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    Summary
    EudraCT Number:2014-001463-12
    Sponsor's Protocol Code Number:P130936
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2015-02-27
    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 ConcernedFrance - ANSM
    A.2EudraCT number2014-001463-12
    A.3Full title of the trial
    A phase III multi-centre double-blind placebo controlled study analysing the efficacity and safety of daily administration of a P2Y12 inhibitor (Clopidogrel) for the treatment of locally advanced or metastatic pancreatic cancer
    A.3.2Name or abbreviated title of the trial where available
    PANCREADOGREL
    A.4.1Sponsor's protocol code numberP130936
    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 SponsorASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)
    B.1.3.4CountryFrance
    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 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 Plavix
    D.2.1.1.2Name of the Marketing Authorisation holderSanofi Clir SNC
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    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 namePlavix
    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 INNclopidogrel
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number75
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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 placeboFilm-coated 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
    Patients with confirmed locally advanced or metastatic pancreatic adenocarcinoma treated by chemotherapy .
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.1
    E.1.2Level PT
    E.1.2Classification code 10033610
    E.1.2Term Pancreatic carcinoma metastatic
    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
    Primary objective:
    The aim of this prospective randomized controlled trial in patients with locally advanced or metastatic pancreatic cancer is to demonstare that Clopidogrel treatment can increase on Progression free Survival (PFS) at 6 months.
    E.2.2Secondary objectives of the trial
    Secondary objectives are to assess the impact of clopidogrel treatment on:
    -the occurrence venous thromboembolism events: Pulmonary embolism (PE), Lower Extremity DVT, Upper extremity DVT, Head/neck DVT, Visceral vein event.
    -the bleeding complications and safety of clopidogrel as measured by the rate of minor and major haemorrhages when used with chemotherapy and occasionally along with either curative (if onset of venous thrombo-embolism) or prophylactic dose of low molecular weight heparin as it can now be used in cancer patients for primary venous thromboembolism prophylaxis.
    -the overall response rate and overall survival.
    -the correlation between tumour regression / formation of metastasis and microparticules level before and after chemotherapy.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Inclusion criteria
    - 18 years of age or older
    - Histologically and cytologically confirmed adenocarcinoma of the pancreas
    - Locally advanced or metastatic pancreatic adenocarcinoma
    - Measurable primary pancreatic cancer or metastasis
    - Pancreatic adenocarcinoma that has not previously been treated with chemotherapy either in an adjuvant or metastatic setting
    - Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
    - Adequate bone marrow: granulocyte count superior or equal to 1.5 G/L; and platelet count superior or equal to 100 G/L
    - Adequate liver function: bilirubin inferior or equal to 2 times the upper limit of the normal range, transaminases (AST and ALT) inferior or equal to 3 times the upper limit of the normal range
    - Adequate renal function: calculated clearance rate > 60 m.mn1 (Estimated glomerular filtration rate using Modification of Diet in Renal Disease (MDRD) formula or Cockcroft-Gault formula)
    - Women of childbearing potential must use an effective birth control method.
    E.4Principal exclusion criteria
    Non-inclusion criteria
    - Endocrine or acinar pancreatic carcinoma
    - Pancreatic metastasis of other primary tumors
    - Previous radiotherapy for measurable lesions
    - Previous chemotherapy
    - History of brain metastases, uncontrolled spinal cord compression, or carcinomatous meningitis or new evidence of brain or leptomeningeal disease
    - Other prior malignancy. Adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix or any other cancer from which the patient has been disease free for > 5 years are allowed.
    - Known acquired immunodeficiency syndrome (AIDS-related illnesses) or known HIV disease requiring antiretroviral treatment.
    - Acute infection
    - Hemorrhagic diathesis
    - Aspirin with a daily dose > 75 mg
    - Curative dose of LMWH
    - Recent venous thromboembolism (1 year)
    - Patients under VKA
    - Lesion of the digestive tract that could be hemorrhagic with clopidogrel treatment
    - History of another major cancer except basal cell carcinoma of skin
    - Active infection
    - Chronic diarrhea
    - Clinically significant history of cardiac disease defined as a left ventricular ejection fraction below 45%
    - Pregnancy or breast-feeding
    - Hypersensitivity to clopidogrel or its excipients
    - Patients with severe hepatic impairment
    - Patients who are pregnant or breast feeding, or who are not using effective birth control methods
    - Participation in another clinical research protocol, participation in a trial of routine care is authorized at the same time as PANCREADOGREL
    - Patient under tutorship or curatorship
    - Patients unwilling or unable to comply with the protocol
    - Not affiliated to health system (bénéficiaire ou ayant droit)
    E.5 End points
    E.5.1Primary end point(s)
    Primary assessment criterion
    Progression-free survival covers the period when there is no evidence of disease progression. The diagnosis of progression disease by x-rays, computed tomography scans, magnetic resonance imaging or scans will be dated from the first positive record, even if determined in retrospect. The beginning of progression-free survival will be calculated starting from the time of inclusion.

    Secondary assessment criteria
    - Venous thromboembolic events
    - Diagnosis of pulmonary embolism deep venous thrombosis and visceral vein event.
    - Bleedings( will be classified as major, clinically relevant non-major, trivial, or no bleeding).
    - Overall response rate
    Tumor response will be determined according to the Response Evaluation Criteria in Solid Tumors (RECIST 1.1).
    - Overall survival
    Overall survival is defined as time from randomization to death from any cause.
    - Correlation between between tumour regression / formation of metastasis and microparticules level
    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 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.8.3 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 concerned7
    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 Information not present in EudraCT
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    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.1.3Elderly (>=65 years) Yes
    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 state264
    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 Decision2015-02-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-03-13
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-04-23
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