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The European Union Clinical Trials Register allows you to search for protocol and results information on:
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    The EU Clinical Trials Register currently displays   42883   clinical trials with a EudraCT protocol, of which   7063   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2014-000722-38
    Sponsor's Protocol Code Number:1203-GITCG
    National Competent Authority:Germany - PEI
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2015-03-24
    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 ConcernedGermany - PEI
    A.2EudraCT number2014-000722-38
    A.3Full title of the trial
    INtegratioN of trastuzumab, with or without pertuzumab, into periOperatiVe chemotherApy of HER-2 posiTIve stOmach caNcer: the INNOVATION-TRIAL
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    INtegratioN of trastuzumab, with or without pertuzumab, into periOperatiVe chemotherApy of HER-2 posiTIve stOmach caNcer: the INNOVATION-TRIAL
    A.3.2Name or abbreviated title of the trial where available
    INNOVATION
    A.4.1Sponsor's protocol code number1203-GITCG
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02205047
    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 SponsorEuropean Organization for the Research and Treatment of Cancer
    B.1.3.4CountryBelgium
    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 supportEuropean Organization for the Research and Treatment of Cancer (EORTC)
    B.4.2CountryBelgium
    B.4.1Name of organisation providing supportF. Hoffmann-La Roche
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationEuropean Organization for the Research and Treatment of Cancer (EORTC)
    B.5.2Functional name of contact pointRegulatory Affairs Department
    B.5.3 Address:
    B.5.3.1Street AddressAv E. Mounier 83/11
    B.5.3.2Town/ cityBrussels
    B.5.3.3Post code1200
    B.5.3.4CountryBelgium
    B.5.4Telephone number+3227741054
    B.5.5Fax number+3227727063
    B.5.6E-mailregulatory@eortc.org
    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 Perjeta
    D.2.1.1.2Name of the Marketing Authorisation holderRoche
    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.3.1Product namePertuzumab
    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 INNPERTUZUMAB
    D.3.9.1CAS number 380610-27-5
    D.3.9.3Other descriptive namePERTUZUMAB
    D.3.9.4EV Substance CodeSUB16455MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    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 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) 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 Yes
    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 Herceptin
    D.2.1.1.2Name of the Marketing Authorisation holderRoche
    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.3.1Product nameTrastuzumab
    D.3.4Pharmaceutical form Powder for 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 INNTRASTUZUMAB
    D.3.9.1CAS number 180288-69-1
    D.3.9.4EV Substance CodeSUB12612MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    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) 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) Yes
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Yes
    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
    HER-2 positive, resectable gastric cancer
    E.1.1.1Medical condition in easily understood language
    Her-2 positive, resectable gastric cancer
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10066896
    E.1.2Term HER-2 positive 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
    To increase the major pathological response rate (< 10% vital tumor cells) to neoadjuvant treatment by integrating both trastuzumab and pertuzumab into perioperative chemotherapy for HER-2 positive, resectable gastric cancer.
    E.2.2Secondary objectives of the trial
    Not applicable
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1) REGISTRATION
    For determination of the HER-2 status, European sites will have the choice, patient by patient, between the two options:
    a) Assessment of HER-2 status of potentially eligible patient in the central lab OR b) Assessment of HER-2 status by IHC only in the local lab& mandatory confirmation of the HER-2 positive result in central lab
    In EUROPE: if the site selects option a) FFPE blocks or 20 x 3-5 µm (ideally 20 slides but exceptionally minimum of 15 slides is acceptable) unstained paraffin sections from the diagnostic endoscopic biopsies for all potentially eligible patients must be sent. If site selects option b) & performs local assessment of the HER-2 status by IHC, FFPE blocks or 20 x 3-5 µm(ideally 20 slides, but exceptionally a minimum of 15 slides is acceptable)unstained paraffin sections for all patients with HER-2 IHC status 1+, 2+ or 3+ must be sent for confirmation to central lab
    In ASIA all patients are screened locally. Material from patients with a positive HER-2 status (2+ or 3+ by IHC) has to be sent to central lab for confirmation
    Asian sites are requested to send only FFPE blocks or 20 x 3-5 µm (ideally 20 slides,but exceptionally a minimum of 15 slides is acceptable)unstained paraffin sections from diagnostic
    endoscopic biopsies for HER-2 positive patients if 2+ or 3+ by IHC as per local assessment
    ♦ All patients (HER-2 positive and negative) should be registered in the trial asap after written informed consent for screening according to ICH/GCP & national/local regulations
    ♦ Histologically proven, gastric or GE-junction adenocarcinoma (Siewert I-III)
    ♦ Absence of distant metastases on CT scan of thorax & abdomen
    ♦ Patient medically fit for gastrectomy/oesophagectomy as decided by investigator
    ♦ Age ≥ 18 years
    ♦ WHO performance status 0 – 1
    2) RANDOMIZATION
    ♦ HER-2 overexpression, as determined by central testing using immunohistochemistry (IHC 3+) or the combination of IHC 2+ & HER-2 FISH positive (please see pathology guidelines)
    ♦ Amenable to gastrectomy/oesophagectomy with curative intent confirmed by multidisciplinary team discussion
    ♦ UICC tumor stage Ib to III, as defined by CT scan and/or MRI Endosonography (EUS) is recommended but not mandatory. EUS should especially be considered to distinguish T1&T2 tumors
    &to evaluate local resectability. (In case of conflicting results of CT scan and/or MRI and endoscopic ultrasound, the final decision on which finding the staging is based should be taken by the multidisciplinary team
    ♦ The cardiac ejection fraction (LVEF) as determined by echocardiography,MUGA or cardiac MRI should be at least 55%
    ♦ Adequate organ function:
    ♦ White blood cell count (WBC) > 3 x 109/L
    ♦ Absolute neutrophil count (ANC) > 1.5 x 109/L
    ♦ Platelets ≥ 100 x 109/L
    ♦ Hemoglobin ≥ 9 g/dL (transfusions are permitted to reach this value)
    ♦ Estimated glomerular filtration rate (eGFR) according to MDRD should be > 50 ml/min (for patients treated with oxaliplatin-based regimens upfront)
    NOTE: For patients that will receive CISPLATIN upfront a GFR > 60 ml/min is required
    ♦ Total bilirubin within normal limits (if the patient has documented Gilbert’s disease ≤ 1.5 × ULN or direct bilirubin ≤ ULN)
    ♦ Aspartate transaminase (AST) & alanine transaminase (ALT) ≤ 2.5 × ULN
    ♦ Absence of preexisting neuropathy > grade I
    ♦ Investigator and patient have to agree to replace any oral anticoagulations by subcutaneous administration of low-molecular weight heparin (LMWH) in equivalent doses before treatment start, or if on oral anticoagulations &unwilling to switch to LMWH, patients have to be treated with mandatory 5-FU i.v. instead of capecitabine
    ♦ Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with study protocol & follow-up schedule; those conditions should be discussed with the patient before registration in trial
    ♦ For women who are not postmenopausal (> 12 months of non- therapy induced amenorrhea)or surgically sterile(absence of ovaries and/or uterus):
    ♦ agreement to remain abstinent or use single or combined contraceptive methods that result in a failure rate of < 1% per year during treatment period &for at least 7 months after last
    treatment dose
    ♦ Negative serum pregnancy test (β-human chorionic gonadotropin [β-hCG]) result should be available before randomization &within 7 days from treatment start should be performed
    ♦ For men:agreement to remain abstinent or use a condom plus additional contraceptive method that together result in a failure rate
    of < 1% per year during the treatment period &for at least 7
    months after last dose of study treatment. Abstinence is only acceptable if in line with preferred & usual lifestyle of the patient. Periodic abstinence (e.g. calendar, ovulation, symptothermal, or postovulation methods) & withdrawal are not acceptable methods for contraception
    E.4Principal exclusion criteria
    2) Randomization
    ♦Prior chemo- or antibody therapy
    ♦History of significant cardiac disease defined as:
    -Symptomatic CHF (NYHA classes II-IV, see Appendix D)
    -High-risk uncontrolled arrhythmias, i.e. atrial tachycardia with a heart rate > 100/min at rest, significant ventricular arrhythmia (ventricular tachycardia) or higher-grade AV-block (second degree AV-block Type 2 [Mobitz 2] or third degree AV-block)
    -History of myocardial infarction within 6 months prior to randomization
    -Clinically significant valvular heart disease
    ♦Central nervous system metastasis or leptomeningeal tumor spread. For patients without any neurological symptoms, a brain MRI is recommended, but not obligatory. For patients with any clinical symptoms, which may be attributed to brain metastases, a brain MRI is compulsory to rule out cerebral metastases.
    ♦Known hypersensitivity to the components of trastuzumab, pertuzumab, oxaliplatin, docetaxel, 5-FU or capecitabine
    ♦Patients with interstitial lung disease
    ♦Known dihydropyrimidine dehydrogenase (DPD) deficiency (testing not required). In case of specific recommendations due to institutional and/or national guidelines please proceed accordingly
    ♦Ongoing or concomitant use of the antiviral drug sorivudine or its chemically related analogs, such as brivudine
    ♦Chronic treatment with high-dose intravenous corticosteroids (> 10 mg/day prednisone equivalents)
    ♦Previous malignancy within the last 5 years, with the exception of adequately treated cervical carcinoma in situ, localized non-melanoma skin cancer, or other curatively treated cancer without impact on the patient’s overall prognosis according to the judgment of the investigator.
    ♦ Female patients should NOT be breast feeding
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint of the phase II study is the major pathological response rate (< 10% vital tumor cells).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Post surgery.
    The analysis of the primary endpoint will occur:
    1. 30 days after all patients have undergone surgery
    2. the trial is mature for the analysis of the primary endpoint as defined in the protocol
    3. the database has been fully cleaned and frozen for the analysis
    E.5.2Secondary end point(s)
    1 - R0 resection rate
    2 -Pathological complete response
    3 - Locoregional failure
    4 - Distant failure
    5 - Progression-free survival (according to Recist v1.1)
    6 - Recurrence-free-survival (from surgery)
    7 - Overall survival
    8 - Adverse event assessment according to CTCAE v 4.0
    E.5.2.1Timepoint(s) of evaluation of this end point
    1 & 2 - Post Surgery
    3, 4, 5 & 6 - Disease evaluation will be performed with contrast-enhanced CT-scan and/or MRI of thorax and abdomen every 6 months since the date of surgery for the first 2 years, and every 12 months for the subsequent 4 years (thus for at least 6 years).
    7 - Patients will be followed up for at least 6 years following end of treatment or until death.
    8 - AEs will be collected until 30 days after end of treatment and during follow-up (as specified in protocol)
    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 No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Elderly Minimal Dataset Comprehensive Geriatric Assessment for patients ≥ 70 years of age at 28 days after end of treatment.
    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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial3
    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 Yes
    E.8.5.1Number of sites anticipated in the EEA48
    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 No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Belgium
    Estonia
    France
    Germany
    Israel
    Italy
    Korea, Republic of
    Netherlands
    Norway
    Portugal
    Singapore
    Spain
    Switzerland
    United Kingdom
    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
    Each patient will be followed until death for a minimum of 6 years from surgery
    1. Thirty days after all patients have stopped protocol treatment
    2. All patients have been followed up for at least 6 years from randomization
    3. The database has been fully cleaned and frozen for the analysis of secondary endpoints.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years10
    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 years10
    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 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: 85
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 140
    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 state25
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 108
    F.4.2.2In the whole clinical trial 215
    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)
    According to the discretion of the treating physician.

    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 Decision2015-04-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-06-16
    P. End of Trial
    P.End of Trial StatusOngoing
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