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    The EU Clinical Trials Register currently displays   42517   clinical trials with a EudraCT protocol, of which   7000   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2014-000411-14
    Sponsor's Protocol Code Number:1.1.1
    National Competent Authority:Finland - Fimea
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2016-10-11
    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 ConcernedFinland - Fimea
    A.2EudraCT number2014-000411-14
    A.3Full title of the trial
    A randomised double blind dose non-inferiority trial of a daily dose of 600mg versus 300mg versus 100mg of enteric coated aspirin as a cancer preventive in carriers of a germline pathological mismatch repair gene defect, Lynch Syndrome. Project 3 in the Cancer Prevention Programme (CaPP3).
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    CAPP3Fi
    CAPP3FI
    A.4.1Sponsor's protocol code number1.1.1
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberISRCTN16261285
    A.5.4Other Identifiers
    Name:EudraCTNumber:2014-000411-14
    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 SponsorMecklin Jukka-Pekka
    B.1.3.4CountryFinland
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMecklin Jukka-Pekka
    B.5.2Functional name of contact pointMecklin Jukka-Pekka
    B.5.3 Address:
    B.5.3.1Street AddressKSSHP, Keskussairaalantie 19
    B.5.3.2Town/ cityJyväskylä
    B.5.3.3Post code40620
    B.5.3.4CountryFinland
    B.5.4Telephone number358503615921
    B.5.6E-mailjukka-pekka.mecklin@ksshp.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 aspirin
    D.2.1.1.2Name of the Marketing Authorisation holderbayer
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 nameaspirin
    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 INNACETYLSALICYLIC ACID
    D.3.9.1CAS number AS1
    D.3.9.4EV Substance CodeSUB12730MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.3Concentration number300
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNACETYLSALICYLIC ACID
    D.3.9.4EV Substance CodeSUB12730MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.3Concentration number100
    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 Yes
    D.3.11.13.1Other medicinal product typePlacebo will be added to maintain dose blinding
    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 placeboCoated tablet
    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
    Lynch Syndrome also known as HNPCC (non hereditary non polyposis colorectal cancer).
    E.1.1.1Medical condition in easily understood language
    An inherited disorder that increases the risk of many types of cancer, particularly cancers of the colon (large intestine) and rectum, and also other cancers.
    E.1.1.2Therapeutic area Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    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 Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective is to find out which daily dose of Aspirin, 600mg or 300mg or 100mg, taken for 2 years is best at preventing cancers in patients with lynch syndrome. We will measure this by comparing the total number of Lynch Syndrome cancers (cancers that people with lynch syndrome are more likely to get) after a minimum of 5 years from study entry.
    E.2.2Secondary objectives of the trial
    • Compare overall primary colorectal cancers in the three treatment groups
    • Compare overall primary endometrial cancers in the three treatment groups.
    • Compare overall cancers of all types,in the three treatment groups.
    • Compare the burden of adverse events in three treatment groups.
    . compare levels of antibodies against abnormal proteins released by Lynch Syndrome cancers.
    • Through a linked biobanking strategy:
    a)Identify reliable markers in the blood that predict future cancer development. This will help establish other cancer prevention strategies.
    b)Help identify the likely mechanism of action on tumour formation.
    c)Identify the influence of individual variability in aspirin metabolism
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Age over 18
    2. Proven MMR gene defect carrier
    3. CAPP2 participants, at least 10 years since enrolled into that study
    4. Willing to take randomised blinded dose (100, 300, 600mg) of aspirin for two years & self-report numbers of tablets taken
    5. Agreement for indefinite clinical follow up with a minimum of 5 years
    6. Availability of Micro satellite instability and or immunohistochemical analysis of mismatch repair proteins to establish whether any lesions are likely to be Lynch syndrome related, are all non-negotiable
    7. Biobanking (bloods for DNA & serum) and sharing tissue sections to allow pharmacogenetic sub studies, FSP(Frame shift peptide) antibody testing and effects of aspirin on molecular tumour phenotype are desirable but not essential
    E.4Principal exclusion criteria
    1. Regular use of a non-steroidal anti-inflammatory agent (except aspirin) on a
    prescription and/or long-term basis. Regular is defined as > 3 doses per week.
    2. Regular use of aspirin (> 3 doses per week or on a prescription basis) that cannot be replaced with any one of the randomised arms of the study followed by 100mg dose.
    3. Current methotrexate use.
    4. Known aspirin intolerance or hypersensitivity, including aspirin-sensitive asthma.
    5. Existing clinically significant liver impairment.
    6. Existing renal failure defined as creatinine clearance <10ml/min.
    7. Active peptic ulcer disease within the previous three months or any previous proven peptic ulcer.
    8. Known bleeding diathesis or concomitant warfarin therapy.
    9. Inability to comply with study procedures and agents.
    10. Women reporting that they are pregnant or actively planning to achieve a pregnancy within the next two years.
    11. Women who are currently breastfeeding.
    12. Any significant medical illness that would interfere with study participation.
    13. Previous participation in this trial. [Participation in the previous CAPP2 study will not exclude patients from this study. The protocol requires that it be at least 10 years since they joined CAPP2. Recruitment to CAPP2 closed in 2006].
    E.5 End points
    E.5.1Primary end point(s)
    The number of new primary mismatch repair deficient cancers (“Lynch syndrome cancers”) at 5 years and beyond which develop in participants who remain on prescribed treatment for a minimum of 2 years
    E.5.1.1Timepoint(s) of evaluation of this end point
    Five years after last recruit enters trial
    E.5.2Secondary end point(s)
    • The number of new colorectal cancers at 5 years and beyond which develop in participants who remain on prescribed treatment for a minimum of 2 years.
    • The number of new endometrial cancers at 5 years and beyond which develop in participants who remain on prescribed treatment for a minimum of 2 years.
    • The number of new cancers of all types at 5 years and beyond which develop in participants who remain on prescribed treatment for a minimum of 2 years.
    • Changes at 2 & 5 years in the titre of frameshift peptide antibodies from commencement of the prescribed treatment.
    E.5.2.1Timepoint(s) of evaluation of this end point
    • The number of new colorectal cancers at 5 years and beyond which develop in participants who remain on prescribed treatment for a minimum of 2 years.
    • The number of new endometrial cancers at 5 years and beyond which develop in participants who remain on prescribed treatment for a minimum of 2 years.
    • The number of new cancers of all types at 5 years and beyond which develop in participants who remain on prescribed treatment for a minimum of 2 years.
    • Changes at 2 & 5 years in the titre of frameshift peptide antibodies from commencement of the prescribed treatment
    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 Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    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 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 concerned2
    E.8.5The trial involves multiple Member States No
    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 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
    End of study is defined as five years from randomisation of the last patient
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years6
    E.8.9.1In the Member State concerned months11
    E.8.9.1In the Member State concerned days30
    E.8.9.2In all countries concerned by the trial years6
    E.8.9.2In all countries concerned by the trial months11
    E.8.9.2In all countries concerned by the trial days30
    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: 300
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 50
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state300
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 3000
    F.4.2.2In the whole clinical trial 3000
    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)
    There is no continued provision for intervention for patients after the 7 year study
    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 Decision2016-11-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-01-16
    P. End of Trial
    P.End of Trial StatusOngoing
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