Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43876   clinical trials with a EudraCT protocol, of which   7294   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2015-003780-11
    Sponsor's Protocol Code Number:PPHM1401
    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:2016-02-03
    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 number2015-003780-11
    A.3Full title of the trial
    An Open-Label, Randomized, Phase II/III Trial of Taxane Therapy With or Without Bavituximab for the Treatment of HER2-Negative Metastatic Breast Cancer
    Ensayo de fase II/III, abierto y aleatorizado, del tratamiento con un taxano, con o sin bavituximab, de pacientes con cáncer de mama metastásico negativo para HER-2
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical study investigating Taxane Therapy With or Without Bavituximab for the Treatment of HER2-Negative Metastatic Breast Cancer
    Estudio clínico para investigar la terapia de taxano, con o sin bavituximab para el tratamiento del cáncer de mama metastásico negativo para HER-2.
    A.4.1Sponsor's protocol code numberPPHM1401
    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 SponsorPeregrine Pharmaceuticals 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 supportPeregrine Pharmaceuticals, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPeregrine Pharmaceuticals Inc.
    B.5.2Functional name of contact pointManager Clinical Research
    B.5.3 Address:
    B.5.3.1Street Address14282 Franklin Avenue
    B.5.3.2Town/ cityTustin
    B.5.3.3Post codeCA 92780
    B.5.3.4CountryUnited States
    B.5.4Telephone number34913913443
    B.5.5Fax number1714551 1264
    B.5.6E-mailbreastcancertrial@peregrineinc.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 nameBavituximab
    D.3.4Pharmaceutical form 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 INNBAVITUXIMAB
    D.3.9.1CAS number 648904-28-3
    D.3.9.3Other descriptive namech3G4
    D.3.9.4EV Substance CodeSUB177207
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number24
    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.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 HER2-negative breast cancer
    cáncer de mama metastásico negativo para HER-2
    E.1.1.1Medical condition in easily understood language
    metastatic breast cancer
    cáncer de mama metastásico
    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 LLT
    E.1.2Classification code 10027475
    E.1.2Term Metastatic breast cancer
    E.1.2System Organ Class 100000004864
    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 efficacy of bavituximab in combination with taxane therapy in patients with MBC
    Evaluar la eficacia del tratamiento con bavituximab en combinación con un taxano en pacientes con cáncer de mama metastásico (CMM)
    E.2.2Secondary objectives of the trial
    To characterize the safety and tolerability of bavituximab plus taxane therapy in patients with MBC

    Exploratory:
    - to assess immune effects in patients treated with bavituximab in combination with taxane therapy
    - serum levels of beta2-GP1
    caracterizar la seguridad y la tolerabilidad del tratamiento con bavituximab más un taxano en pacientes con CMM.

    Exploratorio:
    - evaluar los efectos inmunitarios en pacientes tratados con bavituximab en combinación con un taxano.
    - niveles séricos de beta2-GP1
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Written informed consent obtained prior to screening.
    2. Females or males at least 18 years of age.
    3. Histologically or cytologically documented metastatic HER2-negative breast cancer.
    4. Measurable disease per RECIST 1.1 (Phase II; Appendix 2); evaluable disease (Phase III).
    5. ECOG performance status of 0 or 1 (Appendix 1).
    6. Adequate hematologic function: absolute neutrophil count >=1500 cells/microL; hemoglobin >=9 g/dL; platelets >=100,000/microL.
    7. Adequate renal function: serum creatinine <=1.8 mg/dL or calculated creatinine clearance >50 mL/min using the Cockcroft-Gault equation.
    8. Adequate hepatic function: total bilirubin <= upper limit of normal (ULN), serum albumin >=3.0 g/dL, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) <=1.5 × ULN. ALT and/or AST may be <=5 × ULN if due to liver metastases. If ALT or AST is >1.5 and <=5 × ULN in patients with liver metastases, alkaline phosphatase must be <=2.5 × ULN. Patients with Gilbert's syndrome are allowed if total bilirubin is <=2 × ULN and direct bilirubin is <=ULN.
    9. Prothrombin time (PT) and/or international normalized ratio (INR) <=1.5 × ULN and activated partial thromboplastin time (aPTT) <=1.5 × ULN if patient is not on anticoagulant therapy (a therapeutic PT and/or INR and aPTT is acceptable if the
    patient is on anticoagulants).
    10. Patients must have a negative serum human chorionic gonadotropin (hCG) test within 1 week of Day 1 (pregnancy test not required for patients with bilateral oophorectomy and/or hysterectomy or for those patients who are >1 year postmenopausal).
    11. All patients of reproductive potential (ie, not surgically sterile or postmenopausal) must agree to use a highly effective method of contraception (<1% failure rate per year) during and 3 months after end of study treatment (female) or during and 6 months after end of study treatment (male).
    1. Consentimiento informado por escrito obtenido antes del examen de selección inicial.
    2. Mujeres o varones de edad igual o superior a 18 años.
    3. Cáncer de mama HER-2-negativo, metastásico, documentado mediante histología o citología.
    4. Enfermedad medible según los criterios RECIST 1.1 (fase II; Apéndice 2); enfermedad evaluable (fase III).
    5. Estado funcional ECOG 0 o 1 (Apéndice 1).
    6. Función hematológica adecuada: recuento absoluto de neutrófilos >= 1500 células/microL; hemoglobina >= 9 g/dL; plaquetas >= 100.000/microL.
    7. Función renal adecuada: creatinina sérica <= 1,8 mg/dL o bien aclaramiento de creatinina > 50 mL/min calculado con el empleo de la ecuación de Cockcroft-Gault.
    8. Función hepática adecuada: bilirrubina total <= límite superior de la normalidad (LSN), albúmina en suero >= 3,0 g/dL, alanina aminotransferasa (ALT) y aspartato aminotransferasa (AST) <= 1,5 × LSN. Los valores de ALT y/o AST pueden ser <= 5 × LSN si se deben a metástasis hepáticas. Si la ALT o la AST es > 1,5 y <= 5 × LSN en pacientes con metástasis hepáticas, la fosfatasa alcalina debe ser <= 2,5 × LSN. Los pacientes con síndrome de Gilbert pueden ser aceptados en el estudio si el valor de bilirrubina total es <= 2 × LSN y la bilirrubina directa es <= LSN.
    9. Tiempo de protrombina (TP) y/o ratio normalizada internacional (INR) <= 1,5 × LSN y tiempo de tromboplastina parcial activado (TTPa) <= 1,5 × LSN si el paciente no está recibiendo un tratamiento anticoagulante (un TP y/o una INR y TTPa terapéuticos son aceptables si el paciente está recibiendo tratamiento con anticoagulantes).
    10. Las pacientes deben tener una prueba de gonadotropina coriónica humana (hCG) en suero negativa en un plazo de 1 semana respecto al Día 1 del estudio (no es necesaria una prueba de embarazo en las pacientes con antecedentes de ooforectomía bilateral y/o histerectomía ni en las que han estado en estado postmenopáusico desde hace > 1 año).
    11. Todos los pacientes con potencial fértil (es decir, sin esterilización quirúrgica ni estado postmenopáusico) deben aceptar el uso de un método de anticoncepción de alta eficacia (tasa de fallos < 1 % al año) durante y en los 3 meses posteriores a la finalización del tratamiento del estudio (mujeres) o bien durante y hasta 6 meses después de la finalización del tratamiento en estudio (varones).
    E.4Principal exclusion criteria
    1. HER2-positive breast cancer.
    2. Less than 6 months since last dose of prior adjuvant non-taxane regimen.
    3. Less than 12 months since last dose of prior adjuvant taxane-containing regimen.
    4. Any chemotherapy regimen for MBC within 3 weeks before Day 1.
    5. Known history of bleeding diathesis or coagulopathy (eg, von Willebrand disease or hemophilia).
    6. Bleeding
    a) Clinically significant bleeding, such as gross hematuria, gastrointestinal bleeding, and hemoptysis within the 6 months before screening, unless the cause has been identified and adequately treated (eg, cystitis, ulcer).
    b) Minor biopsy-related bleeding lasting <24 hours and resolved at least 1 week before Day 1 is allowed.
    7. Thromboembolic events (eg, deep vein thrombosis, pulmonary embolism, arterial thrombosis) within 6 months before screening.
    8. Grade 2 or higher peripheral neuropathy (eg, numbness, tingling, and/or pain in distal extremities).
    9. Radiotherapy within 1 week preceding Day 1; ongoing acute toxicity from prior radiotherapy.
    10. Either symptomatic or clinically active brain metastases (ie, requiring ongoing treatment). Patients are eligible if brain metastases are adequately treated. Patients must be either off corticosteroids, or on a stable or decreasing dose of <=10 mg daily prednisone (or equivalent).
    11. Major surgery within 4 weeks of Day 1.
    12. Uncontrolled intercurrent disease (eg, diabetes, hypertension, thyroid disease, active infections).
    13. Autoimmune disease, being treated with immunosuppressive drugs (eg, methotrexate or biological agents), or other conditions requiring immunosuppressive therapy (eg, prior allotransplantation).
    14. History of hypersensitivity to bavituximab, docetaxel, paclitaxel, or to any of their excipients.
    15. Symptomatic coronary artery disease, cerebrovascular accident or transient ischemic attack, myocardial infarction, arterial embolism, or unstable angina pectoris within 6 months of screening.
    16. Currently pregnant, nursing, or planning a pregnancy during the study.
    17. Investigational therapy within 28 days prior to Day 1.
    18. Patient has a condition or is in a situation which, in the investigator's opinion, may put the patient at significant risk, may confound the study results, or may interfere significantly with the patient's participation in the study.
    1. Cáncer de mama HER-2-positivo.
    2. Menos de 6 meses transcurridos desde la última dosis de una pauta de tratamiento adyuvante distinta de los taxanos.
    3. Menos de 12 meses transcurridos desde la última dosis de una pauta de tratamiento adyuvante con contenido de taxanos.
    4. Cualquier régimen de quimioterapia para el CMM en las 3 semanas anteriores al Día 1.
    5. Antecedentes conocidos de diátesis hemorrágica o de coagulopatía (por ejemplo, enfermedad de von Willebrand o hemofilia).
    6. Sangrado
    a) Sangrado clínicamente relevante, como hematuria macroscópica, hemorragia digestiva o hemoptisis en los 6 meses previos al examen de selección inicial, a no ser que se haya identificado la causa y se haya tratado de manera adecuada (por ejemplo, cistitis, úlcera).
    b) Se acepta un sangrado de carácter menor asociado a una biopsia y de una duración < 24 horas que se resuelve al menos 1 semana antes del Día 1 del estudio.
    7. Episodios tromboembólicos (por ejemplo, trombosis venosa profunda, embolia pulmonar, trombosis arterial) en los 6 meses previos al examen de selección inicial.
    8. Neuropatía periférica de grado 2 o superior (por ejemplo, entumecimiento, hormigueo y/o dolor en partes distales de extremidades).
    9. Radioterapia en el plazo de 1 semana antes del Día 1 del estudio; toxicidad aguda persistente tras una radioterapia previa.
    10. Metástasis cerebrales sintomáticas o bien clínicamente activas (es decir, que requieran un tratamiento continuado). Los pacientes son considerados aptos para el estudio si las metástasis cerebrales son tratadas de forma adecuada. Los pacientes deben estar sin tratamiento con corticosteroides o bien deben recibir una dosis estable o decreciente de <= 10 mg al día de prednisona (o su equivalente).
    11. Intervención de cirugía mayor en un plazo de 4 semanas respecto al Día 1 del estudio.
    12. Enfermedad intercurrente no controlada (por ejemplo, diabetes, hipertensión, enfermedad tiroidea, infecciones activas).
    13. Enfermedad autoinmune, en tratamiento con fármacos inmunosupresores (por ejemplo, metotrexato o fármacos biológicos), o bien otros trastornos que requieran un tratamiento inmunosupresor (por ejemplo, antecedentes previos de alotrasplante).
    14. Antecedentes de hipersensibilidad a bavituximab, docetaxel, paclitaxel o a cualquiera de sus excipientes.
    15. Enfermedad arterial coronaria sintomática, accidente vascular cerebral o ataque isquémico transitorio, infarto de miocardio, embolia arterial o angina de pecho inestable en los 6 meses previos al examen de selección inicial.
    16. Embarazo actual, lactancia o previsión de embarazo durante el estudio.
    17. Uso de un tratamiento en fase de investigación en los 28 días previos al Día 1 del estudio.
    18. El paciente presenta un trastorno o se encuentra en una situación que, en opinión del investigador, puede comportar un riesgo significativo, puede introducir una confusión en los resultados del estudio o puede interferir de forma importante en la participación del paciente en el estudio.
    E.5 End points
    E.5.1Primary end point(s)
    Phase II:
    ORR: percentage of patients whose best overall response is complete or partial response (CR or PR).

    Phase III:
    PFS
    Fase II:
    Tasa de respuesta global (TRO): porcentaje de pacientes en los que la mejor respuesta global es una respuesta completa o parcial (RC o RP).

    Fase III:
    Supervivencia sin progresión (SSP)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Tumor response will be assessed radiographically every 8 weeks (±3 days) for the first approximately 24 weeks, then every 12 weeks (±3 days) thereafter.
    La respuesta tumoral se evaluará radiográficamente cada 8 semanas (+/- 3 días) durante aproximadamente las primeras 24 semanas, y a partir de entonces cada 12 semanas (+/- 3 días).
    E.5.2Secondary end point(s)
    Phase II efficacy:
    - disease control rate (DCR): percentage of patients whose best overall response is CR, PR, or stable disease
    - DOR: number of days from first CR or PR (whichever is first recorded) until the first documented tumor progression (per RECIST 1.1; Appendix 2) or death due to any cause, whichever occurs first
    - PFS: number of days from randomization until the first documented tumor progression (per RECIST 1.1) or death due to any cause, whichever occurs first
    - overall survival (OS): number of days from randomization until death regardless of cause

    Phase III efficacy:
    - ORR
    - DCR
    - DOR
    - OS

    Safety endpoints:
    - AEs
    - laboratory measurements: hematology (complete blood count with differential; platelets), biochemistry, and ADA

    Exploratory endpoints:
    - immune correlates
    - serum levels of beta2-GP1
    Fase II (Eficacia)
    - tasa de control de la enfermedad (TCE): porcentaje de pacientes en los que la mejor respuesta global es una RC, RP o una enfermedad estable.
    - DR: Número de días transcurridos desde la primera RC o RP (optando por la que se registre antes) hasta la primera progresión del tumor documentada (según los criterios RECIST 1.1; Apéndice 2) o la muerte por cualquier causa, optando por lo que suceda antes.
    - SSP: número de días transcurridos desde la aleatorización hasta la primera progresión del tumor documentada (según los criterios RECIST 1.1) o la muerte por cualquier causa, optando por lo que ocurra antes.
    - supervivencia global (SG): número de días transcurridos desde la asignación aleatoria hasta la muerte con independencia de su causa.

    Fase III (Eficacia)
    - TRO
    - TCE
    - DR
    - SG

    Variables de valoración secundarias de seguridad
    - AA
    - determinaciones de análisis de laboratorio: hematología (hemograma completo con fórmula leucocitaria; plaquetas), bioquímica y ADA.

    Exploratorias
    - parámetros inmunitarios correlacionados
    - niveles séricos de beta2-GP1
    E.5.2.1Timepoint(s) of evaluation of this end point
    Hematology and biochemistry: Day 1 of each 3-week cycle or Days 1, 8, 15 of each 4-week cycle.
    ADA: Q8W for 24W, then Q12W
    Hematología y bioquímica: Día 1 de cada ciclo de 3 semanas ó Día 1, 8, 15 de cada ciclo de 4 semanas.
    ADA: cada 8 semanas durante 24 semanas, y luego cada 12 semanas
    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 No
    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 Yes
    E.6.13.1Other scope of the trial description
    Tumor tissue for ImmunoProfiling and gene expression
    Análisis de tejido tumoral para determinar el inmunoperfil y la expresión génica
    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) 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 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
    Terapia habitual con taxanos sin Bavituximab
    Standard Therapy Taxane without Bavituximab
    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 EEA165
    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
    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
    Last Visit [i.e. survival assessment (can be by telephone)] Last Subject
    Última visita del último paciente (Determinación de la supervivencia (puede llevarse a cabo por teléfono)
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned 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 months6
    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: 470
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 83
    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 state80
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 276
    F.4.2.2In the whole clinical trial 553
    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)
    The investigator is responsible for ensuring that consideration has been given to the post-trial care of the subject's medical condition including subsequent anticancer therapy (if applicable)
    El investigador será responsable de asegurar que se consideren las opciones de tratamiento para la condición médica del paciente tras el estudio, incluyendo las terapias subsecuentes contra el cáncer (si aplica)
    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 Decision2016-03-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-03-09
    P. End of Trial
    P.End of Trial StatusOngoing
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Thu May 09 22:55:49 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA