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    Summary
    EudraCT Number:2010-020189-37
    Sponsor's Protocol Code Number:IRST151.01
    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:2012-03-14
    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 number2010-020189-37
    A.3Full title of the trial
    A randomised phase II study of pre-operative or peri-operative docetaxel, oxaliplatin, capecitabine (DOX) regimen in patients with locally advanced resectable gastric cancer
    STUDIO DI FASE II RANDOMIZZATO CON DOCETAXEL, OXALIPLATINO, CAPECITABINA (DOX) COME TRATTAMENTO PREOPERATORIO O PERIOPERATORIO (PRIMA E DOPO LA GASTRECTOMIA) IN PAZIENTI CON CARCINOMA GASTRICO LOCALMENTE AVANZATO RESECABILE.
    A.3.2Name or abbreviated title of the trial where available
    IRST 151.01
    IRST 151.01
    A.4.1Sponsor's protocol code numberIRST151.01
    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 SCIENTIFICO ROMAGNOLO PER LO STUDIO E LA CURA DEI TUMORI
    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.2.1.2Country 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 Concentrate 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 INNPLANT ALKALOIDS AND OTHER NATURAL PRODUCTS
    D.3.10 Strength
    D.3.10.1Concentration unit mg/m2 milligram(s)/square meter
    D.3.10.3Concentration number35
    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.2.1.2Country 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 INNOTHER ANTINEOPLASTIC AGENTS
    D.3.10 Strength
    D.3.10.1Concentration unit mg/m2 milligram(s)/square meter
    D.3.10.3Concentration number80
    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: 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.2.1.2Country 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 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.3.8INN - Proposed INNANTIMETABOLITES
    D.3.10 Strength
    D.3.10.1Concentration unit mg/m2 milligram(s)/square meter
    D.3.10.3Concentration number750
    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
    Patient with potentially resectable adenocarcinoma of the stomach
    Pazienti con carcinoma dello stomaco potenzialmente resecabile
    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 10017758
    E.1.2Term Gastric cancer
    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
    The percentage of patients receiving all the planned chemotherapeutic cycles.
    La percentuale dei pazienti che hanno ricevuto tutti i cicli di chemioterapia programmati.
    E.2.2Secondary objectives of the trial
    • Downstaging according to Recist criteria • pT1-3 vs pT0. • Safety: number of patients with grade 3-4 toxicity • The role of PET Scan as predictor of response • Curative vs palliative surgery • TTP • OS • Diagnostic correlation between the various staging methods • Possible correlations between CT scan, CT/PET, laparoscopy; • Molecualr marker related to toxicity: DPYD, MTHFR, TS, XPD, ERCC1, XRCC1; • Molecular marker related to prognosis: TYMS, GSTP1, COX-2, RUNX3, methylation profile (Cox2, hMLH1, MGMT); • Molecular marker related to therapy response: TYMS, DPYD, MTHFR, OPRT, ERCC1, XRCC1/2/3, GSTP1, GSTM1, GSTT1, ABCB1, methylation profile (Cox2, hMLH1, MGMT), whole genome arrayCGH
    • Downstaging secondo i criteri RECIST • pT1-3 vs pT0. • Sicurezza: numero di pazienti con grado 3-4 di tossicita' • Ruolo della PET come predittore di risposta • Chirurgia curativa vs chirurgia palliativa • TTP • OS • Correlazione diagnostica fra i vari metodi di staging • Possibile correlazione fra TAC, TAC/PET, laparoscopia; • Markers molecolari relativi alla tossicita': DPYD, MTHFR, TS, XPD, ERCC1, XRCC1; • Markers molecolari relativi alla prognosi: TYMS, GSTP1, COX-2, RUNX3, profilo di metilazione (Cox2, hMLH1, MGMT); • Markers molecolari relativi alla risposta alla terapia: TYMS, DPYD, MTHFR, OPRT, ERCC1, XRCC1/2/3, GSTP1, GSTM1, GSTT1, ABCB1, profilo di metilazione (Cox2, hMLH1, MGMT), whole genome arrayCGH.
    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:1.0
    Date:2010/06/01
    Title:
    Objectives:

    FARMACOGENETICA:
    Vers:1.0
    Data:2010/06/01
    Titolo:STUDIO DI FASE II RANDOMIZZATO CON DOCETAXEL, OXALIPLATINO, CAPECITABINA (DOX) COME TRATTAMENTO PREOPERATORIO O PERIOPERATORIO (PRIMA E DOPO LA
    GASTRECTOMIA) IN PAZIENTI CON CARCINOMA GASTRICO LOCALMENTE AVANZATO RESECABILE.
    Gastric neoadjuvant, biological study
    Obiettivi:• Markers molecolari relativi alla tossicita': DPYD, MTHFR, TS, XPD, ERCC1, XRCC1;
    • Markers molecolari relativi alla prognosi: TYMS, GSTP1, COX-2, RUNX3, profilo di metilazione (Cox2, hMLH1, MGMT);
    • Markers molecolari relativi alla risposta alla terapia: TYMS, DPYD, MTHFR, OPRT, ERCC1, XRCC1/2/3, GSTP1, GSTM1, GSTT1, ABCB1, profilo di metilazione (Cox2, hMLH1, MGMT), whole genome arrayCGH.

    E.3Principal inclusion criteria
    • Male or female 18-75 years of age
    • Diagnosis of histologically confirmed, potentially resectable adenocarcinoma of the stomach
    • cT3 subserosal - cT4a – cT4b (7th edition UICC TNM) or bulky lymph node metastases independently of T
    • ECOG performance status 0-1 at study entry
    • Laboratory requirements (up to 8 days prior to randomization):
    a) Haematology:
    I) Neutrophils > 1.5 x 109 /L
    II) Platelets > 100 x 109 /L
    III) Hemoglobin > 10g/dL
    b) Hepatic function
    I) Total bilirubin < 1.25 UNL
    II) AST (SGOT) and ALT (SGPT)<2.5xUNL
    II) Alkaline phosphatase < 2.5xUNL c) Renal function
    I) Creatinine <1.5 UNL
    In the presence of border-line values, the calculated creatinine clearance should be >= 60 mL/min;
    • Written informed consent signed and dated before randomization procedures, must be obtained and documented according to the local regulatory requirement.
    • Effective contraception for both male and female patients if the risk of conception exists.
    . Maschi o femmine 18-75 anni di eta'
    . Diagnosi istologicamente confermata di adenocarcinoma dello stomaco
    potenzialmente resecabile
    . cT3 sottosierosa - cT4a – cT4b (7th edizione UICC TNM) o metastasi
    linfonodali indipendentemente da T
    . ECOG performance status 0-1 all’ingresso in studio
    . Requisiti di laboratorio (fino a 8 giorni prima della randomizzazione):
    a) Ematologia:
    I) Neutrofili &gt; 1.5 x 109 /L
    II) Piastrine &gt; 100 x 109 /L
    III) Emoglobina &gt; 10g/dL
    b) Funzionalita' epatica
    I) Bilirubina totale &lt; 1.25 UNL
    II) AST (SGOT) e ALT (SGPT) &lt; 2.5xUNL
    III) Fosfatasi alcalina &lt; 2.5xUNL
    c) Funzionalita' renale
    I) Creatinina &lt;1.5 UNL
    In presenza di valori border-line, la clearance della creatinina
    calcolata dovrebbe essere &gt;= 60 mL/min;
    · Un consenso informato scritto firmato e datato deve essere ottenuto e
    documentato secondo le esigenze locali di regolamentazione, prima delle
    procedure di randomizzazione.
    · Se esiste il rischio di concepimento, deve essere utilizzato un
    contraccettivo efficace sia per i pazienti maschi e che per le pazienti
    femmine.
    E.4Principal exclusion criteria
    • Early gastric cancer (if N0)
    • T2 (according to 7th edition of UICC TNM) if N0
    • Linitis plastica
    • Positive peritoneal cytology
    • Distant metastases
    • Tumor involving the gastro-esophageal junction
    • Peritoneal involvement
    • Concurrent chronic systemic immune therapy
    • Any investigational agent(s) 4 weeks prior to study entry
    • Clinically relevant coronary artery disease, a history of myocardial infarction or a history of hypertension not controlled by therapy within the last 12 months
    • Known grade 3 or 4 allergic reaction to any of the components of the treatment
    • Known drug abuse/alcohol abuse
    • Legal incapacity or limited legal capacity
    • Medical or psychological condition which, in the opinion of the investigator, would not permit the patient to complete the study or sign meaningful informed consent
    • Women who are pregnant or breastfeeding
    • Acute or subacute intestinal occlusion
    • Any concurrent malignancy other than non-melanoma skin cancer, or carcinoma in situ of the cervix. (Patients with a previous malignancy but without evidence of disease for ≥ 5 years will be allowed to enter the trial)
    . Early gastric cancer (se N0)
    . T2 (secondo la 7th edizione della UICC TNM) se N0
    . Linite plastica
    . Citologia peritoneale positiva
    . Metastasi a distanza
    . Tumori che coinvolgono la giunzione gastro-esofagea
    . Coinvolgimento peritoneale
    . Concomitante terapia sistemica immunitaria
    . Utilizzo di qualsiasi agente sperimentale nelle 4 settimane precedenti lo studio
    . Malattia coronaria clinicamente significativa, storia di infarto al
    miocardio o storia di ipertensione non controllata entro gli ultimi 12 mesi
    . Reazione allergica nota di Grado 3 o 4 ad uno qualsiasi dei componenti
    del trattamento
    . Abuso noto di farmaci e alcol
    . Incapacita' legale o limitata capacita' legale
    . Condizione medica o psicologica che, ad opinione del medico, non
    potrebbe consentire al paziente di completare lo studio o firmare il
    consenso informato
    . Donne che sono incinte o che allattano
    . Occlusione intestinale acuta o subacuta
    . Qualsiasi altra neoplasia diversa dal tumore cutaneo non melanoma o
    carcinoma in situ della cervice. (Pazienti con precedente neoplasia ma
    senza evidenza di malattia per un periodo ≥ 5 anni potranno entrare in
    studio)
    E.5 End points
    E.5.1Primary end point(s)
    The percentage of patients receiving all the planned chemotherapeutic cycles.
    La percentuale dei pazienti che hanno ricevuto tutti i cicli di chemioterapia programmati
    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 Yes
    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) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    - Stesso farmaco ad altro dosaggio
    - same IMP used at different dosage
    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 concerned11
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months80
    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 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 state90
    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 Decision2010-08-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-07-21
    P. End of Trial
    P.End of Trial StatusOngoing
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