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    Summary
    EudraCT Number:2019-004314-34
    Sponsor's Protocol Code Number:CaEP-R
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-01-21
    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 ConcernedGermany - BfArM
    A.2EudraCT number2019-004314-34
    A.3Full title of the trial
    PHASE II INVESTIGATION OF CALCIUM ELECTROPORATION AS A
    TREATMENT FOR CUTANEOUS AND SUBCUTANEOUS MALIGNANT TUMOURS
    Phase-II-Studie zur Calciumelektroporation als Behandlung von Haut – und Unterhautmetastasen
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    PHASE II INVESTIGATION OF CALCIUM ELECTROPORATION AS A
    TREATMENT FOR CUTANEOUS AND SUBCUTANEOUS MALIGNANT TUMOURS
    Phase-II-Studie zur Calciumelektroporation als Behandlung von Haut – und Unterhautmetastasen
    A.4.1Sponsor's protocol code numberCaEP-R
    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 SponsorJulie Gehl
    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 supportInterreg
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationRegion Zealand
    B.5.2Functional name of contact pointMille Vissing
    B.5.3 Address:
    B.5.3.1Street AddressSygehusvej 10
    B.5.3.2Town/ cityRoskilde
    B.5.3.3Post code4000
    B.5.3.4CountryDenmark
    B.5.6E-mailemlh@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 Calciumchlorid 5,5 % Baxter
    D.2.1.1.2Name of the Marketing Authorisation holderBaxter Deutschland GmbH
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntratumoral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCalcium chloride dihydrate
    D.3.9.3Other descriptive nameCalcium chloride
    D.3.9.4EV Substance CodeSUB12664MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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
    Cutaneous or subcutaneous malignant tumours
    Haut- oder Unterhautmetastasen
    E.1.1.1Medical condition in easily understood language
    Cutaneous or subcutaneous malignant tumours
    Haut- oder Unterhautmetastasen
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10026693
    E.1.2Term Malignant skin neoplasm NOS
    E.1.2System Organ Class 100000004864
    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 endpoint of this study is to evaluate the clinical overall
    response rate of calcium electroporation treatment of malignant tumours
    of the skin after two months. The evaluation will use the modified
    RECIST criteria, clinical examination with calliper measurement and
    photographical documentation using adhesive rulers for scale. Response
    rate will be definded as number of responding lesions (partial or
    complete response) relative to treated lesions.
    Der primäre Endpunkt dieser Studie ist die Beurteilung der
    Gesamtansprechrate der Calciumelektroporation als Therapie von
    malignen Haut- oder Unterhauttumoren nach 2 Monaten. Die Beurteilung
    erfolgt nach modifizierten RECIST-Kriterien, klinischer Untersuchung mit
    Ausmessen und Fotodokumentation mit Klebelineal als Maßstab. Die
    Ansprechrate ist definiert als Anzahl der ansprechenden Läsionen
    (Teiloder
    Vollremission) pro behandelte Läsionen.
    E.2.2Secondary objectives of the trial
    Secondary endpoints are to
    - Evaluate treatment response at month 1, 3, 4, 6 and 12 in addition to
    evaluating treatment response after 2 months.
    - Assess tumour and surrounding tissue response to treatment from
    biopsis of the treated area after 1 year.
    - Assess response after treatment on MRI scans on a subset of patients
    before and immediately after treatment, as well as after 2months.
    - Evaluate patient quality of life before treatment, after 2 months and
    after 1 year through.
    - EORTC questionnaires.
    - Qualitative interviews (subset of patients).
    - Investigate any sign of systemic immunogenic response from any
    routine scans before and after treatment in the inclusion period.
    - To list response rates and response duration according to tumours
    histology.
    - To determine complete and partial remissions for all tumours treated.
    - To determine rate of response for each individual patient.
    Sekundäre Endpunkte sind:
    - Zusätzliche Beurteilung des Therapieansprechens nach 1, 3, 4, 6 und 12
    Monaten
    - pathologische Begutachtung des Therapieansprechens von Tumor und
    umgebendem Gewebe nach 1 Jahr mittels Biopsie
    - Beurteilung des Therapieansprechens mittels MRT in einer Untergruppe
    von Patienten vor und unmittelbar nach Behandlung, sowie nach 2
    Monaten
    - Begutachtung der Lebensqualität vor Behandlung, nach 2 Monaten und
    nach 1 Jahr.
    - EORTC Fragebögen
    - Qualitative Interviews (einer Untergruppe)
    - Untersuchung nach Anzeichen von systemischem Immunansprechen
    innerhalb des regulären Re-Stagings vor und nach Behandlung im
    Rahmen der Studiendauer
    - Auflisten von Ansprechraten und Ansprechdauer entsprechend der
    Tumorhistologie
    - Bestimmung von vollständigem und teilweisem Ansprechen aller
    behandelten Läsionen
    - Bestimmung der Ansprechrate jeder/s einzelnen Patientin/en
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    CaEP-R-MRI:
    Asses response after treatment on MRI scans on a subset of patients
    before and immediately after treatment, as well as after 2 months.
    CaEP-R-QOL:
    Evaluate patient quality of life before treatment, after 2 months and
    after 1 year through
    - EORTC questionnaires
    - Qualitative interviews (in a subset of patients)
    CaEP-R-MRI:
    Beurteilung des Therapieansprechens mittels MRT in einer Untergruppe
    von Patienten vor und unmittelbar nach Behandlung, sowie nach 2
    Monaten.
    CaEP-R-QOL:
    Begutachtung der Lebensqualität vor Behandlung, nach 2 Monaten und
    nach 1 Jahr.
    - EORTC Fragebögen
    - Qualitative Interviews (einer Untergruppe)
    E.3Principal inclusion criteria
    • Trial subject ≥ 18 years.
    • Trial subject must be able to understand the participant information.
    • Histologically verified cutaneous or subcutaneous, primary or
    secondary cancer of any histology.
    • The patient must have been offered other relevant standard treatment
    for their cancer disease.
    • The patient can undergo any simultaneous medical treatment
    (endocrine therapy, chemotherapy, immunotherapy etc.) if progressive
    or stable disease is present after a treatment period of two months or
    more.
    • The patient can undergo radiation therapy, provided that the treatment
    field does not involve treated area.
    • Performance status ECOG/WHO ≤2.
    • At least one cutaneous or subcutaneous tumour measuring up to 3 cm.
    • Both men and women who are sexually active must use safe
    contraception (contraceptive coil, deposit injection of gestagen,
    subdermal implantation, hormonal vaginal ring or transdermal patch).
    • Signed informed consent.
    - Alter ≥ 18 Jahre
    - Die/Der Teilnehmer/in muss in die Patienteninformation verstehen
    - histologisch bestätigte Haut- oder Unterhautmetastase jeden
    Primärtumors
    - Der/Dem Teilnehmer/in muss die Standardtherapie angeboten worden
    sein
    - Die/Der Teilnehmer/in kann gleichzeitig jedwede andere Therapie
    erhalten (endokrine Therapie, Chemotherapie, Immuntherapie, etc.) und
    nach mindestens 2 Monaten der laufenden Therapie muss eine stabile
    oder progrediente Erkrankung vorliegen.
    - eine Strahlentherapie ist zulässig, solange die behandelte Läsion
    außerhalb des bestrahlten Bereichs liegt
    - ECOG Performance Status ≤ 2
    - mindestens eine Haut- oder Unterhautmetastase von bis zu 3 cm Größe
    - Gewährleistung einer sicheren Verhütungsmethode von Männer und
    Frauen, die sexuell aktiv sind (Spirale, Depot-Gestagen, Implantation,
    hormoneller Vaginalring oder Hormonpflaster).
    - unterschriebene Einverständniserklärung
    E.4Principal exclusion criteria
    - Pregnancy or lactation
    - Schwangerschaft und Stillzeit
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint of this study is to evaluate the clinical overall
    response rate of calcium electroporation treatment of malignant tumours
    of the skin after two months. The evaluation will use the modified
    RECIST criteria, clinical examination with calliper measurement and
    photographical documentation using adhesive rulers for scale. Response
    rate will be defined as number of responding lesions (partial or complete
    response) relative to treated lesions.
    Der primäre Endpunkt dieser Studie ist die Beurteilung der
    Gesamtansprechrate der Calciumelektroporation als Therapie von
    malignen Haut- oder Unterhauttumoren nach 2 Monaten. Die Beurteilung
    erfolgt nach modifizierten RECIST-Kriterien, klinischer Untersuchung mit
    Ausmessen und Fotodokumentation mit Klebelineal als Maßstab. Die
    Ansprechrate ist definiert als Anzahl der ansprechenden Läsionen (Teiloder
    Vollremission) pro behandelte Läsionen.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Evaluating treatment response after 2 months.
    Beurteilung des Therapieansprechens nach 2 Monaten.
    E.5.2Secondary end point(s)
    Secondary endpoints are to
    - Evaluate treatment response at month 1, 3, 4, 6 and 12 in addition to
    evaluating treatment response after 2 months.
    - Assess tumour and surrounding tissue response to treatment from
    biopsis of the treated area after 1 year.
    - Assess response after treatment on MRI scans on a subset of patients
    before and immediately after treatment, as well as after 2months.
    - Evaluate patient quality of life before treatment, after 2 months and
    after 1 year through.
    - EORTC questionnaires.
    - Qualitative interviews (subset of patients).
    - Investigate any sign of systemic immunogenic response from any
    routine scans before and after treatment in the inclusion period.
    - To list response rates and response duration according to tumours
    histology.
    - To determine complete and partial remissions for all tumours treated.
    - To determine rate of response for each individual patient.
    - To investigate response (overall, as well as complete and partial)
    depending whether the treated tumour was in a previously irradiated
    area.
    - To measure current during treatment as measured by the pulse
    generator.
    Sekundäre Endpunkte sind:
    - Zusätzliche Beurteilung des Therapieansprechens nach 1, 3, 4, 6 und 12
    Monaten
    - pathologische Begutachtung des Therapieansprechens von Tumor und
    umgebendem Gewebe nach 1 Jahr mittels Biopsie - Beurteilung des
    Therapieansprechens mittels MRT in einer Untergruppe
    von Patienten vor und unmittelbar nach Behandlung, sowie nach 2
    Monaten
    - Begutachtung der Lebensqualität vor Behandlung, nach 2 Monaten und
    nach 1 Jahr.
    - EORTC Fragebögen
    - Qualitative Interviews (einer Untergruppe)
    - Untersuchung nach Anzeichen von systemischem Immunansprechen
    innerhalb des regulären Re-Stagings vor und nach Behandlung im
    Rahmen der Studiendauer
    - Auflisten von Ansprechraten und Ansprechdauer entsprechend der
    Tumorhistologie
    - Bestimmung von vollständigem und teilweisem Ansprechen aller
    behandelten Läsionen
    - Bestimmung der Ansprechrate jeder/s einzelnen Patientin/en
    - Untersuchung des Ansprechens (Gesamtansprechen, sowie
    vollständiges und teilweises Ansprechen) in Abhängigkeit von
    Lokalisation innerhalb eines vorbestrahlten Areals.
    - Messung des geflossenen Stroms während der Behandlung mithilfe des
    Pulsgenerators.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Evaluate treatment response at month 1, 3, 4, 6 and 12 in addition to
    evaluating treatment response after 2 months.
    Beurteilung des Therapieansprechens nach Monat 1, 3, 4, 6 und 12 zusätzlich zur Beurteilung nach 2 Monaten.
    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 No
    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.8.3 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.8.4.1Number of sites anticipated in Member State concerned1
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA3
    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 trial is planned to end August 1, 2022.
    geplantes Ende der Studie am 01. August 2022.
    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 months6
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    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: 15
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 15
    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 state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 30
    F.4.2.2In the whole clinical trial 30
    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.
    keine
    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 Decision2021-04-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-06-30
    P. End of Trial
    P.End of Trial StatusOngoing
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