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    Summary
    EudraCT Number:2017-000722-35
    Sponsor's Protocol Code Number:ECO-01
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2017-05-08
    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 ConcernedDenmark - DHMA
    A.2EudraCT number2017-000722-35
    A.3Full title of the trial
    Perioperative metformin treatment for colon cancer - a randomized trial
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Trial to investigate the effect of metformin treatment before and after surgery in patients with colon cancer
    A.3.2Name or abbreviated title of the trial where available
    MECORA
    A.4.1Sponsor's protocol code numberECO-01
    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 SponsorIsmail Gögenur
    B.1.3.4CountryDenmark
    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 supportDepartment of surgery, Slagelse Hospital
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationDepartment of surgery Slagelse Hospital
    B.5.2Functional name of contact pointDepartment of surgery
    B.5.3 Address:
    B.5.3.1Street AddressFælledvej 11
    B.5.3.2Town/ citySlagelse
    B.5.3.3Post code4200
    B.5.3.4CountryDenmark
    B.5.4Telephone number4561335122
    B.5.6E-maileco@regionsjaelland.dk
    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 metformin
    D.2.1.1.2Name of the Marketing Authorisation holderTeva Danmark A/S
    D.2.1.2Country which granted the Marketing AuthorisationDenmark
    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 Capsule
    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 INNMETFORMIN HYDROCHLORIDE
    D.3.9.1CAS number 1115-70-4
    D.3.9.4EV Substance CodeSUB03200MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number500
    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 placeboCapsule
    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
    Colon cancer
    E.1.1.1Medical condition in easily understood language
    Bowel cancer
    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 PT
    E.1.2Classification code 10009944
    E.1.2Term Colon 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 aim of the study is to investigate the effect of treatment with metformin on cell proliferation and on metabolic and immunological changes in non-diabetic patients with colon cancer.
    The primary outcome is determination of the difference of the level of proliferation after the intervention (time of surgery) adjusted for the level seen at baseline (time of colonoscopy). Another primary outcome is the difference in tumorinfiltrating CD3 and CD8 positive lymphocytes after the intervention adjusted for the level seen at baseline.
    E.2.2Secondary objectives of the trial
    Secondary outcomes:
    - The difference in the level of apoptosis after the intervention adjusted for levels seen at baseline.
    - the difference in proliferation, migration and adhesion of colon cancer cell lines treated with plasma from the patients.
    - Blood samples will be analyzed for metabolic and immunological changes.
    - analyses of up- and down regulation of relevant genes in blood and tumor samples using the NanoString technology.
    - postoperative hyperglycemia and insulin resistance will be measured by analyzing the difference in insulin resistance and plasma glucose levels before surgery and on postoperative day 1 and 2.
    - Postoperative complications within 30 days from surgery will be assessed and classified according to the Clavien-Dindo classification.
    - the effect of metformin on relevant pathways in enterocytes and hepatocytes respectively
    - the effect of metformin on bacterial microbiota in blood samples and biopsies of the gut
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Patients with adenocarcinoma of the colon planned for elective curative intended surgery at Slagelse hospital
    - Age of 18 or above
    - Must be able to understand and sign informed content
    - Sufficient amount of representative tumor material from the biopsies taken at the initial colonoscopy must be present
    E.4Principal exclusion criteria
    - Patients diagnosed with diabetes mellitus
    - Patients who are receiving or have received metformin or other oral antidiabetics
    - Impaired kidney function (eGFR < 60mL/min)
    - Severe liver disease (defined as transaminases above X 3 normal levels)
    - Participation in another pharmacological intervention trial
    - Predictable poor compliance (for instance not speaking fluent Danish, mentally impaired)
    - Presenting with metastatic disease
    - Patients undergoing neoadjuvant chemotherapy
    - Pregnancy or lactation (fertile women must have a negative serum or urine pregnancy test to participate)
    - Fertile women who do not use safe contraception during the study period.
    E.5 End points
    E.5.1Primary end point(s)
    The primary outcome is determination of the difference of the level of proliferation (Ki67 expression) after the intervention (time of surgery) adjusted for the level seen at baseline (time of colonoscopy). Another primary outcome is the difference in tumor infiltration CD3 and CD8 positive lymphocytes after the intervention adjusted for the level seen at baseline
    E.5.1.1Timepoint(s) of evaluation of this end point
    This will be evaluated at time of surgery when patients' have received metformin or placebo for 20 days.
    E.5.2Secondary end point(s)
    Secondary outcomes:
    - The difference in the level of apoptosis after the intervention adjusted for levels seen at baseline.
    - The effect of metformin will be measured by examining the difference in proliferation, migration and adhesion of colon cancer cell lines treated with plasma from the patients.
    - Blood samples stored will be analyzed for metabolic and immunological changes.
    - Blood and tumor samples will be analyzed for differences in up- and down regulation of genes using the NanoString technology
    - The effect of metformin on postoperative hyperglycemia and insulin resistance will be measured by analyzing the difference in insulin resistance and plasma glucose levels before surgery and on postoperative day 1 and 2.
    - Postoperative complications within 30 days from surgery will be assessed and classified according to the Clavien-Dindo classification.
    - the effect of metformin on pathways in enterocytes and hepatocytes
    -the effect of metformin on the composition of the microbiota in blood samples and biopsies
    E.5.2.1Timepoint(s) of evaluation of this end point
    Changes between baseline and at time of operation (before surgery either the same day as the operation or a couple of days before) will be measures as well as the levels on postoperative day 1,2 and 10.
    The effect of metformin on hyperglycemia and insulin resistance will be measured at time of surgery and on postoperative day 1 and 2.
    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 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 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 Yes
    E.8.2.3Other No
    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 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 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
    The end of the trial is 30 days after the operation of the last subject.
    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 months4
    E.8.9.1In the Member State concerned days
    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: 15
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 33
    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 state48
    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)
    Patients will receive standard care and treatment for colon cancer after completion of the trial.
    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 Decision2017-07-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-01-29
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2021-10-08
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