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    Summary
    EudraCT Number:2015-004544-18
    Sponsor's Protocol Code Number:CL2-95005-002
    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:2016-02-19
    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 number2015-004544-18
    A.3Full title of the trial
    An open-label, randomised, phase 2 study comparing S 95005 plus bevacizumab to capecitabine plus bevacizumab in patients with previously untreated metastatic colorectal cancer who are non-eligible for intensive therapy
    Estudio abierto, aleatorizado, fase 2 que compara S 95005 con bevacizumab frente a capecitabina con bevacizumab en pacientes con cáncer colorrectal metastásico no tratado previamente que no son candidatos para una terapia intensiva
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A phase 2 study comparing S 95005 plus bevacizumab to capecitabine plus bevacizumab in patients with previously untreated colorectal cancer who are non-eligible for intensive therapy
    Estudio fase 2 en el que se compara S 95005 con bevacizumab frente a capecitabina con bevacizumab en pacientes con cáncer colorrectal metastásico no tratado previamente que no son candidatos para una terapia intensiva
    A.4.1Sponsor's protocol code numberCL2-95005-002
    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 SponsorLaboratorios Servier S.L.
    B.1.3.4CountrySpain
    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 supportLaboratorios Servier S.L.
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationLaboratorios Servier S.L.
    B.5.2Functional name of contact pointDpto. Investigación y Desarrollo
    B.5.3 Address:
    B.5.3.1Street AddressAvda. de los Madroños 33
    B.5.3.2Town/ cityMadrid
    B.5.3.3Post code28043
    B.5.3.4CountrySpain
    B.5.4Telephone number+3491 748 90 14
    B.5.5Fax number+3491 300 32 49
    B.5.6E-mailitziar.fernandezgonzalez@servier.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 Yes
    D.2.1.1.1Trade name Lonsurf
    D.2.1.1.2Name of the Marketing Authorisation holderTaiho Pharmaceutical Co., Ltd
    D.2.1.2Country which granted the Marketing AuthorisationJapan
    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 nameS95005
    D.3.2Product code S95005
    D.3.4Pharmaceutical form Film-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 INNTRIFLURIDINE
    D.3.9.3Other descriptive nameTRIFLURIDINE
    D.3.9.4EV Substance CodeSUB11291MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number15
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTIPIRACIL HYDROCHLORIDE
    D.3.9.3Other descriptive nameTIPIRACIL HYDROCHLORIDE
    D.3.9.4EV Substance CodeSUB174132
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number7.065
    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 Yes
    D.2.1.1.1Trade name Lonsurf
    D.2.1.1.2Name of the Marketing Authorisation holderTaiho Pharmaceutical Co., Ltd
    D.2.1.2Country which granted the Marketing AuthorisationJapan
    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 nameS95005
    D.3.2Product code S95005
    D.3.4Pharmaceutical form Film-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 INNTRIFLURIDINE
    D.3.9.3Other descriptive nameTRIFLURIDINE
    D.3.9.4EV Substance CodeSUB11291MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTIPIRACIL HYDROCHLORIDE
    D.3.9.3Other descriptive nameTIPIRACIL HYDROCHLORIDE
    D.3.9.4EV Substance CodeSUB174132
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number9.42
    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: 3
    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 Yes
    D.2.1.1.1Trade name Avastin
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Registration Limited
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 namebevacizumab
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    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 INNBEVACIZUMAB
    D.3.9.1CAS number 216974-75-3
    D.3.9.4EV Substance CodeSUB16402MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    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 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) 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 Yes
    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: 4
    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 Yes
    D.2.1.1.1Trade name Avastin
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Registration Limited
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 namebevacizumab
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    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 INNBEVACIZUMAB
    D.3.9.1CAS number 216974-75-3
    D.3.9.4EV Substance CodeSUB16402MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    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 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) 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 Yes
    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: 5
    D.1.2 and D.1.3IMP RoleComparator
    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 Yes
    D.2.1.1.1Trade name Xeloda
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Registration Limited
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameCapecitabine
    D.3.4Pharmaceutical form Film-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 INNCapecitabine
    D.3.9.3Other descriptive nameCAPECITABINE
    D.3.9.4EV Substance CodeSUB12474MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    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: 6
    D.1.2 and D.1.3IMP RoleComparator
    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 Yes
    D.2.1.1.1Trade name Xeloda
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Registration Limited
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameCapecitabine
    D.3.4Pharmaceutical form Film-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 INNCapecitabine
    D.3.9.3Other descriptive nameCAPECITABINE
    D.3.9.4EV Substance CodeSUB12474MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number500
    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
    Metastatic colorectal cancer
    Cancer colorectal metastásico
    E.1.1.1Medical condition in easily understood language
    Colorectal cancer
    Cancer colorectal
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.1
    E.1.2Level PT
    E.1.2Classification code 10052358
    E.1.2Term Colorectal cancer metastatic
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the progression-free survival (PFS) in patients receiving S 95005 + bevacizumab (experimental arm) or capecitabine + bevacizumab (control arm) as first-line treatment for metastatic colorectal cancer in patients non-eligible for intensive therapy.
    Evaluar la supervivencia libre de progresión (SLP) en pacientes que reciban S95005+ bevacizumab (brazo experimental) ó capecitabina +bevacizumab (brazo control) como primera línea de tratamiento para el cancer colorectal metastásico en pacientes que no son candidatos para una terapia intensiva.
    E.2.2Secondary objectives of the trial
    ­To evaluate the­ overall response rate (ORR), ­duration of response (DR), disease control rate (DCR), overall survival (OS), safety and tolerability, quality of life (QoL) in patients receiving S 95005 + bevacizumab (experimental arm) or capecitabine + bevacizumab (control arm) as first-line treatment for metastatic colorectal cancer in patients non-eligible for intensive therapy.
    Exploratory: Evaluate the biomarkers potentially predictive of response and resistance to S 95005 given in combination using blood samples and archived tumour biopsy (if available).
    Evaluar la ­ Tasa de respuesta global (TRG), duración de la respuesta (DR), tasa de control de la enfermedad (TCE), supervivencia global (SG)
    ,tolerabilidad y seguridad, calidad de vida en pacientes que reciban S95005+ bevacizumab (brazo experimental) ó capecitabina +bevacizumab (brazo control) como primera línea de tratamiento para el cancer colorectal metastásico en pacientes que no son candidatos para una terapia intensiva.
    Exploratorio: ­Evaluar los biomarcadores potencialmente predictivos de respuesta y resistencia a S 95005 dado en combinación, utilizando muestras de sangre y biopsias tumorales archivadas (si están disponibles).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Written informed consent obtained.
    - Male or Female participant aged ?18 years old.
    - Has ECOG performance status of 0, 1 or 2 at the time of the randomisation.
    - Has definitive histologically or cytologically confirmed adenocarcinoma of the colon or rectum.
    - RAS status must have been determined (mutant or wild).
    - Has at least one measurable metastatic lesion.
    - No previous anticancer therapy for metastatic colorectal cancer.
    - Previous adjuvant (or neoadjuvant for patients with rectal cancer) chemotherapy is allowed only if if it has been completed more than 6 months before start of study treatment.
    - In the judgment of the Investigator, patient is not a candidate for combination chemotherapy with irinotecan or oxaliplatin, or for curative resection of metastatic lesions.
    - Is able to take medication orally (i.e., no feeding tube).
    - Has adequate organ function.
    - Coagulation parameters in normal limit.
    - Women of childbearing potential must have been tested negative in a serum pregnancy test. Male and female patients who have the potential to reproduce must agree to use a highly effective method of birth control.
    - Is willing and able to comply with scheduled visits and study procedures.
    -Obtener el consentimiento informado por escrito
    -Paciente hombre o mujer de ? 18 años.
    -Estado funcional ECOG de 0, 1 o 2 en el momento de la aleatorización
    -Adenocarcinoma de colon o recto histológica o citológicamente confirmado.
    -Estado del biomarcador RAS determinado (mutado o salvaje).
    -Presentar, como mínimo, una lesión metastásica medible
    - No terapia antineoplásica previa para el cáncer colorrectal metastásico.
    - Sólo se permite quimioterapia adyuvante previa (o neoadyuvante para pacientes con cáncer rectal) si ha transcurrido más de 6 meses desde su finalización y el inicio de la medicación del estudio.
    -Según la opinión del investigador, el paciente no es candidato para la quimioterapia combinada con irinotecán u oxaliplatino.
    -Capacidad de tomar el medicamento por vía oral(es decir, sin sonda nasogástrica).
    -Adecuada función orgánica
    -Parámetros de la coagulación dentro de los limtes de normalidad
    -Las mujeres en edad fértil deben haber obtenido un resultado negativo en la prueba de embarazo en suero . Los pacientes hombres y mujeres que estén en edad fertil deben aceptar el uso de un método anticonceptivo altamente eficaz .
    -Está dispuesto y puede cumplir con las visitas programadas y los procedimientos del estudio.
    E.4Principal exclusion criteria
    - Foreseeable poor compliance to the study procedures.
    - Is a pregnant or lactating female.
    - Is inappropriate for entry into this study in the judgment of the Investigator.
    - Has certain serious illness or serious medical condition(s) described in the protocol.
    - Has had certain other recent treatment e.g. major surgery, field radiation, received investigational agent, within the specified time frames prior to study drug administration.
    - Has previously received S 95005 or history of allergic reactions attributed to compounds of similar or biologic composition to S 95005.
    -Bajo cumplimiento predecible de los procedimientos del estudio.
    -Mujer embarazada o lactante.
    -No es adecuada su inclusión en este estudio según la opinión del investigador.
    -Presenta una enfermedad grave o una condición médica grave descrita en el protocolo.
    -Haber tenidociertos tratamientos como por ejemplo: cirugia mayor, radiación de campo, haber recibido agentes en investigación, durante el periodo de tratamiento previo a la administración de la medicación del estudio.
    -Haber recibido previamente s95005 ó antecedentes de reacciones alérgicas a compuestos de composición biológica similar a la del S95005.
    E.5 End points
    E.5.1Primary end point(s)
    Progression free survival (PFS)
    Supervicencia libre de progresión
    E.5.1.1Timepoint(s) of evaluation of this end point
    Tumour measurements within 28 days prior to Day 1 of Cycle 1 and every 8 weeks thereafter.
    Evaluaciones tumorales en los 28 días previos al día 1 del ciclo 1 y posteriormente cada 8 semanas.
    E.5.2Secondary end point(s)
    - Overall Response Rate (ORR).
    - Duration of Response (DR) ­
    - Disease control rate (DCR)
    ­- Overall Survival
    ­- Safety and tolerability assessed by:
    ? Incidence of Adverse Events (AE).
    ? Laboratory tests: haematology, blood biochemistry, coagulation, urinalysis.
    ? Physical examination and performance status (ECOG).
    ? Vital signs: blood pressure (BP), heart rate (HR), body temperature, respiration rate, body weight.
    ? 12-leads ECG parameters.
    - Quality of Life assessed by a quality of life questionnaire.
    - Exploratory endpoints:Biomarkers using blood samples and archived tumour biopsy (if available).
    ­- Tasa de respuesta global (TRG)
    ­- Duración de la respuesta (DR)
    ­- Tasa de control de la enfermedad (TCE)
    ­- Supervivencia global (SG)
    ­- Tolerabilidad y seguridad evaluada mediante:
    -Incidencia de Acontecimeintos Adversos
    -Pruebas de laboratorio: hematología, bioquímica en sangre, coagulación y urianálisis.
    -Exploración física y estado funcional (ECOG)
    -Constantes vitales: presión arterial (PA), frecuencia cardíaca (FC), temperatura corporal, frecuencia respiratoria y peso corporal.
    ? -ECG de 12 derivaciones.
    -Calidad de vida evaluada mediante cuestionarios de calidad de vida.
    -Criterios exploratorios de valoración: Biomarcadores utilizando muestras de sangre y biopsias tumorales archivadas (si están disponibles).
    E.5.2.1Timepoint(s) of evaluation of this end point
    - ORR, DR, DCR: tumour measurements within 28 days prior to Day 1 of Cycle 1 and every 8 weeks thereafter.
    ­- Overall Survival: survival status obtained at scheduled 8-week intervals until patient death or until 100 PFS events are reached and the final analysis has been performed.
    - Adverse Events: all over the study.
    - Laboratory tests, physical exam, ECOG, vital signs: within 5 days prior randomisation, within 3 days prior C1D1, C1D15 (except for coagulation, physical exam, ECOG), Day 1 of subsequent cycles, Day 15 of subsequent cycles (only for vital signs), withdrawal visit.
    - Quality of life assessments: every 12 weeks.
    - Biomarkers measurements: blood samples collected at C1D1 and withdrawal visit.
    TRG, DR y TCE: evaluaciones tumorales en los 28 días previos C1D1 y luego cada 8 semanas.
    SG: estado de supervivencia obtenido cada 8 semanas hasta que el paciente fallezca ó hasta que se alcancen 100 acontecimientos de supervivencia libre de progresión y se haya realizado el análisis final.
    AA: a lo largo de todo el estudio.
    Pruebas de laboratorio, exploración física, ECOG, constantes vitales: en los 5 días previos a la aleatorización , en los 3 días previos a C1D1, C1D15 (excepto coagulación, exploración física y el ECOG) en el D1 de los siguientes ciclos , en el D15 de los siguientes ciclos sólo constantes vitales), en la visita de retirada.
    Evaluaciones de Q de V: cada 12 sem
    mediciones de biomarcadores: muestras sangre recogidas en C1D1 y en la visita de retirada.
    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 No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    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 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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Capecitabina
    Capecitabine
    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 EEA45
    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
    Australia
    Belgium
    Brazil
    Denmark
    France
    Germany
    Italy
    Netherlands
    Poland
    Russian Federation
    Spain
    United Kingdom
    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
    LVLS
    Ultima visita del ultimo paciente
    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 months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    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 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 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 state70
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 120
    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 the discontinuation of the IMP, the participant will access to an appropriate medical care by his doctor, who will provide the best support care.
    Specific rules may be followed in some countries according to local regulation.
    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 Decision2016-03-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-03-04
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2020-09-01
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