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    The EU Clinical Trials Register currently displays   43865   clinical trials with a EudraCT protocol, of which   7286   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2005-002438-37
    Sponsor's Protocol Code Number:2005/VCC/0018(WCTU02)
    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:2006-11-22
    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 number2005-002438-37
    A.3Full title of the trial
    A randomised phase III clinical trial investigating the effect of FRAGMin® Added to standard Therapy In patients with lung Cancer
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The aim of this trial, which is called FRAGMATIC, is to assess the effect of adding a blood thinning drug called dalteparin (FRAGMIN®) for 24 weeks to standard treatment for patients with lung cancer to see if if has any affect on survival.
    A.3.2Name or abbreviated title of the trial where available
    FRAGMATIC
    A.4.1Sponsor's protocol code number2005/VCC/0018(WCTU02)
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberISRCTN80812769
    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 SponsorVelindre NHS Trust
    B.1.3.4CountryUnited Kingdom
    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 supportCancer Research UK
    B.4.2CountryUnited Kingdom
    B.4.1Name of organisation providing supportPfizer
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationWales Cancer Trials Unit
    B.5.2Functional name of contact pointGareth Griffiths
    B.5.3 Address:
    B.5.3.1Street Address6th floor Neuadd Meirionnydd
    B.5.3.2Town/ cityHeath Park
    B.5.3.3Post codeCf14 4YS
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number02920687500
    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 Fragmin
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer Limited
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 nameFragmin
    D.3.2Product code N/A
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    Subcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNDalteparin Sodium
    D.3.9.1CAS number 9041-08-1
    D.3.9.3Other descriptive nameDALTEPARIN SODIUM
    D.3.10 Strength
    D.3.10.1Concentration unit IU/ml international unit(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5000
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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
    Lung cancer
    E.1.1.1Medical condition in easily understood language
    This trial investigates the treatment of lung cancer
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10025044
    E.1.2Term 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
    To assess the effect of adding 24 weeks of daily dalteparin (Fragmin) to standard treatment for patients with lung cancer in terms of overall survival. Assessed using an open randomised trial.
    E.2.2Secondary objectives of the trial
    Venous thrombotic event (VTE) free survival
    Serious adverse events (SAEs)
    Metastasis-free survival
    Toxicity
    Quality of life
    Levels of breathlessness
    Anxiety and depression
    Cost effectiveness
    Cost utility
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    T-FRAG Collection and storage of tumour and blood samples from participants with lung cancer in the FRAGMATIC trial.

    Protocol v2.0 February 2010. Sponsored by Velindre NHS Trust.
    E.3Principal inclusion criteria
    1. Histopathological or cytological diagnosis of primary bronchial carcinoma (small cell or non-small cell) within the last 7 weeks.
    2. Age 18 or over.
    3. ECOG Performance status 0, 1, 2 or 3.
    4. Willing and able to self-administer LMWH by daily sub-cutaneous injection or have it administered to them by a carer.
    5. Willing and able to give informed consent.
    E.4Principal exclusion criteria
    1. Patients with other intrathoracic tumours (e.g. carcinoid, mesothelioma, lymphoma, lung metastases from another primary site).
    2. Any previous illness or treatment likely to interfere with protocol treatment or comparisons.
    3. Clinically apparent brain metastases.
    4. Patients who have had a haemorrhagic stroke in the last 3 months
    5. Haemoptysis of CTC Grade 2 (symptomatic haemoptysis requiring medical intervention) or above.
    6. Known bleeding disorder.
    7. Known pregnancy or lactation. Effective contraception is essential for all female patients (of reproductive potential) if sexually active.
    8. Known hypersensitivity to dalteparin or other low molecular weight heparins and/or heparins (eg history of confirmed or suspected immunologically mediated heparin induced thrombocytopenia; acute gastroduodenal ulcer; subacute endocarditis)
    9. Platelet count lower than 100 x 10 9/L.
    10. Renal impairment with serum creatinine greater than 150 mol/L.
    11. Patients who have received therapeutic anticoagulation in the last 12 months.
    12. Patients taking Ketorolac (toradol) - this is a non steroidal anti-inflammatory drug (NSAID) with a well documented risk of causing increased bleeding when given with LMWH
    13. Patients who at the time of randomisation have a central venous catheter in place and the local practice specifies the use of thromboprophylaxis
    14. Any other active malignancy in the last 5 years, except completely treated non-melanoma skin cancer or in-situ carcinoma of cervix. Patients with previous malignancies in remission for at least 5 years can be included, provided that there is a clear MDT decision that this is a new primary.
    E.5 End points
    E.5.1Primary end point(s)
    Overall survival.
    E.5.1.1Timepoint(s) of evaluation of this end point
    At the end of the trial and follow up period
    E.5.2Secondary end point(s)
    analysis of VTE free survival and matastasis free survival
    E.5.2.1Timepoint(s) of evaluation of this end point
    at the end of the trial and after the follow up period
    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 Yes
    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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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 No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Standard practice alone
    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 concerned130
    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
    The trial will be considered closed when the last patient has completed protocol treatment. Further observational follow up of all patients will continue for a minimum of two years.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    E.8.9.1In the Member State concerned months6
    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.1.2.1Number of subjects for this age range: 2000
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 200
    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 state2200
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 2200
    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)
    As per normal clinical practice.
    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 Decision2006-12-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-08-08
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2012-06-08
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