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    Summary
    EudraCT Number:2010-024595-26
    Sponsor's Protocol Code Number:287-11-201
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2011-09-05
    Trial results View 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 number2010-024595-26
    A.3Full title of the trial
    Phase 2 Placebo-controlled Double-Blind Trial of Dasatinib Added to Gemcitabine for Subjects with Locally-Advanced Pancreatic Cancer
    Studio di fase 2, controllato con placebo, in doppio cieco, su dasatinib in combinazione con gemcitabina in soggetti affetti da cancro pancreatico localmente avanzato
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study for people with locvally advanced pancreatic cancer (inoperable but without distant spread) of gemcitabine chemiotherapy plus either dasatinib or placebo
    Studio in pazienti con tumore pancreatico localmente avanzato (non operabile ma in assenza di metastasi)sulla combinazione della terapia con gemcitabina piu' dasatinib o placebo.
    A.4.1Sponsor's protocol code number287-11-201
    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 SponsorOTSUKA PHARMACEUTICAL DEVELOPMENT AND COMMERCIALISATION INC
    B.1.3.4CountryUnited States
    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 supportOTSUKA PHARMACEUTICAL DEVELOPMENT AND COMMERCIALISATION INC
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCovance CAPS
    B.5.2Functional name of contact pointKonstantin Stoitchkov
    B.5.3 Address:
    B.5.3.1Street AddressAve. Marcel Thiry 77
    B.5.3.2Town/ cityBrussels
    B.5.3.3Post code1200
    B.5.3.4CountryBelgium
    B.5.4Telephone number+32 2 779 1870
    B.5.5Fax number+32 2 779 1870
    B.5.6E-mailkonstantin.stoitchkov@covance.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 SPRYCEL
    D.2.1.1.2Name of the Marketing Authorisation holderBRISTOL-MYERS SQUIBB PHARMA EEIG
    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 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.3.9.3Other descriptive nameDASATINIB MONOHYDRATE
    D.3.9.4EV Substance CodeSUB23159
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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 SPRYCEL
    D.2.1.1.2Name of the Marketing Authorisation holderBRISTOL-MYERS SQUIBB PHARMA EEIG
    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 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.3.9.3Other descriptive nameDASATINIB MONOHYDRATE
    D.3.9.4EV Substance CodeSUB23159
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboTablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Locally-advanced Pancreatic Adenocarcinoma
    Adenocarcinoma Pancreatico Localmente Avanzato
    E.1.1.1Medical condition in easily understood language
    Locally advanced pancreatic cancer (inoperable but without distant spread)
    Tumore pancreatico localmente avanzato non operabile, ma in assenza di metastasi)
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.0
    E.1.2Level HLT
    E.1.2Classification code 10033633
    E.1.2Term Pancreatic neoplasms malignant (excl islet cell and carcinoid)
    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 compare overall survival (OS) of
    subjects with locally advanced pancreatic cancer (LAPC) who are
    randomized to receive dasatinib added to standard of care (gemcitabine
    [GEM]) versus standard of care (GEM) plus placebo
    •Confrontare la sopravvivenza generale dei soggetti affetti da cancro pancreatico localmente avanzato randomizzati a ricevere il dasatinib in combinazione allo standard di cura (gemcitabina [GEM]) rispetto allo standard di cura (GEM) più placebo.
    E.2.2Secondary objectives of the trial
    - To compare progression-free survival (PFS) in subjects receiving dasatinib added to standard of care (gemcitabine [GEM]) versus standard of care (GEM) plus placebo.
    - To compare safety in subjects receiving dasatinib added to standard of care (GEM) versus standard of care (GEM) plus placebo.
    - Confrontare la sopravvivenza senza progressione dei soggetti che ricevono il dasatinib in combinazione allo standard di cura (gemcitabina [GEM]) rispetto allo standard di cura (GEM) più placebo.
    - Confrontare la sicurezza dei soggetti che ricevono il dasatinib in combinazione allo standard di cura (GEM) rispetto allo standard di cura (GEM) più placebo.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male and female subjects ≥ 18 years of age.
    2. Histologic or cytologic documentation of adenocarcinoma of the pancreas.
    3. Unresectable disease due to local extension or invasion, for example:
     Tumor extension precluding resection, eg, mesenteric or retroperitoneal structures, vascular encasement, etc, or
     Lymph node involvement beyond the surgical field.
    4. Recovery from toxicity of previous procedures that establishes diagnosis of locally advanced disease (patients with previous pancreatic resection are excluded)
    5. ECOG PS 0 or 1
    6. Adequate organ function:
    − Absolute neutrophil count ≥ 1,500/µL
    − Platelets ≥ 100,000/µL
    − Bilirubin ≤ 2.0 X upper limit of normal (ULN)
    − Creatinine ≤ 1.5 mg/dL
    − Aspartate transaminase ≤ 2.5 X ULN
    1. Pazienti di sesso maschile e femminile ≥ 18 anni d'età
    2. Documentazione istologica o citologica di adenocarcinoma del pancreas.
    3. Malattia non resecabile a causa di invasione o estensione locale, ad esempio:
    Estensione del tumore che preclude la resezione, ad esempio strutture mesenteriche o retroperitoneali, encasement vascolare, ecc, o
    Coinvolgimento dei linfonodi oltre il campo chirurgico.
    4. Recupero dalla tossicità di procedure precedenti che definisce la diagnosi di malattia localmente avanzata (i pazienti con precedente resezione pancreatica sono esclusi)
    5. ECOG PS 0 o 1
    6. Funzione degli organi adeguata:
    - Conta assoluta dei neutrofili ≥ 1.500/µL
    − Piastrine ≥ 100.000/µL
    − Bilirubina ≤ 2,0 volte il limite superiore dell’intervallo normale di riferimento (upper limit of normal - ULN)
    − Creatinina ≤ 1,5 mg/dL
    − Aspartato transaminasi ≤ 2,5 volte il limite superiore dell’intervallo normale di riferimento
    E.4Principal exclusion criteria
    1.Evidence of metastatic disease based on symptoms, laboratory values, or imaging studies ≤ 21 days prior to the first dose of IMP
    2.Previous radiotherapy or chemoradiotherapy
    3.History of or current pleural effusion (any cause, ≥ Grade 1) within 6 months prior to the first dose of IMP. An equivocal finding at the costophrenic angle is allowed
    4.History of significant cardiovascular disease or the following events within 6 months prior to the first dose of IMP: coronary infarction, life-threatening arrhythmia, or QTc prolongation > 470 ms
    5.Clinically significant bleeding disorder or coagulopathy (eg, von Willebrand’s disease)
    6.Requirement for a concomitant medication that is a strong inhibitor of Cytochrome P450 (CYP) 3A4
    1.Evidenza di malattia metastatica in base a sintomi, valori di laboratorio o studi di diagnostica per immagini ≤ 21 giorni prima della dose iniziale del farmaco sperimentale
    2.Radioterapia o chemioterapia precedente
    3.Effusione pleurica pregressa o corrente (qualsiasi causa, ≥ grado 1) entro 6 mesi prima della dose iniziale del farmaco sperimentale. È consentito un risultato equivoco a livello dell'angolo costofrenico
    4.Anamnesi di malattia cardiovascolare significativa o dei seguenti eventi entro 6 mesi prima della dose iniziale del farmaco sperimentale: infarto coronario, aritmia potenzialmente letale o QTc prolungato &gt; 470 ms
    5.Coagulopatia o disturbo emorragico clinicamente significativo (ad esempio, malattia di von Willebrand)
    6.Necessità di farmaco concomitante che è un forte inibitore del citocromo P450 (CYP) 3A4
    E.5 End points
    E.5.1Primary end point(s)
    Overall survival: The primary objective of this trial is to compare OS of subjects receiving standard of care treatment (GEM) plus dasatinib
    versus GEM plus placebo. Subjects will be followed after discontinuation
    of study therapy to record time to death. The final analysis will be conducted after 135 subject deaths.
    Sopravvivenza globale: l'obiettivo principale di questo studio è confrontare la OS dei soggetti che ricevono il trattamento di cura standard (GEM) più dasatinib. rispetto a l trattamento GEM più placebo.
    I pazienti saranno seguiti dopo la discontinuazione della terapia in studio per registrare la data del decesso. L'analisi finale sarà eseguita dopo che si sono verificati 135 decessi.
    E.5.1.1Timepoint(s) of evaluation of this end point
    The final analysis will be conducted
    after 135 subject deaths.
    L'analisi finale sarà eseguita dopo che si sono verificati 135 decessi.
    E.5.2Secondary end point(s)
    Progression Free Survival: Subjects will be assessed by imaging after
    every 2 cycles (ie, Weeks 8, 16, 24, etc). Progression events will be
    investigator determined according to Response
    Evaluation Criteria in Solid Tumor (RECIST) 1.1 criteria. Worsening pain,
    fatigue, ECOG PS, and/or CA19-9 are not by themselves considered
    evidence of disease progression
    but may be considered in the investigator's evaluation of disease.
    • Safety: All AEs will be recorded with onset date, resolution or
    stabilization date, severity grade, and relatedness to study treatment.
    - Sopravvivenza libera da malattia: i soggetti saranno valutati mediante diagnostica per immagini dopo ogni 2 cicli (cioè, Settimane 8, 16, 24, ecc.) Gli eventi di progressione sarnno
    determinati dallo sperimentatore in base alla Risposta.
    Evaluation Criteria in Solid Tumor (RECIST) criterio 1.1. Peggioramento del dolore, affaticamento, ECOG PS, e / o CA19-9 non sono di per sé considerati evidenza di progressione di malattia, ma possono essere considerate nella valutazione della malattia da parte dello sperimentatore.
    • Sicurezza: tutti eventi avversi saranno registrati con la data inizio, data di risoluzione o data di stabilizzazione, grado di gravità, e correlazione con il trattamento in studio.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Progression Free Survival: every 2 cycles
    Sopravvivenza libera da malattia: ogni due cicli
    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 Yes
    E.6.13.1Other scope of the trial description
    CA19-9 response will be analyzed
    sarà misurato il livello di CA19-9 nel siero
    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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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 concerned7
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA53
    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
    Australia
    Canada
    Russian Federation
    South Africa
    United States
    E.8.7Trial has a data monitoring committee Yes
    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
    The End of Trial Date will be determined by the sponsor after at least 135 death events have occurred.
    LA conclusione della sperimentazione sarà determinata dallo sponsor dopo che si sono verificati almeno 135 decesi
    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
    E.8.9.2In all countries concerned by the trial years3
    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.1.1.1In 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: 120
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 80
    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 state35
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 130
    F.4.2.2In the whole clinical trial 200
    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)
    Patients remaining on the study after the final study analysis is conducted, once 135 deaths have occured, will be offered commercially available Dasatinib depending on the availability within their country
    I soggetti possono continuare a ricevere la terapia sperimentale fino all'esecuzione dell'analisi finale dello studio dopo che si sono verificati 135 decessi. I soggetti che hanno ricevuto la terapia sperimentale fino a quel momento, possono ricevere forniture commerciali a discrezione dello sperimentatore secondo le indicazioni cliniche.
    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 Decision2011-09-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-06-30
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-06-15
    As of 1.2.2020, the UK is no longer an EU Member State. However, EU law still applies to the UK during the transition period
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