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    Summary
    EudraCT Number:2016-003548-35
    Sponsor's Protocol Code Number:MesaCAPP
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2017-05-31
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2016-003548-35
    A.3Full title of the trial
    Mesalamine for Colorectal Cancer Prevention Program in Lynch syndrome
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Mesalamine for Colorectal Cancer Prevention Program in Lynch syndrome
    A.4.1Sponsor's protocol code numberMesaCAPP
    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 SponsorMedical University of Vienna
    B.1.3.4CountryAustria
    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 supportFonds zur Förderung de wissenschaftlichen Forschung (FWF)
    B.4.2CountryAustria
    B.4.1Name of organisation providing supportFonds zur Förderung de wissenschaftlichen Forschung (FWF)
    B.4.2CountryGermany
    B.4.1Name of organisation providing supportDutch Cancer Society KWF
    B.4.2CountryNetherlands
    B.4.1Name of organisation providing supportThe National Centre for Research and Development
    B.4.2CountryPoland
    B.4.1Name of organisation providing supportThe Chief Scientist Office of the Ministry of Health
    B.4.2CountryIsrael
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationLeiden University Medical Center
    B.5.2Functional name of contact pointJanneke Ringelberg
    B.5.3 Address:
    B.5.3.1Street AddressAlbinusdreef 2
    B.5.3.2Town/ cityLeiden
    B.5.3.3Post code2333 ZA
    B.5.3.4CountryNetherlands
    B.5.6E-mailjanneke@stoet.nl
    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 Mezavant 1200 mg
    D.2.1.1.2Name of the Marketing Authorisation holderShire Pharmaceutical Contracts Ltd
    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 nameMezavant 1200 mg
    D.3.4Pharmaceutical form 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 INNMESALAZINE
    D.3.9.1CAS number 89-57-6
    D.3.9.4EV Substance CodeSUB08782MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1200
    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 placeboTablet
    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
    Colorectal Cancer Prevention in Lynch syndrome
    E.1.1.1Medical condition in easily understood language
    Colorectal Cancer Prevention in Lynch syndrome
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10051981
    E.1.2Term Lynch syndrome
    E.1.2System Organ Class 100000004850
    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 the study is to test whether 5-ASA reduces occurence of colonic benign or malignant neoplasia compared to placebo in LS patients as detected by any colonoscopy until the end of study.
    E.2.2Secondary objectives of the trial
    To test wheter 5-ASA reduces the number of neoplasms (tumor multiplicity) and tumor progression to placebo in LS patients at the end of the study. Advanced adenomas are defined by a diameter above 1 cm villous or tubulu villous histology or high grade dysplasia.
    - To investigate if differences between 5-ASA effects and placebo effects on the occurrence of colonic neoplasia, tumor multiplicity or tumor
    progression depend on the history of colorectal cancer, sex and patients age (LS patients below 45 years of age or 45 years of age and older).
    - To investigate differences between low and high dose 5-ASA with respect to the occurrence of colonic neoplasia, to tumor multiplicity and
    tumor progression.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Proven tumor-free (including patients in which the polyps are removed endoscopically) carriers of a germline pathologic mutation on one of the MMR genes including MLH1, MSH2 (including EpCAM) and MSH6.
    - Male or female subjects with the age > 30 years
    - Signed written informed consent prior to inclusion in the study
    E.4Principal exclusion criteria
    - Presence of colonic endoscopically non-removable benign neoplasia (patient can be included if the adenoma is removed)
    - Carriers of germline mutations in PMS 2.
    - Patients with history of stage 3 and 4 cancer are excluded
    - Presence of metastatic disease
    - Regular use of Aspirin: daily use of ≥100mg in more than 3 continuous months within the last year
    - Regular use of NSAIDs or COX-2 inhibitors: daily use in more than 3 continuous months within the last year
    - Hypersensitivity to 5-ASA
    - Patients after total or subtotal colectomy
    - Colorectal surgery within the previous 6 months
    - Unwillingness to participate or who is considered incompetent to give an informed consent
    - Pregnant or breastfeeding women
    - Participation in another clinical study investigating another IMP within 1 month prior to screening
    - Renal insufficiency (GFR <30ml/min/1.73m2)
    - Severe liver disease or liver failure (elevation of liver enzymes above 3xULN)
    - Current or history of serious psychiatric disorder or alcohol/drug abuse that in the opinion of the investigator may impact the assessment of
    safety, efficacy or protocol adherence
    - Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study
    participation or ability to comply with study procedures, investigational product administration and, in the judgment of the investigator, would
    make the subject inappropriate for entry into this study.
    E.5 End points
    E.5.1Primary end point(s)
    Occurrence of neoplasms between groups is described by absolute frequencies and percentages with 95 % confidence intervals.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Active treatment period and follow up period.
    E.5.2Secondary end point(s)
    - The number of neoplasms per patient will be tested between groups by an analysis of variance, adjusting for country and history of cancer before randomization. In case of non-normally distributed residuals a suitable transformation to achieve normal distribution is considered.
    - The tumor progress in the 4 ordered stages will be tested between groups by a chi-square trend test stratified for country and and history of cancer before randomization and modelled by an ordinal logistic regression.Tumor progression will be tested between groups by a chisquare trend test.
    - Tumor occurrence in the right and left colon (location) will be described by absolute and relative frequencies The dependence of treatment effects on history of colorectal cancer, sex and patients age (<45 years and ≥45 years) will be assessed by modelling interactions between these factors and treatment in the corresponding regression models.
    - Differences between high and low dose ASA for the occurrence of colonic neoplasia, tumor multiplicity and tumor progression will be analysed by the same methods as for the comparison between ASA and placebo.
    - Occurrence and location of serrated benign or malignant neoplasms will be described by absolute and relative frequencies all tests are two-sided and a significance level of 5% is used.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Active treatment period and follow up period.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy Yes
    E.6.4Safety No
    E.6.5Efficacy No
    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 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 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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA17
    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
    Austria
    Germany
    Israel
    Netherlands
    Sweden
    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 months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years3
    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: 270
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 270
    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 state170
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 500
    F.4.2.2In the whole clinical trial 540
    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)
    standard of care
    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 Decision2017-05-31
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-11-23
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2018-12-12
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