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    Summary
    EudraCT Number:2018-003522-86
    Sponsor's Protocol Code Number:P18.210
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2019-05-09
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2018-003522-86
    A.3Full title of the trial
    Imaging tumor angiogenesis using 18F-Fluciclatide PET/CT in patients with colorectal and pancreatic cancer.
    Tumor angiogenese beeldvorming door middel van 18F-Fluciclatide PET/CT in patienten met colorectaal en pancreas carcinoom.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Imaging tumor bloodvessels using 18F-Fluciclatide PET scan.
    Beeldvorming van tumor geassocieerde bloedvaten met een 18F-Fluciclatide PET scan.
    A.3.2Name or abbreviated title of the trial where available
    18F-Fluciclatide tumor imaging
    18F-Fluciclatide tumor beeldvorming
    A.4.1Sponsor's protocol code numberP18.210
    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 SponsorLeiden University Medical Center
    B.1.3.4CountryNetherlands
    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 supportEuropean Research Council
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationLeiden University Medical Center
    B.5.2Functional name of contact pointPhD student
    B.5.3 Address:
    B.5.3.1Street AddressAlbinusdreef 3
    B.5.3.2Town/ cityLeiden
    B.5.3.3Post code2333RA
    B.5.3.4CountryNetherlands
    B.5.4Telephone number0031715265130
    B.5.6E-mailf.a.vuijk@lumc.nl
    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 No
    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 name18F-Fluciclatide
    D.3.2Product code Fluciclatide
    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 IMPIntravenous bolus use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNFLUCICLATIDE (18F)
    D.3.9.1CAS number Unknown
    D.3.9.2Current sponsor codeUnknown
    D.3.9.3Other descriptive name18F-Fluciclatide
    D.3.9.4EV Substance CodeSUB129452
    D.3.10 Strength
    D.3.10.1Concentration unit MBq megabecquerel(s)
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number300
    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 Yes
    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
    Patient suffering from colorectal or pancreatic adenocarcinoma.
    Patienten met een colorectaal of pancreas carcinoom.
    E.1.1.1Medical condition in easily understood language
    Patients suffering from colorectal and pancreatic cancer.
    Patienten met darm of alvleesklierkanker.
    E.1.1.2Therapeutic area Not possible to specify
    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
    Assess feasibility and sensitivity of imaging tumor angiogenesis in PDAC and colorectal adenocarcinoma, using 18F-Fluciclatide. When successful, the data of this study will allow for a larger trial.
    Evalueren van de toepasselijkheid en sensitiviteit van tumor angiogenese beeldvorming bij colorectaal en pancreas carcinoom patienten, door middel van 18F-Fluciclatide. Daarnaast zal de mogelijkheid tot tumor response bepaling worden onderzocht.
    E.2.2Secondary objectives of the trial
    To define the most optimal PET acquisition time interval after i.v. administration of 18F-Fluciclatide PET/CT;
    Assess the feasibility of monitoring tumor response after neoadjuvant therapy will be assessed.
    To validate 18F-Fluciclatide as a clinical marker of angiogenesis by immunohistochemistry assessment of angiogenesis in PDAC and colorectal adenocarcinoma resection specimens.
    Optimale tijd van acquisitie bepalen voor 18F-Fluciclatide.
    Evalueren of het monitoren van tumor response mogelijk is met 18F-Fluciclatide.
    Valideren van 18F-Fluciclatide als klinische marker van angiogenese door middel van immunohistochemie.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Biopsy proven primary colorectal adenocarcinoma or suspected pancreatic ductal adenocarcinoma, as agreed on by multidisciplinary team;
    No prior chemo(radio)therapy in rectal cancer patients.
    Patients treated in the LUMC.
    Before patient registration, written informed consent must be given according to ICH/GCP, and national/local regulations.
    Primair colorectaal adenocarcinoom of verdacht pancreas adenocarcinoom.
    Geen eerdere chemo(radio)therapie in rectum carcinoom patienten.
    Patient wordt behandeld in het LUMC.
    Voorafgaand aan patient registratie, informed consent moet getekend zijn zoals beschreven in ICH/GCP en nationale richtlijnen.
    E.4Principal exclusion criteria
    Contraindication for PET (pregnancy, breast-feeding and severe claustrophobia);
    Impaired renal function (creatinine clearance < 60 mL/min according to the Cockcroft-Gault equation or ureum < 2x ULN (Upper limit of normal);
    Impaired liver function (ALAT, ASAT > 3 ULN or total bilirubin >2x ULN);
    Known allergy to pABA (p-aminobenzoate sodium salt);
    Presence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule;
    Inability to tolerate lying supine for the duration of a PET/CT examination (~30min).
    Contraindicatie voor PET (zwanger, borstvoeding en ernstige claustrofobie).
    Slechte nierfunctie (kreatinine klaring <60 mL/min en ureum <2x upper limit of normal).
    Slechte leverfunctie (ALAT, ASAT >3x upper limit of normal of totaal bilirubine >2x upper limit of normal).
    Allergie voor pABA (p-aminobenzoate sodium salt)
    Psychologische, familiaire, sociologische of geografische conditie die mogelijk deelname aan studie kan verhinderen.
    Onvermogen om in rugligging te verkeren voor 30 minuten.
    E.5 End points
    E.5.1Primary end point(s)
    Sensitivity of 18F-Fluciclatide.
    Sensitiviteit van 18F-Fluciclatide.
    E.5.1.1Timepoint(s) of evaluation of this end point
    After first 5 patients and at the end of the trial.
    Na de eerste 5 patienten en aan het einde van de studie.
    E.5.2Secondary end point(s)
    Optimal time of acquisition
    Percentage difference in SUV before and after neoadjuvant treatment
    Immunohistochemical overlap with imaging findings.
    Optimale tijdpunt voor acquisitie.
    Percentage verschil in SUV voor en na neoadjuvante therapie
    Overlap van immunohistochemie en beeldvorming.
    E.5.2.1Timepoint(s) of evaluation of this end point
    End of trial.
    End of trial.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Yes
    E.6.2Prophylaxis No
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    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 No
    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.8.5The 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
    LVLS
    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 months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    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: 10
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    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 state20
    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)
    Normal treatment.
    Normale behandeling.
    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 Decision2019-03-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-03-21
    P. End of Trial
    P.End of Trial StatusOngoing
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