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    Summary
    EudraCT Number:2013-004089-33
    Sponsor's Protocol Code Number:CHDR1317
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2013-10-18
    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 number2013-004089-33
    A.3Full title of the trial
    A Phase 1, Open Label, Exploratory Study for the Intra-operative Imaging of Folate Receptor Alpha Positive Ovarian and Lung Cancer using the Tumor Specific Imaging Agent EC17
    Een fase 1, open label, verkennende studie naar de intraoperatieve beeldvorming van folaat receptor alpha positieve ovarium en long tumoren met behulp van het tumor-specifieke contrastmiddel EC17
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Detection of ovarian and lung cancer during an operation with the fluorescent agent 'EC17'
    Onderzoek naar het opsporen van eierstok- en longkanker tijdens een operatie met de fluorescente stof ‘EC17’
    A.4.1Sponsor's protocol code numberCHDR1317
    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 SponsorCentre for Human Drug Research
    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 supportOn Target Laboratories, LLC
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCentre for Human Drug Research
    B.5.2Functional name of contact pointRecruitment
    B.5.3 Address:
    B.5.3.1Street AddressZernikedreef 8
    B.5.3.2Town/ cityLeiden
    B.5.3.3Post code2333 CL
    B.5.3.4CountryNetherlands
    B.5.4Telephone number+31(0)71524 64 00
    B.5.5Fax number+31(0)71524 64 99
    B.5.6E-mailrecruit@chdr.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.3.2Product code EC17
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNn.a.
    D.3.9.1CAS number n.a.
    D.3.9.2Current sponsor codeEC17
    D.3.9.3Other descriptive nameFolate-5-fluorescein isothiocyanate
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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
    primary ovarian carcinoma and primary non small cell lung carcinoma
    primair ovarium carcinoom en primair niet kleincellig long carcinoom
    E.1.1.1Medical condition in easily understood language
    ovarian cancer and lung cancer
    eierstokkanker en longkanker
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04]
    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 safety of a single dose of intravenous EC17 injection in patients with ovarian or lung cancer.

    To assess concordance of fluorescent signal and tumor status of resected tissue.
    Om de veiligheid van een enkele dosis intraveneuze injectie EC17 bij patiënten met eierstokkanker of longkanker beoordelen.

    Om overeenstemming van het fluorescente signaal en de tumorstatus van het operatief verwijderd weefsel te beoordelen.
    E.2.2Secondary objectives of the trial
    To assess the efficacy of EC17 for the intra-operative detection of FR-a positive ovarian or lung cancer.

    Feasibility to detect tumor positive resection margins with intra-operative fluorescence imaging.
    Om de werkzaamheid van EC17 bepalen bij het intra-operatief detecteren van FR-a positieve ovarium-of longkanker.

    Haalbaarheid om positieve resectie marges van tumoren te detecteren met intra-operatieve fluorescentie beeldvorming.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    General Inclusion Criteria
    1. Subjects 18 years of age and older
    2. Normal and clinically acceptable medical history, medical physical examination and vital signs at screening
    3. Patients are clinically fit for surgery
    4. Absence of anaphylactic reactions to EC17 or insects or allergy to fluorescein
    5. No pregnancy, excluded by pregnancy test
    6. The patients screening ECG and clinical laboratory test results are within normal range or are clinically insignificant
    7. Absence 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
    8. Before patient registration, written informed consent must be given
    9. No impaired renal or liver function. Impaired renal function defined as eGFR<50 and impaired liver function defined as evidenced by greater than 3x the upper limit of normal (ULN) for ALT, AST, or total bilirubin.

    Lung Cancer Specific Inclusion Criteria
    1. Primary diagnosis of primary NSCLC lung cancer with FR-a positive tumor proven by biopsy planned for surgery
    2. No previous thorax surgery, except for mediastinoscopy
    3. No previous radiation therapy for lung cancer

    Ovarian Cancer Specific Inclusion Criterium
    1. Known or high clinical suspicion of primary ovarian cancer planned for either primary debulking surgery , intervaldebulking or staging procedure
    Algemene Inclusie Criteria
    1. Proefpersonen van 18 jaar en ouder
    2. Normale en klinisch aanvaardbare medische voorgeschiedenis, lichamelijk onderzoek en de vitale functies bij de screening
    3. Patiënten zijn klinisch geschikt voor chirurgie
    4. Afwezigheid van anafylactische reacties op EC17 of insecten of allergie voor fluoresceïne
    5. Geen zwangerschap, uitgesloten d.m.v. zwangerschapstest
    6. Bij screening normale of klinisch niet significant afwijkende ECG en klinisch laboratorium testresultaten
    7. Ontbreken van een psychologische, familiale, sociologische of geografische toestand die naleving van het onderzoeksprotocol en het follow-up schema potentieel belemmeren; deze voorwaarden moeten met de patiënt worden besproken vóór de inclusie
    8. Vóór de inclusie van de patiënt, moet schriftelijk toestemming worden gegeven
    9. Geen verminderde nier-of leverfunctie. Verminderde nierfunctie gedefinieerd als eGFR <50 en een gestoorde leverfunctie gedefinieerd, als meer dan 3x de bovengrens van normaal (ULN) voor ALT, AST, of totaal bilirubine.

    Longkanker Specifieke Inclusie Criteria
    1. Primaire diagnose van de primaire NSCLC longkanker met FR-a positieve tumor bewezen door biopsie gepland voor een operatie
    2. Geen eerdere thorax chirurgie, behalve mediastinoscopie
    3. Geen eerdere radiotherapie voor longkanker

    Eierstokkanker Specifieke Inclusie Criterium
    1. Bevestigde of hoge klinische verdenking op primaire eierstokkanker gepland voor zowel primaire debulking chirurgie, intervaldebulking of stagerings procedure
    E.4Principal exclusion criteria
    1. Any condition that in the opinion of the investigators could potentially jeopardize the health status of the patient
    1. Een aandoening die naar de mening van de onderzoekers potentieel de gezondheidstoestand van de patiënt in gevaar zou kunnen brengen
    E.5 End points
    E.5.1Primary end point(s)
    1. Concordance rate of at least 80% between the pathology results and the imaging assessment

    2. Safety: TEAE’ using MedDRA for the administration of EC17 during the study period (cycle of 14 days), and relevant changes in serum biochemistry, vital signs, injection site status and general physical examination.
    1. Overeenstemming van ten minste 80% tussen de pathologieresultaten en beeldvormend onderzoek met fluorescentie

    2. Veiligheid: TEAE 'met MedDRA voor het toedienen van EC17 tijdens de studie periode (cyclus van 14 dagen), en relevante veranderingen in serum biochemie, vitale functies, injectieplaats status en algemeen lichamelijk onderzoek.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Endpoint 1: From administration up to 14 days post dose

    Endpoint 2: From predose to infinity
    Eindpunt 1: Van toediening tot 14 dagen na dosering


    Eindpunt 2: Van predosis tot oneindig
    E.5.2Secondary end point(s)
    1. TBR signal, defined as fluorescent signal of tumor tissue compared to fluorescence signal of tissue surrounding the tumor.

    2. Number and location of FR-a+, cancer+ tumor lesions identified under normal light only, under both normal light and fluorescent light, and under fluorescent light only.

    3. Pharmacokinetics: Cmax, T½, AUC, Tmax, Clearance
    1. TBR signaal gedefinieerd als fluorescentiesignaal van tumorweefsel vergeleken met fluorescentiesignaal van weefsel rond de tumor.

    2. Aantal en de locatie van de FR-a +​​, kanker + tumorlaesies geïdentificeerd onder normaal licht alleen, zowel onder normaal licht en fluorescent licht, en alleen onder fluorescent licht.

    3. Farmacokinetiek: Cmax, T ½, AUC, Tmax, Clearance
    E.5.2.1Timepoint(s) of evaluation of this end point
    Endpoint 1 & 2: From start to end of surgical procedure

    Endpoint 3: From predose up to 24 hours post dose
    Eindpunt 1 & 2: Van begin tot einde van de chirurgische ingreep

    Eindpunt 3: Van predosis tot 24 uur na toediening
    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 No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    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) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    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
    Laatste bezoek van de laatste patient
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months
    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: 60
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 60
    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 state60
    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)
    None
    Geen
    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 Decision2013-10-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-11-26
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-04-01
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