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    The EU Clinical Trials Register currently displays   43873   clinical trials with a EudraCT protocol, of which   7293   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:2019-004217-14
    Sponsor's Protocol Code Number:P21.128
    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:2022-08-06
    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 number2019-004217-14
    A.3Full title of the trial
    FLUOPANC-trial - Intraoperative near-infrared fluorescence imaging in pancreatic- and extrahepatic bile duct tumors using cRGD-ZW800-1 and dedicated imaging systems: A phase II feasibility, dose-ranging and optimal dose-(interval) selection trial
    FLUOPANC-trial - Onderzoek naar opsporen van alvleesklier- en galweg tumoren met cRGD-ZW800-1 en dedicated nabij-infrarode fluorescentie camera systemen: Een fase II feasability, dose-raning en optimale dosis bepaling trial
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Detecting pancreatic and bile duct cancer using tumor specific fluorescence imaging with cRGD-ZW800-1
    Opsporing van alvleesklier- en galwegkanker met tumor specifieke fluorescentie beeldvorming gebruik makend van cRGD-ZW800-1
    A.3.2Name or abbreviated title of the trial where available
    Fluorescence imaging of pancreatic and extrahepatic bile duct tumors using cRGD-ZW800-1
    Fluorescentie beeldvorming van alvleesklier- en extrahepatische galweg tumoren middels cRGD-ZW800-1
    A.4.1Sponsor's protocol code numberP21.128
    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 supportLeiden University Medical Center
    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 pointA.L. Vahrmeijer
    B.5.3 Address:
    B.5.3.1Street AddressAlbinusdreef 2
    B.5.3.2Town/ cityLeiden
    B.5.3.3Post code2333ZA
    B.5.3.4CountryNetherlands
    B.5.4Telephone number+31715262309
    B.5.6E-maila.l.vahrmeijer@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 namecRGD-ZW800-1
    D.3.2Product code cRGD-ZW800-1
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous bolus use (Noncurrent)
    Intravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNcRGD-ZW800-1
    D.3.9.3Other descriptive nameRPR109881
    D.3.9.4EV Substance CodeSUB22849
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.725
    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
    Pancreatic cancer (pancreatic carcinoma)
    Extrahepatic bile duct cancer (cholangiocarcinoma)
    Pancreascarcinoom
    Extrahepatisch cholangiocarcinoom
    E.1.1.1Medical condition in easily understood language
    Pancreatic cancer
    Bile duct cancer
    Alvleesklierkanker
    Galwegkanker
    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
    - To assess the feasibility, safety and tolerability of cRGD-ZW800-1 for visualization of (neoadjuvantly treated) pancreatic carcinomas, perihilar or distal cholangiocarcinomas and if present associated metastatic lymph nodes and their distant metastases using dedicated NIR fluorescence imaging systems.
    - Beoordelen van de haalbaarheid, veiligheid en verdraagbaarheid van cRGD-ZW800-1 voor visualisatie van (neoadjuvant behandelde) pancreascarcinomen, perihillaire of distale cholangiocarcinomen en indien aanwezig geassocieerde metastatische lymfeklieren en hun verre metastasen, gebruikmakend van specifieke NIR fluorescentie beeldvormingssystemen.
    E.2.2Secondary objectives of the trial
    - To define the optimal dose and dose interval of a single intravenous bolus injection of cRGD-ZW800-1.
    - Het bepalen van de optimale dosis en dosisinterval van een enkele intraveneuze bolusinjectie van cRGD-ZW800-1.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Patients > 18 years old;
    - Patients scheduled and eligible for open/robotic resection because of (histologically proven) pancreatic carcinoma with or without neoadjuvant treatment. As well as patients scheduled and eligible for resection because of (histologically proven) distal or perihilar cholangiocarcinoma with or without neoadjuvant treatment.
    - All women of childbearing potential and all males must practice effective contraception during the study and be willing and able to continue contraception for at least 30 days after their last dose of study treatment.
    - Patients should be capable and willing to give informed consent before study specific procedures;
    - Patiënten > 18 jaar;
    - Patiënten die gepland zijn en in aanmerking komen voor open/robotische resectie vanwege (histologisch bewezen) pancreascarcinoom met of zonder neoadjuvante behandeling. Evenals patiënten die gepland zijn en in aanmerking komen voor resectie vanwege (histologisch bewezen) distaal of perihilar cholangiocarcinoom met of zonder neoadjuvante behandeling.
    - Alle vrouwen in de vruchtbare leeftijd en alle mannen moeten effectieve anticonceptie toepassen tijdens de studie en bereid en in staat zijn om anticonceptie te blijven toepassen gedurende ten minste 30 dagen na de laatste dosis van de studiebehandeling.
    - Patiënten moeten in staat en bereid zijn om geïnformeerde toestemming te geven voor studiespecifieke procedures;
    E.4Principal exclusion criteria
    - History of a clinically significant allergy or anaphylactic reactions;
    - Patients with renal insufficiency (eGFR<60 ml/min/1,73 m2);
    - Patients with a previous kidney transplantation in the medical history;
    - Pregnant women, or women giving breast feeding;
    - Patients who are immunocompromised and do not have the ability to respond normally to an infection due to an impaired or weakened immune system, caused by either a pre-existing disease or concomitant medications (excluding intended neoadjuvant treatment);
    - Presence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial;
    - Any condition that the investigator considers to be potentially jeopardizing the patients well-being or the study objectives.
    - Voorgeschiedenis van een klinisch significante allergie of anafylactische reacties;
    - Patiënten met nierinsufficiëntie (eGFR<60 ml/min/1,73 m2);
    - Patiënten met een eerdere niertransplantatie in de medische voorgeschiedenis;
    - Zwangere vrouwen, of vrouwen die borstvoeding geven;
    - Patiënten die immuungecompromitteerd zijn en niet in staat zijn normaal te reageren op een infectie als gevolg van een verminderd of verzwakt immuunsysteem, veroorzaakt door hetzij een reeds bestaande ziekte of gelijktijdige medicatie (met uitzondering van geplande neoadjuvante behandeling);
    - de aanwezigheid van een psychologische, familiale, sociologische of geografische aandoening die de naleving van het onderzoeksprotocol en het follow-up-schema kan belemmeren; deze aandoeningen moeten met de patiënt worden besproken voordat hij/zij bij de proef wordt ingeschreven;
    - elke aandoening die volgens de onderzoeker het welzijn van de patiënt of de onderzoeksdoelstellingen in gevaar kan brengen.
    E.5 End points
    E.5.1Primary end point(s)
    Visualization of the primary tumor using cRGD-ZW800-1 and dedicated NIR-Fluorescence imaging system. Visualization is measured using the tumor-to-background ratio (TBR) in in-vivo and ex-vivo setting. A tumor-to-background ratio (TBR) of at least ≥1.5 provides sufficient contrast for adequate visualization/delineation and will therefore be used as cut-off value.
    Visualisatie van de primaire tumor met behulp van cRGD-ZW800-1 en een speciaal NIR-fluorescentiebeeldvormingssysteem. Visualisatie wordt gemeten met behulp van de tumor-to-background ratio (TBR) in in-vivo en ex-vivo setting. Een TBR van ten minste ≥ 1,5 biedt voldoende contrast voor adequate visualisatie/delineatie en zal daarom als afkapwaarde worden gebruikt.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Peri-operatively in-vivo/ex-vivo, post-operatively ex-vivo
    Peri-operatief in-vivo/ex-vivo, post-operatief ex-vivo
    E.5.2Secondary end point(s)
    - Number and grade of treatment-emergent (serious) adverse events ((S)AEs).
    - Concordance between clinical assessment, histopathologic examination and NIR-Fluorescence imaging assessment of the resected tumor, lymph nodes and/or metastatic lesions and their histopathologic result.
    - Define the optimal dose and dose interval of a single intravenous bolus injection of cRGD-ZW800-1. The optimal dose and ideal time window between administration of the study drug and intra-operative imaging during surgery will be assessed after all consecutive patients have been included, the endpoint for the combination of optimal dose and dose-interval is a tumor-to-background ratio of at least ≥1.5.
    - Tumor positive margins detected with NIR fluorescence imaging using cRGD-ZW800-1, referenced to histopathology.
    - Number of tumor-positive lymph nodes and metastases detected by NIR fluorescence imaging using cRGD-ZW800-1, referenced to histopathology.
    - Aantal en graad van behandelingsgerelateerde (ernstige) ongewenste voorvallen ((S)AE's).
    - Overeenstemming tussen klinische beoordeling, histopathologisch onderzoek en NIR-fluorescentie beeldvorming van de geresecteerde tumor, lymfeklieren en/of metastatische laesies en hun histopathologisch resultaat.
    - Bepaling van de optimale dosis en het dosisinterval van een enkele intraveneuze bolusinjectie van cRGD-ZW800-1. De optimale dosis en het ideale tijdsinterval tussen de toediening van het studiegeneesmiddel en de intraoperatieve beeldvorming tijdens de operatie zullen worden beoordeeld nadat alle opeenvolgende patiënten zijn geïncludeerd; het eindpunt voor de combinatie van optimale dosis en dosis-interval is een tumor/achtergrondratio van ten minste ≥1,5.
    - Tumorpositieve marges gedetecteerd met NIR-fluorescentiebeeldvorming met cRGD-ZW800-1, gerefereerd aan definitieve histopathologie uitslagen.
    - Aantal tumorpositieve lymfeklieren en metastasen die zijn opgespoord met NIR-fluorescentiebeeldvorming met gebruikmaking van cRGD-ZW800-1, in vergelijking met histopathologie.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Peri-operatively, post-operatively and at follow-up
    Per-operatief, postoperatief en gedurende follow-up
    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 Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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 trial1
    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 months6
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months6
    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 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 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)
    No specific plan, not different from the expected normal treatment
    Geen specifiek plan, niet verschillend van de verwachte 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 Decision2022-11-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-07-28
    P. End of Trial
    P.End of Trial StatusOngoing
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