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    Summary
    EudraCT Number:2021-005530-42
    Sponsor's Protocol Code Number:imPaCT-PRO-01
    National Competent Authority:Greece - EOF
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2021-11-12
    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 number2021-005530-42
    A.3Full title of the trial
    The impact of Thromboprophylaxis on Progression Free Survival of Patients with Advanced Pancreatic Cancer. The Pancreatic Cancer & Tinzaparin Prospective (imPaCT-PRO) study
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The prevention of thrombosis in patients with pancreatic cancer using Tinzaparin
    A.3.2Name or abbreviated title of the trial where available
    imPaCT-PRO
    A.4.1Sponsor's protocol code numberimPaCT-PRO-01
    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 SponsorInstitute of Molecular Medicine and Biomedical Research (IMBE)
    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 Pharmaceuticals Hellas SA
    B.4.2CountryGreece
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationInstitute of Molecular Medicine and Biomedical Research (IMBE)
    B.5.2Functional name of contact pointCommunication IMBE
    B.5.3 Address:
    B.5.3.1Street AddressPanepistimiou 56
    B.5.3.2Town/ cityAthens
    B.5.3.3Post code106 78
    B.5.3.4CountryGreece
    B.5.4Telephone number+302130237967
    B.5.5Fax number+302130237967
    B.5.6E-mailk.doulaveri@imibe.org
    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® 20.000 Anti-Xa IU/ml
    D.2.1.1.2Name of the Marketing Authorisation holderLEO Pharmaceuticals
    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 nameInnohep
    D.3.4Pharmaceutical form Solution for injection/infusion 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.3.9.3Other descriptive nameTINZAPARIN SODIUM
    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 typerange
    D.3.10.3Concentration number10000 to 18000
    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
    Thromboprophylaxis in patients with advanced pancreatic cancer
    E.1.1.1Medical condition in easily understood language
    Prophylaxis from thrombosis in patients with locally advanced pancreatic cancer
    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 PT
    E.1.2Classification code 10043607
    E.1.2Term Thrombosis
    E.1.2System Organ Class 10047065 - Vascular disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10068067
    E.1.2Term Tumour thrombosis
    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
    Primary objectives
    •Evaluate the impact of VTE prevention on progression-free survival (PFS).
    •Investigate the efficacy of long term VTE prevention with simultaneously administration of tinzaparin during 1st line chemotherapy in patients undergoing anticancer treatment with NabG for locally advanced or metastatic PC.
    E.2.2Secondary objectives of the trial
    Secondary Objective
    •Determine the safety and tolerability of tinzaparin in combination with NabG for locally advanced or metastatic PC during the study.
    •Determine overall response rates (ORR) according to Response Evaluation Criteria (Response Evaluation Criteria in Solid Tumors (RECIST) in advanced PC subjects during the study.
    •Evaluation of the effect of VTE prevention on overall survival (OS) of
    patients with advanced PC during the study
    •Determine quality of life (QoL).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Locally Advanced or metastatic PC (confirmed by the recommended histological and imaging methods).
    2.Age ≥ 18 years.
    3.Planning to start 1st line chemotherapy with NabG.
    4.Eastern Cooperative Group (ECOG) 0-2.
    5.Life expectancy >6 months.
    6.Written informed consent.
    E.4Principal exclusion criteria
    1.Subjects with contraindication to receive anticoagulant:
    a. Any hypersensitivity to anticoagulant or excipients.
    b. History of heparin-induced thrombocytopenia type II (HIT II).
    c. Active major bleeding or pre-diathesis for major bleeding
    d. Septic endocarditis.
    2.Creatinine clearance <20 mL/min according to Cockcroft-Gault formula.
    3.Platelet count < 50 G/L at inclusion.
    4.Hepatic dysfunction defined as at least one of the following: AST and/or ALT > 5 x ULN, bilirubin > 2 x ULN.
    5.Recent (< 1 month) oncological surgery, major abdominal or thoracic surgery, major orthopedic surgery, vascular surgery.
    6.Recent (< 1 month) acute coronary syndrome or any other arterial thrombosis, thrombotic or hemorrhagic stroke.
    7.Patients on chronic anticoagulation or on dual anti-platelet treatment.
    8.Pregnancy/lactation or insufficient contraception during the study and up to 3 months after the study.
    9.Severe concomitant disease that as per investigator’s judgement is not compatible with participation in the study.
    E.5 End points
    E.5.1Primary end point(s)
    •PFS of patients receiving thromboprophylaxis with tinzaparin, in comparison with the PFS of patients not receiving such prevention (primary endpoint).
    •All objectively confirmed VTE events during the study per treatment arm including symptomatic distal deep vein thrombosis (DVT), symptomatic or incidental proximal DVT (including iliac and cava thrombosis), symptomatic or incidental pulmonary embolism (PE) or both DVT and PE (co-primary endpoint) or fatal PE or vein thrombosis of rare localisation (i.e., splanchnic vein or cerebral vein thrombosis).
    E.5.1.1Timepoint(s) of evaluation of this end point
    PFS will be calculated from entry date onto thromboprophylaxis until date of objective disease progression or death from any cause using the RECIST criteria. The VTE events will be evaluated during the study.
    E.5.2Secondary end point(s)
    •% of patients experiencing at least one major bleeding event, according to the International Society on Thrombosis and Haemostasis (ISTH) criteria during the study per treatment arm.
    •% of patients experiencing any bleeding event, including major, clinically relevant non-major bleeding (CRNMB) and minor bleeding events during the study per treatment arm.
    •Incidence of VTE events, per event type, during the study per treatment arm.
    •ORR, defined as the percentage of patients with complete response (CR) or partial response (PR) based on RECIST criteria.
    •Overall Survival (OS) of patients receiving tinzaparin
    thromboprophylaxis compared to OS of patients not receiving such
    prophylaxis.
    •Change from baseline in QoL at 4 months and 10 months per treatment arm.
    QoL will be determined with the EORTC QLQ-C30 version 3.0. and EORTC QOL-PAN26 questionnaires according to the corresponding scoring manual.
    E.5.2.1Timepoint(s) of evaluation of this end point
    The VTE events, bleedings and other outcomes will be evaluated during the study. The changes in QoL will be evaluated at 6 months and 10 months after treatment initiation.
    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 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) 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) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    The other arm receives only standard of care
    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 concerned13
    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
    Last patient last visit
    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 months10
    E.8.9.1In the Member State concerned days
    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: 300
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 150
    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 state450
    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)
    Patients will receive the standard of care for their disease
    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 Decision2021-12-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-11-18
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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