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    Summary
    EudraCT Number:2013-003595-12
    Sponsor's Protocol Code Number:VEG116731/CPZP034X2203
    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:2017-10-02
    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 number2013-003595-12
    A.3Full title of the trial
    A Phase II Study of Pazopanib (GW786034, NSC# 737754) in
    Children, Adolescents and Young Adults with Refractory Solid
    Tumors
    Estudio fase II de pazopanib (GW786034, Nº NSC 737754) en niños, adolescentes y adultos jóvenes con tumores sólidos refractarios
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Pazopanib Pediatric Phase II Trial Children's Oncology Group in Solid Tumors
    Ensayo pediatrico fase II de pazopanib grupo de oncologia infantil en tumors sólidos
    A.4.1Sponsor's protocol code numberVEG116731/CPZP034X2203
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/061/2016
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorNovartis Farmacéutica, S.A.
    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 supportNovartis Pharma AG
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNovartis Farmacéutica, S.A.
    B.5.2Functional name of contact pointJavier Malpesa
    B.5.3 Address:
    B.5.3.1Street AddressGran Vía de les Corts Catalanes, 764
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08013
    B.5.3.4CountrySpain
    B.5.4Telephone number34933064464
    B.5.5Fax number34933064615
    B.5.6E-maileecc.novartis@novartis.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 Votrient
    D.2.1.1.2Name of the Marketing Authorisation holderNovartis Europharm ltd
    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 nameVotrient
    D.3.2Product code GW786034
    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 INNPAZOPANIB
    D.3.9.1CAS number 444731-52-6
    D.3.9.2Current sponsor codePZP034/ GW786034
    D.3.9.4EV Substance CodeSUB29175
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product namePazopanib
    D.3.2Product code GW786034
    D.3.4Pharmaceutical form Powder for oral suspension
    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 INNPAZOPANIB
    D.3.9.1CAS number 444731-52-6
    D.3.9.4EV Substance CodeSUB29175
    D.3.10 Strength
    D.3.10.1Concentration unit mg/g milligram(s)/gram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number384
    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 Votrient
    D.2.1.1.2Name of the Marketing Authorisation holderNovartis Europharm ltd
    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 nameVotrient
    D.3.2Product code GW786034
    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 INNPAZOPANIB
    D.3.9.1CAS number 444731-52-6
    D.3.9.2Current sponsor codePZP034/ GW786034
    D.3.9.4EV Substance CodeSUB29175
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number400
    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
    Rhabdomyosarcoma, non-rhabdomyosarcomatous soft tissue sarcoma (including synovial sarcoma, alveolar soft part sarcoma and desmoplastic small round cell tumor), Ewing sarcoma/peripheral Primitive Neuro Ectodermal Tumor (PNET), hepatoblastoma, neuroblastoma (measurable and evaluable), and osteosarcoma
    Rabdomiosarcoma, sarcoma de tejidos blandos no rabdomiosarcomatoso (incluyendo sarcoma sinovial, sarcoma de partes blandas alveolares y tumor desmoplásico de células pequeñas y redonda), Sarcoma de Ewing/ tumor neuroectodérmico primitivo periférico (PNET), Hepatoblastoma, Neuroblastoma (medible y evaluable) y osteosarcoma
    E.1.1.1Medical condition in easily understood language
    Children, adolescents and young adults have one of the above tumors that have come back after treatment or is not responding to current treatment.
    Niños, adolescents y adultos jóvenes que tengan uno de los tumores antes mencionados que hayan vuelto a aparecer después del tratamiento o no responden al tratamiento actual.
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level HLT
    E.1.2Classification code 10019825
    E.1.2Term Hepatoblastomas
    E.1.2System Organ Class 100000005101
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10029260
    E.1.2Term Neuroblastoma
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 15.1
    E.1.2Level HLGT
    E.1.2Classification code 10041299
    E.1.2Term Soft tissue sarcomas
    E.1.2System Organ Class 100000004864
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10031291
    E.1.2Term Osteosarcoma
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level HLT
    E.1.2Classification code 10039023
    E.1.2Term Rhabdomyosarcomas
    E.1.2System Organ Class 100000143528
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10015560
    E.1.2Term Ewing's sarcoma
    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 determine the investigator- assessed objective response rate of pazopanib in children, adolescents and young adults (patients) with relapsed or refractory solid tumors of the following types (each defining a cohort):
    1. rhabdomyosarcoma,
    2. non-rhabdomyosarcomatous soft tissue sarcoma, or
    3. Ewing sarcoma/peripheral Primitive Neuro Ectodermal Tumor (PNET).
    Determinar la tasa de respuestas objetivas evaluada por el investigador de pazopanib en niños, adolescentes y jóvenes adultos (pacientes) con tumores sólidos refractarios o en recidiva de los siguientes tipos (cada uno define una cohorte):
    1. rabdomiosarcoma,
    2. sarcoma de tejidos blandos no rabdomiosarcomatoso, o
    3. sarcoma de Ewing/tumor neuroectodérmico primitivo periférico (PNET)
    E.2.2Secondary objectives of the trial
    To determine the investigator- assessed objective response rate of pazopanib in children, adolescents, and young adults (patients)
    1 osteosarcoma,
    2 neuroblastoma (measurable),
    3 neuroblastoma (evaluable), or
    4 hepatoblastoma
    •To further define and describe the toxicities of oral pazopanib
    •To further characterize the pharmacokinetics (PK) of pazopanib after administration of the powder suspension formulation
    •To determine progression free-survival
    •To determine the time to progression
    •To determine the therapeutic activity
    •To assess duration of response
    •To further examine the biologic relationship between tumor response and angiogenic cytokines.
    •To assess the genotype/phenotype relationships of VEGF in children with soft tissue sarcoma.
    •To further explore pazopanib pharmacokinetic/pharmacodynamic
    •To assess overall survival (OS) in patients with relapsed or refractory solid tumors per cohort
    Determinar la tasa de respuestas objetivas evaluada por el investigador de pazopanib en niños, adolescentes y jóvenes adultos (pacientes)
    1 osteosarcoma,
    2 neuroblastoma (medible),
    3 neuroblastoma (evaluable), o
    4 hepatoblastoma
    . Definir y describir mejor las toxicidades de pazopanib oral
    . Caracterizar mejor la farmacocinética (PK) de pazopanib después de la administración de la formulación de suspensión en polvo
    . Determinar la supervivencia libre de progression
    . Determinar el tiempo hasta la progression
    . Determinar la actividad terapéutica
    . Evaluar la duración de la respuesta
    . Evaluar la relación genotipo/fenotipo del factor de crecimiento endotelial vascular (VEGF) en niños con sarcoma de tejidos blandos.
    . Explorar mejor la relación farmacocinética/farmacodinámica de pazopanib
    . Evaluar la supervivencia global (SG) en pacientes con tumores sólidos refractarios o en recidiva por cohorte
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    •Age: Patients must be at least 1 year and less than or equal to 18 years of age at the time of study entry.
    •Diagnosis: Patients must have had histologic verification of one of the malignancies listed below at original diagnosis or at relapse.
    1.Rhabdomyosarcoma
    2.Non-rhabdomyosarcomatous Soft Tissue Sarcoma (including desmoplastic small round cell tumor)
    3.Ewing Sarcoma/Peripheral PNET
    4.Osteosarcoma
    5.Neuroblastoma (Measurable)
    6.Neuroblastoma (Evaluable)
    7.Hepatoblastoma
    •Patient must have disease that has either relapsed or is refractory to prior therapy
    . Edad: El paciente deberá tener al menos 1 año y menos de o igual a 18 años en el momento de la inclusión en el estudio.
    . Diagnóstico: Los pacientes deberán disponer de verificación histológica de una de las neoplásicas malignas listadas a continuación en el diagnóstico original o en la recaída
    1. Rabdomiosarcoma
    2. Sarcoma de tejidos blandos no rabdomiosarcomatoso (incluyendo tumor desmoplásico de células pequeñas y redondas )
    3. Sarcoma de Ewing/ tumor neuroectodérmico primitivo periférico (PNET)
    4. Osteosarcoma
    5. Neuroblastoma (medible)
    6. Neuroblastoma (evaluable)
    7. Hepatoblastom
    . Los pacientes deberán presentar enfermedad en recidiva o refractaria a la terapia previa.
    E.4Principal exclusion criteria
    •Pregnant or breast-feeding women are not eligible for this study
    •Concomitant Medications
    1.Corticosteroids: Patients requiring corticosteroid who have not been on a stable or decreasing dose of corticosteroid for the 7 days prior to enrollment are not eligible.
    2.Investigational Drugs: Patients who are currently receiving another investigational drug are not eligible.
    3.Anti-Cancer Agents or Radiation Therapy: Patients who are currently receiving other anti-cancer agents or radiation therapy are not eligible.
    4.Anti-hypertensive: Patients who are currently receiving more than one anti-hypertensive medication (Grade 3) or whose blood pressure is not controlled (i.e. as defined in Section 3.2.8.) are not eligible for study enrollment.
    5.Anti-coagulation: Patients must not be on therapeutic anticoagulation. ((Warfarin (coumadin®) and/or low molecular weight heparin are prohibited.) Prophylactic anticoagulation (ie intraluminal heparin) of venous or arterial access devices is allowed.
    6.CYP3A4 Substrates and drugs causing QTc prolongation: Patients receiving drugs with a known risk of torsades de pointes are not eligible. See Appendices IIIA and IIIB and Section 4.8 for a list of enzyme inducing, enzyme inhibiting and other adversely interacting drugs and the appropriate washout periods required prior to study enrollment
    Note: This list includes the prohibition of grapefruit juice for 14 days prior to enrollment and while receiving pazopanib.
    7.Thyroid Replacement Therapy: Patients who require thyroid replacement therapy are not eligible if they have not been receiving a stable replacement dose for at least 4 weeks prior to study enrollment
    •Patients who are unable to swallow tablets or liquid are not eligible. Pazopanib cannot be administered via NG tube or G-tube
    . Las mujeres embarazadas o lactantes no son elegibles para este studio
    . Medicaciones concomitants
    1. Corticosteroides: Los pacientes que precisen corticosteroides que no hayan mantenido una dosis estable o reducida de corticosteroides durante los 7 días antes de la inclusión, no son elegibles.
    2. Fármacos en investigación: Los pacientes que estén recibiendo actualmente otro fármaco en investigación no son elegibles.
    3. Agentes antineoplásicos o radioterapia: Los pacientes que estén recibiendo actualmente otros agentes antineoplásicos o radioterapia no son elegibles.
    4. Medicación antihipertensiva: Los pacientes que estén recibiendo actualmente más de una medicación antihipertensiva (grado 3) o cuya presión arterial no esté controlada (es decir, como se define en el Apartado 3.2.8) no son elegibles para inclusión en el estudio.
    5. Anticoagulación: Los pacientes no deberán recibir anticoagulación terapéutica. (La warfarina (coumadin®) y o la heparina de bajo peso molecular están prohibidas). Se permite anticoagulación profiláctica (es decir, heparina intraluminal) de dispositivo de acceso arterial o venoso.
    6. Sustratos de CYP3A4 y fármacos que causen prolongación del QTc: Los pacientes que reciban fármacos con un riesgo conocido de torsades de pointes no son elegibles. Véase Suplemento IIIA y IIIB y Apartado 4.8 para una lista de inductores de enzimas, inhibidores de enzimas y de otros fármacos que interactúan negativamente y los periodos de lavado apropiados requeridos antes de la inclusión en el estudio.
    Nota: Esta lista incluye la prohibición del consumo de zumo de pomelo durante 14 días antes de la inclusión y mientras estén recibiendo pazopanib.
    7. Terapia sustitutiva tiroidea: Los pacientes que precisen terapia sustitutiva tiroidea no son elegibles si no han estado recibiendo una dosis de sustitución estable durante por lo menos 4 semanas antes de la inclusión en el estudio
    . Los pacientes que no puedan tragar comprimidos o líquidos no son elegibles. Pazopanib no puede administrarse a través de sonda nasogástrica o sonda gástrica
    E.5 End points
    E.5.1Primary end point(s)
    Objective response rate (ORR) for the 3 tumor types of primary interest
    Tasa de respuesta objetiva (ORR) para los 3 tipos de tumors de interés primario
    E.5.1.1Timepoint(s) of evaluation of this end point
    Primary analysis will be performed 20 weeks after LPFV in the 3 cohorts of primary interest
    Un primer analisis se realizará 20 semanas despues del LPFV en los 3 cohorts de interés primario.
    E.5.2Secondary end point(s)
    ORR for the 4 tumor types of secondary interest
    Progression-free survival (PFS)
    Overall survival (OS)
    Time to progression (TTP)
    Safety measures
    Duration of response (DoR)
    ORR para los 4 tipos de tumores de interes secundario
    supervivencia libre de progression (PFS).
    Supervivencia global (OS)
    tiempo hasta la progression (TTP)
    Medidas de seguridad
    Duración de la respuesta (DoR)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Primary analysis will be performed 20 weeks after LPFV in the 3 cohorts of primary interest
    El análisis principal se realizará 20 semanas despues de la última visita
    del ultimo paciente en los 3 cohorts de interés principal
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    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 No
    E.8.1.1Randomised No
    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 No
    E.8.2.4Number of treatment arms in the trial7
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA11
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Canada
    Czech Republic
    France
    Hungary
    Italy
    Slovakia
    Spain
    United States
    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
    One year from the date of the last patient’s first visit.
    Un año desde la fecha de la primera visita del último 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 months6
    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 Yes
    F.1.1Number of subjects for this age range: 154
    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) Yes
    F.1.1.4.1Number of subjects for this age range: 6
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 51
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 82
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 15
    F.1.3Elderly (>=65 years) No
    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 state8
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 33
    F.4.2.2In the whole clinical trial 154
    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)
    For patients who are still on treatment and continue to derive benefit from it at the time of study completion, and for whom no other treatment options are available, Novartis will discuss individual patient cases with investigators to identify possible access to study treatment after termination of the VEG116731/ADVL1322/PZP034X2203 trial.
    Para los pacientes que aún estén en tratamiento y continuen beneficiandose de este en el momento de la finalización del studio, y para quienes no estén disponibles otras opciones de tratamiento, Novartis analizará individualmente los casos de los pacientes con los investigadores para identificar posibles accesos al tratamiento del etudio después de la finalización del ensayo VEG116731/ADVL1322/PZP034X2203
    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 Decision2017-12-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-11-28
    P. End of Trial
    P.End of Trial StatusCompleted
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
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