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    Summary
    EudraCT Number:2015-001482-57
    Sponsor's Protocol Code Number:SAKK_41/13-Aspirin
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2016-04-22
    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 ConcernedGermany - BfArM
    A.2EudraCT number2015-001482-57
    A.3Full title of the trial
    Adjuvant aspirin treatment in PIK3CA mutated colon cancer patients. A randomized, double-blinded, placebo-controlled, phase III trial
    Ergänzende Aspirin-Behandlung bei Dickdarmkrebs. Eine randomisierte, doppelblinde, Placebo-kontrollierte Phase III Studie.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Adjuvant aspirin treatment in PIK3CA mutated colon cancer patients
    Ergänzende Aspirin-Behandlung bei Dickdarmkrebs
    A.4.1Sponsor's protocol code numberSAKK_41/13-Aspirin
    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 SponsorSAKK Swiss Group for Clinical Cancer Research
    B.1.3.4CountrySwitzerland
    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 supportMerck Serono
    B.4.2CountryGermany
    B.4.1Name of organisation providing supportBayer Vital GmbH
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCrolll GmbH
    B.5.2Functional name of contact pointDr. Tobias Leidig
    B.5.3 Address:
    B.5.3.1Street AddressWörnitzstr. 115a
    B.5.3.2Town/ cityNürnberg
    B.5.3.3Post code90449
    B.5.3.4CountryGermany
    B.5.4Telephone number004991125268846
    B.5.5Fax number004991125268840
    B.5.6E-mailtobias.leidig@crolll.de
    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 Vital GmbH
    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.3.4Pharmaceutical form Gastro-resistant 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 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 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 placeboGastro-resistant 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
    PIK3CA mutated colon cancer
    E.1.1.1Medical condition in easily understood language
    colon cancer
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The objective of the trial is to demonstrate a statistically significant and clinically relevant disease free survival benefit in stage II and III PIK3CA mutated colon cancer patients taking daily adjuvant aspirin for 3 years.
    E.2.2Secondary objectives of the trial
    Secondary endpoints of the trial are:
     Time to recurrence (TTR)
     Overall survival (OS)
     Cancer-specific survival (CSS)
     Adverse events (AEs)
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    - Tumoral expression of COX-2 (Version 1.0, 05 June 2015)
    - PI3K Downstream signaling (Version 1.0, 05 June 2015)
    - Tumoral Expression of HLA class I Antigen (Version 1.0, 05 June 2015)
    - Tumoral BRAF V600E mutations and microsatellite instability (Version 1.0, 05 June 2015)
    - Germline genetics (Version 1.0, 05 June 2015)

    The objective of the ancillary substudies of SAKK 41/13 is to explore individual patient’s tumor tissue and peripheral blood for important predictive (COX-2 overexpression by immunohistochemistry (IHC), HLA class I antigen expression, germline genetics) and prognostic (BRAF V600E mutations, tumoral MSI status) factors. This will allow to gain a comprehensive understanding of the therapeutic impact of low-dose aspirin in this group of patients. Biobanks for both tumor tissue and peripheral blood will be implemented to permit future research on colon cancer.
    E.3Principal inclusion criteria
    1 Written informed consent according to ICH/GCP regulations before inclusion and prior to any trial-related investigations.
    2 Histologically confirmed diagnosis of adenocarcinoma of the colon.
    3 Stage II (pT3/T4 N0 cM0) or stage III (pTx pN+ cM0) colon cancer.
    4 Availability of cancer tissue for central molecular testing.
    5 Presence of predefined, activating PIK3CA mutation in exons 9 or 20 (centrally assessed, see section 17).
    6 Complete resection of the primary tumor (R0) within 14 weeks maximum before registration.
    7 WHO performance status 0-2 (see Appendix 3).
    8 Age ≥18 years.
    9 Adequate hematological values: hemoglobin ≥ 80 g/L, platelets ≥ 50 x 10^9/L.
    10 Adequate hepatic function: total bilirubin ≤1.5xULN, AST ≤2.5xULN, ALT ≤2.5xULN, AP ≤2.5xULN.
    11 Calculated creatinine clearance > 30 mL/min, according to the formula of Cockcroft-Gault (see Appendix 2).
    12 Women with child-bearing potential are using effective contraception (see 9.6), are not pregnant or lactating and agree not to become pregnant during trial treatment. A negative pregnancy test before inclusion (within 7 days) into the trial is required for all women with child-bearing potential.
    E.4Principal exclusion criteria
    1 Previous or concomitant malignancy within 3 years of registration, except for adequately treated cervical carcinoma in situ or localized non-melanoma skin cancer.
    2 Multiple adenocarcinomas of the colon.
    3 Rectal cancer (defined as distance from anal verge to proximal/oral tumor edge ≤15 cm).
    4 Severe or uncontrolled cardiovascular disease (congestive heart failure NYHA III or IV (see Appendix 4), unstable angina pectoris, history of myocardial infarction) within three months prior to registration.
    5 Systemic rheumatic diseases or degenerative disorders affecting the musculoskeletal system with a relevant risk of requiring treatment with NSAIDs in the future.
    6 Comorbidities that require regular (i.e. more than 3x per month, any dose) intake of acetylsalicylic acid or other NSAIDs or COX-2 inhibitors.
    7 Clinically relevant upper gastrointestinal bleeding within 12 months prior to registration.
    8 Presence of any bleeding disorder that is an absolute contraindication to the use of aspirin.
    9 General tendency to hypersensitivity and history of asthma triggered by salicylates of substances with a similar mechanism of action, and non-steroidal anti-inflammatory drugs in particular.
    10 Any serious underlying medical condition, at the judgment of the investigator, which could impair the ability of the patient to participate in the trial (e.g. uncontrolled infection, active autoimmune disease, uncontrolled diabetes).
    11 Concurrent treatment with other experimental drugs or treatment in an interventional clinical trial within 30 days prior to trial entry. Concomitant use of adjuvant chemotherapy for stage III and high risk stage II colon cancer according to international Treatment guidelines is allowed (chemotherapy regimens include intravenous 5-fluorouracil or oral
    capecitabine either alone or in combination with intravenous oxaliplatin).
    12 Psychiatric disorder precluding understanding of trial information, giving informed consent or interfering with compliance for oral drug intake.
    13 Any familial, sociological or geographical condition potentially hampering proper staging and compliance with the trial protocol.
    14 Known or suspected hypersensitivity to any component of the trial drug or any agent given in association with this trial.
    15 Known galactose-1-phosphate uridyl transferase deficiency, UDP galactose 4 epimerase deficiency, galactokinase deficiency, Fanconi-Bickel syndrome, congenital lactase deficiency or glucose-galactose malabsorption (due to lactose-containing placebo).
    16 Any concomitant drugs contraindicated for use with the trial drug according to the approved product information.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint of the trial is:
     Disease-free survival (DFS)
    E.5.1.1Timepoint(s) of evaluation of this end point
    DFS: time from surgery until one of the following events, whichever comes first: recurrence, second cancer, death due to any reason; evaluation by CT every 12 months
    E.5.2Secondary end point(s)
    Secondary endpoints of the trial are:
     Time to recurrence (TTR)
     Overall survival (OS)
     Cancer-specific survival (CSS)
     Adverse events (AEs)
    E.5.2.1Timepoint(s) of evaluation of this end point
    TTR: time from surgery until recurrence or death due to colon cancer.
    OS: time from surgery until death from any cause.
    CSS: time from surgery until death due to colon cancer, whether due to the original tumor or to a second primary same cancer.
    AEs: continuously throughout study. AEs will be assessed according to NCI CTCAE v4.0.
    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 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) 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 concerned22
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA40
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Switzerland
    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
    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: 30
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 60
    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 state90
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 130
    F.4.2.2In the whole clinical trial 185
    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)
    Individual patients will receive Treatment for 3 years or until disease Progression/intolerable toxicity/withdrawal of informed consent. Afterwards they remain in observational follow up until death, lost to follow up or study closure. patients receive medical Treatment according to the discretion of the treating physician, bot not in the context of this 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 Decision2016-09-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-07-12
    P. End of Trial
    P.End of Trial StatusOngoing
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