics and survival data of patients.
    -Valutare l'attività antitumorale di IM in combinazione
    con GEM in termini di tasso di risposta obiettiva
    secondo i criteri RECIST (criteri RECIST modificati per
    mesotelioma pleurico maligno) ed in termini di durata
    della risposta.
    -Valutare l'attività antitumorale di IM in combinazione
    con GEM in termini di sopravvivenza globale (OS)
    - Valutare il profile di sicurezza della combinazione
    IM/GEM.
    -Valutare il profilo molecolare dei pazienti arruolati con
    la piattaforma di sequenziamento di nuova
    generazione Ion PGM Torrent correlando I profile
    identificati con le caratteristiche cliniche ed i dati di
    risposta e sopravvivenza dei pazienti.
    E.5.2.1Timepoint(s) of evaluation of this end point
    November 2018
    Novembre 2018
    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 No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    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) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    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.8.5The 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 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.1.1.1In 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: 30
    F.1.3Elderly (>=65 years) No
    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 state30
    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)
    Treated until disease progression
    Trattamento fino a progressione della malattia
    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 Decision2014-10-31
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-09-17
    P. End of Trial
    P.End of Trial StatusOngoing
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