Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register allows you to search for protocol and results information on:
  • interventional clinical trials that are conducted in the European Union (EU) and the European Economic Area (EEA);
  • clinical trials conducted outside the EU / EEA that are linked to European paediatric-medicine development.
  • Learn   more about the EU Clinical Trials Register   including the source of the information and the legal basis.


    The EU Clinical Trials Register currently displays   42336   clinical trials with a EudraCT protocol, of which   6971   are clinical trials conducted with subjects less than 18 years old.
    The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).


    Phase 1 trials conducted solely in adults and that are not part of an agreed PIP are not public in the EU CTR (refer to European Guidance 2008/C 168/02   Art. 3 par. 2 and   Commission Guideline 2012/C 302/03,   Art. 5) .

    Clinical Trials marked as "Trial now transitioned" were transitioned to the Clinical Trial Regulation 536/2014 and can be further followed in the Clinical Trial Information System  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2013-002647-29
    Sponsor's Protocol Code Number:ELECTROCHEMO-1
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2013-12-27
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2013-002647-29
    A.3Full title of the trial
    Clinical trial to evaluate the efficacy and tolerability of electrochemotherapy for palliative treatment in patients with head and neck squamous cell carcinoma
    Ensayo clínico para evaluar la eficacia y tolerabilidad de la Electroquimioterapia como tratamiento paliativo en pacientes con carcinoma escamoso de cabeza y cuello
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study to evaluate electrochemotherapy for palliative treatment in patients with head and neck cancer
    Estudio para evaluar la electroquimioterapia como tratamiento paliativo en pacientes con cancer de cabeza y cuello
    A.4.1Sponsor's protocol code numberELECTROCHEMO-1
    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 SponsorFundació Clínic per a la Recerca Biomèdica
    B.1.3.4CountrySpain
    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 supportNA
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationClinical Trials Unit (CTU)
    B.5.2Functional name of contact pointJudit Pich
    B.5.3 Address:
    B.5.3.1Street AddressVillarroel, 170
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08036
    B.5.3.4CountrySpain
    B.5.4Telephone number349322754002815
    B.5.5Fax number34932279877
    B.5.6E-mailjpich@clinic.ub.es
    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 Bleomicina Mylan
    D.2.1.1.2Name of the Marketing Authorisation holderMylan Pharmaceuticals, S.L.
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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 namebleomycin
    D.3.4Pharmaceutical form Powder for solution 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 INNBLEOMYCIN
    D.3.9.1CAS number 11056-06-7
    D.3.9.4EV Substance CodeSUB00842MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/m2 milligram(s)/square meter
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number15
    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
    head and neck squamous cell carcinoma
    carcinoma escamoso de cabeza y cuello
    E.1.1.1Medical condition in easily understood language
    head and neck cancer
    cancer de cabeza y cuello
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.1
    E.1.2Level PT
    E.1.2Classification code 10060121
    E.1.2Term Squamous cell carcinoma of head and neck
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.1
    E.1.2Level HLGT
    E.1.2Classification code 10019190
    E.1.2Term Head and neck therapeutic procedures
    E.1.2System Organ Class 10042613 - Surgical and medical procedures
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.1
    E.1.2Level PT
    E.1.2Classification code 10067821
    E.1.2Term Head and neck cancer
    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
    Palliation of symptoms in patients who have one or more tumors cutaneous or subcutaneous as relapse or progression of carcinoma of head and neck palliative chemotherapy-resistant and those no other effective local treatments can be offered.
    Paliación de síntomas en pacientes que presenten uno o más tumores cutáneos o subcutáneos como recidiva o progresión de carcinoma de cabeza y cuello resistentes a quimioterapia paliativa y en los que no se pueda ofrecer otros tratamientos locales eficaces.
    E.2.2Secondary objectives of the trial
    1 Evaluation of tumor response
    2. Progression-free survival
    3. Overall survival
    4 Tolerance and toxicity of the procedure
    5. Exploratory analysis of possible factors involved in response and clinical progression
    1. Valoración de la respuesta tumoral
    2. Supervivencia libre de progresión
    3. Supervivencia global
    4. Tolerancia y toxicidad del procedimiento
    5. Análisis exploratorio de posibles factores pronósticos implicados en la respuesta y en la progresión clínica
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1) Patients of both sexes and equal to or more than 18 years old
    2) Patients with one or more cutaneous or subcutaneous local or locoregional tumors as relapse or progression of squamous cell carcinoma of head and neck
    3) Patients with a tumor that does not invade the wall of the artery carotid with risk of rupture
    4) Patients whose target lesion is resistant to palliative chemotherapy and which cannot be applied palliative local treatments such as radiotherapy, surgery of scarce mutilation or first-line systemic chemotherapy
    5) Patients with a expectation of life of 2-3 months
    6) Patients with a degree of activity of the ECOG scale of 2 or less
    7) Patients who, properly informed, consent in writing to participate in the study and submit to the tests and procedures required by the study
    1) Pacientes de ambos sexos y de edad igual o superior a 18 años
    2) Pacientes que presenten uno o más tumores cutáneos o subcutáneos locales o locorregionales como recidiva o progresión de carcinoma escamoso de cabeza y cuello
    3) Pacientes con un tumor que no invada la pared de la arteria carótida con riesgo de ruptura
    4) Pacientes cuya lesión diana sea resistente a quimioterapia paliativa y a los que no se puedan aplicar tratamientos paliativos locales como radioterapia, cirugía de escasa mutilación o quimioterapia sistémica de primera línea
    5) Pacientes con una expectativa de vida de entre 2 y 3 meses
    6) Pacientes con un grado de actividad de la escala ECOG de 2 o menor
    7) Que, adecuadamente informados, otorguen su consentimiento por escrito para participar en el estudio y someterse a las pruebas y exploraciones que ello comporta
    E.4Principal exclusion criteria
    1) Pregnancy or lactation during the study period
    2) Patients with allergy to Bleomycin
    3) Patients who have received the maximum dose of Bleomycin (400 mgm2)
    4) Patients with previous pulmonary fibrosis or hemolytic uremic syndrome
    5) Use of drugs contraindicated in the study procedure
    6) Contraindication for the use of any of the drugs /products of the study
    7) Hypersensitivity to any components of the anesthesia used during the procedure
    8) Patients with creatinine> 1.5 values mgdL
    9) Patients with severe coagulopathy prior at the entry of the study
    10) Patients enrolled in other clinical trials at the same time
    1) Embarazo o lactancia durante el periodo del estudio
    2) Pacientes con alergia previa a Bleomicina
    3) Pacientes que hayan recibido la dosis máxima de Bleomicina (400 mg/m2)
    4) Pacientes con fibrosis pulmonar previa o síndrome hemolítico urémico
    5) Utilización de fármacos contraindicados en el procedimiento en estudio
    6) Contraindicación para el uso de alguno de los fármacos/productos del estudio
    7) Hipersensibilidad conocida a cualquiera de los componentes de la anestesia a utilizar durante el procedimiento
    8) Pacientes con valores de creatinina > 1.5 mg/dL
    9) Pacientes con coagulopatías graves previas
    10) Pacientes incluidos en otros ensayos clínicos al mismo tiempo
    E.5 End points
    E.5.1Primary end point(s)
    Assessment of changes in symptoms using the test of quality of life of Edmonton at 6 weeks after the procedure with respect to the baseline.
    Evaluación de los cambios en los síntomas mediante el test de calidad de vida de Edmonton a las 6 semanas del procedimiento respecto al basal.
    E.5.1.1Timepoint(s) of evaluation of this end point
    6 weeks
    6 semanas
    E.5.2Secondary end point(s)
    1. Response rate objective: incidence of complete response or partial response or tumor stabilization according to RECIST 1.1 criteria at 6 and 12 weeks of treatment.
    2. Time elapsed since the date of the inclusion until progression of disease according to RECIST 1.1 criteria
    3. Time elapsed since the date of the inclusion until the date of death.
    4 Incidence of systemic and local events related to the study procedure
    5 Incidence of events adverse serious procedure in study-related
    6. Exploratory analysis of possible factors involved in response and clinical progression
    1. Tasa de respuesta objetiva: incidencia de Respuesta Completa (RC) o Respuesta Parcial (RP) o Estabilización Tumoral (ET) según los criterios RECIST 1.1 a las 6 y 12 semanas de tratamiento.
    2. Tiempo transcurrido desde la fecha de la inclusión hasta la fecha de progresión de la enfermedad según los criterios RECIST 1.1
    3. Tiempo transcurrido desde la fecha de la inclusión hasta la fecha de la muerte.
    4. Incidencia de acontecimientos locales y sistémicos relacionados con el procedimiento en estudio
    5. Incidencia de Acontecimientos Adversos Graves relacionados con el procedimiento en estudio
    6. Análisis exploratorio de posibles factores pronósticos implicados en la respuesta y en la progresión clínica
    E.5.2.1Timepoint(s) of evaluation of this end point
    6 weeks, 12 weeks, at the end of study
    6 semanas, 12 semanas, al finalizar el estudio
    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 No
    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 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.8.5The 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
    last visit last patient
    última vista del último paciente
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned 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: 30
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 30
    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 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 state30
    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)
    normal treatment for that condition
    tratamiento estandar para la condición en estudio
    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 Decision2014-02-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-10-31
    P. End of Trial
    P.End of Trial StatusOngoing
    For support, visit the EMA Service Desk , log in using your EMA account and open a ticket specifying "EU CTR" in your request.
    If you do not have an account, please visit the EMA Account management page page click on "Create an EMA account" and follow the instructions.
    The status of studies in GB is no longer updated from 1.1.2021
    For the UK, as from 1.1.2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
    European Medicines Agency © 1995-2022 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    Legal notice
    EMA HMA