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    Summary
    EudraCT Number:2014-004049-29
    Sponsor's Protocol Code Number:ISSBRIL0264
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2015-04-07
    Trial results View 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 number2014-004049-29
    A.3Full title of the trial
    Investigating Aspirin and Ticagrelor for the prevention of tumour cell-induced platelet aggregation
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Could Aspirin and Ticagrelor be used to help stop the spread of cancer?
    A.3.2Name or abbreviated title of the trial where available
    Ticagrelor for prevention of tumour cell-induced platelet aggregation
    A.4.1Sponsor's protocol code numberISSBRIL0264
    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 Leicester
    B.1.3.4Country
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleComparator
    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 holderIntrapharm Laboratories Ltd
    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 nameAspirin
    D.3.2Product code Acetylsalicylic Acid
    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 INNAspirin
    D.3.9.1CAS number 50-78-2
    D.3.9.4EV Substance CodeAS2
    D.3.10 Strength
    D.3.10.1Concentration unit mg/g milligram(s)/gram
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number75 to 100
    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.IMP: 2
    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 Brilique
    D.2.1.1.2Name of the Marketing Authorisation holderAstra Zeneca 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 nameBrilique
    D.3.4Pharmaceutical form Film-coated 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 INNTicagrelor
    D.3.9.1CAS number 274693-27-5
    D.3.9.4EV Substance CodeAS1
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number90 to 180
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Solid cancer metastasis
    E.1.1.1Medical condition in easily understood language
    Spread of cancers to remote sites (metastatsis)
    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
    Does Ticagrelor effect platelets in ways that are likely to reduce the spread of cancer in the blood of people taking Ticagrelor (i.e. in vivo), and does Ticagrelor seem to have more effect than Aspirin.
    E.2.2Secondary objectives of the trial
    Does dual therapy with both Aspirin and Ticagrelor have more effect on pro-metastatic tumour cell platelet interactions than monotherapy with either drug alone
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Healthy Volunteers
    Provision of informed consent prior to any study specific procedures
    Male or female aged 18-85
    Adequate level of spoken and written English to give informed consent
    Use of 2 types of contraception for duration of involvement
    Check of TOPS reveals no over-volunteering
    Use of appropriate contraceptive measures

    Cardiovascular patients
    Provision of informed consent prior to any study specific procedures
    Male or female aged 18-85
    Adequate level of spoken and written English to give informed consent
    Use of appropriate contraceptive measures

    Generic cancer patients – for blood sampling only
    Provision of informed consent prior to any study specific procedures
    Male or female aged 18-85
    Any metastatic solid tumour
    Adequate level of spoken and written English to give informed consent

    Breast Cancer patients
    Provision of informed consent prior to any study specific procedures
    Female aged 18-85
    WHO performance status 0-2
    Presence of metastases in at least one organ/system eg. Liver, lungs, lymphadenopathy.
    Haematological and biochemical indices within the ranges shown below:
    Haemoglobin (Hb) ≥10g/dl,
    Neutrophils ≥2000/µl,
    Platelet count ≥ 100.000/µl and ≤500,000/ µl,
    AST or ALT ≤ 3 ULN, alkaline phosphatase ≤ 2x ULN,
    Serum Bilirubin ≤ 1.5 ULN,
    Creatinine Clearance ≥ 45ml/min
    Adequate level of spoken and written English to give informed consent
    Use of 2 types of contraception for duration of involvement
    Use of appropriate contraceptive measures

    Colorectal Cancer patients
    Provision of informed consent prior to any study specific procedures
    Male or female aged 18-85
    Who performance status 0-2
    Presence of metastases in at least one organ/system eg. Liver, lungs, lymphadenopathy.
    Haematological and biochemical indices within the ranges shown below:
    Haemoglobin (Hb) ≥10g/dl,
    Neutrophils ≥ 2000/µl,
    Platelet count ≥ 100.000/µl and ≤500,000/ µl,
    AST or ALT ≤ 3 ULN, alkaline phosphatase ≤ 2x ULN,
    Serum Bilirubin ≤ 1.5 ULN,
    Creatinine Clearance ≥ 45ml/min
    Adequate level of spoken and written English to give informed consent
    Use of 2 types of contraception for duration of involvement
    Use of appropriate contraceptive measures
    E.4Principal exclusion criteria
    Previous history of intracranial bleed
    Any pre-existent bleeding disorder
    History of gastrointestinal bleeding requiring transfusion in the last year or peptic ulceration in the last year
    Current prescription of any antiplatelet therapy for another clinical indication
    Current anticoagulation
    Currently receiving cytotoxic chemotherapy
    Currently receiving tamoxifen (other endocrine therapies are allowed)
    More than 3 lines of chemotherapy for metastatic disease
    Current treatment with NSAIDS
    Current or long term use of oral corticosteroids
    Previous history of aspirin or Ticagrelor intolerance.
    Pregnancy or breast feeding
    History of other malignancy less than 5 years before the diagnosis of breast or colorectal cancer, EXCLUDING the following: Non-melanoma skin cancer, in situ carcinoma of the cervix treated surgically with curative intent, other malignant tumours that have been treated curatively and patient is deemed disease-free
    Any other physical condition which is associated with increased risk of aspirin-related morbidity or, in the opinion of the Investigator, makes the patient unsuitable for the trial, including patients with a high risk of mortality from another cause within the trial treatment period.
    Inadequate level of spoken and written English to give informed consent
    Pregnancy / trying to get pregnant. Pregnancy is an absolute dicontinuation criteria.
    Use of strong CYP 3A4 inhibiting medicines including Boceprevir, Clarithromycin, Cobicistat,HIV-protease inhibitors boosted with ritonavir, nefazodone, atazanavir, Itraconazole,Ketoconazole,Nelfinavir,Ritonavir,Saquinavir,Telaprevir,Telithromycin,
    Voriconazole
    Patients with gout
    E.5 End points
    E.5.1Primary end point(s)
    This will not be a clinical endpoint study. The primary outcome will be an assessment of the differential effect of the study drugs on tumour cell platelet interaction assays in vitro with each of the study drugs
    E.5.1.1Timepoint(s) of evaluation of this end point
    Comparison will be made of in vitro tumour-cell platelet interactions prior to treatment with the same assays repeated after 2-weeks treatment with each study drug alone. There will be a 2-week washout period after the first drug and patients will be randomised as to which study drug they receive first.
    E.5.2Secondary end point(s)
    This will not be a clinical endpoint study. The secondary outcome will be an assessment of the differential effect of the study drugs given in combination on tumour cell platelet interaction assays in vitro
    E.5.2.1Timepoint(s) of evaluation of this end point
    Comparison will be made of in vitro tumour-cell platelet interactions prior to treatment, and following administration of single study drug therapy with both study drugs given in combination.
    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 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 Yes
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over Yes
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    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.8.4.1Number of sites anticipated in Member State concerned1
    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
    LVLS
    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 months0
    E.8.9.1In the Member State concerned days1
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days1
    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: 200
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 100
    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 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 state300
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 300
    F.4.2.2In the whole clinical trial 300
    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)
    This study is early phase and will therefore only indicate if the effect of Ticagrelor on platelets justifies investment in research to determine if it is clinically effective. The findings of this study will not be sufficient to justify clinical application. The participant information sheet makes clear that the study drugs will not be provided to patient-participants after the end of the project.
    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 Decision2015-02-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-03-10
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2020-01-29
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