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    Summary
    EudraCT Number:2014-001977-15
    Sponsor's Protocol Code Number:KCP-330-009
    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:2014-11-19
    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 number2014-001977-15
    A.3Full title of the trial
    A Phase 2b Open-label, Randomized, Two-arm Study of Selinexor (KPT-330) with Low Dose Dexamethasone in Patients with Relapsed/Refractory Diffuse Large B-Cell Lymphoma (DLBCL)
    Estudio de fase 2b aleatorizado, abierto y de dos grupos, de selinexor (KPT-330) en asociación con dexametasona a dosis bajas en pacientes con linfoma difuso de células B grandes (LDCBG) refractario o recidivante.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase 2b Open-label, Randomized, Two-arm Study of Selinexor (KPT-330) with Low Dose Dexamethasone in Patients with Relapsed/Refractory Diffuse Large B-Cell Lymphoma (DLBCL)
    Estudio de fase 2b aleatorizado, abierto y de dos grupos, de selinexor (KPT-330) en asociación con dexametasona a dosis bajas en pacientes con linfoma difuso de células B grandes (LDCBG) refractario o recidivante.
    A.3.2Name or abbreviated title of the trial where available
    SADAL: Selinexor and Dexamethasone (Sel-Dex) in Aggressive Lymphoma
    A.4.1Sponsor's protocol code numberKCP-330-009
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02227251
    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 SponsorKaryopharm Therapeutics, 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 supportKaryopharm Therapeutics, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationKaryopharm Therapeutics, Inc.
    B.5.2Functional name of contact pointClinical Trial Information Desk
    B.5.3 Address:
    B.5.3.1Street Address85 Wells Ave
    B.5.3.2Town/ cityNewton
    B.5.3.3Post codeMA 02459
    B.5.3.4CountryUnited States
    B.5.6E-mailclinicaltrials@karyopharm.com
    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/3/14/1317
    D.3 Description of the IMP
    D.3.1Product nameSelinexor 25mg coated tablets
    D.3.2Product code KPT-330
    D.3.4Pharmaceutical form Coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNSelinexor
    D.3.9.1CAS number 1393477-72-9
    D.3.9.2Current sponsor codeKPT-330
    D.3.9.4EV Substance CodeSUB168135
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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 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/3/14/1317
    D.3 Description of the IMP
    D.3.1Product nameSelinexor 10mg coated tablets
    D.3.2Product code KPT-330
    D.3.4Pharmaceutical form Coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNSelinexor
    D.3.9.1CAS number 1393477-72-9
    D.3.9.2Current sponsor codeKPT-330
    D.3.9.4EV Substance CodeSUB168135
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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
    Relapsed/Refractory DLBCL
    Linfoma difuso de células B grandes (LDCBG) refractario o recidivante.
    E.1.1.1Medical condition in easily understood language
    Relapsed/Refractory DLBCL
    Linfoma difuso de células B grandes (LDCBG) refractario o recidivante.
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.1
    E.1.2Level HLT
    E.1.2Classification code 10012819
    E.1.2Term Diffuse large B-cell lymphomas
    E.1.2System Organ Class 100000004851
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To determine the overall response rate (ORR) to selinexor 100 mg with low dose dexamethasone (High-Sel-Dex) compared to selinexor 60 mg with low dose dexamethasone (Low-Sel-Dex) in patients with relapsed/refractory DLBCL and to evaluate the efficacy of Sel-Dex in comparison to a minimally effective lower threshold level of ORR at 20%.
    Determinar la tasa de respuesta global (TRG) a 100 mg de selinexor con dexametasona en dosis bajas (Alta-Sel-Dex) en comparación con 60 mg de selinexor con dexametasona en dosis bajas (Baja-Sel-Dex) en pacientes con LDCBG recidivante o refractario y evaluar la eficacia de Sel-Dex en comparación con un nivel inferior mínimamente eficaz de la TRG del 20 %.
    E.2.2Secondary objectives of the trial
    ? To determine duration of response (DOR) for each study arm
    ? To compare the safety of the High-Sel-Dex versus Low-Sel-Dex regimens assessed according to the frequency and severity of adverse events (AEs)
    ? To compare the disease control rate (DCR=ORR + stable disease [SD]), median progression-free survival (PFS) and median overall survival (OS) of patients with relapsed/refractory DLBCL, treated with High-Sel-Dex versus Low-Sel-Dex
    ? To compare PFS, ORR, DOR, DCR, and OS obtained with High-Sel-Dex versus Low-Sel-Dex, and with combined High-Sel-Dex and Sel-Dex?Low, in patients with germinal center B-cell (GCB) versus non-germinal center (non-GCB) DLBCL
    ? To compare Quality of Life (QoL) in patients treated with High-Sel-Dex versus Low-Sel-Dex using the Functional Assessment of Cancer Therapy ? Lymphoma (FACT-Lym) questionnaire (Webster 2005; Appendix 3)
    ? Determinar la duración de la respuesta en cada grupo del estudio
    ? Comparar la seguridad de los tratamientos con Alta-Sel-Dex frente a Baja-Sel-Dex evaluada conforme a la frecuencia e intensidad de los acontecimientos adversos
    ? Comparar la tasa de control de la enfermedad (TCE = TRG + enfermedad estable [EE]), LA mediana de la supervivencia libre de progresión (SLP) y la mediana de la supervivencia global (SG) de los pacientes con LDCBG recidivante o refractario tratados con Alta-Sel-Dex frente a Baja-Sel-Dex
    ? Comparar la SLP, la TRG, la DR, la TCE y la SG obtenidas con Alta-Sel-Dex frente a Baja-Sel-Dex, y con los tratamientos combinados Alta-Sel-Dex y Baja-Sel-Dex, en pacientes con LDCBG con células B derivadas del centro germinal (BCG) frente a LDCBG sin células B del centro germinal (no BCG).
    ? Comparar la calidad de vida en pacientes tratados con Alta-Sel-Dex frente a Baja-Sel-Dex utilizando el cuestionario Functional Assessment of Cancer Therapy ? Lymphoma (FACT-Lym)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients, age ? 18 years, with pathologically confirmed DLBCL whose disease is relapsed and/or refractory, with documented evidence of disease progression after the most recently administered chemotherapy regimen (according to International Working Group (IWG) criteria for progression of lymphoma, Cheson 2007), and who in the opinion of the investigator are not candidates for high-dose chemotherapy with autologous stem cell rescue, may be considered for enrollment. Patients must have received at least 2 but no more than 4 previous systemic multi-agent regimens for the treatment of their DLBCL including at least one course of anthracycline-based chemotherapy (unless absolutely contraindicated due to cardiac dysfunction, in which case etoposide must have been given) and at least two courses of anti-CD20 immunotherapy (e.g., rituximab), unless contraindicated due to severe toxicity. Prior stem cell transplantation is allowed; induction, consolidation, stem cell collection, preparative regimen and transplantation ± maintenance are considered a single line of therapy. Patients should have an estimated life expectancy of more than 3 months at study entry. Patients will undergo a pre-screening biopsy to confirm DLBCL histology, define DLBCL subtype (GCB or non-GCB) as well as DH-DLBCL status (Myc, BCL2, and BCL6 translocation and expression).
    Se podrán considerar para su inclusión los pacientes ? 18 años, con LDCBG confirmado anatomopatológicamente y refractario o recidivante o resistente, que presenten signos documentados de progresión de la enfermedad después del último tratamiento con quimioterapia administrado (según los criterios del International Working Group [IWG] para la progresión del linfoma, Cheson 2007) y, que en opinión del investigador, no sean candidatos para recibir quimioterapia en altas dosis con rescate autólogo de células madre.Los pacientes deberán haber recibido un mínimo de 2 pero no más de 4 politerapias sistémicas previas para el LDCBG incluido, al menos un ciclo de quimioterapia basada en antraciclinas (a menos que estén totalmente contraindicadas debido a insuficiencia cardíaca, en cuyo caso se debe haber administrado un etopósido) y un mínimo de dos ciclos de inmunoterapia con anticuerpos anti-CD20 (p. ej., rituximab), salvo que esté contraindicado debido a toxicidad intensa.Se permite trasplante de células madre previo; la inducción, la consolidación, la recolección de células madre, el tratamiento preparatorio y el trasplante ± el mantenimiento se considerarán una única línea de tratamiento.Los pacientes deberán tener una esperanza de vida estimada superior a 3 meses en el momento de su inclusión en el estudio.Se les realizará una biopsia antes del proceso de selección para confirmar el tipo histológico del LDCBG, definir el subtipo de LDCBG (subtipo CGB o no CGB), y determinar el estado de doble translocación del LDCBG (translocación y expresión de Myc, BCL2 y BCL6).
    E.4Principal exclusion criteria
    Patients with histologies other than de novo DLBCL, (i.e., patients with DLBCL transformed from indolent lymphomas, primary mediastinal (thymic) large B-cell lymphoma (PMBL), or active central nervous system (CNS) lymphoma, will be excluded from this study. Patients with severe intolerance to glucocorticoids (e.g., due to uncontrolled diabetes mellitus) who are unable to receive a minimum dose of 8 mg of dexamethasone twice weekly (i.e., with each dose of selinexor) are also excluded from this study. Patients must not be eligible for high-dose therapy with stem cell rescue and documentation for ineligibility must be provided.
    Quedarán excluidos del estudio los pacientes con histologías que no sean LDCBG de novo,es decir, los pacientes con LBDCG transformado de linfomas indolentes, linfoma primario mediastínico (tímico) de células B grandes (LPMB) o linfoma del sistema nervioso central (SNC).También quedarán excluidos del estudio los pacientes con intolerancia grave a los glucocorticoides (p. ej., debido a diabetes mellitus no controlada) que no puedan recibir una dosis mínima de 8 mg de dexametasona dos veces a la semana (es decir, con cada dosis de selinexor).Los pacientes no deben ser elegibles para recibir tratamiento en dosis altas con rescate de células madre y deberá facilitarse la documentación en la que se constate que no son elegibles.
    E.5 End points
    E.5.1Primary end point(s)
    The data used for primary statistical analysis will be from a central review of the radiological disease assessments.
    ? ORR to High-Sel-Dex compared to Low-Sel-Dex
    ? ORR to Sel-Dex (High-Sel-Dex + Low-Sel-Dex) compared to a minimally effective lower threshold level of ORR at 20%.
    Los datos utilizados para el análisis estadístico principal procederán de una revisión central de las evaluaciones radiológicas de la enfermedad.

    Determinar la TRG a 100 mg de selinexor con dexametasona en dosis bajas (Alta-Sel-Dex) en comparación con 60 mg de selinexor con dexametasona en dosis bajas (Baja-Sel-Dex) en pacientes con LDCBG recidivante o refractario y evaluar la eficacia de Sel-Dex en comparación con un nivel inferior mínimamente eficaz de la TRG del 20 %.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Disease response will be assessed by the Revised IWG Response Criteria for NHL (Cheson 2007; Appendix 1) in patients on Cycle 3 Day 1 and every 2 months of therapy thereafter until disease progression. There is no maximum treatment duration.
    La respuesta de la enfermedad se evaluará mediante los criterios de evaluación de la respuesta del IWG revisados para el LNH (Cheson 2007; Anexo 1) en los pacientes el día 1 del ciclo 3 y cada 2 meses de tratamiento a partir de entonces y hasta la progresión de la enfermedad.No hay duración máxima del tratamiento.
    E.5.2Secondary end point(s)
    ? DOR for each study regimen
    ? Safety of High-Sel-Dex versus Low-Sel-Dex regimen as measured by frequency and severity of AEs
    ? DCR, PFS, and OS compared for High-Sel-Dex and Low-Sel-Dex regimens
    ? Comparison of PFS, ORR, DOR, DCR, QoL, and OS for patients of GCB versus non-GCB DLBCL
    ? Quality of Life assessment of High-Sel-Dex patients versus Low-Sel-Dex patients using the FACT-Lym questionnaire
    ? DR para cada pauta del estudio
    ? Seguridad del tratamiento Alta-Sel-Dex frente a Baja-Sel-Dex evaluada conforme a la frecuencia e intensidad de los AA.
    ? TCE, SLP y SG comparadas para las pautas Alta-Sel-Dex y Baja-Sel-Dex.
    ? Comparación de la SLP, la TRG, la DR, la TCE, la CdV y la SG para los subtipos de LDCBG de BCG y no BCG.
    ? Evaluación de la calidad de vida de los pacientes con Alta-Sel-Dex frente a los pacientes con Baja-Sel-Dex mediante el cuestionario FACT-Lym
    E.5.2.1Timepoint(s) of evaluation of this end point
    End of study
    Fin de 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 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 Yes
    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 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 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 concerned8
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA52
    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 No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Belgium
    Canada
    Israel
    Spain
    United States
    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
    LPLV
    Ultima visita del ultimo paciente
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months9
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months9
    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: 100
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 100
    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 state28
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 104
    F.4.2.2In the whole clinical trial 200
    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)
    After a patient has ceased his/her participation in the study, his/her medical doctor will offer the most appropriate treatment currently available.
    Una vez que el paciente finalize su participacion en el estudio, su Dr le ofrecerá el tratamiento más adecuado que esté en ese momento disponible
    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 Decision2015-01-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-12-04
    P. End of Trial
    P.End of Trial StatusOngoing
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