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    Summary
    EudraCT Number:2015-001707-31
    Sponsor's Protocol Code Number:Protocolversion1.0
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2015-05-14
    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 number2015-001707-31
    A.3Full title of the trial
    The SCaIPEL study: Survival and Quality of Life of Cancer Patients with Incidental Pulmonary Embolism Treated with LMWH
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Survival and quality of life of cancer patients diagnosed with previously unsuspected pulmonary embolism
    A.3.2Name or abbreviated title of the trial where available
    Survival and Quality of life of Cancer Patients with incidental PE
    A.4.1Sponsor's protocol code numberProtocolversion1.0
    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 SponsorHull & East Yorkshire Hospitals NHS Trust
    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 supportinternal academic funds
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationHull & East Yorkshire Hospitals NHS Trust
    B.5.2Functional name of contact pointProfessor Anthony Maraveyas
    B.5.3 Address:
    B.5.3.1Street AddressAcademic Oncology, Queen's Centre for Oncology and Haematology, Castle Hill Hospital, Castle Road
    B.5.3.2Town/ cityCottingham
    B.5.3.3Post codeHU16 5JQ
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number01482461245
    B.5.6E-mailanthony.maraveyas@hey.nhs.uk
    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® 5000 IU
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer Limited Ramsgate Road Sandwich KENT CT13 9NJ United Kingdom
    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 nameDalteparin
    D.3.4Pharmaceutical form Solution for injection in pre-filled syringe
    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 INNdalteparin Sodium
    D.3.9.4EV Substance CodeAS1
    D.3.10 Strength
    D.3.10.2Concentration typenot less then
    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
    Incidental Pulmonary Embolism in Cancer Patients
    E.1.1.1Medical condition in easily understood language
    Cancer patients who develop a pulmonary embolism.
    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
    Do patients with i-PE conventionally treated with anti-coagulation live for a shorter time than matched patients without an I-PE?
    E.2.2Secondary objectives of the trial
    • What is the impact of the symptom burden on survival and on other clinically significant events (e.g hospitalisation).
    • Are there subgroups of patients with low risk of PE (or VTE) recurrence or patients with a high risk of recurrence, and could these have survival implications?
    • What is the impact of the treatment on the QoL of these patients?
    • Is there any predictive value of particular prothrombotic markers of the malignancy (TF, PAR2 and thrombin generation) for occurrence of i-PE (or more broadly VTE) and survival?
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    A. i-PE group:
    1) Adults ≥18 years.
    2) Active cancer.
    3) Incidentally diagnosed with pulmonary embolism.
    4) Able to provide written informed consent.
    5) Able to complete study assessments
    6) LMWH considered as standard care

    B. prospective recruited control group
    1) Adults ≥18 years.
    2) Active cancer.
    3) Able to provide written informed consent.
    4) Able to complete study assessments.
    E.4Principal exclusion criteria
    1) No Cancer.
    2) No PE.
    3) Other thrombosis without concurrent PE (deep vein thrombosis (DVT), splanchnic VTE)
    4)Anticoagulation contraindications.
    a) Brain metastasis.
    b) Platelets ≤ 50x 10 log 9/l
    c) Known bleeding tumour with active bleeding, eg:
    - Bladder tumour with haematuria
    - Lung tumour with haemoptysis
    - Gastric tumour with hematemesis
    5) Allergy reaction/ previous side effects of heparin (heparin-induced thrombocytopenia [HIT])
    6) Patients already on warfarin or already anticoagulated with LMWH
    7) Recent brain surgery within 6 months.
    8) Vascular surgery within 6 months
    9) Other arterial event (without concurrent PE)
    E.5 End points
    E.5.1Primary end point(s)
    The primary outcome measure for the study is patient survival at 6 months, i.e. the number of patients still alive after 6 months. Data will be analysed as intention to treat. The SPSS computer package will be used with a p-value of <0.05 taken as the level of significance. In terms of survival analysis, this will be measured from the first diagnosis of the tumour stage within which the i-PE occurred, rather than from the event itself, so as to avoid lead time bias.
    E.5.1.1Timepoint(s) of evaluation of this end point
    This end point will be evaluated at the end of the study, allowing for a 6-month follow-up of the last patient recruited.
    E.5.2Secondary end point(s)
    Secondary outcome measures will be quality of life and symptom burden, as determined using the questionnaires, and their relative impact on survival. Performance status and its relation to survival will be another key measure.

    Other clinically significant events will also be measured: number of patients experiencing recurrence of PE/VTE; cancer progression or recurrence; adverse events from LMWH treatment; and 30-day post-commencement of LMWH hospitalisation, as well as the number of days spent in hospital and the mortality rate.

    Laboratory analyses will provide specific measures of levels of key coagulation biomarkers in blood and tissue samples of participants.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Cancer patients enrolled in the study will be evaluated on a regular basis; following the baseline visit, Visit 1 will be 7 days from the start of treatment; Visit 2 will be after 30 days (+/- 3 days); Visit 3 will be after 60 days (+/- 3 days); Visit 4 will be after 90 days (+/- 3 days); and Visit 5 will be after 180 days (+/- 3 days). In each visit patients will be asked to give a blood sample for laboratory analysis and to fill in the Quality of Life and symptom questionnaires.

    The control patients will give no further blood samples after the baseline visit, but will be asked to complete the QoL and symptom questionnaires at the baseline visit, baseline +90 days and baseline + 180 days timepoints.
    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) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised No
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Prospective case-controlled cohort study
    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
    Matched cancer patient without VTE
    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 years2
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days1
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months6
    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: 0
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 0
    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 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 state390
    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 an observational case-control study, so it will not interfere with the routine management of the i-PE. At all times before, during and after the study, patients will remain under their usual clinician for their clinical management.
    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 Decision2015-05-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-07-10
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2016-09-23
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