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    Summary
    EudraCT Number:2016-002827-27
    Sponsor's Protocol Code Number:EMI-137-CRC-001
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2016-10-26
    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 number2016-002827-27
    A.3Full title of the trial
    A Phase IIb, Open Label Study for the Detection of Dysplastic Colorectal Polyps during Colonoscopy after EMI-137 Injection in Patients with High Suspicion of Colorectal Cancer.
    Fase IIb, open studie voor de detectie van dysplastische, colorectale poliepen tijdens colonoscopie na EMI-137 injectie in patienten verhoogde verdenking van colorectaal kanker.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    fluorescence assisted colonoscopy for detection of bowel polyps
    fluorescentie-geassisteerde colonoscopie voor detectie van darmpoliepen.
    A.3.2Name or abbreviated title of the trial where available
    EMI-137 for detection of dysplastic colorectal polyps
    EMI-137 voor detectie van dysplastische, colorectale poliepen.
    A.4.1Sponsor's protocol code numberEMI-137-CRC-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 SponsorEdinburgh Molecular Imaging Ltd.
    B.1.3.4CountryUnited Kingdom
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportEdinburgh Molecular Imaging Ltd.
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCHDR
    B.5.2Functional name of contact pointJ. Burggraaf
    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+31715246400
    B.5.5Fax number+31715246499
    B.5.6E-mailclintrials@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.3.1Product nameEMI-137
    D.3.2Product code EMI-137
    D.3.4Pharmaceutical form Powder 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 INNEMI-137
    D.3.9.1CAS number N.A.
    D.3.9.2Current sponsor codeEMI-137
    D.3.9.3Other descriptive nameAH112543 ammonium acetate salt
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number4.8
    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 Yes
    D.3.11.13.1Other medicinal product typeoptical imaging agent
    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
    Dysplastic Colorectal Polyps
    Dysplastische colorectale poliepen.
    E.1.1.1Medical condition in easily understood language
    Colorectal cancer
    Colorectaal carcinoom
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level SOC
    E.1.2Classification code 10029104
    E.1.2Term Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    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
    To assess the efficacy of 0.13mg/kg EMI-137 IV injection to detect lesions during colonoscopy, in subjects at high suspicion of developing colorectal cancer by:
    - Comparing the number of pathological lesions detected with WL with the number of lesions detected with WL+FL
    - Investigating the concordance of fluorescence intensity, C-Met expression and histologic status.
    - Establishing target to background ratio (TBR) of fluorescent lesions.
    Om de effectiviteit van 0.13mg beoordelen / kg EMI-137 IV injectie laesies tijdens colonoscopie bij patiënten met een hoog risico op colorectale kanker door:
    • Vergelijking van het aantal pathologische laesies gevonden met wit licht, met het aantal laesies gevonden met wit licht en fluorescent licht.
    • Overeenstemming van de fluorescentie (intensiteit) met histologische status (maligne/non maligne) en met c-MET expressie.
    • Laesie-achtergrond ratios vaststellen van fluorescerende laesies.
    E.2.2Secondary objectives of the trial
    • To assess the safety and tolerability of 0.13mg/kg EMI-137 iv injection;
    • To assess the practical application of the technique, eg.
    - Ease of use of the SurgVision Explorer Endoscope camera system (SVEE);
    - Ease of use of EMI-137 for injection;
    • To assess the tissue pharmacokinetics of a single IV injection of 0.13mg/kg EMI-137 by in vivo quantification of fluorescence signals in polyps and normal tissue by spectroscopy;
    • To assess the optimal time window between dose administration and fluorescence imaging (stage 1);
    • To assess c-MET expression and fluorescence on fluorescence microscopy in biopsied lesions.
    • Om de veiligheid en verdraagbaarheid van 0.13mg beoordelen / kg EMI-137 iv injectie;
    • Om de praktische toepassing van de techniek te beoordelen, bijv.
    - Gebruiksgemak van de SurgVision Explorer Endoscope camera system (SVEE);
    - Gebruiksgemak van EMI-137 voor injectie;
    • Om de weefsel farmacokinetiek van een enkele IV injectie van 0.13mg/kg EMI-137 te beoordelen door in vivo kwantificering van fluorescentie signalen in poliepen en normaal weefsel door spectroscopie;
    • Om het optimale tijdvenster tussen toediening en fluorescentie beeldvorming te beoordelen (stage 1);
    • Om c-MET expressie en fluorescentie op fluorescentiemicroscopie te beoordelen biopsie laesies.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Stage 1: The SVEE will be used in the first part of the study (15 patients) to assess for optimal time window and feasibility of the Surgvision colonoscope (as described in the secondary objectives)
    Stage 1: De SVEE zal worden gebruikt in een sub-studie, voor beoordeling van het optimale tijdsraam en de werkbaarheid van meerdere colonoscopen met het product.
    E.3Principal inclusion criteria
    1. Signed informed consent prior to any study-mandated procedure;
    2. Healthy male or female subjects aged 18 years or older;
    3. Female subjects need to be either surgically sterile (has had a documented bilateral
    oophorectomy and/or documented hysterectomy), post-menopausal (cessation of
    menses for more than 1 year), or pre-menopausal with a negative urine pregnancy test
    performed at screening and a negative urine pregnancy test performed within 24 hours
    of administration of EMI-137 Injection. Pre-menopausal female subjects should also
    employ an effective method of birth control up to 90 days after EMI-137 administration. Barrier contraceptives must be used throughout the study in both sexes.
    4. The subject has a positive FOB test or clinical suspicion on colorectal cancer and is scheduled to undergo a colonoscopy.
    5. The subject has a normal or clinically acceptable medical history, physical examination,
    and vital signs findings at screening (within 21 days prior to administration of study
    drug).
    6. The subject’s screening ECG and clinical laboratory tests are within normal limits, or if
    any are outside of normal limits they are considered to be clinically insignificant.
    1. Getekend informed consent voorafgaand aan een studie in opdracht procedure;
    2. Gezonde mannelijke of vrouwelijke patiënten van 18 jaar of ouder;
    3. Vrouwelijke proefpersonen nodig ofwel chirurgisch steriel zijn (heeft een gedocumenteerde bilaterale
    ovariëctomie en / of gedocumenteerde hysterectomie), post-menopauze (stopzetting van de
    menses langer dan 1 jaar), of pre-menopauze met een negatieve urine zwangerschapstest
    uitgevoerd bij screening en een negatieve urine zwangerschapstest uitgevoerd binnen 24 uur
    van toediening van EMI-137 Injection. Pre-menopausale vrouwelijke proefpersonen moet ook
    gebruik van een effectieve methode van anticonceptie tot 90 dagen na de EMI-137 administratie. Barriere anticonceptiva moeten gedurende de hele studie in beide geslachten worden gebruikt.
    4. Het onderwerp heeft een positieve FOB-test of een klinische verdenking op colorectale kanker en is gepland voor het ondergaan van een colonoscopie.
    5. De patient heeft een normale of klinisch aanvaardbare medische anamnese, lichamelijk onderzoek,
    en vitale parameters bij inclusie (binnen 21 dagen voorafgaande aan toediening van het studiemedicijn).
    6. Screening ECG en klinische laboratoriumtesten Het onderwerp zijn binnen de normale grenzen, of als
    ieder zijn buiten de normale grenzen zij worden beschouwd als klinisch significant te zijn.
    E.4Principal exclusion criteria
    1. If female, the subject is lactating or pregnant.
    2. The subject is being treated or has been treated with chemotherapy or radiation within the 3 months before enrolment.
    3. A biopsy has been obtained from the colon within the 3 weeks before enrolment.
    4. The subject has been previously included in this study.
    5. Treatment with another IMP within 3 months prior to screening or more than 4 times in
    the past year.
    6. Loss of blood outside the limits of Sanquin within 3 months prior to screening.
    7. The subject has had any significant change in their regular prescription or non-prescription medication between 14 days and 1 day prior to EMI-137 administration.
    8. The subject has a history of alcohol and/or drug abuse within the previous 12 months, based on a review of medical records.
    1. Indien vrouwelijk: als de patient borstvoeding geeft of zwanger is.
    2. De patient is onder behandeling met chemotherapie of radiotherapie, of is dit geweest in de afgelopen 3 maanden.
    3. Er is in de afgelopen 3 weken een biopt genomen van het colon.
    4. De patient is eerder geincludeerd geweest in deze studie
    5. Behandeling met een ander IMP binnen 3 maanden voor de screening of meer dan 4 keer in het afgelopen jaar.
    6. Bloedverlies of donatie buiten de limieten van sanquin, binnen 3 maanden voor de screening.
    7. De patient heeft een significante verandering in zijn reguliere medicatie gehad binnen 14 dagen voor EMI-137 toediening
    8. De patient heeft een geschiedenis van alcohol en/of drugs misbruik binnen 12 maanden voorafgaand aan de studie
    E.5 End points
    E.5.1Primary end point(s)
    Efficacy
    - Detection of additional pathological lesions using WL+ FL compared to WL only
    - Fluorescence signal of lesions
    - TBR signal, defined as fluorescent signal of the lesion compared to fluorescence signal
    of tissue surrounding the lesion
    - Concordance between fluorescence, tumor status and C-Met expression.
    Werkzaamheid
    - Aantal laesies gevonden in FL + WL colonoscopie vergelijking met alleen WL
    - Fluorescentiesignaal van gevonden laesies.
    - TBR signaal, gedefinieerd als fluorescerend signaal van de laesie ten opzichte fluorescentiesignaal
    van weefsel rondom de laesie
    - Overeenstemming tussen fluorescentie met tumorstatus en C-met expressie.
    E.5.1.1Timepoint(s) of evaluation of this end point
    - Interim analysis: after 15 colonoscopies in stage 2
    - End of study.
    - Interim analyse na inclusie van 15 patienten in fase 2
    - Na afloop van de studie
    E.5.2Secondary end point(s)
    Safety and tolerability endpoints
    - Treatment-emergent (serious) adverse events ((S)AEs).
    - Concomitant medication
    - Clinical laboratory tests
    o Haematology
    o Chemistry
    o Urinalysis
    - Vital signs
    o Pulse Rate (bpm)
    o Systolic blood pressure (mmHg)
    o Diastolic blood pressure (mmHg)
    o Body temperature ( ̊C )
    - Presence of injection site reactions

    Pharmacokinetic endpoints
    Pharmacokinetics will be assessed by a single, in vivo, spectroscopy derived, quantitative measurement of the lesion (target) and normal bowel tissue (background). These parameters will later be converted to a target to background ratio.
    Eindpunten voor veiligheid en verdraagbaarheid
    - Behandeling-gerelateerde (ernstige) bijwerkingen ((S) AE's).
    - Gelijktijdige medicatie
    - Klinische laboratoriumtests
    o Hematologie
    o Chemie
    o Urinalyse
    - Vitale parameters
    o Hartfrequentie (bpm)
    o Systolische bloeddruk (mmHg)
    o Diastolische bloeddruk (mmHg)
    o Lichaamstemperatuur (̊C)
    - Aanwezigheid van reacties op de injectieplaats

    Farmacokinetische eindpunten
    De farmacokinetiek zal worden beoordeeld aan de hand van een enkele, in vivo, spectroscopische, kwantitatieve meting van de laesie (target) en het normale darmweefsel (background). Deze parameters worden later geconverteerd naar een target to background ratio.
    E.5.2.1Timepoint(s) of evaluation of this end point
    In-study analysis of optimal time-window after inclusion of 15 patients, other outcomes: after end of study
    In-studie analyse van de optimale tijd-venster na het opnemen van 15 patiënten. Ander uitkomsten: end of study
    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 Yes
    E.6.7Pharmacodynamic No
    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 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
    Fluorescent licht
    Fluorescent light
    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 concerned2
    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 follow-up moment van de laatste patient.
    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 days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months6
    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: 200
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 200
    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 Yes
    F.3.3.7.1Details of other specific vulnerable populations
    Elderly
    Ouderen
    F.4 Planned number of subjects to be included
    F.4.1In the member state200
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 200
    F.4.2.2In the whole clinical trial 200
    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)
    Follow-up phonecall
    Follow-up telefoontje
    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 Decision2016-10-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-12-16
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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