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    Summary
    EudraCT Number:2013-002973-23
    Sponsor's Protocol Code Number:GAP
    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:2013-09-24
    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 number2013-002973-23
    A.3Full title of the trial
    A Phase II randomized trial comparing a combination of Abraxane and Gemcitabine versus Gemcitabine alone as first line treatment in locally advanced unresectable pancreatic cancer.
    Studio clinico di fase II randomizzato (Gemcitabina vs Gemcitabina + Abraxane) come trattamento di I linea nel carcinoma del pancreas localmente avanzato, non resecabile.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Abraxane and Gemcitabine versus Gemcitabine alone in locally advanced unresectable pancreatic cancer.
    Gemcitabina + Abraxane vs Gemcitabina nel carcinoma del pancreas localmente avanzato, non resecabile.
    A.3.2Name or abbreviated title of the trial where available
    Gemcitabine Abraxane Pancreas
    Gemcitabina Abraxane Pancreas
    A.4.1Sponsor's protocol code numberGAP
    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 SponsorFondazione GISCAD
    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 supportCelgene
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFondazione GISCAD
    B.5.2Functional name of contact pointData Center
    B.5.3 Address:
    B.5.3.1Street AddressVia Vittorio Alfieri, 45
    B.5.3.2Town/ cityParabiago (MI)
    B.5.3.3Post code20015
    B.5.3.4CountryItaly
    B.5.4Telephone number00390031490052
    B.5.5Fax number00390031553720
    B.5.6E-mailcentrotrialgiscad@yahoo.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 abraxane
    D.2.1.1.2Name of the Marketing Authorisation holderCelgene
    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 nameabraxane
    D.3.2Product code EU/1/07/428/001
    D.3.4Pharmaceutical form Powder and solution for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    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 RoleComparator
    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 Gemcitabine
    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.3.1Product nameGemcitabine
    D.3.2Product code AIC 029452012
    D.3.4Pharmaceutical form Powder and solution for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    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
    124 locally advanced unresectable pancreatic cancer patients will be randomized in a 1:1 ratio to receive abraxane/gemcitabine (arm A) or gemcitabine alone (arm B), as first-line chemotherapy
    124 pazienti affetti da carcinoma pancreatico localmente avanzato, non resecabile saranno sottoposti ad una randomizzazione 1:1 a ricevere abraxane/gemcitabina (braccio A) verso la sola gemcitabina (braccio B), come terapia di I linea
    E.1.1.1Medical condition in easily understood language
    locally advanced unresectable pancreatic cancer
    carcinoma pancreatico localmente avanzato, non resecabile
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    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 nab-paclitaxel in combination with gemcitabine may reduce the progression rate versus gemcitabine alone in patients with locally advanced unresectable pancreatic cancer and be worthy of further studies.
    Confrontare se l’associazione Nab-paclitaxel più gemcitabina possa ridurre il tasso di Progressione verso la Gemcitabina da sola in pazienti con carcinoma pancreatico localmente avanzato, non resecabile
    E.2.2Secondary objectives of the trial
    • Quality of Response
    • Safety profile
    • Progression Free Survival (PFS)
    Overall Survival (OS)
    • Qualità della Risposta
    • Tollerabilità
    • Sopravvivenza libera da malattia (PFS)
    • Sopravvivenza globale (OS)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Written informed consent
    • Age < 75 years
    • Histologically/cytologically confirmed locally advanced, unresectable pancreatic cancer
    • At least one lesion measurable with CT or MRI scan
    • Performance Status (ECOG) 0-1 at study entry
    • Life expectancy of at least 3 months
    • Adequate marrow, liver and renal function
    • Effective contraception if the risk of conception exists
    • Consenso informato scritto
    • Età < 75 anni
    • Diagnosi confermata istologicamente/mitologicamente di tumore del pancreas localmente avanzato, non resecabile
    • Almeno una lesione misurabile con TC o RM
    • Performance Status (ECOG) 0-1
    • Aspettativa di vita di almeno 3 mesi
    • adeguata funzionalità midollare, epatica e renale
    • Adeguata copertura contraccettiva
    E.4Principal exclusion criteria
    • Previous chemotherapy or radiotherapy for pancreatic cancer
    • CNS metastases
    • Severe cardiovascular disease
    • Thrombotic or embolic events
    • Acute or subacute intestinal occlusion or history of inflammatory bowel disease
    • Known hypersensitivity to study drug
    • Known drugs or alcohol abuse
    • Pregnant or breastfeeding women
    • Previous or concurrent malignancy; except for basal or squamous cell skin cancer and/or in situ carcinoma of the cervix, or other solid tumors treated curatively and with evidence of no recurrence for at least 5 years prior to randomization
    • Unable to sign informed consent
    • Precedente chemioterapia o radioterapia per tumore del pancreas
    • Metastasi al SNC (Sistema nervosa Centrale)
    • Malattie cardiovascoari severe
    • Eventi trombotici o embolici
    • significative patologie gastrointestinali
    • Nota ipersensibilità ad un farmaco oggetto dello studio
    • Noto abuso di alcol o droghe
    • Gravidanza o allattamento
    • Altre neoplasie maligne, eccetto melanoma in situ o carcinoma della cervice uterina o tumori solidi trattati e con alcuna evidenza di recidiva per almeno 5 anni precedenti l’ingresso in studio
    • Incapacità a fornire il consenso informato
    E.5 End points
    E.5.1Primary end point(s)
    Progression rate
    Tasso di progressione
    E.5.1.1Timepoint(s) of evaluation of this end point
    progression rate will be evaluated after 3 cycles of chemotherapy
    il tasso di progressione verrà valutato dopo 3 cvicli di chemioterapia
    E.5.2Secondary end point(s)
    - Quality of response
    - Toxicity
    - Progression Free Survival
    - Overall Survival
    - Qualità della risposta
    - Tossicità
    - Sopravvivenza libera da malattia
    - Sopravvivenza globale
    E.5.2.1Timepoint(s) of evaluation of this end point
    - Response to treatment is evaluated according to the RECIST criteria at the end of chemotherapy
    - Toxicity will be analysed by treatment groups and CTCAE grade
    - Progression free survival time will be defined as the time from randomization until the date of first observed disease progression or death
    - Overall survival time will be defined as the time from randomization to the date of death
    - La risposta è valutata secondo i criteri RECIST alla fine della chemioterapia
    - La tossicità verrà analizzata secondo il gruppo di trattamento e con i gradi CTCAE
    - La progressione libera di malattia è definita dalla data di randomizzazione alla data del primo evento di recidiva o morte
    - La sopravvivenza globale è definita dal momento della random alla morte
    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 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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    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 concerned30
    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
    ultima visita dell'ultimo paziente randomizzato
    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 months8
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months8
    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.1.1.1In 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: 124
    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 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 state124
    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)
    • Complete physical examination, including Performance Status and weight
    • Vital signs
    • Record of adverse events, SAE and concomitant medications.
    • Laboratory tests: haematology, full biochemistry analysis, coagulation and urinalysis or dipstick for glucose, Ca 19-9, protein and blood
    • Radiological assessment for tumour measurement (RECIST).
    Esami fisici completi, incluso PS e peso
    Segni vitali
    Record degli eventi avversi, delle SAE o eventuali terapie concomitanti
    Test di laboratorio: ematologico, biochimico, esame delle urine e del glucosio, CA 19-9, proteine
    Esami strumentali per la valutazione del tumore (RECIST)
    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 Decision2013-11-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-10-22
    P. End of Trial
    P.End of Trial StatusOngoing
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