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    Summary
    EudraCT Number:2013-004862-32
    Sponsor's Protocol Code Number:IEO883/13F
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2014-05-21
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2013-004862-32
    A.3Full title of the trial
    A Randomized Phase II Trial of Low Dose Aspirin versus Placebo in High-Risk Individuals with CT Screen Detected Subsolid Lung Nodules.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Clinical Trial of Low Dose Aspirin versus Placebo in High-Risk Individuals of Lung Cancer.
    A.4.1Sponsor's protocol code numberIEO883/13F
    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 SponsorIstituto Europeo Oncologia
    B.1.3.4CountryItaly
    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 supportNCI-Division of Cancer Prevention
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationIstituto Europeo Oncologia
    B.5.2Functional name of contact pointUfficio studi clinici & Att. Regola
    B.5.3 Address:
    B.5.3.1Street AddressRamusio 1
    B.5.3.2Town/ citymilan
    B.5.3.3Post code20141
    B.5.3.4CountryItaly
    B.5.4Telephone number00390257489848
    B.5.5Fax number00390257489781
    B.5.6E-mailufficio.studiclinici@ieo.it
    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 Cardioaspirin
    D.2.1.1.2Name of the Marketing Authorisation holderBayer S.p.A.
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    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
    Lung cancer increased risk in current or former heavy smokers, with CT SCAN screen detected subsolid lung nodules (Cosmos Project)
    E.1.1.1Medical condition in easily understood language
    Lung cancer increased risk in current or former heavy smokers
    E.1.1.2Therapeutic area Not possible to specify
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.0
    E.1.2Level PT
    E.1.2Classification code 10025065
    E.1.2Term Lung carcinoma cell type unspecified recurrent
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the effect on the diameter and the number of pulmonary non-solid or partially solid nodules, after one year treatment in an for subject analysis.
    E.2.2Secondary objectives of the trial
    Secondary objective of the study will be the modulation of biological markers after treatment and the correlation of these findings with modification of lung nodules diameters. In particular we will evaluate the effect of Aspirin on a signature of serum microRNA correlated to subsolid nodules. The per-lesion analysis including the evaluation of lung nodule density before and after treatment, the number and size of non target lesions including solid nodules and evaluation of response according to modified RECIST criteria. Modulation of ultrasensitive circulating hs-CRP, the evaluation of urinary cotinine as marker of tobacco exposure and investigation of the potential effect of aspirin according to its concentration, the measurement of urinary prostaglandin metabolites (PGEM) and leukotriene (LTE4), both normalized normalized to urinary creatinine concentration. Serum concentration of thromobxane B2 (TXB2) will be determined as a measure of compliance. Tolerability of treatment
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Asymptomatic current or former smokers (having stopped within the last 20 years),
    • Age > 50 years (risk of lung cancer in subjects under 50 is low thus screening is not indicated by actual international guidelines).
    • Smoking history > 20 pack/years, subjects must be included in an ongoing annual screening with low dose CT scan (Cosmos 1 or Cosmos 2).
    • Subjects must have subsolid (non solid or partially solid) nodules with size between 4 and 10 mm with any Volume Doubling Time (VDT) and/or
    subsolid (non solid or partially solid) nodule larger than 10 mm with VDT higher than 400 days and not candidate to surgical excision.
    • All nodules should be persistent at least after three months follow up with ld-CT
    • ECOG performance status ≤1 (Karnofsky ≥70%; see Appendix A)
    • Participants must have normal organ and marrow function
    • Ability to understand and the willingness to sign a written informed consent document.
    • Signed informed consent
    E.4Principal exclusion criteria
    • Subjects with chronic treatment (at least twice/week for more than 3 months) with Aspirin or other NSAIDs (representing 15% of Cosmos 1 population)
    • History of allergic reactions attributed to compounds of similar chemical or biological composition to aspirin, NSAIDs, COX2 inhibitors
    • Invasive malignancy (with the exclusion of basal cell carcinoma or skin squamous cell carcinoma) diagnosed during the last 2 years before randomization
    • History of therapeutic doses of anticoagulants
    • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
    • Pregnant women are excluded from this study because Aspirin is an agent with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with Aspirin, breastfeeding should be discontinued if the mother is treated with Aspirin
    • Participants with bleeding diathesis, history of gastric/duodenal ulcers, NSAID-precipitated bronchospasm, patients unwilling or unable to limit alcohol consumption to i.e. ≤ 2 alcohol drinks a day.
    • Participants who in the opinion of the PI will be at higher risk of ASA-related complications.
    E.5 End points
    E.5.1Primary end point(s)
    Size reduction of pulmonary nodules evaluated with the by subject analysis. For single nodules clinically meaningful reduction of 30% or more of the larger diameter will be considered remission after one year of treatment. The growth of 20% or more with a minimum of 2mm will be considered progression. In the case of multiple lesions will be considered the sum of the maximum diameters of all nodules target, using the same parameters to define remission or progression (respectively 30% reduction and 20% increase).
    E.5.1.1Timepoint(s) of evaluation of this end point
    12 months
    E.5.2Secondary end point(s)
    Secondary endpoints will be the modulation of biological markers after treatment and the correlation of these findings with modification of lung nodules diameters. In particular we will evaluate the effect of Aspirin on a signature of serum miRNA correlated to subsolid nodules. Other secondary endpoints will be the per-lesion analysis including the evaluation of lung nodule density before and after treatment and the number and size of non target lesions. Additional biomarkers will include the modulation of hs-CRP, the evaluation of urinary cotinine as marker of tobacco exposure and investigation of the potential effect of aspirin according to its concentration, the measurement of urinary prostaglandin metabolites (PGEM) and urine leukotriene E4 (LTE4) both normalized to urinary creatinine concentration. Serum concentration of thromboxane B2 (TXB2) will be determined as a measure of compliance. We will also evaluate the tolerability of Aspirin at dose of 100 mg/day.
    E.5.2.1Timepoint(s) of evaluation of this end point
    12 months
    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 No
    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) 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 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 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 years
    E.8.9.1In the Member State concerned months36
    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: 90
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 38
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers Yes
    F.3.2Patients No
    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 state128
    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)
    partecipation in the lung screening program
    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 Decision2014-10-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-05-07
    P. End of Trial
    P.End of Trial StatusOngoing
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