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    Summary
    EudraCT Number:2013-001676-38
    Sponsor's Protocol Code Number:D1532C00079
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Temporarily Halted
    Date on which this record was first entered in the EudraCT database:2013-09-05
    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 number2013-001676-38
    A.3Full title of the trial
    A Phase III, Double-Blind, Randomised, Placebo-Controlled Study to Assess the Efficacy and Safety of Selumetinib (AZD6244; ARRY-142886) (Hyd-Sulfate) in Combination with Docetaxel, in Patients receiving second line treatment for KRAS Mutation-Positive Locally Advanced or Metastatic Non Small Cell Lung Cancer (Stage IIIB ? IV) (SELECT-1)
    Ensayo fase III, doble ciego, aleatorizado, controlado con placebo, para evaluar la eficacia y seguridad de Selumetinib (AZD6244; ARRY-142886) (hidrógeno-sulfato) en combinación con Docetaxel, en pacientes con cáncer de pulmón no microcítico localmente avanzado o metastásico (estadío IIIB - IV) con mutación KRAS positiva en 2ª línea de tratamiento (SELECT-1)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The purpose of this study is to confirm the efficacy and safety of selumetinib in combination with docetaxel (75mg/m2) in patients with locally advance or metastatic NSCLCs that harbor mutations of KRAS. This study will also assess the PK, safety, patient reported outcomes (PRO) and tolerability profile of the selumetinib/docetaxel combination, compared to placebo in combination with docetaxel.
    El objetivo de este estudio es confirmar la eficacia y seguridad de selumetinib en comparación con docetaxel (75mg/m2) en pacientes con cáncer de pulmón no microcítico localmente avanzado o metastásico con mutación KRAS positiva. Este estudio va a evaluar también la FC, seguridad, los resultados reportados de los pacientes y tolerabilidad de selumetinib en combinación con docetaxel en comparación con placebo en combinación con docetaxel
    A.3.2Name or abbreviated title of the trial where available
    SELECT-1
    SELECT-1
    A.4.1Sponsor's protocol code numberD1532C00079
    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 SponsorAstraZeneca AB
    B.1.3.4CountrySweden
    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 supportAstraZeneca AB
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAstraZeneca
    B.5.2Functional name of contact pointInformation Centre
    B.5.3 Address:
    B.5.3.1Street AddressNot Applicable
    B.5.3.2Town/ cityNot Applicable
    B.5.3.3Post codeNot Applicable
    B.5.3.4CountryUnited States
    B.5.6E-mailinformation.centre@astrazeneca.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 nameSelumetinib
    D.3.2Product code AZD6244 capsula azul de 25 mg
    D.3.4Pharmaceutical form Capsule, hard
    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 INNselumetinib
    D.3.9.1CAS number 943332-08-9
    D.3.9.2Current sponsor codeAZD6244 hidrógeno sulfato
    D.3.9.3Other descriptive nameModified INN: Selumetinib hydrogen sulphate
    D.3.9.4EV Substance CodeSUB36237
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule, hard
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Locally Advanced or Metastatic Non Small Cell Lung Cancer stage IIIb - IV
    Cáncer de pulmón no microcítico localmente avanzado o metastásico (estadío IIIB - IV)
    E.1.1.1Medical condition in easily understood language
    Advanced or Metastatic Non Small Cell Lung Cancer
    Cáncer de pulmón localmente avanzado o metastásico
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the efficacy in terms of Progression-Free-Survival (PFS) of selumetinib in combination with docetaxel, compared to placebo in combination with docetaxel
    PFS using investigator site assessments according to RECIST 1.1
    Evaluar la eficacia en términos de supervivencia libre de progresión (SLP) de selumetinib comparado con docetaxel en comparación con placebo en combinación con docetaxel
    SLP usando evaluaciones del investigador del centro de investigación según los RECIST 1.1
    E.2.2Secondary objectives of the trial
    To assess the efficacy of selumetinib in combination with docetaxel, compared with placebo in combination with docetaxel in terms of
    - OS
    - ORR using investigator site assessments according to RECIST 1.1
    - DoR using investigator site assessments according to RECIST 1.1

    To assess the efficacy of selumetinib in combination with docetaxel compared with placebo in combination with docetaxel on NSCLC symptoms. ASBI of the six symptoms (appetite, fatigue, coughing, shortness of breath, blood in sputum and pain) in the LCSS will be used to assess: Time to symptom progression and Symptom improvement rate
    To assess the safety and tolerability profile of selumetinib in combination with docetaxel compared with placebo in combination in terms of AEs, Clinical chemistry, haematology and urinalysis, Vital signs and ECHO/MUGA
    To investigate the PK of selumetinib and N-desmethyl
    selumetinib when administered in combination with docetaxel (other selumetinib metabolites may also be assessed)
    Evaluar eficacia selumetinib en combinación con docetaxel, en comparación con placebo en combinación con docetaxel en términos de:Supervivencia global(SG) y tasa de respuesta objetiva(TRO) y duración de respuesta(DdR) usando evaluaciones del investigador del centro invest. según RECIST 1.1.
    Evaluar eficacia selumetinib en combinación con docetaxel, en comparación con placebo en combinación con docetaxel sobre síntomas CPNM.
    ASBI de 6 síntomas (apetito, cansancio, tos, falta de aliento, sangre en esputo y dolor) en LCSS para evaluar: Tiempo hasta progresión de síntomas y tasa mejoría de síntomas.
    Evaluar perfil seguridad y tolerabilidad de selumetinib en combinación con docetaxel en comparación con placebo en combinación con docetaxel en términos de: AA, Bioquímica, hematología y análisis de orina, constantes vitales y ECO/MUGA.
    Investigar FC de selumetinib y N-desmetil selumetinib cuando administra en combinación con docetaxel (podrían evaluarse otros metabolitos de selumetinib)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Provision of signed, written and dated informed consent prior to any study specific procedures
    Male or female, aged 18 years or older
    Histological or cytological confirmation of locally advanced or metastatic NSCLC (IIIB-IV)
    KRAS mutation positive tumour sample as determined by the designated testing laboratory
    Failure of 1st line anti-cancer therapy due to radiological documentation of disease progression in advanced disease or subsequent relapse of disease following 1st line therapy
    Obtención del consentimiento informado firmado, escrito y fechado con anterioridad a la realización de cualquiera de los procedimientos específicos del ensayo.
    Hombre o mujer, de 18 o más años.
    Confirmación histológica o citológica de CPNM localmente avanzado o metastásico (IIIB-IV).
    Muestra tumoral positiva para mutación de KRAS determinada por el laboratorio designado.
    Fracaso del tratamiento antineoplásico de 1ª línea (ya sea documentación radiológica de progresión de la enfermedad o debido a toxicidad) en la enfermedad avanzada o recidiva posterior de la enfermedad después del tratamiento de 1ª línea.
    E.4Principal exclusion criteria
    Mixed small cell and non-small cell lung cancer histology
    Received >1 prior anti-cancer drug regimen for advanced or metastatic NSCLC. Patients who develop disease progression while on switch maintenance therapy (maintenance using an agent not in the first-line regimen) will not be eligible.
    Any systemic anti-cancer therapy within 4 weeks prior to starting study treatment (6 weeks for nitrosoureas, mitomycin, and suramin) or any anti-cancer therapy which has not been cleared from the body by the time of starting study treatement.
    Prior treatment with a MEK inhibitor or any docetaxel-containing regimen (prior treatment with paclitaxel is acceptable)
    Histología de cáncer de pulmón no microcítico
    Haber recibido > 1 régimen de medicamentos oncológicos para el CPNM avanzado o metastásico. No serán elegibles los pacientes que desarrollen progresión de la enfermedad mientras estén en terapia de mantenimiento de cambio (mantenimiento usando un agente que no esté en el régimen de primera línea).
    Estar recibiendo o haber recibido terapia oncológica sistémica dentro de las 4 semanas previas al comienzo del tratamiento del ensayo (6 semanas para las nitrosoureas, mitomicina y suramina) o cualquier tratamiento oncológico que no se haya eliminado del cuerpo en el momento de comenzar el tratamiento del ensayo.
    Tratamiento previo con un inhibidor de MEK o cualquier régimen con docetaxel (es aceptable el tratamiento previo con paclitaxel).
    E.5 End points
    E.5.1Primary end point(s)
    Progression-Free Survival (PFS)

    Progression free survival is defined as the time from randomisation until the date of objective disease progression (RECIST 1.1) or death (by any cause in the absence of progression).
    Supervivencia libre de progresión (SLP)
    La supervivencia libre de progresión se define como el tiempo desde la aleatorización hasta la fecha de la progresión objetiva (RECIST 1.1) de la enfermedad o la muerte (por cualquier causa en ausencia de progresión).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Measured at baseline until the date of first documented objective disease progression, assessed up to 33 months
    Medido desde el momento basal hasta la fecha de la primera progresión objetiva de la enfermedad documentada, evaluado hasta los 33 meses.
    E.5.2Secondary end point(s)
    Overall Survival (OS)
    Overall Survival is defined as the time from the date of randomisation until death due to any cause.
    Objective Response Rate (ORR)
    ORR is defined as the number (%) of subjects with at least one visit response of complete response (CR) or partial response (PR).
    Duration of Response (DoR)
    Duration of response will be defined as the time from the date of first documented response until date of documented progression or death in the absence of disease progression.


    Symptom improvement rate (using ASBI from LCSS)
    Time to symptom progression (using ASBI from LCSS)

    The safety and tolerability profie of Selumetinib in Combination with Docetaxel by assessing of adverse events, Clinical chemistry, haematology and urinalysis, vital signs, ECG and Echocardiogram

    The pharmacokinetics (PK) of selumetinib and N-desmethyl selumetinib when administered in combination with docetaxel by assessment of area under plasma concentration time curve (AUC + Cmax)
    Supervivencia global (SG)
    La SG se define como el tiempo desde la fecha de la aleatorización hasta la muerte por cualquier causa
    Tasa de respuesta objetiva (TRO)
    La TRO se define como el número (%) de sujetos con al menos una respuesta en al visita de RC o RP
    Duración de la respuesta (DdR)
    La duración de la respuesta se definirá como el tiempo desde la fecha de la primera respuesta documentada hasta la fecha de progresión documentada o la muerte en ausencia de progresión de la enfermedad.
    Tasa mejoría de síntomas (usando ASBI desde LCSS).
    Tiempo hasta progresión de síntomas (usando ASBI desde LCSS).

    La seguridad y tolerabilidad de selumetinib en combinación con docetaxel en comparación con placebo en combinación con docetaxel en términos de: AA, Bioquímica, hematología y análisis de orina, constantes vitales y ECG y Ecocardiograma.

    La Farmacocinética (FC) de selumetinib y N-desmetil selumetinib cuando administra en combinación con docetaxel evaluando el área bajo la curva de concentración plasmática (AUC + Cmax)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Overall Survival (OS)
    Measured at baseline until date of death due to any cause, assessed up to 41 months
    Objective Response Rate (ORR)
    Measured at baseline until the date of first documented objective disease progression, assessed up to 33 months
    Symptom improvement rate (using ASBI from LCSS); Measured from date of randomisation until 30 days post treatment discontinuation, assessed up to 33 months Time to symptom progression (using ASBI from LCSS); Measured from date of randomisation until 30 days post treatment discontinuation, assessed up to 33 months.

    The safety and tolerability profie of Selumetinib in Combination with Docetaxel; Measured from date of randomisation until 30 days post treatment discontinuation, assessed up to 33 months

    PK samples will be taken on day 22
    Supervivencia global:Medida desde momento basal hasta muerte por cualquier causa, evaluado hasta 41 meses.
    Tasa respuesta objetiva;Medida desde momento basal hasta fecha de la primera progresión objetiva documentada, evaluado hasta 33 meses. Tasa mejoría síntomas(usando ASBI desde LCSS); Medida desde fecha aleatorización hasta 30 días después de discontinuación de tratamiento, evaluado hasta 33 meses. Tiempo hasta progresión síntomas(usando ASBI desde LCSS);Medido desde fecha aleatorización hasta 30 días después de discontinuación de tratamiento, evaluado hasta 33 meses. Seguridad y tolerabilidad de selumetinib en combinación con docetaxel; Medida desde fecha aleatorización hasta 30 días después de discontinuación del tratamiento, evaluado hasta 33 meses. Muestras FC se tomarán el día 22.
    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 No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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 Yes
    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 EEA100
    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
    Argentina
    Australia
    Brazil
    Bulgaria
    Canada
    Chile
    France
    Germany
    Hungary
    Israel
    Italy
    Mexico
    Netherlands
    Poland
    Romania
    Russian Federation
    Spain
    Turkey
    Ukraine
    United Kingdom
    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
    LVLS
    La última visita del último sujeto que participe en el ensayo
    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 months5
    E.8.9.1In the Member State concerned days14
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months5
    E.8.9.2In all countries concerned by the trial days14
    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: 190
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 444
    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 state25
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 320
    F.4.2.2In the whole clinical trial 634
    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)
    Standard of care
    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 Decision2013-11-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-10-30
    P. End of Trial
    P.End of Trial StatusTemporarily Halted
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