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    Summary
    EudraCT Number:2014-003601-15
    Sponsor's Protocol Code Number:ASA-CRCLM-2014
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2017-12-19
    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 number2014-003601-15
    A.3Full title of the trial
    ACETYLSALICYLIC ACID AS SECONDARY PREVENTION IN
    COLORECTAL CANCER (ASAC TRIAL)
    A multi-centre, double-blinded, randomized, placebo-controlled clinical intervention trial with ASA in patients undergoing liver resection for CRC metastasis
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    ACETYLSALICYLIC ACID AS SECONDARY PREVENTION IN COLORECTAL CANCER (ASAC TRIAL)
    A.3.2Name or abbreviated title of the trial where available
    ASAC
    A.4.1Sponsor's protocol code numberASA-CRCLM-2014
    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 SponsorOslo University Hospital
    B.1.3.4CountryNorway
    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 supportOslo University Hospital
    B.4.2CountryNorway
    B.4.1Name of organisation providing supportThe Research Council of Norway
    B.4.2CountryNorway
    B.4.1Name of organisation providing supportThe Norwegian Cancer Society
    B.4.2CountryNorway
    B.4.1Name of organisation providing supportThe national programme for clinical therapy research (KLINBEFORSK)
    B.4.2CountryNorway
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationOslo University Hospital
    B.5.2Functional name of contact pointDepartment of HPB Surgery
    B.5.3 Address:
    B.5.3.1Street AddressP.O.Box 4950 Nydalen
    B.5.3.2Town/ cityOslo
    B.5.3.3Post code0424
    B.5.3.4CountryNorway
    B.5.4Telephone number4747287853
    B.5.6E-mailbbjoer@ous-hf.no
    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 Trombyl
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameTrombyl
    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 INNACETYLSALICYLIC ACID
    D.3.9.3Other descriptive nameACETYLSALICYLIC ACID
    D.3.9.4EV Substance CodeSUB12730MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number160
    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
    Liver metastasis from colorectal cancer.
    E.1.1.1Medical condition in easily understood language
    Cancer of the large bowel (colon) spreading 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 10010029
    E.1.2Term Colorectal cancer NOS
    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
    This is a multi-centre, double-blinded, randomized, placebo-controlled clinical intervention trial with acetylsalicylic acid (ASA, Trombyl) in patients undergoing liver resection for colorectal cancer liver metastasis (CRCLM). The main objective is to determine whether treatment with 160 mg ASA (Trombyl) once daily for 3 years can improve Disease Free
    Survival (DFS) in patients treated with resection for CRCLM, compared with placebo.
    E.2.2Secondary objectives of the trial
    Secondary objectives are to determine the effect of Trombyl on Time to Recurrence (TTR), Overall Survival (OS), and QoL in CRCLM patients, compared with placebo. Determine if ASA can improve DFS and OS in patients with mutations in PIK3CA.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    All subjects undergoing liver resection for CRCLM as a part of a curative
    intent may be included in the study if
    • They meet one of the following criteria:
    o First time CRCLM (synchronous or metachronous)
    o Recurrence of CRCLM (not previously included in this trial)
    • Histologically verified free resection margins (R0 resection or R1 (<1mm margin + chemotherapy))
    • Must be ambulatory with a performance status ECOG 0-2
    • Must be at least 18 years of age
    • Signed informed consent and expected cooperation of the patients for
    the treatment and follow up must be obtained and documented
    according to ICH GCP, and national/local regulations.
    E.4Principal exclusion criteria
    Concomitant use of ASA or other anticoagulants or platelet inhibitors such as warfarin or klopidogrel
    • Ongoing regular use of corticosteroids, NSAIDs
    • Inherited or acquired coagulopathy (hemophilia)
    • Severe heart failure (classified as NYHA class >III) or kidney failure
    • CRCLM treated with radiofrequency or microwave ablation technique
    • Pregnancy or breastfeeding (negative pregnancy test will be required
    when indicated)
    • Childbearing potential without proper contraceptive measures such as oral contraceptives, other hormonal contraceptives (vaginal products, skin patches, or implanted or injectable products), or mechanical products such as an intrauterine device or barrier methods (diaphragm, condoms, spermicides) to avoid pregnancy for the entire study period
    • Liver cirrhosis with a Child-Pugh score >B7
    • Contraindication listed on the Summary of Product Characteristics (SmPC) of Trombyl:
    • Hypersensitivity/allergies to ASA
    • Previous severe gastrointestinal haemorrage/peptic ulcer due to ASA/NSAID
    • Active peptic ulcer
    • Hemophilia
    • Need to use medications contraindicated according to SmPC of
    Trombyl from Medicines Agency
    E.5 End points
    E.5.1Primary end point(s)
    Time from randomisation to disease recurrence (by CT scan or MRI) or death by any cause (DFS).
    E.5.1.1Timepoint(s) of evaluation of this end point
    All included patients will be monitored with CT-scan of the chest and abdomen every 4 months for 1 year and further every 6 months till end of study period ( total three years). This is in-line with the Norwegian National Guidelines for follow-up of patients operated for CRC liver metastases.
    E.5.2Secondary end point(s)
    Efficacy endpoints
    - Time from randomisation to disease recurrence (TTR)
    - Time from randomisation to death by any cause (OS)
    HRQOL outcome measures:
    - SF36
    - EQ-5D health surveys
    E.5.2.1Timepoint(s) of evaluation of this end point
    All included patients will be monitored with CT-scan of the chest and abdomen every 4 months for 1 year and further every 6 months till end of study period ( total three years).
    Health-related QoL surveys (SF36 and EQ-D5) will be filled out by the patient at every clinical control, which is every 4 months for 1 year and further every 6 months till end of study period ( total three years).
    Time of death will be registered until end of study period (total three years)
    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 No
    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 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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA14
    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
    LVLS
    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 months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years6
    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: 500
    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 state100
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 800
    F.4.2.2In the whole clinical trial 800
    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 (back to care according to normal national practice).
    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 Decision2018-03-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-07-04
    P. End of Trial
    P.End of Trial StatusOngoing
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