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 are conducted in the European Union (EU) and the European Economic Area (EEA);
  • clinical trials conducted outside the EU / EEA that are linked to European paediatric-medicine development.
  • Learn   more about the EU Clinical Trials Register   including the source of the information and the legal basis.


    The EU Clinical Trials Register currently displays   39818   clinical trials with a EudraCT protocol, of which   6535   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).
     
    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:2018-002932-26
    Sponsor's Protocol Code Number:D9108C00002
    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:2019-05-27
    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 number2018-002932-26
    A.3Full title of the trial
    A Phase 2 Open-label, Multicenter, Randomized, Multidrug Platform Study of Neoadjuvant Durvalumab Alone or in Combination with Novel Agents in Subjects with Resectable, Early-stage (I [> 2 cm] to IIIA) Non-small Cell Lung Cancer (NeoCOAST)
    Estudio de plataforma multifármaco en fase II, abierto, multicéntrico y aleatorizado de durvalumab neoadyuvante en monoterapia o en combinación con fármacos novedosos en sujetos con cáncer de pulmón no microcítico en fase temprana (I [> 2 cm] a IIIA) resecable (NeoCOAST)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Neoadjuvant Durvalumab Alone or in Combination with Novel Agents in Resectable Non-Small Cell Lung Cancer
    Durvalumab neoadyuvante en monoterapia o en combinación con fármacos novedosos en cáncer de pulmón no microcítico resecable
    A.3.2Name or abbreviated title of the trial where available
    NeoCOAST
    A.4.1Sponsor's protocol code numberD9108C00002
    A.5.4Other Identifiers
    Name:IND numberNumber:140575
    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 SponsorMedImmune, LLC, a wholly owned subsidiary of AstraZeneca PLC
    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 supportMedImmune, LLC, a wholly owned subsidiary of AstraZeneca PLC
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMedImmune, LLC, a wholly owned subsidiary of AstraZeneca PLC
    B.5.2Functional name of contact pointClinical Trial Enquiries
    B.5.3 Address:
    B.5.3.1Street AddressOne MedImmune Way
    B.5.3.2Town/ cityGaithersburg, Maryland
    B.5.3.3Post code20878
    B.5.3.4CountryUnited States
    B.5.4Telephone number+1301398 0000
    B.5.6E-mailclinicaltrialenquiries@medimmune.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 namedurvalumab
    D.3.2Product code MEDI4736
    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 INNdurvalumab
    D.3.9.1CAS number 1428935-60-7
    D.3.9.2Current sponsor codeMEDI4736
    D.3.9.3Other descriptive nameImmunoglobulin G1, anti-human CD antigen
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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: 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 nameoleclumab
    D.3.2Product code MEDI9447
    D.3.4Pharmaceutical form Concentrate and solvent 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 INNoleclumab
    D.3.9.2Current sponsor codeMEDI9447
    D.3.9.3Other descriptive namehuman IgG1λ monoclonal antibody
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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: 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 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 namemonalizumab
    D.3.2Product code IPH2201
    D.3.4Pharmaceutical form Lyophilisate 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 INNmonalizumab
    D.3.9.2Current sponsor codeIPH2201
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number375
    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 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 namedanvatirsen
    D.3.2Product code AZD9150
    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 INNdanvatirsen
    D.3.9.1CAS number 1402100-56-4
    D.3.9.2Current sponsor codeAZD9150
    D.3.9.3Other descriptive nameISIS481464
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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
    Early-stage (I [> 2 cm] to IIIA) Non-small Cell Lung Cancer
    Cáncer de pulmón no microcítico en fase temprana (I [> 2 cm] a IIIA)
    E.1.1.1Medical condition in easily understood language
    Early-stage Non-small Cell Lung Cancer
    Cáncer de pulmón no microcítico en fase temprana
    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 PT
    E.1.2Classification code 10029517
    E.1.2Term Non-small cell lung cancer stage I
    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 PT
    E.1.2Classification code 10029518
    E.1.2Term Non-small cell lung cancer stage II
    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 20.1
    E.1.2Level PT
    E.1.2Classification code 10029520
    E.1.2Term Non-small cell lung cancer stage IIIA
    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
    Efficacy
    - Assess the antitumor activity of durvalumab alone and/or in combination with novel agents
    Eficacia
    - Evaluar la actividad antitumoral de durvalumab en monoterapia y/o en combinación con fármacos innovadores
    E.2.2Secondary objectives of the trial
    Safety
    - Assess the feasibility of receiving the planned surgical resection
    - Assess the safety and tolerability of durvalumab alone and/or in combination with novel agents

    Efficacy
    - Assess the antitumor activity of durvalumab alone and/or in combination with novel agents

    Pharmacokinetics
    - To describe the PK of durvalumab alone and/or in combination with novel agents

    Immunogenicity
    (a) To assess the immunogenicity of durvalumab alone or in combination with novel agents
    (b) To assess the immunogenicity of novel biologic agents in combination with durvalumab
    Seguridad
    - Evaluar la viabilidad de la realización de la resección quirúrgica programada
    - Evaluar la seguridad y tolerabilidad de durvalumab en monoterapia y/o en combinación con fármacos innovadores

    Eficacia
    - Evaluar la actividad antitumoral de durvalumab en monoterapia y/o en combinación con fármacos innovadores

    Farmacocinética
    - Describir la FC de durvalumab en monoterapia y/o en combinación con fármacos innovadores

    Inmunogenia
    (a) Evaluar la inmunogenia de durvalumab en monoterapia o en combinación con fármacos innovadores
    (b) Evaluar la inmunogenia de agentes biológicos innovadores en combinación con durvalumab
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Cytologically and/or histologically-documented NSCLC
    (a) Stage I (> 2 cm) to IIIA (For subjects with N2 disease, only those with 1 single nodal station <= 3 cm are eligible) NSCLC
    (b) Amenable to complete surgical resection
    (c) Have not received any other therapy for this condition
    2. Age >=18 years old
    3. Predicted FEV1 >=≥ 50%
    4. Predicted DLCO ≥ 50%
    5. ECOG 0 or 1
    6. Adequate organ function
    1. CPNM confirmado mediante histología o citología
    (a) CPNM en estadio de I (>2 cm) a IIIA (en pacientes con enfermedad N2, solo son aptos aquellos con 1 sola estación ganglionar <=3 cm)
    (b) Susceptible de resección quirúrgica completa
    (c) No haber recibido ningún otro tratamiento para la enfermedad

    2. Edad >=18 años de edad
    3. VEF1 previsto >=50 %
    4. DLCO prevista >=50 %
    5. ECOG 0 o 1
    6. Funcionamiento adecuado de los órganos
    E.4Principal exclusion criteria
    1. Subjects with small-cell lung cancer or mixed small-cell lung cancer
    2. Subjects who require or may require pneumonectomy
    3. Prior treatment with PD-L1, PD-L1, or CTLA-4 inhibitors
    4. Current or prior use of immunosuppressive medication within 14 days before the first dose of study drug.
    5. Active or prior documented autoimmune or inflammatory disorders. The following are exceptions to this criterion:
    a. Subjects with vitiligo or alopecia
    b. Subjects with hypothyroidism on hormone replacement
    c. Any chronic skin condition that does not require systemic therapy
    d. Subjects without active disease in the last 5 years may be included but only after consultation with the study physician
    e. Subjects with celiac disease controlled by diet alone
    6. Pregnant or breast-feeding female
    7. Major surgical procedure within prior 30 days
    8. History of active primary immunodeficiency
    9. Active infection including tuberculosis, hepatitis B, hepatitis C, or HIV
    10. QTc interval (QTc) >= 470 ms
    11. Uncontrolled intercurrent illness that would limit compliance with study requirement, substantially increase risk of incurring AEs or compromise the ability of the subject to give written informed consent
    12. Receipt of live attenuated vaccination within 30 days prior to study entry
    13. History of another primary malignancy except for:
    a. Curative-treated malignancy with no known active disease > 2 years before enrollment on the study
    b. Curative-treated non-melanoma skin cancer and/or carcinoma in-situ
    1. Pacientes con cáncer de pulmón microcítico o cáncer de pulmón microcítico mixto
    2. Pacientes que requieren o puedan requerir una neumonectomía
    3. Tratamiento previo con PD-L1 o inhibidores de CTLA-4
    4. Uso simultáneo o previo de inmunosupresores en los 14 días anteriores a la primera dosis de fármaco del estudio
    5. Trastornos autoinmunitarios o inflamatorios documentados o activos. Se aplicarán las siguientes excepciones a este criterio:
    a. Pacientes con vitíligo o alopecia
    b. Pacientes con hipotiroidismo que reciban tratamiento de reposición hormonal
    c. Cualquier enfermedad cutánea crónica que no requiera tratamiento sistémico
    d. Los pacientes sin actividad de la enfermedad en los últimos 5 años pueden incluirse, pero solo después de consultar al médico del estudio
    e. Pacientes con enfermedad celíaca controlada solo con dieta

    6. Mujeres embarazadas o en período de lactancia
    7. Pacientes que se hayan sometido a cirugía mayor en los 30 días anteriores
    8. Antecedentes de inmunodeficiencia primaria activa
    9. Infección activa, incluida tuberculosis, hepatitis B, hepatitis C o VIH
    10. Intervalo QTc (QTc) >=470 ms
    11. Enfermedad intercurrente no controlada que limitaría el cumplimiento de los requisitos del estudio, que incrementaría sustancialmente el riesgo de AA provocados o que comprometería la capacidad del paciente para otorgar el consentimiento informado por escrito
    12. Administración de una vacuna atenuada elaborada con microbios vivos en los 30 días anteriores a la inclusión en el estudio
    13. Antecedentes de otra neoplasia maligna primaria, excepto:
    a. Neoplasia maligna tratada con tratamiento curativo sin enfermedad activa conocida >2 años antes de la inclusión en el estudio
    b. Cáncer de piel no melanocítico o carcinoma in situ tratado con tratamiento curativo
    E.5 End points
    E.5.1Primary end point(s)
    Clinical activity
    - Major Pathological Response (MPR) rate
    Actividad clínica:
    - Tasa de respuesta anatomopatológica mayor (RAM)
    E.5.1.1Timepoint(s) of evaluation of this end point
    MPR will be done in the resected specimen. Surgery is planned to take place within 14 days after the 4 weeks treatment period.
    Se investigará una respuesta anatomopatológica mayor en la muestra resecada. Se prevé que la cirugía se produzca en el plazo de 14 días tras el periodo de tratamiento de 4 semanas.
    E.5.2Secondary end point(s)
    Safety
    - Feasibility, defined as having the planned surgical resection within Day 29 to Day 42 after Week 1, Day 1
    - Presence of AEs, SAEs, laboratory abnormalities, and vital signs

    Efficacy
    - Pathological Complete Response (pCR) rate

    Pharmacokinetics
    - Concentration of durvalumab or novel agents in plasma or serum

    Immunogenicity
    - ADA incidence of durvalumab or novel biologic agents
    Seguridad
    - Viabilidad que se define como la realización de la resección quirúrgica programada entre el día 29 y el día 42 después del día 1 de la semana 1
    - Presencia de AA, AAG, anomalías de laboratorio y constantes vitales

    Eficacia
    - Tasa de respuesta anatomopatológica completa (RAC)

    Farmacocinética
    - Concentración de durvalumab o de agentes innovadores en suero o plasma

    Inmunogenia
    - Incidencia de AAF contra durvalumab o agentes biológicos innovadores
    E.5.2.1Timepoint(s) of evaluation of this end point
    Safety
    - Feasibility - Surgery is planned to take place within 14 days after the 4 weeks treatment period.
    - AEs, SAEs, laboratory abnormalities, and vital signs - Up to 126 days after C1D1

    Efficacy
    - pCR will be done in the resected specimen. Surgery is planned to take place within 14 days after the 4 weeks treatment period.

    Pharmacokinetics and Immunogenicity
    - Up to 126 days after C1D1
    Seguridad
    - Viabilidad: se prevé que la cirugía se produzca en el plazo de 14 días tras el periodo de tratamiento de 4 semanas.
    - AA, AAG, anomalías de laboratorio y constantes vitales: hasta 126 días después de D1C1

    Eficacia
    - Se investigará una respuesta anatomopatológica completa en la muestra resecada. Se prevé que la cirugía se produzca en el plazo de 14 días tras el periodo de tratamiento de 4 semanas.

    Farmacocinética e inmunogenia
    - Hasta 126 días después de D1C1
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Immunogenicity
    Inmunogenia
    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 Yes
    E.8.1.7.1Other trial design description
    Estudio de plataforma
    Platform study
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial4
    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 EEA10
    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
    France
    Italy
    Portugal
    Spain
    Switzerland
    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
    The end of the study (“study completion”) is defined as the date of the last protocol-specified visit/assessment for the last subject in the study. This date will be 1 year after the final subject is entered into the study or when the sponsor stops the study, whichever occurs first.
    El fin del Estudio (“conclusión del estudio”) se define como la fecha de la última visita/evaluación especificada en el protocolo del último paciente del estudio. Esta fecha será 1 año después de la entrada en el estudio del último paciente o cuando el promotor detenga el estudio, lo que suceda primero.
    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 months1
    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 months5
    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: 96
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 64
    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 state19
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 67
    F.4.2.2In the whole clinical trial 160
    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)
    None
    Ninguno
    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 Decision2019-05-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-04-12
    P. End of Trial
    P.End of Trial StatusOngoing
    The status of studies in GB is no longer updated from 1.1.2021
    For the UK, as from 1.1.2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
    European Medicines Agency © 1995-2021 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    Legal notice
    EMA HMA