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    Summary
    EudraCT Number:2018-001230-18
    Sponsor's Protocol Code Number:PRO-001
    National Competent Authority:Greece - EOF
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2018-12-05
    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 ConcernedGreece - EOF
    A.2EudraCT number2018-001230-18
    A.3Full title of the trial
    Long-term thromboprophylaxis with tinzaparin in high-risk prostate or breast cancer patients. A prospective, randomised, international multicentre, open-label, blinded-endpoint Phase III study. PROBE design
    PRONIA-CAT study
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical study for the long-term protection of prostate and breast cancer patients from thrombosis

    A.3.2Name or abbreviated title of the trial where available
    PRONIA-CAT study
    A.4.1Sponsor's protocol code numberPRO-001
    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 SponsorHellenic Genito-Urinary Cancer Group (HGUCG)
    B.1.3.4CountryGreece
    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 supportLEO Pharma A/S
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationHôpitaux Universitaires de l'Est Parisien Tenon – APHP
    B.5.2Functional name of contact pointGrigoris Gerotziafas
    B.5.3 Address:
    B.5.3.1Street Address4 rue de la Chine
    B.5.3.2Town/ cityParis
    B.5.3.3Post code75020
    B.5.3.4CountryFrance
    B.5.6E-mailgregtnn@gmail.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 INNOHEP®
    D.2.1.1.2Name of the Marketing Authorisation holderLEO Pharmaceutical Hellas S.A.
    D.2.1.2Country which granted the Marketing AuthorisationGreece
    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 nameTinzaparin (Innohep)
    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 INNTINZAPARIN SODIUM
    D.3.9.1CAS number 9041-08-1
    D.3.9.4EV Substance CodeSUB12369MIG
    D.3.10 Strength
    D.3.10.1Concentration unit IU/ml international unit(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number4500
    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
    Long-term thromboprophylaxis with tinzaparin in high-risk prostate or breast cancer patients.
    E.1.1.1Medical condition in easily understood language
    Prevention of blood clot formation
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10049909
    E.1.2Term Venous thromboembolism prophylaxis
    E.1.2System Organ Class 100000004865
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The objective of the PRONIA-CAT trial is to investigate the efficacy and safety of long-term VTE prevention with administration of tinzaparin (4500 anti-Xa IU s.c. o.d. for 6 months) in patients scheduled to start anticancer treatment or receiving standard care anticancer for a maximum period of 1 month, for breast or prostate cancer and who are identified at high thromboembolic risk according to the COMPASS-CAT RAM stratification.
    E.2.2Secondary objectives of the trial
    Not applicable
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    •Histologically confirmed breast or prostate cancer, including previously untreated patients and patients with recurrent disease after previous local and/or systemic therapy
    •Age ≥18 years
    •Planned endocrine therapy, chemotherapy, or targeted anticancer therapy within 1 month from study enrolment; patients may also have started such therapy less than 1 month before study enrolment
    •High risk for VTE according to the COMPASS-CAT RAM (score ≥7)
    •ECOG 0-2
    •Life expectancy >6 months
    •Written informed consent
    E.4Principal exclusion criteria
    •Hypersensitivity to heparin
    •History of heparin-induced thrombocytopenia
    •Ongoing anticoagulant treatment (patients receiving antiplatelet agents are not excluded)
    •Objectively confirmed VTE at inclusion before treatment group assignment or incidental VTE found when imaging methods for disease staging are performed
    •Creatinine clearance <20 mL/min according to Cockcroft-Gault formula
    •Active bleeding
    •Platelet count <50 G/L at inclusion
    •Hepatic dysfunction defined as at least 1 of the following: Serum aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) >5 × ULN, bilirubin >2 × ULN
    •Cancer treated exclusively with supportive care
    •Patient enrolled in another trial at the time of screening
    •Recent (<1 month) oncological surgery, major abdominal or thoracic surgery, major orthopaedic surgery, vascular surgery
    •Recent (<1 month) acute coronary syndrome or any other arterial thrombosis, thrombotic or haemorrhagic stroke
    •Pregnancy
    E.5 End points
    E.5.1Primary end point(s)
    The composite of all objectively confirmed VTE events during the 6-month treatment period including: symptomatic or incidental distal DVT; symptomatic or incidental proximal DVT (including iliac and cava thrombosis); symptomatic or incidental PE, or both (DVT and PE); symptomatic or incidental CVC thrombosis or upper limb vein thrombosis (not related to the CVC); vein thrombosis of rare localisation (i.e., splanchnic vein or cerebral vein thrombosis); or death due to PE.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Primary efficacy and safety endpoints will be assessed at 180 days after randomisation. Total observation period will be 360 days.
    E.5.2Secondary end point(s)
    •Objectively confirmed symptomatic VTE and death due to PE during the 6-month treatment period
    •Objectively confirmed symptomatic or incidental VTE during the 12-month study period
    •Objectively confirmed symptomatic or incidental VTE during the 6-month treatment period in the predefined subgroup of patients with breast cancer
    •Objectively confirmed symptomatic or incidental VTE during the 6-month treatment period in the predefined subgroup of patients with prostate cancer
    •Overall mortality and causes of death during the 6-month treatment period and during the overall 12-month study period
    •Progression-free survival in patients in each studied group
    •Progression-free survival in patients with antiangiogenic treatments
    •Evaluation of the burden of VTE (using data of the control group) and estimation of the cost of VTE treatment as well as of the socioeconomic benefit from the application of thromboprophylaxis with tinzaparin
    E.5.2.1Timepoint(s) of evaluation of this end point
    During each visit, the search for VTE events, bleeding, and other study endpoints will be done systematically using a structured questionnaire. All CT reports will be checked for VTE and bleeding events. All suspected outcomes will be centrally adjudicated by a clinical events committee unaware of treatment allocation.
    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 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 Yes
    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 No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA18
    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
    A pre-planned end-of-study follow-up visit will be conducted at the same time as the Day 360 visit. This refers only for all patients still enrolled as of the Day 360 visit ± 20 . The patient will be taken off the study early in case of death or at the request of the patient, at the request of the treating physician, or if the patient is lost to follow-up.
    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
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months0
    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 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: 632
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 420
    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 state400
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 1052
    F.4.2.2In the whole clinical trial 1052
    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)
    Standard care
    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 Decision2019-01-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-01-25
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2019-03-28
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