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    Summary
    EudraCT Number:2006-002584-70
    Sponsor's Protocol Code Number:155-CL-009
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2007-07-20
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2006-002584-70
    A.3Full title of the trial
    Estudio en Fase II, Multicéntrico y Abierto de YM155 en pacientes con Linfoma Difuso de Células-B Grandes (LDCBG) Refractario
    A.4.1Sponsor's protocol code number155-CL-009
    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 SponsorAstellas Pharma US, 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 No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameYM155
    D.3.2Product code YM155
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    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.3.9.2Current sponsor codeYM155
    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) 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) No
    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
    Linfoma Difuso de Células-B Grandes Refractario
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level PT
    E.1.2Classification code 10012822
    E.1.2Term Diffuse large B-cell lymphoma refractory
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Evaluar la tasa de respuesta global (Remisión Completa [RC] + Remisión Parcial [RP]) de YM155 según los Criterios del Grupo de Trabajo Internacional (IWG, 2007) durante 15 ciclos de tratamiento
    E.2.2Secondary objectives of the trial
    Evaluar la eficacia, seguridad y tolerabilidad de YM155 durante 15 ciclos de tratamiento.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Sub estudio QT: incluido en el estudio principal. El objetivo del Sub-estudio es valorar el efecto potencial de YM155 en los intervalos cardíacos, incluyendo el QT.

    Sub estudio farmacogenómico: incluido en el estudio principal. El objetivo de este estudio es analizar de forma comprensiva:
    • Genes sospechosos relacionados con la enfermedad
    • Genes potencialmente involucrados en la excreción del fármaco y/o el metabolismo
    • Genes de relevancia para los temas de toxicidad/seguridad, que serán identificados en un entorno de prevención / retrospectivo

    Sub estudio de biomarcadores: incluido en el estudio principal. El objetivo de esta investigación es el de analizar de forma comprensiva la expresión protéica que puede estar involucrada en el crecimiento del tumor.
    E.3Principal inclusion criteria
    - Hombres o mujeres > 18 años
    - LDCBG confirmado histológicamente en cualquier estadío
    - Paciente refractario al ultimo régimen de tratamiento, definido por alguno de los siguientes criterios:
    • El paciente no obtuvo ni siquiera una RP en ningún momento mientras recibía el régimen de tratamiento previo.
    • El paciente obtuvo al menos una RP durante el régimen de tratamiento previo, pero mostró después una progresión mientras seguía siendo tratado con dicho régimen de tratamiento.
    • El paciente obtuvo al menos una RP al régimen de tratamiento previo pero progresó en los 6 meses siguientes a completar el régimen de tratamiento previo.
    - Los pacientes tienen que haber sido tratados previamente con los siguientes regímenes de tratamiento:
    • Quimioterapia de combinación basada en Antraciclina con rituximab
    • Quimioterapia de combinación en segunda línea
    • Transplante autólogo de médula ósea (TAMO) o un transplante autólogo de células madre de sangre periférica (TACMSP) si eran candidatos para ello y no lo rechazaron.
    - Al menos una lesión medible definida como > o igual a 1.5 cm en su diámetro transversal más largo mediante TC
    - Paciente sin afectación conocida del sistema nervioso central (SNC)
    - Puntuación ECOG (Eastern Cooperative Oncology Group) < o igual a 2
    E.4Principal exclusion criteria
    - Cualquier terapia para el linfoma en los 21 días previos a la primera dosis de YM155
    - En las 4 semanas previas a la PET-FDG basal, los pacientes no podrán haber sido sometidos a lo siguiente:
    • Radioterapia
    • Procedimientos quirúrgicos (excepto biopsias y colocación del catéter/puerto central)
    • Infección activa (torrente sanguíneo o tejido profundo)
    - Función renal, hepática y/o de médula inadecuada en la Visita Basal, definida como:
    • Creatinina Sérica > o igual a 1.5 x Límite Superior Normal (LSN) o cálculo de aclaración de creatinina sérica < 60 mL/min
    • Recuento Absoluto de Neutrófilos (RAN) < o igual a 750/mm3
    • Plaquetas < o igual a 50,000/mm3
    • Alanina Transaminasa (ALT) y Aspartato Transaminasa (AST) > o igual a 2.5 x LSN; > o igual a 5 x LSN si secundario a metástasis de hígado
    - Pacientes que hayan recibido > 3 regímenes de tratamiento previo para su linfoma. Para calcular el número de regímenes de tratamiento previos, se tendrá en cuenta lo siguiente:
    • Cualquier terapia de mantenimiento prevista será considerada como parte del régimen de tratamiento previo.
    • Cualquier tratamiento de preparación (quimioterapia de rescate, quimioterapia de dosis alta, radioterapia, etc.) será considerado, junto con el TAMO o el TACMSP como un único régimen de tratamiento.
    - Transplante alogénico de médula ósea o transplante alogénico de células madre de sangre periférica
    - Historia de otro tumor que requirió tratamiento en los últimos 2 años previos a la primera dosis de YM155, excepto para el carcinoma de piel de células escamosas o basales tratado o el cáncer cervical in situ.
    E.5 End points
    E.5.1Primary end point(s)
    Tasa de Respuesta Global (RC+RP) según los criterios de IWG (Grupo Internacional de Trabajo, IWG 2007)
    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 Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic Yes
    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 Information not present in EudraCT
    E.8.4 The trial involves multiple sites in the Member State concerned Information not present in EudraCT
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA30
    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 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
    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 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 state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 120
    F.4.2.2In the whole clinical trial 250
    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)
    Los pacientes con RC, RP o EE podrán ser elegibles para continuar recibiendo YM155 si cumplen los criterios de re-tratamiento y por acuerdo del Investigador y del Monitor Médico de Astellas, como parte de un estudio de extensión.
    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 Decision2007-09-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-08-02
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2009-04-23
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