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The European Union Clinical Trials Register allows you to search for protocol and results information on:
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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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    Summary
    EudraCT Number:2017-003621-15
    Sponsor's Protocol Code Number:CENTER
    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:2021-06-17
    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 number2017-003621-15
    A.3Full title of the trial
    A Phase II study of a Combination of Eribulin and capecitabiNe in second line Treatment after the failure of gemcitabine/abraxane first line in advanced pancreatic cancer
    Studio di Fase II di eribulina in combinazione con capecitabina per il trattamento di seconda linea in pazienti affetti da carcinoma pancreatico avanzato dopo fallimento di terapia di prima linea con gemcitabina/abraxane.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase II study of a Combination of Eribulin and capecitabiNe in second line Treatment after the failure of gemcitabine/abraxane first line in advanced pancreatic cancer
    Studio di Fase II di eribulina in combinazione con capecitabina per il trattamento di seconda linea in pazienti affetti da carcinoma pancreatico avanzato dopo fallimento di terapia di prima linea con gemcitabina/abraxane.
    A.3.2Name or abbreviated title of the trial where available
    Phase II study, single-arm with eribulin + capecitabine after gemcitabine / abraxane failure in pati
    Studio di Fase II a singolo braccio con eribulina + capecitabina dopo fallimento di gemcitabina/abra
    A.4.1Sponsor's protocol code numberCENTER
    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 OSPEDALIERO-UNIVERSITARIA DI MODENA
    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 supportEISAI srl
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationServizio Formazione, Ricerca e Innovazione
    B.5.2Functional name of contact pointClinical Trial Quality Team
    B.5.3 Address:
    B.5.3.1Street AddressAOU di Modena Via del Pozzo 71
    B.5.3.2Town/ cityModena
    B.5.3.3Post code41124
    B.5.3.4CountryItaly
    B.5.4Telephone number0594225868
    B.5.5Fax number0594224369
    B.5.6E-mailricercainnovazione@policlinico.mo.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 HALAVEN - 0.44MG/ML - SOLUZIONE INIETTABILE - USO ENDOVENOSO - FLACONCINO(VETRO) 2ML 6 FLACONCINI
    D.2.1.1.2Name of the Marketing Authorisation holderEISAI LTD
    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 nameHALAVEN
    D.3.2Product code [-]
    D.3.4Pharmaceutical form 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.3.9.2Current sponsor code-
    D.3.10 Strength
    D.3.10.1Concentration unit mg/m2 milligram(s)/square meter
    D.3.10.2Concentration typenot less then
    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 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 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 CAPECITABINA ACCORD - 150 MG - COMPRESSA RIVESTITA CON FILM - USO ORALE - BLISTER (PVC/PVDC/ALU) - 120 COMPRESSE
    D.2.1.1.2Name of the Marketing Authorisation holderACCORD HEALTHCARE 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 nameCapecitabina accord 150
    D.3.2Product code [-]
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor code-
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number3000
    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 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 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.2.1.1.1Trade name CAPECITABINA ACCORD - 500 MG - COMPRESSA RIVESTITA CON FILM - USO ORALE - BLISTER (PVC/PVDC/ALU) - 120 COMPRESSE
    D.2.1.1.2Name of the Marketing Authorisation holderACCORD HEALTHCARE 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 nameCapecitabina Accord 500
    D.3.2Product code [-]
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor code-
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number3000
    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 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 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 pancreatic cancer
    tumore del pancreas avanzato
    E.1.1.1Medical condition in easily understood language
    advanced pancreatic cancer
    tumore del pancreas avanzato
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level LLT
    E.1.2Classification code 10033599
    E.1.2Term Pancreatic adenocarcinoma metastatic
    E.1.2System Organ Class 100000004864
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Progression rate after 3 months of treatment
    Safety (NCICTC version 4.0)
    Tasso di progressione dopo 3 mesi di trattamento
    Sicurezza (versione NCICTC 4.0)
    E.2.2Secondary objectives of the trial
    Response rate (RECIST version 1.1), PFS and median OS; assessment of reversion from epithelial to mesenchymal cells
    Tasso di risposta (RR) (versione RECIST 1.1), PFS e OS mediana; valutazione della reversione da cellule epiteliali a mesenchimali
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    age =18 and < 75 years
    Histologically/cytologically confirmed advanced, unresectable pancreatic cancer
    Patients Resistant/refractory to a first line chemotherapy including nab-paclitaxel/gemcitabine
    Willing and able to comply with all aspects of the protocol
    Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1 at study entry
    Life expectancy of at least 3 months
    Età compresa tra i 18 e i 75 anni;
    Carcinoma pancreatico avanzato non resecabile
    confermato istologicamente/citologicamente
    Pazienti che hanno fallito una chemioterapia di prima linea con nab-paclitaxel/gemcitabina Performance Status (ECOG) 0-1
    Aspettativa di vita di almeno 3 mesi
    E.4Principal exclusion criteria
    Previous chemotherapy with capecitabine or 5fluorouracil within 6 months of study entry
    Evidence of clinically symptomatic CNS metastases
    Patients with only non measurable disease according to RECIST 1.1 criteria
    Treatment with chemotherapy or any anti-cancer drug within 3 weeks of the study entry
    Chemioterapia precedente con capecitabina o 5
    fluorouracil entro 6 mesi dall'entrata in studio
    Presenza di metastasi clinicamente sintomatiche del CNS
    Pazienti con solo malattia non misurabile secondo i criteri RECIST 1.1
    Trattamento con la chemioterapia o qualsiasi farmaco anticancro entro 3 settimane dalla data di arruolamento
    E.5 End points
    E.5.1Primary end point(s)
    The primary objectives of this trial is to assess the safety and anti-tumor activity of eribulin in
    combination with capecitabine, as measured by the rate of progression after three months of treatment
    based on local investigator’s assessment according to RECIST v1.1
    L'end point primario è il tasso di progressione a 3 mesi e la sicurezza della
    combinazione tra eribulina e capecitabina
    E.5.1.1Timepoint(s) of evaluation of this end point
    after three months
    dopo 3 mesi
    E.5.2Secondary end point(s)
    The secondary efficacy endpoints are: PFS, ORR, OS and the assessment of the potential biological effect of eribulin on the mesenchymal to epithelial cell reversion assessed by plasma exosomes. Response to treatment has to be assessed by using the same techniques performed at baseline. At the end of treatment tumor assessment will be performed every 3 months, during follow up visits until PD, for all patients who goes off study for other reason than PD. After PD, six-month assessment of the patient status (dead or alive; with or without recurrence or second primary tumor) is required.
    Gli endpoint secondari di efficacia sono: PFS, ORR, OS e la valutazione del potenziale effetto biologico di eribulina sulla reversione mesenchimale a quella epiteliale valutata dagli esosomi plasmatici. La risposta al trattamento deve essere valutata utilizzando le stesse tecniche eseguite al basale. Alla fine del trattamento la valutazione del tumore verr¿ eseguita ogni 3 mesi, durante le visite di follow up fino al PD sia per tutti i pazienti che vanno fuori studio per altre ragioni rispetto al PD. Dopo PD, ¿ necessaria una valutazione semestrale dello stato del paziente (vivo o morto, con o senza recidiva o secondo tumore primario).
    E.5.2.1Timepoint(s) of evaluation of this end point
    every 3 months during treatment until disease progression
    every 6 months after progression of the disease
    ogni 3 mesi durante il trattamento fino a progressione della malattia
    ogni 6 mesi dopo progressione della malattia

    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 Yes
    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 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 Yes
    E.8.1.7.1Other trial design description
    singolo braccio
    arm single
    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.8.2.4Number of treatment arms in the trial1
    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 Yes
    E.8.5.1Number of sites anticipated in the EEA1
    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 Information not present in EudraCT
    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
    last chemotherapy treatment of the last patient being treated
    ultimo trattamento chemioterapico dell'ultimo paziente in trattamento
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months18
    E.8.9.1In the Member State concerned days54
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months18
    E.8.9.2In all countries concerned by the trial days54
    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: 14
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    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 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 state24
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 25
    F.4.2.2In the whole clinical trial 25
    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 best available therapy
    la miglior terapia disponibile
    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 Decision2018-01-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-12-12
    P. End of Trial
    P.End of Trial StatusOngoing
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