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    Summary
    EudraCT Number:2015-004240-19
    Sponsor's Protocol Code Number:ALASCCA
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2017-02-23
    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 number2015-004240-19
    A.3Full title of the trial
    A randomized double-blind placebo-controlled study with ASA treatment in
    colorectal cancer patients with mutations in the PI3K signaling pathway
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    ALASCCA-A randomized double-blind placebo-controlled study with ASA
    treatment in colorectal cancer patients with mutations in the PI3K
    signaling pathway.
    A.4.1Sponsor's protocol code numberALASCCA
    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 SponsorKarolinska University Hospital, Department of Molecular medicine and Surgery Karolinska Institutet, Gastrocentrum
    B.1.3.4CountrySweden
    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 supportThe Swedish Research Council
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationKarolinska Institute
    B.5.2Functional name of contact pointCoordinating Investigator
    B.5.3 Address:
    B.5.3.1Street AddressDepartment of Molecular medicine and Surgery Karolinska Institutet, Gastrocentrum
    B.5.3.2Town/ cityStockholm
    B.5.3.3Post code17176
    B.5.3.4CountrySweden
    B.5.6E-mailAnna.Martling@ki.se
    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 AB
    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.3.9.1CAS number 50-78-2
    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
    Colon or rectal cancer tumor stage II-III, tumor with somatic alterations
    in PIK3CA, PIK3R1 or PTEN.
    E.1.1.1Medical condition in easily understood language
    Colon or rectal cancer.
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level LLT
    E.1.2Classification code 10010029
    E.1.2Term Colorectal cancer NOS
    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
    To determine whether adjuvant treatment with 160 mg ASA once daily
    for 3 years can improve Time To Recurrence (TTR) in patients with
    colorectal cancer with somatic alterations in the PIK3CA (exon 9 and 20)
    compared with placebo.
    E.2.2Secondary objectives of the trial
    To determine whether adjuvant treatment with 160 mg ASA once daily
    for 3 years can improve Disease-Free Survival (DFS) in patients with
    colorectal cancer with somatic alterations in the PIK3CA (exon 9 and 20)
    compared with placebo.
    To determine whether adjuvant treatment with 160 mg ASA once daily
    for 3 years can improve DFS in patients with colorectal cancer with
    somatic alterations in the PIK3CA (other than exon 9 and 20), PIK3R1 or
    PTEN genes compared with placebo.
    To determine whether adjuvant treatment with 160 mg ASA once daily
    for 3 years can improve TTR in patients with colorectal cancer with
    somatic alterations in the PIK3CA (other than exon 9 and 20), PIK3R1 or
    PTEN genes compared with placebo
    To compare overall survival (OS) at 5 years from randomization in
    patients receiving low-dose ASA versus placebo.
    To assess overall safety and tolerability.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Tumor with somatic alterations in PIK3CA, PIK3R1 or PTEN
    - Colon or rectal cancer tumor stage II-III
    - Patient between18-80 years (including)
    - Radical surgery according to surgeon and pathologist
    - Karnofsky performance status ≥70%
    - Platelets ≥ 100 x 109 / L
    - Clean Colonoscopy or Computed Tomography (CT) colon within 3
    months preoperatively or postoperatively but before randomization
    - Patient able to swallow tablets
    E.4Principal exclusion criteria
    Hereditary colorectal cancer linked to familial colonic polyposis or
    Lynch syndrome
    - Inflammatory bowel disease (Crohn's disease or ulcerative colitis)
    - Distant metastases
    - Other cancers (excluding colorectal cancer or other skin cancer than
    melanoma) within 3 years from screening
    - Known bleeding diathesis (such as hemophilia)
    - Concomitant antiplatelet therapy (eg clopidrogrel or ticlopidine) or
    anticoagulant therapy (warfarin or low molecular weight heparin).
    Postoperative
    treatment with low molecular weight heparin must be
    withdrawn before administration of study treatment
    - Active gastritis or peptic ulcer, or significant surgical post-op bleeding,
    within the previous three months assessed at screening and
    randomization
    - Ongoing regular use of corticosteroids, Nonsteroidal Anti-Inflammatory
    Drug (NSAID)
    - Uncontrolled hypertension according to Investigator's judgment
    - Clinically significant liver impairment according to Investigators
    judgment
    - Existing renal failure according to Investigator's judgment. Renal
    failure with decreased creatinine clearance <60 should lead to
    consultation with a nephrologist.
    - Significant medical illness that would interfere with study participation
    - Pregnancy or breastfeeding females
    - Known allergy to NSAIDs or ASA
    - Current participation in another clinical trial that will be in conflict with
    the present study
    - Patients who are unlikely to comply with the protocol (e.g.
    uncooperative attitude, inability to return for subsequent visits) and/or
    otherwise considered by the Investigator to be unlikely to complete the
    study
    Patients with regular administration of ASA, defined as >3 doses/week,
    will be included in the observation group. Other additional regular use of
    ASA must be withdrawn before randomization.
    E.5 End points
    E.5.1Primary end point(s)
    Time To Recurrence (TTR) at 3 years in patients with tumors harboring
    PIK3CA mutations in exon 9 and 20.
    E.5.1.1Timepoint(s) of evaluation of this end point
    3 years.
    Interim analyses on the safety endpoints after one year.
    E.5.2Secondary end point(s)
    Disease-Free Survival (DFS) at 3 years, in patients with tumors
    harboring PIK3CA mutations in exon 9 and 20.
    Disease-Free Survival (DFS) at 3 years, in patients with tumors
    harboring PIK3CA mutations other than in exon 9 and 20 and in PIK3R1
    and PTEN.
    Time To Recurrence (TTR) at 3 years, in patients with tumors harboring
    PIK3CA mutations other than in exon 9 and 20 and in PIK3R1 and PTEN.
    OS at 5 years in patients with tumors harboring PIK3CA mutations in
    exon 9 and 20, other than in exon 9 and 20, and in PIK3R1 and PTEN.
    E.5.2.1Timepoint(s) of evaluation of this end point
    3 years.
    Interim analyses on the safety endpoints after one year.
    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 Yes
    E.8.1.7.1Other trial design description
    Stratification based on clinical stage, cancer localisation (rectal/colon), type of mutation.
    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 Yes
    E.8.5.1Number of sites anticipated in the EEA25
    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 years10
    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 years10
    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: 240
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 360
    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 Yes
    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 state60
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 600
    F.4.2.2In the whole clinical trial 600
    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.
    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 Decision2017-05-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-02-07
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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