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    Summary
    EudraCT Number:2021-002614-13
    Sponsor's Protocol Code Number:ElechtraPlatinum
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-12-10
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2021-002614-13
    A.3Full title of the trial
    Electrochemotherapy with Carboplatinum plus Bleomycin versus Bleomycin alone in vulvar cancer: the ElechtraPlatinum Study. A Randomized Controlled Trial
    Elettrochemioterapia a base di carboplatino e bleomicina versus sola bleomicina nel trattamento del cancro vulvare: studio ElechtraPlatinum. Trial randomizzato controllato.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Electrochemotherapy with Carboplatinum plus Bleomycin versus Bleomycin alone in vulvar cancer: the ElechtraPlatinum Study. A Randomized Controlled Trial
    Elettrochemioterapia a base di carboplatino e bleomicina versus sola bleomicina nel trattamento del cancro vulvare: studio ElechtraPlatinum. Trial randomizzato controllato.
    A.3.2Name or abbreviated title of the trial where available
    ElechtraPlatinum
    ElechtraPlatinum
    A.4.1Sponsor's protocol code numberElechtraPlatinum
    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 SponsorAOU DI BOLOGNA POLICLINICO S.ORSOLA-MALPIGHI
    B.1.3.4CountryItaly
    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 supportAOU di Bologna Policlinico S.Orsola
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAOU di Bologna Policlinico S.Orsola
    B.5.2Functional name of contact pointSSD Oncologia Ginecologica - De Iac
    B.5.3 Address:
    B.5.3.1Street Addressvia Albertoni 15
    B.5.3.2Town/ cityBologna
    B.5.3.3Post code40138
    B.5.3.4CountryItaly
    B.5.6E-mailmyriam.perrone@aosp.bo.it
    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 BLEOPRIM - 15 MG POLVERE PER SOLUZIONE INIETTABILE 1 FLACONCINO
    D.2.1.1.2Name of the Marketing Authorisation holderSANOFI-AVENTIS S.P.A.
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 namebleomicina
    D.3.2Product code [bleomicina]
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    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 INNBLEOMICINA SOLFATO
    D.3.9.2Current sponsor codebleomicina
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number30
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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 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 CARBOPLATINO AHCL - 10 MG/ML CONCENTRATO PER SOLUZIONE PER INFUSIONE 1 FLACONCINO DI VETRO DA 5 ML
    D.2.1.1.2Name of the Marketing Authorisation holderACCORD HEALTHCARE LIMITED
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 namecarboplatino
    D.3.2Product code [carboplatino]
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    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 INNCARBOPLATINO
    D.3.9.2Current sponsor codecarboplatino
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number140
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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
    relapsing vulvar carcinoma already subjected to multiple treatments
    carcinoma vulvare recidivante già sottoposto a plurimi trattamenti
    E.1.1.1Medical condition in easily understood language
    cancer of the vulva
    tumore della vulva
    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 10026642
    E.1.2Term Malignant neoplasm of vulva recurrent
    E.1.2System Organ Class 100000004864
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    • Evaluate the oncology response to electroporation after administration of BLM + CBP to BLM alone in terms of local progression-free survival (LPFS) in women with relapsed vulvar cancer after multimodal treatments.
    • Valutare la risposta oncologica alla elettroporazione dopo somministrazione di BLM + CBP verso la sola BLM in termini di Local progression free survival nelle donne con carcinoma vulvare recidivante dopo trattamenti multimodali.
    E.2.2Secondary objectives of the trial
    • Compare quality of life (HR-QoL) in the two groups of patients with questionnaires (FACT-V, FACT-PAL, E5-5L-D5).
    • To compare Overall Survival in the two study arms.
    • To compare local and systemic toxicity, morbidity and mortality, intraoperative and post-operative complications among the two study arms.
    • To compare costs and cost-effectiveness between the two study arms.
    • Confrontare la qualità della vita (HR-QoL) nei due gruppi di pazienti con questionari (FACT-V, FACT-PAL, E5-5L-D5).
    • Confrontare l'Overall Survival nei due bracci dello studio.
    • valutare la tossicità locale e sistemica, e gli eventi le complicanze intra e post-procedura tra i due bracci in studio.
    • Confrontare i costi e il rapporto costo-efficacia tra i due gruppi in studio
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Age = 18 years old
    2. Recurrent vulvar carcinoma confirmed by histological examination (sec. WHO 2020)
    3. Patient who underwent multiple treatments (surgery and radiation therapy or chemoradiation, radiation therapy or chemoradiation and chemotherapy), alternatively patient not eligible for standard therapies due to the performance
    4. Status life expectancy more than three months
    5. Measurable disease according to RECIST 1.1
    6. Adequate bone marrow, liver, and kidney function (creatinine <1.5 mg/dl), and coagulation parameters as follows:

    - Bone marrow (Hemoglobin = 8.0 g/dL with or without transfusion support, Platelet count = 75 × 109/L?)
    - INR> 1,5
    - Aspartate aminotransferase (AST)/serum glutamic-oxaloacetic transaminase (SGOT), alanine aminotransferase (ALT)/serum glutamic-pyruvate transaminase (SGPT) =3.0 × upper limit of normal (ULN)
    - Total bilirubin =2.0 × ULN or =3 × ULN except for subjects with Gilbert’s
    syndrome
    - Serum creatinine <1.5 mg/dl
    7. For females of childbearing potential, a pregnancy test on negative serum within 15 days of Day 1 of the study.
    8. Signed informed consent obtained prior to initiation of any study-specific procedures and treatment as confirmation of the patient’s awareness and willingness to comply the study requirements.
    1. Età = 18 anni
    2. Carcinoma vulvare ricorrente confermato dall'esame istologico (sec. WHO 2020)
    3. Pazienti sottoposte a più trattamenti (chirurgia e radioterapia o chemioradioterapia, radioterapia o chemioradioterapia e chemioterapia), in alternativa pazienti non idonee alle terapie standard a causa del performance status
    4. Aspettativa di vita superiore a tre mesi
    5. Malattia misurabile secondo RECIST 1.1
    6. Adeguata funzionalità del midollo osseo, del fegato e dei reni e parametri di coagulazione come segue:
    - Midollo osseo (emoglobina = 8,0 g/dL con o senza supporto trasfusionale, conta piastrinica = 75 × 109 / L)
    - INR> 1,5;
    - Aspartato aminotransferasi (AST) / transaminasi glutammico-ossalacetica sierica (SGOT), alanina aminotransferasi (ALT) / glutammico-piruvato transaminasi sierica (SGPT) =3,0 × limite superiore della norma (ULN)
    - Bilirubina totale =2,0 × ULN o =3 × ULN ad eccezione dei soggetti con sindrome di Gilbert
    - Creatinina sierica <1,5 mg / dl
    7. Per le donne in età fertile, un test di gravidanza su siero negativo entro 15 giorni dal Giorno 1 dello studio.
    8. Consenso informato firmato ottenuto prima dell'inizio di qualsiasi procedura o trattamento specifici per lo studio, come conferma della consapevolezza e della volontà del paziente di soddisfare i requisiti dello studio.
    E.4Principal exclusion criteria
    1. History of other malignancies in the previous five years, except basal cell carcinoma of the skin.
    2. History of psychological, familial, sociological, or geographical condition potentially preventing compliance with the study protocol and follow-up schedule.
    3. Allergic reactions to the two chemotherapy drugs (BLM and CBP) and/or their excipients.
    4. Evidence of pulmonary fibrosis.
    5. History of clinically significant cardiovascular abnormalities such as congestive heart failure (New York Heart Association classification =II [NYHA 1994]), myocardial infarction within 6 months of study entry.
    6. Patients requiring treatment for systemic bacterial, fungal, or viral infection ongoing at the day of the procedure. (Patients on antimicrobial, antifungal, or antiviral prophylaxis are not excluded).
    7. Pregnant or breastfeeding.
    8. Disability to understand and complete the questionnaire due to language difficulties, severe psychiatric illness or dementia. Unstable or severe uncontrolled medical condition (e.g., unstable cardiac function, unstable pulmonary condition, uncontrolled diabetes) or any important medical illness or abnormal laboratory finding that would, in the Investigator’s judgment, increase the risk to the patient associated with his or her participation in the study.
    1. Storia di altre neoplasie maligne nei cinque anni precedenti, ad eccezione del carcinoma basocellulare della pelle.
    2. Storia di condizioni psicologiche, familiari, sociologiche o geografiche che potenzialmente impediscono l'osservanza del protocollo di studio e del programma di follow-up.
    3. Reazioni allergiche ai due farmaci chemioterapici (BLM e CBP) e / o ai loro eccipienti.
    4. Evidenza di fibrosi polmonare.
    5. Anamnesi di anomalie cardiovascolari clinicamente significative come insufficienza cardiaca congestizia (classificazione della New York Heart Association =II [NYHA 1994]), infarto miocardico entro 6 mesi dall'ingresso nello studio.
    6. - Pazienti che necessitano di trattamento per infezione sistemica batterica, fungina o virale in corso il giorno della procedura. (I pazienti in profilassi antimicrobica, antimicotica o antivirale non sono esclusi).
    7. Pazienti incinte o in allattamento.
    8. Incapacità di comprendere e completare il questionario a causa di difficoltà di linguaggio, malattia psichiatrica grave o demenza Condizione medica instabile o grave non controllata (p. Es., Funzione cardiaca instabile, condizione polmonare instabile, diabete incontrollato) o qualsiasi malattia medica importante o riscontro di laboratorio anormale che potrebbe, a giudizio dello sperimentatore, aumentare il rischio per il paziente associato alla sua partecipazione allo studio.
    E.5 End points
    E.5.1Primary end point(s)
    local progression free survival
    sopravvivenza libera da progressione locale
    E.5.1.1Timepoint(s) of evaluation of this end point
    2 months
    2 mesi
    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 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.8.4.1Number of sites anticipated in Member State concerned1
    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 Information not present in EudraCT
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years5
    E.8.9.2In all countries concerned by the trial months0
    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: 20
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 50
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    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 No
    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 state70
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 70
    F.4.2.2In the whole clinical trial 70
    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)
    At the end of the study participation, the patients will continue their follow-up checks as per normal care practice or in the event of a further relapse they will receive treatment as appropriate.
    OR
    None (normal care pathway)
    Al termine della partecipazione dello studio le pazienti continueranno i loro controlli di follow up come da nomrale pratica assistenziale o nel caso di ulteriore recidiva riceveranno le cure a seconda del caso.
    OPPURE
    Nessuno (normale percorso assistenziale)
    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 Decision2022-03-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-01-20
    P. End of Trial
    P.End of Trial StatusOngoing
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