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    Summary
    EudraCT Number:2014-000920-26
    Sponsor's Protocol Code Number:KCP-330-008
    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:2014-05-23
    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 number2014-000920-26
    A.3Full title of the trial
    A Randomized, Open Label, Phase 2 Study of the Selective Inhibitor of Nuclear Export (SINE) Selinexor (KPT-330) versus Specified Physician s Choice in Patients older or equal to 60 Years Old with Relapsed/Refractory Acute Myeloid Leukemia (AML) Who are Ineligible for Intensive Chemotherapy and/or Transplantation.
    Ensayo clínico en fase II, aleatorizado y sin enmascaramiento sobre el inhibidor selectivo de la exportación nuclear (SINE) Selinexor (KPT-330) comparado con una determinada opción terapeutica escogida por el médico en pacientes de 60 o mas años de edad con leucemia mieloide aguda (LMA) recidivante o resistente al tratamiento que no son aptos para la quimioterapia intensiva y/o el transplante
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Selinexor (KPT-330) in Older Patients With Relapsed AML
    Selinexor (KPT-330) en pacientes mayores con leucemia mieloide aguda recidivante (LMA)
    A.3.2Name or abbreviated title of the trial where available
    SOPRA (Selinexor in Older Patients with Relapsed AML)
    SOPRA (Selinexor en pacientes mayores con LMA recidivante
    A.4.1Sponsor's protocol code numberKCP-330-008
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02088541
    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 Address2 Mercer Rd
    B.5.3.2Town/ cityNatick
    B.5.3.3Post codeMA 01760
    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 No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameSelinexor
    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.3.10 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.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 No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameSelinexor
    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.3.10 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.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
    Acute Myeloid Leukemia (AML)
    Leucemia Mieloide Aguda (LMA)
    E.1.1.1Medical condition in easily understood language
    Acute Myeloid Leukemia (AML)
    Leucemia Mieloide Aguda (LMA)
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.0
    E.1.2Level LLT
    E.1.2Classification code 10000886
    E.1.2Term Acute myeloid leukemia
    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
    To determine overall survival (OS) of Selinexor as compared to physician choice (PC) in patients older or equal to 60 years old with relapsed/refractory AML that requires treatment and are ineligible for intensive chemotherapy and/or transplantation.
    Determinar la supervivencia global (SG) de Selinexor en comparación con la opción terapéutica escogida por el médico (OEM) en pacientes mayores o igual a 60 años con LMA recidivante o resistente al tratamiento, que requieren tratamiento y que no son aptos para la quimioterapia intensiva y/o el trasplante.
    E.2.2Secondary objectives of the trial
    - To determine the proportion of patients whose OS is at least 3 months (OS3.0),
    - To determine the complete remission rate (CRR) including complete remission with full hematologic recovery (CR), complete response with incomplete hematologic recovery (CRi) including complete response with incomplete platelet recovery (CRp), and bone marrow CR, and median disease free survival (DFS),
    - To determine the overall response rate (ORR) and duration of overall response (DOR), including CR, CRi, bone marrow CR, and partial response (PR),
    - To determine the disease control rate (DCR) defined as ORR + stable disease for more or equal than 4 weeks (SD), and duration of DCR,
    - To assess the safety and tolerability of Selinexor (KPT-330), as compared to physician's choice (PC).
    - Quality of life and patient reported outcomes (FACT-Leukemia) (QoL)
    -Determinar el porcentaje de pacientes en los que la SG sea como mínimo de 3 meses (SG3,0),
    -Determinar la tasa de remisión completa (TRC), incluida la remisión completa con recuperación hematológica completa (RC), la respuesta completa con recuperación hematológica incompleta (RCi), que incluirá la respuesta completa con recuperación plaquetaria incompleta (RCp), y la RC de la médula ósea; así como la mediana de supervivencia sin enfermedad (SSE),
    -Determinar la tasa de respuesta global (TRG) y la duración de la respuesta global (DR), incluida la RC, la RCi, la RC de la médula ósea y la respuesta parcial (RP),
    -Determinar la tasa de control de la enfermedad (TCE), que se define como TRG + enfermedad estable durante 4 semanas o mas (EE), y la duración de la TCE,
    -Evaluar la seguridad y la tolerabilidad de Selinexor (KPT-330), en comparación con la opción terapéutica escogida por el médico
    -La calidad de vida y los resultados comunicados por el paciente (FACT-Leukemia) (CdV)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients age older or equal 60 years with relapsed/refractory AML (defined using WHO criteria) of any type except for AML M3, after one prior therapy only, who have never undergone, and who are not currently eligible for, stem cell transplantation and are currently deemed unfit for intensive chemotherapy.
    Pacientes de 60 años o más con LMA recidivante o resistente al tratamiento (definida según los criterios de la OMS) de cualquier tipo, excepto LMA M3, después de un tratamiento previo solo, que nunca hayan recibido un trasplante de células madre, y que actualmente no sean aptos para recibirlo, y a los que no se considera aptos en este momento para quimioterapia intensiva.
    E.4Principal exclusion criteria
    Patients with acute promyelocytic leukemia (AML M3), known central nervous system (CNS) leukemia, or who are in blast transformation of chronic myeloid leukemia (CML) will be excluded from this study.
    Se excluirá del estudio a los pacientes con leucemia promielocítica aguda (LMA M3), leucemia del sistema nervioso central (SNC) diagnosticada o leucemia mieloide crónica (LMC) en transformación blástica.
    E.5 End points
    E.5.1Primary end point(s)
    Overall survival (OS) is the primary efficacy endpoint of this study.
    La variable principal de eficacia de este estudio es la supervivencia global (SG)
    E.5.1.1Timepoint(s) of evaluation of this end point
    The interim analysis will take place after 62 (50%) OS events.
    El análisis intermedio se realizará tras 62 acontecimientos (50 %)
    E.5.2Secondary end point(s)
    Secondary efficacy endpoints will include the following, assessed in hierarchical fashion in the order presented below:
    - Proportion of patients whose OS is at least 3 months (OS3.0),
    - The complete remission rate (CRR) including complete remission with full hematologic recovery (CR), complete response with incomplete hematologic recovery (CRi) including complete response with incomplete platelet recovery (CRp), and bone marrow CR, and median disease free survival (DFS),
    - The overall response rate (ORR) and duration of overall response (DOR), including CR, CRi, bone marrow CR, and partial response (PR),
    - The disease control rate (DCR) defined as ORR + stable disease for 4 weeks or more (SD), and duration of DCR,
    - The safety and tolerability of Selinexor, as compared to investigator choice (PC).
    - Quality of life and patient reported outcomes (FACT-Leukemia) (QoL)
    Las variables secundarias de eficacia incluyen las siguientes, evaluadas jerárquicamente en el orden que se presenta a continuación, según las definiciones presentadas anteriormente (objetivos secundarios):
    - Determinar el porcentaje de pacientes en los que la SG sea como mínimo de 3 meses (SG3,0),
    - Determinar la tasa de remisión completa (TRC), incluida la remisión completa con recuperación hematológica completa (RC), la respuesta completa con recuperación hematológica incompleta (RCi), que incluirá la respuesta completa con recuperación plaquetaria incompleta (RCp), y la RC de la médula ósea; así como la mediana de supervivencia sin enfermedad (SSE),
    - Determinar la tasa de respuesta global (TRG) y la duración de la respuesta global (DR), incluida la RC, la RCi, la RC de la médula ósea y la respuesta parcial (RP),
    - Determinar la tasa de control de la enfermedad (TCE), que se define como TRG + enfermedad estable durante 4 semanas o más (EE), y la duración de la TCE,
    - Evaluar la seguridad y la tolerabilidad de Selinexor (KPT-330), en comparación con la opción terapéutica escogida por el médico (OEM).
    - La calidad de vida y los resultados comunicados por el paciente (FACT-Leukemia) (CdV)
    E.5.2.1Timepoint(s) of evaluation of this end point
    At end of study.
    Al final del 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 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 Yes
    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 Yes
    E.8.2.3.1Comparator description
    Physician?s Choice as described in the protocol
    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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA35
    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
    Canada
    Israel
    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
    Último paciente última visita
    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 months3
    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 months3
    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: 40
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 110
    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 Yes
    F.3.3.4Nursing women Yes
    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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 75
    F.4.2.2In the whole clinical trial 150
    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.
    El médico del paciente ofrecerá el mejor tratamiento disponible una vez que éste finalice su participación en el 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 Decision2014-07-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-07-09
    P. End of Trial
    P.End of Trial StatusCompleted
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