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    Summary
    EudraCT Number:2007-006033-14
    Sponsor's Protocol Code Number:Version10
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2014-03-17
    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 ConcernedDenmark - DHMA
    A.2EudraCT number2007-006033-14
    A.3Full title of the trial
    A randomized phase III study of standard treatment +/- enoxaparin in small cell lung cancer.
    Randomiserad fas III studie av standard behandling +/- enoxaparin vid småcellig lungcancer.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A randomized phase III study of standard treatment +/- enoxaparin in small cell lung cancer.
    Randomiserad fas III studie av standard behandling +/- enoxaparin vid småcellig lungcancer.
    A.3.2Name or abbreviated title of the trial where available
    RASTEN
    RASTEN
    A.4.1Sponsor's protocol code numberVersion10
    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 Hospital Lund, Thoracic Oncology Unit, Dept of Respiratory Medicine
    B.1.3.4CountrySweden
    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 supportSanofi-Aventis AS
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationLund University Hospital
    B.5.2Functional name of contact pointLars Ek
    B.5.3 Address:
    B.5.3.1Street AddressGetingevägen 4
    B.5.3.2Town/ cityLund
    B.5.3.3Post code221 85
    B.5.3.4CountrySweden
    B.5.4Telephone number+46 4617 10 00
    B.5.5Fax number+4646 17 60 23
    B.5.6E-maillars.ek@skane.se
    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 Klexane
    D.2.1.1.2Name of the Marketing Authorisation holderSanofi-Aventis AS
    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 nameKlexane
    D.3.2Product code Not applicable
    D.3.4Pharmaceutical form Injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNENOXAPARIN SODIUM
    D.3.9.1CAS number 01/08/9041
    D.3.9.2Current sponsor codeNA
    D.3.9.3Other descriptive nameNA
    D.3.9.4EV Substance CodeSUB11933MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Patients with small cell lung cancer, who are going to receive chemotherapy treatment with a platinum- and topoisomeras inhibitor containing regimen.
    Patienter med småcellig lungcancer som skall erhålla kemoterapi med en platinum- och topoisomerashämmare regim.
    E.1.1.1Medical condition in easily understood language
    Small cell lung cancer.
    Småcellig lungcancer.
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.0
    E.1.2Level PT
    E.1.2Classification code 10041067
    E.1.2Term Small cell lung cancer
    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
    The primary objective with the study is to evaluate treatment with chemotherapy with a platinum- and a topoisomeras inhibitor containing regimen versus treatment with the same chemotherapy with addition of enoxaparin comparing overall survival.
    Att utvärdera huruvida behandling med kemoterapi med en platinum- och en topoisomerashämmande regim, samt med tillägg av enoxaparin gentemot inget tillägg av enoxaparin, gen en förläng totalöverlevnad.
    E.2.2Secondary objectives of the trial
    Second objectives are:
    To evaluate toxicity
    To evaluate clinically significant haemorrhagia
    To evaluate progression free survival
    To evaluate thromboembolic events
    To perform translational research
    Utvärdera toxicitet
    Utvärdering av kliniska signifikant blödning
    Att utvärdera progressionsfri överlevnad
    Att utvärdera tromboemboliska händelser
    Translationell forskning
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Histologically or cytologically verified small cell lung cancer, all stages
    WHO Performance Status 0-3
    Age 18 years or older
    Intention and feasibility to treat with chemotherapy consisting of a platinum and a topoisomeras inhibitor
    Platelets over 100 x 10 9/L
    PK (prothrombine komplex) INR and APTT within normal ranges
    Signed informed concent
    Histologiskt eller cytologiskt verifierad småcellig lungcancer, samtliga stadier
    WHO performance status 0-3
    Ålder över 18 år
    Planeras för behandling med en platinum- och en topoisomerasinhiberande regim
    Trombocyter överstigande 100 x 10 9/L
    PK (prothrombine komplex) INR och APTT inom normalgränser
    Signerat samtycke
    E.4Principal exclusion criteria
    Prior systemic chemotherapy for lung cancer
    Concomitant anticoagulation treatment, except for ASA or clopidogrel
    Active overt bleeding of clinical importance or at high risk
    Any other known contraindication for enoxaparine (eg. hypersensitivity against enoxaparine and its derivates
    Pregnancy or breast feeding
    Fertile women not using effective contraceptives or men who do not agree to use effective contraception during the treatment period
    Treatment with any other investigational agent, or participation in any other clinical trial
    Tidigare kemoterapi vid lungcancer
    Samtidig antikoagulantiabehandlingf, förutom ASA och clopidogrel
    Aktiv blödning, eller risk för sådan
    Känd kontraindikation mot enoxaparin
    Gravid eller ammande
    Fertila patienter ovilliga att använda adekvat antikonception
    Behandling med annat studieläkemedel, eller deltagande i annan klinisk prövning
    E.5 End points
    E.5.1Primary end point(s)
    To demonstrate that addition of enoxaparine to standard chemotherapy treatment containing a platinum- and a topoisomeras inhibitor drug results in a significant increase in overall survival.
    Att visa, att tillägg av enoxaparin till standard kemoterapi innehållande en platinum- och en topoisomerashämmande regim ger en signifikant förlängning av den totala överlevnaden.
    E.5.1.1Timepoint(s) of evaluation of this end point
    During study treatment, at follow up 2 and 12 months after end of treatment, and then untill patients death.
    Fortlöpande under studiebehandling, vid uppföljning 2 och 12 månader efter avslutad behandling, sedan fram till att patienten avlider.
    E.5.2Secondary end point(s)
    Toxicity
    Clinically significant hemorrhage
    Progression free survival
    Thromboembolic events
    Relation between different serum- and tumour markers and prognosis with or without enoxaparin
    Toxicitet
    Kliniskt signifikanta blödningar
    Progressionsfri överlevnad
    Tromboemboliska händelser
    Relationen mellan olika serum- och tumörmarkörer och prognos med eller utan tillägg av enoxaparin
    E.5.2.1Timepoint(s) of evaluation of this end point
    During study treatment, at follow up 2 and 12 months after end of treatment.
    Fortlöpande under studiebehandling, vid uppföljning 2 och 12 månader efter avslutad behandling.
    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 Yes
    E.6.13.1Other scope of the trial description
    Translational research
    Translationell forskning
    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 No
    E.8.1.1Randomised Information not present in EudraCT
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    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 Yes
    E.8.5.1Number of sites anticipated in the EEA25
    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
    After end of study regardless of reason, except withdrawn concent, patients will perform follow up visits 3 weeks after last chemotherapy treatment, 2 months after last treatment and a final visit after 12 months.
    Efter fullföljd studiebehandling, kommer deltagande patienter på uppföljning 3 veckor efter avslutad behandling, efter 2 månader, samt efter 12 månader efter sista behandling.
    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 months5
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years7
    E.8.9.2In all countries concerned by the trial months6
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 100
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 290
    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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 390
    F.4.2.2In the whole clinical trial 390
    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)
    According to clinical practice.
    Enligt klinisk praxis.
    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 Decision2014-05-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-01-22
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-05-05
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