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    Summary
    EudraCT Number:2012-005704-17
    Sponsor's Protocol Code Number:AA1232
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2013-03-27
    Trial results View 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 number2012-005704-17
    A.3Full title of the trial
    Calcium electroporation for the treatment of cutaneous metastases.
    Calcium elektroporation til behandling af kutane metastaser.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Calcium electroporation for the treatment of cutaneous metastases.
    Calcium elektroporation til behandling af kutane metastaser.
    A.4.1Sponsor's protocol code numberAA1232
    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 supportDepartment of Oncology, Herlev Hospital
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationDepartment of Oncology, Herlev Hospital
    B.5.2Functional name of contact pointDepartment of Oncology, Herlev Hosp
    B.5.3 Address:
    B.5.3.1Street AddressHerlev Ringvej 75
    B.5.3.2Town/ cityHerlev
    B.5.3.3Post code2730
    B.5.3.4CountryDenmark
    B.5.4Telephone number004538683868
    B.5.6E-mailjulie.gehl@regionh.dk
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleComparator
    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 Calcium-sandoz and Calciumchlorid SAD
    D.2.1.1.2Name of the Marketing Authorisation holderSandoz A/S and Amgros I/S
    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 Solution for injection/infusion
    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 Gluconate
    D.3.9.3Other descriptive nameCALCIUM GLUCONATE, ANHYDROUS
    D.3.9.4EV Substance CodeSUB45927
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number9
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCalcium Chloride
    D.3.9.3Other descriptive nameCALCIUM CHLORIDE DIHYDRATE
    D.3.9.4EV Substance CodeSUB12664MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number9
    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.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    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 A/S
    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 infusion
    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 INNBLEOMYCIN SULFATE
    D.3.9.1CAS number 9041-93-4
    D.3.9.4EV Substance CodeSUB00844MIG
    D.3.10 Strength
    D.3.10.1Concentration unit IU international unit(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number15.000
    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
    Patients suffering from advanced cancer with cutaneous metastases.

    patienter med dissemineret kræftsygdom med spredning til huden.

    E.1.1.1Medical condition in easily understood language
    Patients suffering from advanced cancer with cutaneous metastases.

    Kræftsygdom med spredning til huden.

    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.0
    E.1.2Level LLT
    E.1.2Classification code 10040892
    E.1.2Term Skin metastases
    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
    Evaluate tumorrespons of calcium elctroporation and eletrochemotherapy with intratumoral bleomycin on cutaneous metastases, and compare the effect of the two treatments.
    Evaluere respons af calcium elektroporation og elektrokemoterapi med intratumoral bleomycin på kutane metastaser og sammenligne effekten af de to behandlinger.
    E.2.2Secondary objectives of the trial
    1. Describe advers events of calcium electroporation using Common Terminology for Adverse Events, version 4.0.

    2. Evaluate whether calcium affect the current intensity by electroporation treatments.
    1. Registrere bivirkninger til calcium elektroporation vha. Common Terminology for Adverse Events, version 4.0.

    2. Vurdere om calcium påvirker strømstyrken ved elektroporationsbehandlinger.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Age > 18 years
    2. Patients should understand participants information.
    3. Histologically confirmed cutaneous metastases of any histology.
    4. At least 1. cutaneous metastases, between 0,5 to 3 cm, available to electroporation.
    5. Patient should have been offered standard treatment.
    6. At least 2 weeks since chemotherapy or radiotherapy.
    7. performance status < 2 (ECOG)
    8. Life expectancy >3 months
    9. platelet count >50 mia/l, INR<1,2
    10. Men and women of reproductive age must use effective contraception during the study.
    11. Signed informed consent.

    1. Forsøgsperson ≥ 18 år.
    2. Forsøgspersonen skal kunne forstå deltagerinformationen.
    3. Diagnosen kutane metastaser fra histologisk verificeret cancer af enhver histologi.
    4. Mindst 1 kutan læsion mellem 0,5-3 cm, tilgængelig for elektroporation.
    5. Patienten skal have fået tilbudt gældende standard behandling.
    6. Eventuel kemoterapi eller stråleterapi afsluttet for mindst 2 uger siden.
    7. ECOG performancestatus ≤2.
    8. Forventet restlevetid ≥ 3 måneder.
    9. Trombocytter ≥ 50 mia/l, pp ≥ 40. Medicinsk korrektion er tilladt, f.eks. korrektion af lav pp ved hjælp af K-vitamin.
    10. Både mænd og kvinder, som er seksuelt aktive, skal anvende sikker kontraception
    11. Underskrevet informeret samtykke før inklusion.

    E.4Principal exclusion criteria
    1. previously treatment with bleomycin > 200.000 Units/m2
    2. Allergy to bleomycin.
    3. Clinically significant coagulopathy.
    4. Pregnancy or lactation.
    5. Participation in other clinical trial involving experimental drugs or participation in a clinical trial within 4 weeks before study treatment.

    1. Tidligere bleomycin behandling med over 200.000 Units/m2.
    2. Tidligere alvorlige allergiske reaktioner i forbindelse med bleomycin.
    3. Koagulationsforstyrrelse som ikke kan korrigeres.
    4. Graviditet eller laktation
    5. Samtidig deltagelse i andre kliniske forsøg, som involverer forsøgsmedicin eller har deltaget i et forsøg inden for 4 uger før administration af forsøgsmedicinen.

    E.5 End points
    E.5.1Primary end point(s)
    Evaluate tumorresponse of calcium electroporation and electrochemotherapy with intratumoral bleomycin on cutaneous metastases using RECIST 1.1 -like criteria and compare the effect of the two treatments
    Evaluere respons af calcium elektroporation og elektrokemoterapi med intratumoral bleomycin på kutane metastaser v.hj.a. RECIST-lignende kriterier og sammenligne effekten af de to behandlinger.

    E.5.1.1Timepoint(s) of evaluation of this end point
    4 weeks

    4 uger

    E.5.2Secondary end point(s)
    1. Describe advers events of calcium electroporation using Common Terminology for Adverse Events, version 4.0.

    2. Evaluate if calcium affect the current intensity in elektroporation treatments.
    1. Registrere bivirkninger til calcium elektroporation vha. Common Terminology for Adverse Events, version 4.0.

    2. Vurdere om calcium påvirker strømstyrken i elektroporations behandlinger.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. 4 weeks

    2. 6 months
    1. 4 uger

    2. 6 måneder
    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 Yes
    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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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 Yes
    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
    From the 1. st inclusion until last visit of the last subject.
    Fra 1. inklusion til sidste patientbesøg.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    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: 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 state15
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 15
    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
    ingen
    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 Decision2013-03-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-02-21
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2017-01-23
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