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    Summary
    EudraCT Number:2013-003976-11
    Sponsor's Protocol Code Number:HSG-1-13
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2014-06-06
    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 ConcernedDenmark - DHMA
    A.2EudraCT number2013-003976-11
    A.3Full title of the trial
    Effects of S-1 and capecitabine in combination with oxaliplatin on the coronary artery blood flow in patients metastatic gastrointestinal tract adenocarcinoma
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Effect of two cancer drugs (S-1 and capecitabine) on the blood circulation of the heart.
    A.3.2Name or abbreviated title of the trial where available
    Fluo Heart
    A.4.1Sponsor's protocol code numberHSG-1-13
    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 SponsorHelsinki University Central Hospital
    B.1.3.4Country
    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 supportNordic Drugs Ab
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationHelsinki University Central Hospital
    B.5.2Functional name of contact pointDepartment of Oncology
    B.5.3 Address:
    B.5.3.1Street AddressHaartmaninkatu 4
    B.5.3.2Town/ cityHelsinki
    B.5.3.3Post codeFIN-00290
    B.5.4Telephone number358947173200
    B.5.5Fax number358947174202
    B.5.6E-mailheikki.joensuu@hus.fi
    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 Teysuno is a medicine that contains the active substances tegafur, gimeracil and oteracil.
    D.2.1.1.2Name of the Marketing Authorisation holderNordic Group B.V.
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    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 nameS1
    D.3.4Pharmaceutical form Capsule, hard
    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 INNTEGAFUR
    D.3.9.1CAS number 17902-23-7
    D.3.9.4EV Substance CodeSUB10870MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/m2 milligram(s)/square meter
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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 RoleComparator
    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 (Capecitabine) is a "prodrug" that is converted to 5-fluorouracil (5-FU) in the body, but more is converted in tumor cells than in normal tissues
    D.2.1.1.2Name of the Marketing Authorisation holderAccord Healthcare Limited
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 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 INNXeloda
    D.3.9.3Other descriptive nameCAPECITABINE
    D.3.9.4EV Substance CodeSUB12474MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/m2 milligram(s)/square meter
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2000
    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) Yes
    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 RoleComparator
    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 Oxaliplatin
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 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.3.9.1CAS number 61825-94-3
    D.3.9.4EV Substance CodeSUB09490MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/m2 milligram(s)/square meter
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number130
    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
    Metastatic gastrointestinal tract adenocarcinoma
    E.1.1.1Medical condition in easily understood language
    Malignant tumor disease arising from gastrointestinal tract (e.g. stomach, intestine) belonging to the adenocarcinoma group of tumors
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.0
    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
    The frequency of subclinical coronary artery dysfunction, as assessed with the CFR, as compared with the baseline CFR
    E.2.2Secondary objectives of the trial
    •The CFR between the chemotherapy groups.
    •The coronary flow response to the CPT as compared to the baseline values and between the chemotherapy groups.
    •The presence of left ventricle regional wall motion abnormalities or global systolic dysfunction
    •Cardiac arrhythmias in Holter registration between the 2 groups and as compared to the baseline.
    •Plasma sensitive troponin concentration between the 2 groups and as compared to the baseline.
    •Frequency and severity of cardiac symptoms and chest pain during treatment.
    •Adverse events (Common Terminology Criteria for Adverse Events [CTCAE] version 4.0) between the 2 treatment groups.
    •Response rate of cancer to chemotherapy between the 2 treatment groups (RECIST v. 1.1).
    •Patient preference of chemotherapy (assessed at the completion of chemotherapy when ≥ 3 cycles were given)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Has given written informed consent.
    2.Is >18 years of age.
    3.Has advanced or metastatic gastrointestinal tract adenocarcinoma.
    4.No previous cancer chemotherapy for cancer.
    5.Measurable or evaluable lesions according to RECIST v1.1 criteria.
    6.Is able to take medications orally.
    7.Has ECOG performance status 0 or 1 on Cycle 1, Day 1 (see Appendix A).
    8.Has a life expectancy of at least 3 months.
    9.Serum troponin T or I and creatine phosphokinase (CPK)-MB values < upper limit of normal (ULN) for the institution.
    10.Has adequate organ function as defined by the following criteria:
    a.Aspartate aminotransferase (AST/SGOT) and alanine aminotransferase (ALT/SGPT) ≤2 x ULN; if liver function abnormalities are due to underlying liver metastasis, AST (SGOT) and ALT (SGPT) ≤6 x ULN.
    b.Total serum bilirubin of ≤1.5 x ULN.
    c.Absolute neutrophil count of ≥1,500/mm3 (i.e., ≥1.5 x 109/L by International Units [IU])
    d.Platelet count ≥100,000/mm3 (IU: ≥100 x 109/L) (excluding measurements obtained within 7 days after transfusion).
    e.Hemoglobin value of ≥11.0 g/dL.
    f.Creatinine < 1.5 x ULN. I creatinine clearance is measured, this should be ≥60 mL/min based on calculated creatinine clearance (Cockcroft-Gault13 formula, see Appendix D) or 24-hour urine collection.
    g.Is willing and able to comply with scheduled visits, treatment plan, lab tests and other study procedures
    E.4Principal exclusion criteria
    1.Has had treatment with any of the following within the specified time frame prior to study drug administration:
    a.Cancer considered operable without prior chemotherapy.
    b.Prior chemotherapy to cancer.
    c.Previous therapy with fluoropyrimidines or anthracyclines for any indication.
    d.Inability to swallow tablets.
    e.Patients with known DPD deficiency.
    f.Any investigational agent received either concurrently or within the last4 weeks.
    g.Current enrollment in another interventional clinical study.
    2.Has a serious illness or medical condition(s) including, but not limited to, the following:
    a.Known brain metastasis or leptomeningeal metastasis.
    b.Patient with a history of myocardial infarction within the last 6 months, or with a history of coronary surgery or stenting, severe/unstable angina, coronary/peripheral artery bypass graft, cerebrovascular accident or transient ischemic attack, pulmonary embolism, or deep vein thrombosis within the last 12 months.
    c.Symptomatic congestive heart failure (New York Heart Association [NYHA] class III or IV (see Appendix E).
    d.Ongoing cardiac dysrhythmias (≥Grade 2), atrial fibrillation (any grade), or prolongation of QTc interval (>450 msec for males; >470 msec for females).
    e.Patients with any cardiac disease that requires regular medication (medication for vascular diseases such as hypertension is allowed).
    f.Hypertensive crisis or severe hypertension that is not controlled.
    g.Known acute systemic infection.
    h.Chronic nausea, vomiting, or diarrhea considered to be clinically significant in the opinion of the Investigator.
    i.≥Grade 1 peripheral neuropathy.
    j.Recent hemoptysis, coagulopathy and other bleeding disorders considered by the Investigator to be clinically significant.
    k.Known nephrotic syndrome (proteinuria >2 g/24 hours).
    l.Known clinically significant interstitial lung disease or pulmonary fibrosis.
    m.Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness.
    n.Organ allografts with immunosuppressive therapy required.
    o.Major surgery within 3 weeks prior to study treatment start, or lack of complete recovery from the effects of surgery.
    p.Clinically significant malabsorption syndrome
    q.Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results, and in the judgment of the Investigator would make the patient inappropriate for entry into this study.
    3.Is receiving concomitant treatment with short-acting nitroglycerins, or one or more of the following drugs that may interact with S-1or capecitabine:
    a.Sorivudine, brivudine, uracil, eniluracil, cimetidine, folinate/folinic acid, and dipyridamole (may enhance S-1or capecitabine activity).
    b.Nitroimidazoles, including metronidazole and misonidazole (may enhance S-1 activity)
    c.Clozapine (may increase risk and severity of hematologic toxicity)
    d.Allopurinol (may diminish S-1 activity).
    e.Phenytoin (S-1 may enhance phenytoin activity).
    f.Flucytosine, a fluorinated pyrimidine antifungal agent (may enhance S-1 activity).
    4.Is a pregnant or lactating female.
    5.Female patients of childbearing potential must have negative pregnancy test before initiation of study drug dosing. Postmenopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential. Male and female patients of reproductive potential must agree to employ an effective barrier method of birth control throughout the study and for up to 3 months following discontinuation of study drug.
    6.The cardiac arterial flow tests cannot be done
    E.5 End points
    E.5.1Primary end point(s)
    The frequency of subclinical coronary artery dysfunction, as assessed with the CFR, as compared with the baseline CFR
    E.5.1.1Timepoint(s) of evaluation of this end point
    Each chemotherapy cycle
    E.5.2Secondary end point(s)
    •The CFR between the chemotherapy groups.
    •The coronary flow response to the CPT as compared to the baseline values and between the chemotherapy groups.
    •The presence of left ventricle regional wall motion abnormalities or global systolic dysfunction
    •Cardiac arrhythmias in Holter registration between the 2 groups and as compared to the baseline.
    •Plasma sensitive troponin concentration between the 2 groups and as compared to the baseline.
    •Frequency and severity of cardiac symptoms and chest pain during treatment.
    •Adverse events (Common Terminology Criteria for Adverse Events [CTCAE] version 4.0) between the 2 treatment groups.
    •Response rate of cancer to chemotherapy between the 2 treatment groups (RECIST v. 1.1).
    •Patient preference of chemotherapy (assessed at the completion of chemotherapy when ≥ 3 cycles were given)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Each chemotherapy cycle
    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 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 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 Yes
    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 Yes
    E.8.2.3.1Comparator description
    capecitabine, oxaliplatin
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA7
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    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 years3
    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: 2
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 2
    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 state4
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 40
    F.4.2.2In the whole clinical trial 40
    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)
    Therapy by the physician's choice
    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 Decision2014-09-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-09-08
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2017-04-25
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