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    Summary
    EudraCT Number:2007-005725-29
    Sponsor's Protocol Code Number:EGF110656
    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:2008-06-04
    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 number2007-005725-29
    A.3Full title of the trial
    A PHASE III STUDY OF ERBB2 POSITIVE ADVANCED OR METASTATIC GASTRIC OR ESOPHAGEAL OR GASTROESOPHAGEAL JUNCTION ADENOCARCINOMA TREATED WITH CAPECITABINE PLUS OXALIPLATIN WITH OR WITHOUT LAPATINIB
    A Phase III Study of ErbB2 Positive Advanced or Metastatic Gastric or Esophageal Or Gastroesophageal Junction Adenocarcinoma Treated with Capecitabine Plus Oxaliplatin with or without Lapatinib
    A.3.2Name or abbreviated title of the trial where available
    TRIO-CIRG 013
    TRIO-CIRG 013
    A.4.1Sponsor's protocol code numberEGF110656
    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 SponsorGlaxoSmithKline Research and Development
    B.1.3.4CountryUnited Kingdom
    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 supportGlaxoSmithKline Research and Development
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGlaxoSmithKline
    B.5.2Functional name of contact pointGSK Clinical Support Helpdesk
    B.5.3 Address:
    B.5.3.1Street Address1-3 Iron Bridge Road
    B.5.3.2Town/ cityStockley Park, Uxbridge
    B.5.3.3Post codeUB11 1BU
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number800786766 - 0044 20 8990 4466
    B.5.5Fax number+44 208 990 2589
    B.5.6E-mailGSKClinicalSupportHD@gsk.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 No
    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 namelapatinib
    D.3.2Product code GW572016
    D.3.4Pharmaceutical form 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.3.8INN - Proposed INNlapatinib
    D.3.9.1CAS number 388082-78-8
    D.3.9.2Current sponsor codeGW572016
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.3Concentration number250
    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 placeboCoated tablet
    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
    Subjects with ErbB2-positive advanced or metastatic gastric or oesophageal or gsatro-oesophageal junction adenocarcinoma
    Soggetti con adenocarcinoma gastrico o adenocarcinoma dell esofago o della giunzione esofago-gastrica avanzato o metastatico ErbB2 positivi
    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 LLT
    E.1.2Classification code 10001150
    E.1.2Term Adenocarcinoma gastric
    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
    To compare the overall survival (OS) in subjects treated with CapeOx plus lapatinib versus CapeOx plus placebo.
    Confrontare la sopravvivenza globale (Overall Survival - OS) in soggetti trattati con CapeOx piu` lapatinib versus CapeOx piu` placebo
    E.2.2Secondary objectives of the trial
    -To compare the progression free survival (PFS), response rate (RR), and duration of overall response of both treatment arms; -To compare the rate of clinical benefit (as defined by CR+PR+SD) of both treatment arms; -To compare the severity and incidence of qualitative and quantitative toxicities of both treatment arm.
    -Confrontare la sopravvivenza libera da progressione (Progression Free Survival- PFS),il tasso di risposta (RR) e la durata della risposta nei due bracci di trattamento;-Confrontare il tasso di beneficio clinico (definito da CR+PR+SD) nei due bracci di trattamento;-Confrontare la gravita` e l`incidenza delle tossicita` qualitative e quantitative nei due bracci di trattamento.
    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:00
    Date:2007/12/17
    Title:
    Objectives:

    LIFE QUALITY:
    Vers:
    Date:
    Title:
    Objectives:

    FARMACOGENETICA:
    Vers:00
    Data:2007/12/17
    Titolo:Pharmacogenetics research
    Obiettivi:-Relationship between genetic variants and pharmacokinetics of investigational product
    -Relationship between genetic variants and safety and/or tolerability of investigatinal product
    -Relationship between genetic variants and efficacy of investigational products

    QUALITA DELLA VITA:
    Vers:
    Data:
    Titolo:Qaulity of life and medical resource utilisation
    Obiettivi:

    E.3Principal inclusion criteria
    1. Signed informed consent; willing and able to complete all required components of study. 2. Histologically confirmed gastric adenocarcinoma or adenocarcinoma of the esophagus or gastro-esophageal junction. Pathologic confirmation may be made from the metastatic site. Biopsy of the primary tumor is not necessary. Patients with pathologic confirmation from a metastatic site along with clinical/radiological documentation of gastric involvement and no evidence of another primary tumor are also eligible. Allowable histological subtypes include adenocarcinoma NOS, papillary carcinoma, adenocarcinoma, interstitial type, clear cell adenocarcinoma, mucinous carcinoma, signet ring cell carcinoma, undifferentiated carcinoma, carcinoma NOS. 3.Gastric cancer or Esophageal cancer that is unresectable due to locally advanced, metastatic, or locally recurrent. 4. Measurable or non-measurable, but radiologically evaluable disease, according to RECIST. X-rays, scans, or physical exams for either measurable or non-measurable disease must have been completed within 28 days prior to registration. 5. ErbB2 amplification by FISH assessed by the local or designated central laboratory. 6. Age `‰¥18 years 7. ECOG Performance status `‰¤ 2. 8. Adequate organ function assessed within 14 days prior randomization. 9. Cardiac ejection fraction within institutional range of normal as measured by echocardiogram. 10. Able to swallow and retain oral medications, and/or receive enteral medications via gastrectomy feeding tube. 11. Women and men with potential to have children must be willing to practice acceptable methods of birth control during the study. 12. Prior/Concurrent Therapy-Surgery as indicate in Protocol pag.32.
    1.Sottoscrizione del consenso informato; soggetti volontari e in grado di completare tutte le procedure richieste dello studio. 2.Adenocarcinoma gastrico o adenocarcinoma dell esofago o della giunzione esofago-gastrica confermato istologicamente. 3. Carcinoma gastrico o Tumore esofageo non resecabile in quanto localmente avanzato, metastatico o localmente ricorrente. 4.Malattia misurabile o non misurabile, ma radiologicamente valutabile secondo RECIST. Radiografie, scansioni o esami obiettivi relativi alla malattia misurabile o non misurabile, devono essere stati eseguiti nei 28 giorni precedenti la registrazione. 5.Amplificazione di ErbB2 mediante FISH secondo la valutazione del laboratorio locale o centrale. 6.Eta` `‰¥ 18 anni. 7.Performance Status ECOG `‰¤ 2. 8.Adeguata funzionalita` degli organi valutata nei 14 giorni precedenti la randomizzazione. 9.Frazione di eiezione cardiaca nell intervallo istituzionale di normalita` misurata mediante ecocardiogramma. 10.Soggetto in grado di assumere e trattenere farmaci orali e/o di ricevere farmaci per via enterica mediante tubo di alimentazione per gastrectomia (i soggetti NPO saranno considerati idonei solo dopo verifica del medical monitor dello studio). 11.Donne e uomini potenzialmente fertili devono acconsentire a usare metodi contraccettivi accettabili durante lo studio. 12.Terapia precedente/concomitante come riportato in sinossi pag.16-17.
    E.4Principal exclusion criteria
    1.Pregnant or lactating females at anytime during the study. 2.Known history of active CNS disease. 3.Uncontrolled ascites. 4.Concurrent anti-cancer therapy (chemotherapy, radiation therapy other than for pain relief, immunotherapy, biologic therapy, hormonal therapy or surgery) while taking investigational treatment. 5.Gastric carcinoid, epidermoid, sarcomas, or squamous cell carcinoma. 6.Prior palliative chemotherapy for the treatment of gastric cancer. 7.Prior treatment with oxaliplatin based neoadjuvant or adjuvant chemotherapy completed < 12 months 8.Malabsorption syndrome or uncontrolled inflammatory gastrointestinal disease (such as Crohn s disease or ulcerative colitis). 9.Known history of uncontrolled or symptomatic angina, arrhythmias, or congestive heart failure; 􀁸 Myocardial infarction within past 6 months 􀁸 New York Association Class III or IV congestive heart failure 10. Pre-existing grade 􀂕 2 motor or sensory neuropathy by CTC v3.0. 11. Uncontrolled infection. 12. Concurrent disease or condition that would make the subject inappropriate for study participation or any serious medical condition that would interfere with the subject`s safety. 13.Subjects who have current active hepatic or biliary disease (with exception of patients with Gilbert`s syndrome, asymptomatic gallstones, liver metastases or stable chronic liver disease per investigator assessment). 14. History of other malignancy except: 􀁸 subjects who have been disease-free for 5 years 􀁸 subjects with a history of completely resected non-melanoma skin cancer 􀁸 subjects with successfully treated in situ carcinoma 15. Unresolved or unstable serious toxicity from prior administration of another investigational drug and/or prior cancer treatment. 16. Dementia, altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent. 17. Known history of DPD deficiency. 18. Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to lapatinib, capecitabine, fluorouracil, platins or their excipients. 19. Use of any investigational drug within 30 days prior randomization. 20. Use of concurrent prohibited medications that would interact with study drugs, including herbal remedies and Chinese traditional medicines for cancer, and including any medications or drugs listed in table 1.
    1.Donne in gravidanza o allattamento in qualsiasi stadio dello studio. 2. Storia nota di malattia attiva dell SNC. 3.Ascite incontrollata. 4.Terapia anticancro concomitante (chemioterapia, radioterapia se non per ridurre il dolore, immunoterapia, terapia biologica, terapia ormonale o intervento chirurgico) durante l assunzione del farmaco dello studio. 5. Sarcoma, carcinoide o epidermoide gastrico o carcinoma a cellule squamose. 6. Chemioterapia palliativa precedente per il trattamento del carcinoma gastrico. 7. Trattamento precedente con chemioterapia adiuvante o neoadiuvante a base di oxaliplatino completata da &lt; 12 mesi 8. Sindrome da malassorbimento o malattia gastrointestinale infiammatoria incontrollata (come il morbo di Crohn o la colite ulcerosa). 9. Storia nota di angina incontrollata o sintomatica, aritmia o insufficienza cardiaca congestizia;Infarto del miocardio nei 6 mesi precedenti. Insufficienza cardiaca congestizia di classe III o IV secondo la New York Association 10. Neuropatia motoria o sensoriale preesistente di grado `‰¥ 2 secondo CTC v3.0. 11. Infezione incontrollata. 12. Una malattia o una condizione concomitante tale da rendere il soggetto inadatto alla partecipazione allo studio o qualsiasi patologia medica grave che interferirebbe con la sicurezza del soggetto. Soggetti con concomitante malattia epatica o biliare attiva (ad eccezione dei pazienti con sindrome di Gilbert, calcoli biliari asintomatici, metastasi epatiche o malattia epatica cronica stabile a giudizio dello sperimentatore). 14. Storia di altra malignita` eccetto: soggetti liberi da malattia per 5 anni, soggetti con storia di tumore cutaneo non melanoma completamente resecato, soggetti con carcinoma in situ trattato con esito positivo. 15.Tossicita` grave irrisolta o instabile da precedente somministrazione di un altro farmaco sperimentale e/o trattamento anticancro. 16. Demenza, stato mentale alterato o altra patologia psichiatrica che impedirebbe la comprensione o l ottenimento del consenso informato. 17. Storia nota di deficienza di DPD. 18. Reazione di ipersensibilita` immediata o ritardata nota o idiosincrasia verso farmaci chimicamente correlati a lapatinib, capecitabina, fluorouracile, platino o rispettivi eccipienti 19. Uso di farmaci sperimentali nei 30 giorni precedenti la randomizzazione. 20. Uso di farmaci concomitanti vietati che interagirebbero con i farmaci dello studio, compresi rimedi erboristici e farmaci tradizionali cinesi contro il cancro, e compresi medicamenti o farmaci elencati nella. Altre considerazioni sui criteri di idoneita` In pazienti che assumevano capecitabina in concomitanza con anticoagulanti derivati della cumarina come warfarin e fenprocumone sono state riferite alterazioni dei parametri di coagulazione e/o emorragia. I soggetti che assumono anticoagulanti a base di cumarina in concomitanza con capecitabina devono essere monitorati regolarmente per evidenziare eventuali alterazioni nei parametri di coagulazione (PT o INR). Gli anziani possono essere piu` sensibili a livello farmacodinamico agli effetti tossici di 5-FU e devono essere monitorati attentamente per evidenziare eventuali effetti avversi della capecitabina.
    E.5 End points
    E.5.1Primary end point(s)
    Overall Survival (OS), which is defined as the time from randomization until death due to any cause, is the primary endpoint for this study. Progression Free Survival (PFS), which is defined as the time from randomization until date of progression or death due to any cause will be a secondary endpoint of this study. Date of progression will be defined as the date of the first imaging or exam showing disease progression. Response rate and duration of responses are also secondary efficacy endpoints for this study. Please refer to Section 8.3.5.6 (Efficacy Analyses) for additional details.
    La sopravvivenza globale (OS), definita come il tempo tra la randomizzazione e la morte per qualsiasi causa, e` l`endpoint primario dello studio. La data della progressione e` definita come la data del primo test di imaging o esame indicativo di progressione della malattia. La sopravvivenza libera da progressione (PFS), definita come il tempo tra la randomizzazione e la data della progressione o della morte, e` un endpoint secondario dello studio. Tasso di risposta e durata della risposta sono ulteriori endpoint secondari dell`efficacia di questo studio. Si veda il paragrafo per ulteriori dettagli.
    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 Yes
    E.6.12Pharmacoeconomic Yes
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Quality of life and medical resource utilisation
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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) No
    E.8.2.2Placebo Yes
    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 concerned20
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA123
    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 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
    Last subject last visit
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    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 years4
    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.1.1Number 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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2008-06-04. Yes
    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 state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 135
    F.4.2.2In the whole clinical trial 410
    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 Decision2008-06-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-05-23
    P. End of Trial
    P.End of Trial StatusCompleted
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