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    Summary
    EudraCT Number:2016-000628-24
    Sponsor's Protocol Code Number:MO16/053
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:GB - no longer in EU/EEA
    Date on which this record was first entered in the EudraCT database:2018-05-08
    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 ConcernedUK - MHRA
    A.2EudraCT number2016-000628-24
    A.3Full title of the trial
    A randomised placebo-controlled phase III trial of the effect of the omega-3 fatty acid eicosapentaenoic acid (EPA) on colorectal cancer recurrence and survival after surgery for resectable liver metastases
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    EMT2: EPA for Metastasis Trial
    A.3.2Name or abbreviated title of the trial where available
    EMT2: EPA for Metastasis Trial 2
    A.4.1Sponsor's protocol code numberMO16/053
    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 SponsorUniversity of Leeds
    B.1.3.4CountryUnited Kingdom
    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 supportYorkshire Cancer Research
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationClinical Trials Research Unit, Leeds Institute of Clinical Trials Research
    B.5.2Functional name of contact pointUniversity of Leeds
    B.5.3 Address:
    B.5.3.2Town/ cityLeeds
    B.5.3.3Post codeLS2 9JT
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number01133431477
    B.5.5Fax number01133431471
    B.5.6E-mailemt2@leeds.ac.uk
    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 No
    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 nameIcosapent Ethyl
    D.3.4Pharmaceutical form Capsule, soft
    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 INNIcosapent Ethyl
    D.3.9.1CAS number 73310-10-8
    D.3.9.3Other descriptive nameIPE
    D.3.9.4EV Substance CodeAS2
    D.3.10 Strength
    D.3.10.1Concentration unit g gram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    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 Yes
    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, soft
    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 liver metastases
    E.1.1.1Medical condition in easily understood language
    Bowel cancer spread to the liver
    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 10007095
    E.1.2Term Cancer of liver, secondary
    E.1.2System Organ Class 100000004864
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The trial aims to determine whether oral IPE therapy, started at least 2 weeks before surgery and continued for a minimum of 2 years, improves colorectal cancer recurrence in patients undergoing liver resection surgery for colorectal cancer liver metastases.
    E.2.2Secondary objectives of the trial
    To determine whether IPE treatment improves survival.

    To confirm the safety and tolerability of IPE before and after surgery, including during chemotherapy.

    To determine whether IPE treatment improves quality of life after colorectal cancer liver metastasis surgery, as reported by participants.

    To determine the cost effectiveness of IPE treatment.

    To determine whether IPE treatment has an effect on the diagnosis of new cancers.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Aged ≥18 years
    • Able to provide written informed consent
    • Histological diagnosis of colorectal cancer with evidence of liver metastases
    • Planned liver resection surgery for colorectal cancer liver metastasis with curative intent, including repeat ‘re-do’ colorectal cancer liver metastasis liver surgery (a second independent resection for a separate colorectal cancer liver recurrence)
    • Intention to receive ≥2 weeks treatment with IMP prior to colorectal cancer liver metastasis surgery
    E.4Principal exclusion criteria
    • Incurable extra-hepatic metastases
    • Current (in the last 2 months) or planned regular (>3 doses per week) use of O3FA-containing supplements, including fish oil and cod-liver oil supplements
    • Fish/seafood allergy
    • <2 weeks before planned CRCLM surgery
    • Inability to comply with trial treatment and follow-up schedule
    • Known bleeding tendency/condition (e.g. von Willebrand disease)
    • A previous malignancy within the last 5 years other than:
     - colorectal cancer
     - non-melanoma skin cancer where treatment consisted of resection only or radiotherapy
     - ductal carcinoma in situ (DCIS) where treatment consisted of resection only
     - cervical carcinoma in situ where treatment consisted of resection only
     - superficial bladder carcinoma where treatment consisted of resection only
    • A previous malignancy where the patient has been disease-free for ≤5 years
    • Pregnant or breastfeeding women or women of childbearing potential not willing to use effective contraceptive measures. Women of childbearing potential are defined as fertile, following menarche and until becoming post-menopausal unless permanently sterile.
    • Men defined as fertile (post-pubescent and not permanently sterile by bilateral orchidectomy) and not willing to use effective contraceptive measures if appropriate.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is progression free survival (PFS) during a minimum of 2 years follow-up. PFS is defined as the time from randomisation to death (from any cause), first documented evidence of disease progression, new recurrence or clinical deterioration unequivocally due to disease progression.

    The date of clinical progression is defined as the date of the CT scan or relevant assessment at which disease progression or new recurrence is identified. This can be clinical progression or, for RECIST evaluable disease, radiological progression by RECIST principles. For participants who have clear clinical symptoms of disease progression without confirmatory imaging, the date of progression is defined as the date of the clinical assessment.
    E.5.1.1Timepoint(s) of evaluation of this end point
    The primary endpoint is evaluated at every visit from visit 3 onwards.
    E.5.2Secondary end point(s)
    The secondary endpoints are:
    • Overall Survival (OS), defined as the time from randomisation to death, from any cause (key secondary endpoint)
    • Safety and tolerability of IPE before and after CRCLM surgery, including during chemotherapy
    • Patient reported quality of life, measured using the EQ-5D, EORTC QLQ-C30 and QLQ-LMC21 questionnaires
    • Cost-effectiveness of IPE
    • New primary cancers (excluding DCIS, cervical carcinoma in situ, superficial bladder carcinoma where treatment consisted of resection only and non-melanoma skin cancer where treatment consisted of resection or radiotherapy only)

    The exploratory endpoints are:
    • Red blood cell membrane EPA content, measured at baseline, surgery and 6 months after surgery (only patients from Leeds and Sheffield)
    • Change in lean body mass measured by CT scanning during follow up as assessed by the L3 skeletal muscle index score
    E.5.2.1Timepoint(s) of evaluation of this end point
    Overall survival is evaluated at every visit from visit 2 onwards.

    Safety and tolerability of IPE is evaluated at every visit from visit 2 onwards and at fornightly telephone calls with the research nurse between visit 1 and visit 2 and at the telephone call with the research nurse at 60 days after visit 10/exit visit.

    Patient reported quality of life is collected at visit 1, visit 3 and all visits thereafter.

    Health economic data is collected at all visits and information on hospital resource activity will also be collected at fornightly telephone calls with the research nurse between visit 1 and visit 2.

    Evaluation for new primary cancers will take place at every visit from visit 3 onwards.
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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 trial2
    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 concerned8
    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 trial is defined as the date of the collection of the last participant’s last data item.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months8
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months8
    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.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 0
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 0
    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 state448
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 448
    F.4.2.2In the whole clinical trial 448
    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)
    None. Ongoing treatment of participants will be the responsibility of the treating clinician. IPE is not currently available through the NHS.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2017-06-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-01-12
    P. End of Trial
    P.End of Trial StatusGB - no longer in EU/EEA
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