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    Summary
    EudraCT Number:2005-000146-36
    Sponsor's Protocol Code Number:EMD72000-032
    National Competent Authority:Germany - PEI
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2005-03-02
    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 ConcernedGermany - PEI
    A.2EudraCT number2005-000146-36
    A.3Full title of the trial
    Randomized Phase II open-label controlled study of EMD 72000 (matuzumab) in combination with the chemotherapy regimen ECX or the chemotherapy regimen ECX alone as first-line treatment in subjects with metastatic esophago-gastric adenocarcinoma
    A.3.2Name or abbreviated title of the trial where available
    MATRIX E.G.
    A.4.1Sponsor's protocol code numberEMD72000-032
    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 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 nameMatuzumab
    D.3.2Product code EMD72000
    D.3.4Pharmaceutical form Powder 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 INNMatuzumab
    D.3.9.3Other descriptive nameMab<EGF-R>rH
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    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
    Metastatic Esophago-gastric adenocarcinoma
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10001150
    E.1.2Term Adenocarcinoma gastric
    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 determine the response rates of matuzumab in combination with ECX as background chemotherapy and of ECX alone in subjects with metastatic esophago-gastric cancer.
    E.2.2Secondary objectives of the trial
    The secondary objectives of this study are to assess the following parameters:
    • Response duration
    • Median time to tumor progression
    • Median survival time
    • Safety and tolerability
    • Quality of life
    • Protein biomarkers
    In addition, the following parameters will be assessed for subjects receiving matuzumab
    • Determination of HAHA
    • Matuzumab peak and trough values
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    1. Written informed consent provided prior to any prescreening procedure
    2. Male or female, 18 years or older
    3. Histologically confirmed gastric adenocarcinoma or adenocarcinoma of the lower third of the esophagus
    4. Metastatic disease
    5. Normal cardiac function (left ventricular ejection fraction within the institutional normal range)
    6. At least 1 measurable lesion according to the modified WHO criteria as defined in Section 7.2.2.
    7. Archived tissue available for EGFR testing and immunohistochemical evidence of tumor EGFR (HER-1) expression in the most recent available sample
    8. ECOG (Eastern Cooperative Oncology Group) performance status 0-1
    9. Life-expectancy > 12 weeks
    10. Adequate liver, bone marrow, and renal function, defined as:
    • Bilirubin < 1.5 x upper limit of normal (ULN)
    • Alanine aminotransferase (ALT)/aspartate aminotransferase (AST) < 2.5 x ULN (for subjects with liver metastases ALT/AST < 5 x ULN)
    • Neutrophils > 1500 mm3
    • Platelets > 100 000/µl
    • Hemoglobin > 10g/dl
    • Serum creatinine < 1.5 x ULN or glomerular filtration rate (GFR) of ≥ 60 ml/minute. The GFR is to be based upon the Cockroft-Gault formula for creatinine clearance:
    GFR (ml/min) = c x (140 – age [years]) x weight (kg)
    72 x serum creatinine (mg/100 ml)
    where c = 0.85 for female subjects and c = 1.00 for male subjects
    11. If of childbearing potential, willingness to use effective contraceptive method for the study duration and 2 months post-dosing. [Females of childbearing potential are defined as any females who have experienced menarche and have not undergone successful surgical sterilization (hysterectomy or bilateral oophorectomy), or are not post menopausal (defined as age-related amenorrhea for ≥12 consecutive months)]
    E.4Principal exclusion criteria
    1. Previous chemotherapy, unless neo- adjuvant or adjuvant therapy completed > 12 months prior to study treatment. Subjects previously treated with anthracyclins must not exceed total cumulative dose described in the treatments section.
    2. Radiotherapy or major surgery within the last 4 weeks prior to the start of study treatment
    3. Prior treatment with an EGFR signal transduction directed therapy
    4. Uncontrolled angina pectoris, heart failure, clinically significant uncontrolled cardiac arrhythmias
    5. Clinically significantly abnormal electrocardiogram (ECG) or cardiac history (e.g. subjects with myocardial infarction within the last 6 months)
    6. Treatment with non-permitted medication (as specified in Section 6.8).
    7. Documented or symptomatic brain metastases and/or central nervous system metastases or leptomeningeal disease.
    8. Superior vena cava syndrome contra-indicating hydration
    9. Symptomatic peripheral neuropathy NCI-CTCAE grade ≥2 and/or ototoxicity grade ≥2, except if due to trauma or mechanical impairment due to tumor mass
    10. Known active, uncontrolled infections, uncontrolled severe organ dysfunction or metabolic disorder or any other significant disease which in the investigator’s opinion would exclude the subject from the study
    11. Pregnancy (confirmed by β-HCG) or lactation period
    12. Known hypersensitivity to matuzumab or any of the components of ECX (according to the current investigators’ brochure for matuzumab and the relevant product information sheets for epirubicin, cisplatin and capecitabine)
    13. Known conditions that would interfere with treatment with any of the substances used in this study
    14. Participation in another clinical study within the past 30 days
    15. Concurrent malignancies or invasive cancers diagnosed within the past 5 years, except for: adequately treated basal cell cancer of the skin or in situ cancer of the cervix
    16. Legal incapacity or limited legal capacity
    E.5 End points
    E.5.1Primary end point(s)
    The primary target variable is the tumor response rate based on response assessments made by the Independent Review Committee. Subjects in both groups will be evaluated for tumor response every 6 weeks during treatment (regardless of any treatment delays), and every 3 months after the end of all study treatment, until PD. Response will be classified according to the modified WHO criteria.
    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 Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic Information not present in EudraCT
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic Yes
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Plasma Biomarkers
    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 No
    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 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.8.5The trial involves multiple Member States Yes
    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 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
    After Amendment 8: Previously the End of Study visit was scheduled to take place upon occurrence of PD. The End of Study visit will be conducted upon occurrence of PD, or when at least 18 months has passed since randomization, whichever occurs first. The end of the study is now be defined as the last patient last end of study visit.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months9
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months9
    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 Information not present in EudraCT
    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 2005-03-02. Yes
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    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.3.3.6.1Details of subjects incapable of giving consent
    Women in this group who are suffering from esophago-gastric cancer will be eligible to enter the study, if they choose, however they must be willing to use effective contraceptive method for the study duration and 2 months post-dosing.
    F.3.3.7Others Yes
    F.3.3.7.1Details of other specific vulnerable populations
    Terminally ill patients
    F.4 Planned number of subjects to be included
    F.4.1In the member state11
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 55
    F.4.2.2In the whole clinical trial 70
    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)
    The patient will remain on the study until they experience disease progression, unacceptable toxicities or withdrawal of the consent. It would not be appropriate for patients to continue on study medication after these events. Upon ending their participation in the study, the investigator will advise the patient of the best currently available treatment or courses of action.
    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 Decision2005-05-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2005-07-28
    P. End of Trial
    P.End of Trial StatusCompleted
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