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    Summary
    EudraCT Number:2017-000746-22
    Sponsor's Protocol Code Number:874-2017
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2017-03-09
    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 ConcernedDenmark - DHMA
    A.2EudraCT number2017-000746-22
    A.3Full title of the trial
    Vascular changes in basal cell carcinoma undergoing either electrochemotherapy or photodynamic therapy - assessed with optical coherence tomography
    Vaskulære ændringer i basalcellekræft under behandling med elektrokemoterapi eller fotodynamisk behandling vurderet med optisk kohærens tomografi.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Blood vessel changes in regular skin cancer undergoing either electrochemotherapy or photodynamic therapy assessed with optical coherence tomography
    Ændringer i blodkar i almindelig hudkræft under behandling med elektrokemoterapi eller fotodynamisk behandling vurderet med optisk kohærens tomografi.
    A.4.1Sponsor's protocol code number874-2017
    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 SponsorDepartment of Dermatology, Zealand University Hospital, Roskilde
    B.1.3.4CountryDenmark
    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 supportDepartment of Dermatology, Zealand University Hospital, Roskilde
    B.4.2CountryDenmark
    B.4.1Name of organisation providing supportDen Bøhmske Fond and Region Sjællands Sundhedsvidenskabelige Fond Zealand
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationDepartment of Dermatology, Zealand University Hospital, Roskilde
    B.5.2Functional name of contact pointDepartment
    B.5.3 Address:
    B.5.3.1Street AddressSygehusvej 5
    B.5.3.2Town/ cityRoskilde
    B.5.3.3Post code4000
    B.5.3.4CountryDenmark
    B.5.4Telephone number+4547322600
    B.5.5Fax number+4547322699
    B.5.6E-mailgbj@regionsjaelland.dk
    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 Bleomycin "Baxter"
    D.2.1.1.2Name of the Marketing Authorisation holderBaxter
    D.2.1.2Country which granted the Marketing AuthorisationDenmark
    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.3.4Pharmaceutical form Powder for solution for injection/infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntratumoral use
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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
    Basal cell carcinoma in adults
    Basalcellekræft hos voksne
    E.1.1.1Medical condition in easily understood language
    Regular skin cancer also called basal cell carcinoma
    Almindelig hudkræft, også kaldet basalcellekræft
    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
    The primary objective is to investigate the microvascular changes in BCC during non-surgical treatment using D-OCT. The principally different mechanisms of action with either MAL-PDT or electrochemotharpy will be compared to each other by means of D-OCT.
    Forsøget har til formal at undersøge behandlingseffekten på de mikroskopiske blodkar i basalcellekræft med ikke-kirurgisk behandling. Ændringerne i blodkarrenes struktur og tæthed anvendes til at vurdere, om man tidligere kan forudsige behandlingseffekten. To forskellige behandlinger evalueres. En konventionel, fotodynamisk terapi og én eksperimentel behandling, elektrokemoterapi med bleomycin.
    E.2.2Secondary objectives of the trial
    To assess any predictors in clinical outcome of BCC undergoing non-surgical therapy by means of using D-OCT, futhermore to evaluate the Quality of Life in patients undergoing these treatments.
    At vurdere eventuelle forudsigeligheder i klinisk effect af non-kirurgisk behandling af BCC ved hjælp af D-OCT samt livskvalitet før og efter behandling.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    General inclusion criteria:
    1. Patients must be mentally capable of understanding the information given.
    2. Patients must give written informed consent.
    3. Clinically diagnosed low-risk BCC on the trunk and ekstremities, diameter < 2 cm.
    4. Men or women aged at least 18 years.
    5. Cases reviewed by a dermatological specialist.
    6. ASA class I-III (Classification of the American Society of Anesthesiology)
    7. No prior history of sensitivity or allergies to the chosen treatment drug.
    8. Patients must initially agree to have a punhbiopsy performed at 1-year follow-up
    9. A female of non-childbearing potential: (i.e.i.e., physiologically incapable of becoming pregnant) is eligible in the study if she:
    • Has had a hysterectomy.
    • Has had a bilateral oophorectomy (ovariotomy).
    • Has had a bilateral tuba ligation.
    • Is post menopausalpost-menopausal:
    Post menopausalPost-menopausal definition: Patients not using hormone replacement must have experienced total cassation of menses for  one year and be greater than 45 years in age, or, in questionable cases have a follicle stimulation hormone (FSH) value  40 mIU/mL and an estradiol value  40 pg/mL (<140 pmol/L).

    Patients using Hormone Replacement Therapy must have experienced total cessation of menses > 1 year and be greater than 45 years of age or have had documented evidence of menopause based on FSH and estradiol concentrations prior to Hormone replacement therapy.
    10 A female of childbearing potential: is eligible in the study only if she has had a negative serum or urine pregnancy test within 2 weeks prior to the electroporation treatment.
    11 A woman of childbearing potential and men: Are eligible upon agreement to use adequate contraception since signing the informed consent form until at least 6 months after the last electroporation therapy cycle. The investigator or designated associate is requested to advise the patient how to achieve adequate birth control.
    Generelle inklusionskriterier:
    1. Patienterne skal være habile, dvs. i stand til at forstå den givne information.
    2. Patienterne skal give informeret skriftligt samtykke
    3. Det skal være klinisk diagnosticeret lav-risiko basalcellekræft på over- og underkrop, arme eller ben.
    4. Mænd og kvinder over 18 år.
    5. Patienterne skal være undersøgt af en speciallæge i dermatologi.
    6. ASA klasse I-III (Se vedhæftede beskrivelse af ASA-klasser)*
    7. Ingen tidligere overfølsomhed eller allergier over for den valgte behandling.
    8. Patienterne må initialt give samtykke til at få foretaget en hudbiopsi ved 1 års opfølgningen (samtykke til denne biopsi kan altid tilbagetrækkes senere af patienten).
    9. Kvinder, som ikke kan få børn (ikke er i stand til at blive gravide) er egnede til at indgå i studiet hvis mindst ét af følgende kriterier er opfyldt:
    - De har fået fjernet livmoderen
    - Har fået fjernet begge æggestokke
    - Er blevet steriliseret med overskæring eller klipsning af begge æggeledere.
    - Er gået i overgangsalderen
    10. Kvinder som kan få børn: er egnede til at indgå i studiet, hvis hun har fået en negativ graviditetstest målt i blodprøve eller urin inden for 2 uger før behandlingen.
    11. Kvinder som kan få børn og mænd: er egnede til at indgå i studiet, hvis mande går med til at beskytte sig mod graviditet i mindst 6 måneder efter behandlingen. Det er den forsøgsansvarliges ansvar at rådgive patienten omkring beskyttelse mod graviditet
    E.4Principal exclusion criteria
    Exclusion criteria for ECT-treatment
    1. Coagulation disorder or anticoagulant treatment with INR >1.5.
    2. Platelets <70000/mm3
    3. Cardiac history with manifest cardiac arrhythmia or previous cardiac events in patients with BCC on the anterior chest wall.
    4. Patients with ICD or pacemaker units with BCC on the anterior chest wall.
    5. Patients with epilepsy.
    6. Pregnancy or lactation/breastfeeding.
    7. Patients with known Hepatitis B/C or HIV infection.
    8. Concurrent treatment with an investigational medicinal product.
    9. Patients with any other clinical condition or prior therapy that, in the opinion of the investigator, would make the patient unsuitable for the study or unable to comply with the study recruitments.
    10. Patients with Contraindications for bleomycin:
    • Acute pulmonary infection.
    • Medical history of severe pulmonary disease.
    • Previous allergic reactions to bleomycin.
    • Previous cumulative dose of bleomycin exceeding 400 000 IU/m2.
    11. Patients registered in the Danish “Vævsanvendelsesregister”
    Specifikke eksklusionskriterier for elektrokemoterapi
    1. Sygdom eller tilstand, der forringer blodet evne til at størkne
    2. Sygehistorie med hjerterytmeforstyrrelse eller tidligere anfald af hjertesygdom hos patienter med basalcellekræft på forsiden af brystvæggen.
    3. Patienter med pacemaker* eller ICD (en anden type pacemaker) på forsiden af brystvæggen.
    4. Patienter med epilepsi.
    5. Gravide og ammende kvinder.
    6. Patienter med Hepatitis B/C eller HIV infektion.
    7. Patienter i behandling med anden medicin til klinisk afprøvning.
    8. Patienter som har andre nuværende eller tidligere sygdomme eller tilstande som efter forsøgsansvarliges vurdering gør, at patienten ikke kan deltage i studiet eller opfylde de krav, der stilles i studiet.
    9. Patienter med kontraindikationer til bleomycin, herunder:
    - Akut lungeinfektion
    - Sygehistorie med svær lungesygdom
    - Tidligere allergisk reaktion mod bleomycin
    - Tidligere total dosis af bleomycin over 400.000 enheder/m2
    10. Patienter, der er registreret i vævsanvendelsesregisteret
    E.5 End points
    E.5.1Primary end point(s)
    The primary objective is to investigate the microvascular changes in BCC during non-surgical treatment using D-OCT. The occlusion (diameter of the widest vessel at a given depth), reduction of the proportion of patent vessels at 0, 150, 300 and 500 micrometer depth will be assessed relative to pre-treatment and posttreatment levels according to visits.
    E.5.1.1Timepoint(s) of evaluation of this end point
    30 minuttes after treatment, 1 day, 1 week, 3 months and one year
    E.5.2Secondary end point(s)
    To assess any predictors (thickness, density, attenuation and vascular pattern) in clinical outcome of of BCC undergoing non-surgical therapy by means of using D-OCT.
    To evaluate the quality of life in patients undergoing these treatments by SCQoL.
    To evaluate hyperpigmentation as a side effect of bleomycin
    E.5.2.1Timepoint(s) of evaluation of this end point
    30 minuttes after treatment, 1 day, 1 week, 3 months and one year
    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 Yes
    E.6.4Safety No
    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 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) Yes
    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
    The last visit of the last subject undergoing the trial.
    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 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: 28
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 28
    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 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 state56
    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
    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 Decision2017-06-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-03-13
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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