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    Summary
    EudraCT Number:2015-001630-21
    Sponsor's Protocol Code Number:BAY59-7939/39039039STM4001/18262
    National Competent Authority:Czech Republic - SUKL
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2016-06-01
    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 ConcernedCzech Republic - SUKL
    A.2EudraCT number2015-001630-21
    A.3Full title of the trial
    Efficacy and Safety of Rivaroxaban Prophylaxis Compared with Placebo in Ambulatory Cancer Patients Initiating Systemic Cancer Therapy and at High Risk for Venous Thromboembolism
    Účinnost a bezpečnost profylaxe rivaroxabanem v porovnání s placebem u ambulantních onkologických pacientů, kteří začínají užívat systémovou protinádorovou léčbu a mají vysoké riziko žilní tromboembolie
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study to Evaluate the Efficacy and Safety of Rivaroxaban Venous Thromboembolism (VTE) Prophylaxis in Ambulatory Cancer Participants
    A.4.1Sponsor's protocol code numberBAY59-7939/39039039STM4001/18262
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02555878
    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 SponsorJanssen-Cilag International N.V.
    B.1.3.4CountryBelgium
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportJanssen Research & Development, LLC
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationJanssen Research and Development, LLC
    B.5.2Functional name of contact pointJoAnne Foody, MD, TA Head
    B.5.3 Address:
    B.5.3.1Street Address1125 Trenton-Harbourton Road
    B.5.3.2Town/ cityTitusville, NJ
    B.5.3.3Post code08560
    B.5.3.4CountryUnited States
    B.5.4Telephone number+1609676 7139
    B.5.6E-mailjfoody@its.jnj.com
    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 XARELTO® 10 mg
    D.2.1.1.2Name of the Marketing Authorisation holderBayer Pharma AG
    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 nameRivaroxaban
    D.3.2Product code JNJ-39039039/BAY 59-7939
    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 INNRIVAROXABAN
    D.3.9.1CAS number 366789-02-8
    D.3.9.3Other descriptive nameBAY 59-7939
    D.3.9.4EV Substance CodeSUB29263
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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 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
    Venous thromboembolism (VTE)
    E.1.1.1Medical condition in easily understood language
    Blood clot in a vein
    E.1.1.2Therapeutic area Diseases [C] - Blood and lymphatic diseases [C15]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10066899
    E.1.2Term Venous thromboembolism
    E.1.2System Organ Class 100000004866
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary efficacy objective is to demonstrate that rivaroxaban is
    superior to placebo for reducing the risk of the primary composite
    outcome as defined by objectively confirmed symptomatic lower
    extremity proximal DVT, asymptomatic lower extremity proximal DVT,
    symptomatic lower extremity distal DVT, symptomatic upper extremity
    DVT, symptomatic non-fatal PE, incidental PE, and VTE-related death in
    ambulatory adult subjects with various cancer types receiving systemic
    cancer therapy who are at high risk of developing a VTE.
    E.2.2Secondary objectives of the trial
    The key secondary efficacy objectives of this study are to compare the
    efficacy of rivaroxaban with placebo for reducing the risk of symptomatic
    VTE events and VTE-related deaths and all-cause mortality in ambulatory
    adult subjects with various cancer types receiving systemic cancer
    therapy who are at high risk of developing a VTE. Other secondary
    efficacy objectives include the evaluation of the individual components
    of the primary efficacy composite variable analyzed separately, a
    composite of confirmed fatal/non-fatal arterial thromboembolism (ATE)
    events, a composite of confirmed fatal/non-fatal visceral VTE events,
    and a composite of symptomatic lower extremity proximal DVT,
    symptomatic lower extremity distal DVT, asymptomatic lower extremity
    proximal DVT, symptomatic upper extremity DVT, non-fatal PE,
    incidental PE and all-cause mortality.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Histologically confirmed solid malignancy including but not limited to: pancreas, lung, stomach, colon, rectum, bladder, breast, ovary, renal or lymphoma (hematologic), with locally advanced or metastatic disease
    - Have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 02
    - Have a Khorana thromboembolic risk Score greater than or equal
    to (>=) 2
    - Creatinine clearance (CrCl) >= 30 milliliter per minute (mL/min)
    - Plan to initiate systemic cancer therapy within ±1 week of receiving the first dose of study drug with the intention of receiving systemic cancer therapy during the double-blind treatment period with for an intended duration determined by the treating oncologist according to standard protocols of clinical care.
    E.4Principal exclusion criteria
    - Diagnosis of primary brain tumors
    - Known history of brain metastases
    - Bleeding diathesis, hemorrhagic lesions, active bleeding, and other conditions with a high risk for bleeding
    - Hematologic malignancies with the exception of lymphoma
    - Platelet count less than (<) 50,000/millimeter^3 (mm^3), Life expectancy of less than or equal to (<=) 6 months
    E.5 End points
    E.5.1Primary end point(s)
    1) Primary Efficacy Composite Endpoint is Time From Randomization to
    First Occurrence of Objectively Confirmed Symptomatic and
    Asymptomatic Lower Extremity Proximal DVT, Symptomatic Lower
    Extremity Distal DVT, Symptomatic Upper Extremity DVT, Symptomatic
    Non-Fatal PE, Incidental PE, or VTE-Related Death
    2) The Primary Safety Objective of This Study is to Assess the Major
    Bleeding Events as Defined by ISTH
    E.5.1.1Timepoint(s) of evaluation of this end point
    1) From Randomization to Day 180 (+3 Days) as Adjudicated by an Independent CEC
    2) From the Time of Randomization to Two Days After the Last Dose of Study Drug
    E.5.2Secondary end point(s)
    1) Efficacy endpoint: Symptomatic VTE Events and VTE Related Deaths
    2) Efficacy endpoint: All-cause Mortality
    3) Safety Endpoints Include the Proportion of Clinically Relevant Non-Major Bleeding, Minor Bleeding, any Bleeding (Defined as Major, Clinically Relevant Non-Major, and Minor Bleeding)
    4) Safety endpoint: All-cause Mortality
    5) Number of Participants with Adverse Events (AEs) and Serious AEs
    E.5.2.1Timepoint(s) of evaluation of this end point
    1) and 2): Up to Day 180+3
    3) From the Time of Randomization to Two Days After the Last Dose of Study Drug
    4) Up to Day 180
    5) Screening up to follow-up (30 days after last dose administration)
    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 No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    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 concerned9
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA76
    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
    Belgium
    Canada
    Germany
    United Kingdom
    United States
    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 years1
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months8
    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: 450
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 350
    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 state80
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 340
    F.4.2.2In the whole clinical trial 800
    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 Decision2016-06-01
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-04-27
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-08-24
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