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    Summary
    EudraCT Number:2010-020363-21
    Sponsor's Protocol Code Number:SGN35-010
    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:2010-08-31
    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 number2010-020363-21
    A.3Full title of the trial
    Protocolo en fase 2/3, abierto, referente a la opción de tratamiento con brentuximab vedotin en pacientes con progresión de linfoma de Hodgkin

    An open-label, phase 2/3, treatment-option protocol of brentuximab vedotin in patients with progression of Hodgkin lymphoma
    A.4.1Sponsor's protocol code numberSGN35-010
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorSeattle Genetics, Inc.
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community Yes
    D.2.5.1Orphan drug designation numberEU/3/08/596
    D.3 Description of the IMP
    D.3.1Product namebrentuximab vedotin
    D.3.2Product code SGN-35
    D.3.4Pharmaceutical form
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNPending
    D.3.9.1CAS number 914088-09-8
    D.3.9.2Current sponsor codeSGN-35
    D.3.9.3Other descriptive namecAC10-vcMMAE, cAC10-vcMMAE(4)
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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) Information not present in EudraCT
    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 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 Information not present in EudraCT
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) Yes
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    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
    Pacientes con progresión de linfoma de Hodgkin
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.1
    E.1.2Level LLT
    E.1.2Classification code 10020328
    E.1.2Term Hodgkin's lymphoma
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    • Ofrecer la posibilidad de tratamiento con brentuximab vedotin a aquellos pacientes de la rama de placebo del estudio SGN-005 que experimenten progresión del linfoma de Hodgkin (LH).
    • Evaluar la seguridad y tolerabilidad de brentuximab vedotin
    E.2.2Secondary objectives of the trial
    No hay Objetivos secundarios
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Pacientes que cumplieron todos los criterios de inclusión/exclusión y que participaron en el estudio clínico SGN35-005.
    2.Pacientes que recibieron placebo durante el estudio clínico SGN35-005 después de un trasplante autólogo de células madre hematopoyéticas (ASCT) y experimentaron progresión de LH en base a los Criterios de Respuesta Revisados en Linfomas Malignos (Cheson 2007) según lo definido por el protocolo del estudio SGN35-005.
    3.Edad: mayor o igual de 18 años.
    4.Estado funcional ECOG menor o igual2.
    5.Los pacientes deben haber finalizado cualquier tratamiento previo con radiación, quimioterapia, agentes biológicos y/o productos en investigación como mínimo 4 semanas antes de recibir la primera dosis de SGN-35.
    6.Las mujeres fértiles deberán obtener un resultado negativo en el test Beta-hCG de embarazo en suero u orina en los 7 días anteriores a la primera dosis de brentuximab vedotin. Las mujeres no fértiles son mujeres postmenopáusicas que llevan más de 1 año sin menstruación o mujeres que se han sometido a una ligadura bilateral de trompas o a una histerectomía.
    7.Tanto las mujeres fértiles como los hombres con parejas fértiles deberán aceptar utilizar un método anticonceptivo eficaz durante el estudio y hasta 30 días después de la última dosis del fármaco en estudio.
    8.Son necesarios los siguientes valores iniciales de laboratorio: recuento absoluto de neutrófilos (RAN) mayor o igual 1000 microL, plaquetas mayor o igual 50.000 microL, bilirrubina menor o igual a 1,5 x límite superior de la normalidad (LSN) o menor o igual 3 x LSN en pacientes con la enfermedad de Gilbert, creatinina en suero menor o igual 1,5 x LSN, alanina aminotransferasa (ALT) y aspartato aminotransferasa (AST) menor o igual 2,5 x LSN.
    9.Los pacientes o su representante legal autorizado deben facilitar el consentimiento informado por escrito.
    E.4Principal exclusion criteria
    1.Cualquier infección vírica, bacteriana o fúngica d10. Cualquier infección vírica, bacteriana o fúngica de grado 3 que requiera tratamiento durante 1 semana antes de la primera dosis del estudio.
    2.Pacientes con neuropatía periférica de grado mayor o igual 2.
    3.Antecedentes de otro tumor maligno primario que no haya remitido como mínimo durante los últimos 3 años. (Están exentos del límite de 3 años los siguientes: cáncer de piel no melanocítico, melanoma in situ escindido [Fase 0], cáncer de próstata localizado con tratamiento curativo y carcinoma cervical in situ en una biopsia o una lesión intraepitelial escamosa en un frotis para citología).
    4.Enfermedad cerebral o meníngea conocida.
    5.Tratamiento actual con otros fármacos de tipo sistémico, antineoplásico o en investigación.
    6.Mujeres gestantes o en período de lactancia.
    7.Pacientes con hipersensibilidad conocida a alguno de los excipientes contenidos en la formulación del medicamento.
    8.Pacientes con demencia o alteración de su estado mental que impida la comprensión y prestación del consentimiento información.
    9.Pacientes aptos para su participación en otros estudios clínicos de brentuximab vedotin en su institución
    E.5 End points
    E.5.1Primary end point(s)
    Los criterios de valoración de la seguridad son: tipo, incidencia, intensidad, gravedad y relación del tratamiento en estudio con los AA
    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 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 Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    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 Information not present in EudraCT
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA19
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    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
    Por protocolo
    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 months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years4
    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 Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    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 state6
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 50
    F.4.2.2In the whole clinical trial 80
    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)
    Por Protocolo
    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 Decision2010-12-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-11-30
    P. End of Trial
    P.End of Trial StatusOngoing
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