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    Summary
    EudraCT Number:2011-001720-37
    Sponsor's Protocol Code Number:CRO-2011-12
    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:2011-12-27
    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 number2011-001720-37
    A.3Full title of the trial
    Multi-centre, phase II, single arm study of the docetaxel, oxaliplatin, capecitabine (DOC) combination in untreated patients with advanced or metastatic gastric cancer
    Studio di fase II della combinazione di docetaxel, oxaliplatino e capecitabina (DOC) in pazienti affetti da carcinoma gastrico non pre-trattati
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Multi-centre, phase II, single arm study of the docetaxel, oxaliplatin, capecitabine (DOC) combination in untreated patients with advanced or metastatic gastric cancer
    Studio di fase II della combinazione di docetaxel, oxaliplatino e capecitabina (DOC) in pazienti affetti da carcinoma gastrico non pre-trattati
    A.3.2Name or abbreviated title of the trial where available
    DOC2
    DOC2
    A.4.1Sponsor's protocol code numberCRO-2011-12
    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 SponsorCENTRO DI RIFERIMENTO ONCOLOGICO DI AVIANO
    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 supportCentro di Riferimento Oncologico IRCCS CRO Aviano
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCentro di Riferimento Oncologico IRCCS CRO Aviano
    B.5.2Functional name of contact pointGruppo Ricerca Clinico-terapeutica
    B.5.3 Address:
    B.5.3.1Street AddressVia Franco Gallini 2
    B.5.3.2Town/ cityAviano
    B.5.3.3Post code33081
    B.5.3.4CountryItaly
    B.5.4Telephone number0434 659253
    B.5.6E-maildirscienti@cro.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 TAXOTERE*INFUS FL 160MG/8ML
    D.2.1.1.2Name of the Marketing Authorisation holderSANOFI-AVENTIS 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.3.4Pharmaceutical 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 INNDOCETAXEL
    D.3.9.1CAS number 114977-28-5
    D.3.10 Strength
    D.3.10.1Concentration unit mg/m2 milligram(s)/square meter
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number30
    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 OXALIPLATINO TEVA*INF 100MG/20
    D.2.1.1.2Name of the Marketing Authorisation holderTEVA ITALIA Srl
    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 INNOxaliplatin
    D.3.10 Strength
    D.3.10.1Concentration unit mg/m2 milligram(s)/square meter
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number70
    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.2.1.1.1Trade name XELODA*120CPR RIV 500MG
    D.2.1.1.2Name of the Marketing Authorisation holderROCHE 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.3.4Pharmaceutical 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 INNCAPECITABINE
    D.3.9.1CAS number 154361-50-9
    D.3.10 Strength
    D.3.10.1Concentration unit mg/m2 milligram(s)/square meter
    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
    patients with metastatic gastric carcinoma
    pazienti affetti da carcinoma gastrico metastatico
    E.1.1.1Medical condition in easily understood language
    patients with metastatic gastric carcinoma
    pazienti affetti da carcinoma gastrico metastatico
    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 10063916
    E.1.2Term Metastatic 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
    Response rate (RR) according to the RECIST Criteria
    Valutare il tasso di risposta (RR) in conformità con i criteri RECIST
    E.2.2Secondary objectives of the trial
    - Progression free survival (PFS), - Overall Survival (OS), - Disease Control Rate (DCR), - Safety profile, - Quality of life (EORTC QLQ-C30 and QLQ-STO22).
    Valutare: - Tempo alla progressione (PFS), - Sopravvivenza complessiva (OS), - Beneficio Clinico(CB), - Profilo di sicurezza, - Qualità della vita (EORTC QLQ-C30 and QLQ-STO22).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    -Age ≥18, - Histologically or cytologically confirmed adenocarcinoma of the stomach or lower third of the oesophagus, - HER2/NEU status as negative (IHC 1-2+; FISH negative). - Clinical stage: T4 N-/+ M0 or TxNxM1; local relapse not amenable to curative surgery. - The stage classification is clinical and will be defined by the most appropriate method (Physical exam, EGDS, EUS, CT, MRI). - ECOG Performance Status of 0 or 1. - Royal Marsden Hospital prognostic index, Group 1(See appendix). - No previous chemotherapy for advanced or locally relpsed disease. - Previous adjuvant chemotherapy completed at least 6 months before registration. - Measurable/evaluable disease, according to the (NCI-CTCAE v.3) criteria. - Baseline laboratory values: absolute neutrophil count (ANC) ≥2000/mm3, hemoglobin >10.0 g/dL, platelet count ≥100,000/mm3creatinine <1.5 times the upper limit of normal (ULN); in case of threshold values the creatinine clearance will be evaluated according to the Cockroft-Gault formula and should be > 60 ml/min, transaminases <2.5 times ULN, alkaline phosphatase < 2.5 times ULN, total bilirubin < 1.0 times ULN. -Signed written informed consent. -Patient willing and able to comply with protocol requirements. -Life expectancy > 3 months. -Recovery from acute effects of surgery.
    Pazienti adulti (età ≥18), - Conferma istologica o citologica di adenocarcinoma dello stomaco - Negatività per HER2/NEU (IHC 1-2+; FISH negativo), - Stadio: T4 N-/+M0; TxNxM1; recidiva locale inoperabile, - La classificazione in stadi è clinica e verrà definita con il metodo più appropriato(Esame obiettivo, EGDS, EUS, TAC, RM). - Performance Status 0 or 1 (ECOG), - Indice prognostico del Royal Marsden Hospital, Group 1 (vedere appendice). - Nessun trattamento chemioterapico precedente per malattia metastatica o in ricaduta locale, - Precedente chemioterapia adiuvante completata da più di 6 mesi, - Malattia misurabile/valutabile, secondo i Criteri (NCI-CTCAE v.3), - Valutazione di base: neutrofili totali (ANC) ≥2000/mm3, emoglobina &gt;10.0 g/dL, coagulazione ≥100,000/mm3creatinina &lt;1.5 volte il limite superiore di normalità (ULN); in caso di valori limite, la creatinina clearance sarà calcolata secondo la formula Cockroft-Gault, dovrebbe essere &gt; 60 ml/min, transaminasi &lt;2.5x ULN, fosfatasi alcalina &lt; 2.5xULN, bilirubina totale &lt; 1.0xULN. - Consenso informato scritto. - Paziente consenziente ed in grado di soddisfare i requisiti richiesti dal protocollo. - Spettanza di vita &gt; 3 mesi. - Recupero da eventuale precedente chirurgia.
    E.4Principal exclusion criteria
    - HER2+ positivity (immunohistochemistry 3+ or fluorescence in situ hybridization–amplified). -Previous chemotherapy for metastatic or relapsed disease. -New York Heart Association Class 3 or 4 heart disease. -Clinically significant heart disease, including but not limited to: myocardial infarction within the last 6 months, congestive heart failure, unstable angina, clinically significant pericardial effusion or serious arrhythmia. -Peripheral neuropathy grade ≥ 2 according to the NCI-CTCAE v.3. -Any serious active infection (uncontrolled or requiring treatment). -Any history or evidence of CNS disease, e.g. brain metastases. -Any known hypersensitivity to study drug components. -Lack of physical integrity of the upper gastrointestinal tract, malabsorption syndrome, or inability to take oral medication. -Pregnant or lactating women. -Fertile patients (male and female) unwilling to use effective means of contraception during the study.
    - Positività per HER2 (3+ all’immunoistochimica; FISH positivo). - Precedente chemioterapia per la fase metastatica o di ricaduta locale. - New York Heart Association Class 3 o 4. - Malattie cardiache clinicamente significative che includono, ma non limitate a: infarto miocardio entro i 6 mesi precedenti, scompenso cardiaco, angina instabile, versamento pericardio o aritmie gravi. - Neuropatia periferica di grado ≥ 2 secondo the NCI-CTCAE v.3. - Infezioni gravi ed attive. - Storia o evidenza di malattie del CNS, o di metastasi cerebrali. - Nessuna ipersensibilità ai componenti del farmaco. - Sindrome da malassorbimento, o impossibilità all’assunzione di farmaci orali. - Pazienti in gravidanza o in allattamento. Pazienti in periodo fertile (uomini e donne) devono assumere adeguate misure contraccettive
    E.5 End points
    E.5.1Primary end point(s)
    Response rate (RR) according to the RECIST Criteria
    Tasso di risposta (RR) in conformità con i criteri RECIST.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Taking into account the relatively rarity of the disease and the strict selection criteria (Her2/neu negative and Royal Marsden Prognostic score 0-1), it is anticipated that a total of three eligible patients per month will be randomized, considering also a 10% of not evaluable patients, a 27 month period of accrual and further 18 month of follow up will be estimated to reach the primary and secondary objective
    Considerando la relativa rarità della patologia e i ristrettivi criteri di inclusione, si prevede un periodo di 27 mesi di arruolamento e ulteriori 18 mesi di follow-up. La rilevazione inizierà a questo punto
    E.5.2Secondary end point(s)
    - Progression free survival (PFS), - Overall Survival (OS), - Disease Control Rate (DCR), - Safety profile, - Quality of life (EORTC QLQ-C30 and QLQ-STO22).
    Valutare: - Tempo alla progressione (PFS), - Sopravvivenza complessiva (OS), - Beneficio Clinico(CB), - Profilo di sicurezza, - Qualità della vita (EORTC QLQ-C30 and QLQ-STO22).
    E.5.2.1Timepoint(s) of evaluation of this end point
    Taking into account the relatively rarity of the disease and the strict selection criteria (Her2/neu negative and Royal Marsden Prognostic score 0-1), it is anticipated that a total of three eligible patients per month will be randomized, considering also a 10% of not evaluable patients, a 27 month period of accrual and further 18 month of follow up will be estimated to reach the primary and secondary objective
    Considerando la relativa rarità della patologia e i ristrettivi criteri di inclusione, si prevede un periodo di 27 mesi di arruolamento e ulteriori 18 mesi di follow-up. La rilevazione inizierà a questo punto
    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 No
    E.8.1.1Randomised Information not present in EudraCT
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    E.8.2.4Number of treatment arms in the trial1
    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 concerned13
    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 years0
    E.8.9.1In the Member State concerned months45
    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.1.2.1Number of subjects for this age range: 50
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 21
    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 state71
    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)
    Possible other therapies
    Possibili altre terapie
    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 Decision2011-12-01
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-05-11
    P. End of Trial
    P.End of Trial StatusOngoing
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