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    The EU Clinical Trials Register currently displays   43851   clinical trials with a EudraCT protocol, of which   7283   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).

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    Summary
    EudraCT Number:2005-005139-84
    Sponsor's Protocol Code Number:PM0259CA224J1
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2012-03-15
    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 number2005-005139-84
    A.3Full title of the trial
    Evaluation Of The Rate Of Pathological Complete Response (pCR) For Neoadjuvant Chemoradiotherapy (CT-RT) And For Chemotherapy (CT) Alone in Locally Advanced Non Small Cell Lung Cancer (LA-NSCLC): A Randomised Phase II Trial.
    Evaluación de la Tasa de Respuesta Patológica Completa (pCR) para quimioradioterapia neoadyuvante (CT-RT) y para quimioterapia (CT) sola en Cáncer de Pulmón no Microcítico Localmente Avanzado (LA-NSCLC): Ensayo Aleatorio en Fase II
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Evaluation of the rate of pathological complete response for neoadjuvant chemoradiotherapy and for chemotherapy alone in locally advanced lung cancer.
    Evaluación de la tasa de respuesta completa patológica para la quimioradioterapia neoadyuvante y para quimioterapia sola en cáncer de pulmón localmente avanzado.
    A.4.1Sponsor's protocol code numberPM0259CA224J1
    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 SponsorPIERRE FABRE MEDICAMENT
    B.1.3.4CountryFrance
    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 supportPIERRE FABRE MEDICAMENT
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPIERRE FABRE MEDICAMENT
    B.5.2Functional name of contact pointMarcello RIGGI
    B.5.3 Address:
    B.5.3.1Street Address45 place Abel Gance
    B.5.3.2Town/ cityBoulogne-Billancourt
    B.5.3.3Post code92654
    B.5.3.4CountryFrance
    B.5.4Telephone number0033149108177
    B.5.5Fax number0033149108328
    B.5.6E-mailmarcello.riggi@pierre-fabre.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 Navelbine 20mg cápsulas blandas
    D.2.1.1.2Name of the Marketing Authorisation holderPierre Fabre Ibérica S.A.
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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 nameNavelbine 20mg Soft Capsule
    D.3.4Pharmaceutical form Capsule, soft
    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 INNVinorelbine tartrate
    D.3.9.1CAS number 1253 17-39-7
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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.2.5The 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 nameCisplatin
    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 INNcisplatino
    D.3.10 Strength
    D.3.10.1Concentration unit mg/m2 milligram(s)/square meter
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.5
    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 Navelbine 30 mg capsulas blandas
    D.2.1.1.2Name of the Marketing Authorisation holderPierre Fabre Ibéica SA
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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 nameNavelbine 30mg soft capsule
    D.3.4Pharmaceutical form Capsule, soft
    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 INNVinorelbine tartrate
    D.3.9.1CAS number 1253 17-39-7
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number30
    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: 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.2.5The 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 nameCisplatin
    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 INNcisplatino
    D.3.10 Strength
    D.3.10.1Concentration unit mg/m2 milligram(s)/square meter
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    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
    Locally advanced non small cell lung cancer
    Cancer de pulmón no microcitico locamente avanzado
    E.1.1.1Medical condition in easily understood language
    Lung Cancer
    Cáncer de pulmón
    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 estimate the effect of CT-RT on pCR in resectable patients
    Estimar el efecto de la QT-RT en la RCp en pacientes resecables.
    E.2.2Secondary objectives of the trial
    ? To estimate the effect of CT alone on pCR in marginally resectable patients.
    ? To evaluate the clinical OR rate of complete surgery (R0 rate), event free survival and overall survival.
    ? To assess tolerance
    ? Estimar el efecto de la QT sola en la RCp en pacientes marginalmente resecables.
    ? Evaluar la tasa de RO clínica de la cirugía completa (tasa R0), supervivencia libre de eventos y supervivencia global.
    ? Evaluar la tolerabilidad
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    ? Patients aged between 18 and 75 years
    ? Histologically or cytologically (fine needle aspiration) proven non-small cell lung cancer (NSCLC)
    ? Untreated locally advanced inoperable stage IIIA (only pN2 confirmed by mediastinoscopy)
    ? Patients with a Karnofsky Performance Status ? 80%
    ? Adequate pulmonary function
    ? Life expectancy > 12 weeks
    ? Patients without weight loss > 10% within the previous 3 months
    ? Adequate bone marrow, hepatic and renal functions:
    -Neutrophils > 2.0 x 109/lL
    -Platelets > 100 x 109/lL
    -Haemoglobin > 12 g/dldL
    -Total Bilirubin bilirubin < 1.5 x ULN
    -Transaminases < 2.5 x ULN
    -Alkaline phosphatase < 5 x ULN
    -Glomerular Filtration Rate < 65 mlmL/min per 1.73 m2
    ? Presence of at least one measurable lesion (RECIST)
    ? Absence of any psychological, familial, sociological or geographical conditions potentially hampering compliance with the study protocol
    ? Absence of current or recent (within 2 weeks before registration) severe infection
    ? Absence of renal or hearing impairment
    ? Women of childbearing potential must be using a medically accepted method of contraception (i.e. oral contraceptives, intrauterine devices) to avoid pregnancy during the 2 months preceding the start of study treatment, throughout the study period and for up to 3 months after the last dose of study treatment in such a manner that the risk of pregnancy is minimised. Women of childbearing potential must have a negative serum or urine pregnancy test within 72 hours prior to the start of study treatment
    ? Fertile men must be using an effective method of birth control if their partners are women of childbearing potential.
    ? Patients who give written (personally signed and dated) inform consent before completing any study-related procedure.
    ? Pacientes de edad entre 18 y 75 años
    ? Con cáncer de pulmón no microcítico (CPNM) demostrado histológica o citológicamente (punción aspiración con aguja fina).
    ? Estadio IIIA irresecable localmente avanzado inoperable (sólo pN2 confirmado por mediastinoscopia)
    ? Pacientes con un Estado Funcional de Karnofsky ? 80%
    ? Función pulmonar adecuada
    ? Esperanza de vida > 12 semanas
    ? Pacientes sin pérdida de peso > 10% dentro de los 3 meses anteriores
    ? Funciones de médula ósea, hepática y renal adecuadas:
    -Neutrófilos > 2.0 x 109/L
    -Plaquetas >100 x 109/L
    -Hemoglobina >12 g/dL
    -Bilirrubina total < 1.5 x LSN
    -Transaminasas < 2.5 x LSN
    -Fosfatasa alcalina < 5 x LSN
    -Tasa de filtrado glomerular < 65 mlmL/min por 1.73 m2
    ? Presencia de al menos una lesión medible (RECIST)
    ? Ausencia de cualquier condición psicológica, familiar, sociológica o geográfica que potencialmente obstaculice el cumplimiento del protocolo del estudio.
    ? Ausencia de infección grave actual o reciente (dentro de las 2 semanas anteriores al registro)
    ? Ausencia de afectación renal o auditiva
    ? Las mujeres en edad fértil deberán usar un método anticonceptivo médicamente aceptado (por ejemplo, anticonceptivos orales, dispositivos intrauterinos) para evitar un embarazo durante los 2 meses anteriores al comienzo del tratamiento del estudio, a lo largo del periodo del estudio y durante 3 meses después de la última dosis del tratamiento del estudio, de tal modo que se minimice el riesgo de embarazo. Las mujeres en edad fértil deberán tener una prueba de embarazo negativa en suero u orina en el plazo de 72 previas al comienzo del tratamiento del estudio.
    ? Los hombres fértiles deberán usar un método de control de natalidad eficaz si sus parejas están en edad fértil.
    ? Pacientes que den consentimiento informado por escrito (personalmente firmado y fechado) antes de completar cualquier procedimiento relacionado con el estudio
    E.4Principal exclusion criteria
    ? Patients with NSCLC stages I, II, bulky IIIA (except pN2 confirmed by mediastinoscopy), IIIB and IV.
    ? With tumour extent or location precluding radical radiotherapy as specified in the protocol.
    ? Symptomatic neuropathy (sensory) > grade 1 according to the NCI Common Toxicity Criteria
    ? Hearing impairment ? Grade 2
    ?Concomitant/uncontrolled medical disorder (cardiac failure or myocardial infarction within the previous 3 months; uncontrolled hypertension or arrhythmia; uncontrolled hypercalcaemia; active infection requiring I.V. antibiotics within 2 weeks before the beginning of treatment)
    ? Weight loss > 10% within the previous 3 months.
    ? Pre-existing malignant pleural effusion.
    ? Ascites or pericardial effusion.
    ? Active secondary malignancy except appropriately treated carcinoma in situ of the cervix or skin basal cell cancer. Patients with a history of cancer and at least five years of uneventful follow up and no signs of recurrence may be eligible.
    ? Previous or concomitant treatment with other anticancer drugs during the last 5 years.
    ? Known hypersensitivity to the study drugs or to drugs with similar chemical structures.
    ? Concomitant treatment with systemic corticosteroids except chronic treatment lasting more than 1 month at low doses (? 20 mg/day of methyl prednisolone or equivalent).
    ? Significant malabsorption syndrome or disease affecting the gastrointestinal tract function and the absorption of oral drugs.
    ? Women if pregnant or breast-feeding or with Positive pregnancy test at inclusion.
    ? Male or female of childbearing potential who is unwilling or unable to use a medically accepted method to avoid pregnancy during the 2 months preceding the start of study treatment, throughout the study period and at least 3 months following the last dose of study treatment.
    ? Participation to another clinical trial with any investigational drug study (whatever the use, curative, prophylactic or diagnostic intent) within 30 days prior to registration.
    ? Pacientes con CPNM en estadios I, II, IIIA bulky (excepto pN2 probado citologica e histologicamente), IIIB y IV.
    ? Con una extensión o localización del tumor que impidan radioterapia radical, como se especifica en el protocolo.
    ?Neuropatía sintomática (sensorial) > grado 1 según los Criterios de Toxicidad Comunes del NCI.
    ? Afectación auditiva ? grado 2.
    ? Trastorno médico concomitante/descontrolado (fallo cardiaco o infarto de miocardio dentro de los 3 meses previos; hipertensión no controlada o arritmia; hipercalcemia no controlada; infección activa que requiera antibióticos I.V. dentro de las 2 semanas anteriores al comienzo del tratamiento).
    ? Pérdida de peso> 10% dentro de los 3 meses anteriores.
    ? Derrame pleural maligno preexistente.
    ?Ascitis o derrame pericárdico.
    ? Tumoración maligna secundaria activa, excepto carcinoma in situ del cérvix tratado adecuadamente o carcinoma basocelular de la piel. Los pacientes con historia de cáncer y con al menos cinco años de seguimiento sin incidentes y sin signos de recurrencia pueden ser elegibles.
    ? Tratamiento previo o concomitante con otros fármacos anticancerígenos durante los últimos 5 años.
    ? Hipersensibilidad conocida a los fármacos del estudio, o a fármacos con similares estructuras químicas.
    ?Tratamiento concomitante con corticosteroides sintéticos, excepto tratamiento crónico que dure más de un mes a dosis bajas (? 20 mg/día de metil prednisolona o equivalente).
    ? Síndrome de malabsorción significativo o enfermedad que afecte a la función del tracto gastrointestinal y a la absorción de fármacos orales.
    ? Mujeres embarazadas o lactantes, o con prueba de embarazo positiva en el momento de la inclusión.
    ? Hombres o mujeres en edad fértil que no desean o no pueden usar un método anticonceptivo, médicamente aceptado, para evitar el embarazo durante los 2 meses anteriores al comienzo del tratamiento del estudio, a lo largo del periodo del estudio y al menos 3 meses después de la última dosis del tratamiento del estudio.
    ? Participación en otro ensayo clínico con cualquier estudio de fármaco en investigación (independientemente de su uso, con intención curativa, profiláctica o de diagnóstico) en el plazo de los 30 días anteriores al registro
    E.5 End points
    E.5.1Primary end point(s)
    Pathologic complete response rate (pCR)
    La tasa de respuesta completa patológica (RCp)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Surgery will be performed between 3 and 6 weeks after the end of either CT-RT or CT alone. In these patients, pathological examination will be performed in order to establish the pCR rate.
    E.5.2Secondary end point(s)
    To estimate the effect of CT alone on pCR in marginally resectable patients.
    To evaluate the clinical OR rate of complete surgery (R0 rate), event free survival and overall survival.
    To assess tolerance
    E.5.2.1Timepoint(s) of evaluation of this end point
    Follow-up will continue until death.
    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 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 No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Chemoradiotherapy
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA12
    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 Information not present in EudraCT
    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
    Israel
    Taiwan
    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
    La fecha final de estudio será la fecha de progresión o de la recaída del último paciente evaluable, teniendo en cuenta a todos los pacientes incluidos.
    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 years2
    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 Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 160
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 160
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2012-03-15. Yes
    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 state18
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 150
    F.4.2.2In the whole clinical trial 200
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    NA
    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 Decision2006-11-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-10-09
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2007-12-05
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