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    Summary
    EudraCT Number:2007-004219-75
    Sponsor's Protocol Code Number:EMR200048-052
    National Competent Authority:Austria - BASG
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2008-04-22
    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 ConcernedAustria - BASG
    A.2EudraCT number2007-004219-75
    A.3Full title of the trial
    Open-label, randomized, controlled, multicenter phase III study investigating cetuximab in combination with capecitabine (Xeloda, X) and cisplatin (P) versus XP alone as first-line treatment for subjects with advanced gastric adenocarcinoma including adenocarcinoma of the gastroesophageal junction.
    A.3.2Name or abbreviated title of the trial where available
    EXPAND
    A.4.1Sponsor's protocol code numberEMR200048-052
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorMerck KGaA
    B.1.3.4CountryGermany
    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 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.2.1.1.1Trade name Erbitux 5 mg/ml
    D.2.1.1.2Name of the Marketing Authorisation holderMerck KGaA
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 Solution for infusion
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNCetuximab
    D.3.10 Strength
    D.3.10.1Concentration unit mg/l milligram(s)/litre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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 Yes
    D.3.11.13.1Other medicinal product typeMonoclonal antibody
    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
    Advanced esophago-gastric cancer
    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
    The primary objective of this study is to demonstrate that addition of cetuximab to 1st-line treatment with XP chemotherapy regimen has a clinically relevant benefit for subjects with advanced gastric adenocarcinoma including GEJ adenocarcinoma, in terms of PFS.
    E.2.2Secondary objectives of the trial
    Secondary objectives are to assess cetuximab + XP versus XP alone with respect to overall survival, overall tumor response, quality of life and safety.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Written informed consent before any study-related activities are carried out
    • Age ≥ 18 years
    • Histologically confirmed adenocarcinoma of the stomach or gastroesophageal junction (AEG types I-III according to Siewert classification, see appendix A)
    Diagnosis should be based on recently obtained tumor material. The histological sample on which the diagnosis is based must have been obtained no more than 2 years before enrolment into this study.
    • Archived tumor material sample for at least subsequent standardized EGFR expression assessment Investigators must make sure in advance that appropriate archived tumor material is
    available from a potentially eligible subject, and that a sample can be shipped to a
    central repository if the subject agrees to participate.
    • Unresectable advanced (M0) or unresectable metastatic (M1) disease. In the event of unresectable advanced disease, at least one measurable locoregional
    lymph node or other measurable extraluminal tumor lesion ≥ 2cm must be documented (irrespective of whether it is measured by conventional techniques or spiral CT scan).
    • At least one radiographically documented measurable lesion in a previously nonirradiated area according to RECIST, i.e. this lesion must be adequately measurable in at least one dimension (longest diameter to be recorded) as ≥ 2cm by conventional techniques or ≥ 1 cm by spiral CT scan (see section 7.2). Primary tumor site will be considered as a non-measurable lesion only.
    • ECOG performance status 0-1
    • Estimated life expectancy > 12 weeks
    • Medically accepted contraception (if the risk of conception exists)
    • Glomerular filtration rate (GFR) ≥ 60mL/min
    The GFR is to be based on the Cockroft-Gault formula for creatinine clearance:
    GFR (mL/min)=(C x (140-age [years] x weight [kg]))/(72 x serum creatinine (mg/dL))
    where C = 0.85 for female subjects and C = 1.00 for male subjects
    • ASAT ≤ 2.5 x ULN and ALAT ≤ 2.5 x ULN
    • Bilirubin ≤ 3 x ULN
    • ANC ≥ 1.5 x 109/L
    • Platelets ≥ 100 x 109/L
    • Hemoglobin ≥ 10 g/dL (without transfusions)
    • Sodium and potassium within normal limits or ≤ 10% above or below (supplementation permitted)
    E.4Principal exclusion criteria
    • Prior chemotherapy. However previous (neo-)adjuvant (radio-)chemotherapy is allowed
    if it was finished > 1 year prior to start of study treatment and no more than 300 mg/m2
    cisplatin has been administered
    • Prior treatment with an antibody or molecule targeting EGFR- and/or VEGFR-related
    signaling pathways
    • Brain metastasis and/or leptomeningeal disease (known or suspected)
    • Radiotherapy (except localized radiotherapy for pain relief as outlined in section 6.8.2),
    major surgery or any investigational drug in the 30 days before the start of study
    treatment
    • Concurrent chronic systemic immune or hormone therapy not indicated in this study
    protocol (except for physiologic replacement)
    • Clinically relevant coronary artery disease (NYHA functional angina classification
    III/IV), congestive heart failure (NYHA III/IV), clinically relevant cardiomyopathy,
    history of myocardial infarction in the last 12 months, or high risk of uncontrolled
    arrhythmia
    • Active hepatitis B or C
    • Chronic diarrhea or short bowel syndrome
    • Presence of any contra-indication to treatment with cetuximab, capecitabine and
    cisplatin including:
    - Known hypersensitivity to capecitabine, fluorouracil, cisplatin, cetuximab or to any
    of the excipients of these drugs
    - Known dihydropyrimidine dehydrogenase (DPD) deficiency
    - Subjects with hereditary problems of galactose intolerance, Lapp lactase deficiency
    or glucose-galactose malabsorption
    - Current treatment with sorivudine or chemically related analogues, such as brivudine
    - Symptomatic peripheral neuropathy NCI-CTCAE grade ≥ 2 and/or ototoxicity
    NCI-CTC AE grade ≥ 2, except if due to trauma or mechanical impairment due to
    tumor mass
    • Pregnancy or lactation period
    • Concurrent treatment with a non-permitted drug (see section 6.8.2)
    • Treatment in another clinical study within the past 30 days
    • Previous malignancy other than gastric cancer in the last 5 years except for basal cell cancer of the skin or preinvasive cancer of the cervix
    • Medical or psychological conditions that would not permit the subject to complete the study or sign informed consent
    • Legal incapacity or limited legal capacity
    • Significant disease which, in the investigator’s opinion, would exclude the subject from the study
    E.5 End points
    E.5.1Primary end point(s)
    The primary study endpoint is progression-free survival
    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 Yes
    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 Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    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 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.8.3 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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA90
    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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    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
    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.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    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 2008-04-22. 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 state24
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 700
    F.4.2.2In the whole clinical trial 870
    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 Decision2008-05-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-05-13
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2013-02-17
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