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    EudraCT Number:2016-002017-22
    Sponsor's Protocol Code Number:63723283LUC1001
    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:2016-09-26
    Trial results
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    A. Protocol Information
    A.1Member State ConcernedSpain - AEMPS
    A.2EudraCT number2016-002017-22
    A.3Full title of the trial
    A First-in-Human, Open-label, Phase 1/2 Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Clinical Activity of JNJ-63723283, an Anti-PD-1 Monoclonal Antibody, in Subjects with Advanced Cancers.
    Estudio de primera administración en humanos, abierto, Fase 1/2 para evaluar la seguridad, farmacocinética, farmacodinámica y la actividad clínica de JNJ-63723283, un anticuerpo monoclonal Anti-PD1 en sujetos con cáncer avanzado.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A first-in-human study to evaluate the clinical activity of JNJ-63723283 in patients with advanced cancers.
    Estudio de primera administración en humanos para evaluar la actividad clínica de JNJ-63723283 en sujetos con cáncer avanzado.
    A.4.1Sponsor's protocol code number63723283LUC1001
    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 SponsorJanssen-Cilag International NV
    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 supportJanssen Research & Development, LLC
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationJanssen-Cilag S.A
    B.5.2Functional name of contact pointGlobal Clinical Operations Spain
    B.5.3 Address:
    B.5.3.1Street AddressPaseo de las Doce Estrellas, 5-7
    B.5.3.2Town/ cityMadrid
    B.5.3.3Post code28042
    B.5.4Telephone number+34917228100
    B.5.5Fax number+34917228628
    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.3.2Product code JNJ-63723283
    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 INNNot Assigned
    D.3.9.1CAS number Not Assigned
    D.3.9.2Current sponsor codeJNJ-63723283
    D.3.9.3Other descriptive nameJNJ-63723283-AAA
    D.3.9.4EV Substance CodeSUB183887
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product No
    D. ATIMP (i.e. one involving a medical device) No
    D. 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
    Advanced Stage Solid Tumors
    Tumores sólidos en estado avanzado.
    E.1.1.1Medical condition in easily understood language
    Advanced Stage Solid Tumors
    Tumores sólidos en estado avanzado.
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level LLT
    E.1.2Classification code 10065252
    E.1.2Term Solid tumor
    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 identify the recommended Phase 2 dose(s) (RP2D[s]) for JNJ-63723283 (Part 1)
    • To assess the anti-tumor activity of JNJ-63723283 at the RP2D(s) in subjects with selected advanced cancers including non-small cell lung cancer (NSCLC), melanoma, renal, bladder, small cell lung cancer (SCLC), and gastric/esophageal cancer (Part 2)
    • Identificar la o las DRF2 (dosis recomendada (s) de la fase 2) de JNJ-63723283 (Parte 1).
    • Valorar la actividad antitumoral de JNJ 63723283 en la(s) DRF2 en sujetos con cánceres avanzados seleccionados, incluidos CPNM (carcinoma de pulmón no microcítico), melanoma, cáncer renal, de vejiga y gástrico/esofágico y CPM (carcinoma de pulmón microcítico) (parte 2).
    E.2.2Secondary objectives of the trial
    • To characterize the safety of JNJ-63723283 in subjects with advanced solid tumors
    • To characterize the pharmacokinetics of JNJ-63723283 administered intravenously
    • To assess the immunogenicity of JNJ-63723283
    • To assess the clinical activity of JNJ-63723283
    • Determinar la seguridad de JNJ-63723283 en sujetos con tumores sólidos avanzados.
    • Caracterizar la farmacocinética de JNJ-63723283 administrado por vía intravenosa.
    • Valorar la inmunogenicidad de JNJ-63723283.
    • Valorar la actividad clínica de JNJ-63723283.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. ≥ 18 years of age
    2. Have evaluable disease,
    2a. For Part 2, at least 1 measurable lesion that can be accurately assessed at baseline by CT (or magnetic resonance imaging [MRI] where CT is contraindicated) and is suitable for repeated assessment as per RECIST v1.1
    3. Type of cancer:
    Part 1 of the study:
    Has any type of advanced or refractory solid tumor malignancy, except lymphoma, that is metastatic or unresectable and previously received or was ineligible for standard treatment options including appropriate molecularly targeted therapies (eg, subjects with epidermal growth factor receptor [EGFR] mutant NSCLC or with NSCLC with anaplastic lymphoma tyrosine kinase [ALK] rearrangement).
    Part 2 of the study:
    Histologically or cytologically confirmed diagnosis of 1 of the following unresectable Stage III or IV solid tumor malignancies and previously received or was ineligible for standard treatment options including appropriate molecularly targeted therapies (eg, subjects with EGFR mutant NSCLC or with NSCLC with ALK rearrangement):
    • NSCLC
    • Bladder cancer (urothelial carcinoma)
    • Renal cell carcinoma
    • Gastric/esophageal carcinoma
    • Melanoma
    • SCLC
    4. Have an Eastern Cooperative Oncology Group [ECOG] performance status 0 or 1
    5. Have adequate organ and bone marrow function without blood product support.
    6. Has thyroid function laboratory values within normal range. Note: If thyroid stimulating hormone (TSH) is not within normal limits, the subject may still be eligible if total T3 or free T3 and free T4 are within normal limits.
    7. Women of childbearing potential must have a negative serum pregnancy test at Screening using highly sensitive pregnancy test.
    8. Willing to use contraceptive methods consistent with local regulations for subjects participating in clinical studies during and after the study until 5 months after the last dose of study drug.
    a. Women of childbearing potential must agree to use 2 highly effective methods of contraception consistent with local regulations (<1% per year failure rate when used consistently and correctly).
    b. A man who is sexually active with a woman of childbearing potential and has not had a vasectomy must agree to use a barrier method of birth control.
    c. Women and men must agree not to donate sperm or eggs (ova, oocytes), respectively, during the study and after the study until 5 months after the last dose of study drug.
    9. Willing and able to adhere to the prohibitions and restrictions specified in this protocol.
    10. Each subject (or their legally acceptable representative) must sign an informed consent form (ICF) indicating that he or she understands the purpose of and procedures required for the study and are willing to participate in the study. Consent is to be obtained prior to the initiation of any study-related tests or procedures that are not part of standard of care for the subject’s disease.
    11. Subjects enrolled into Part 2 must have tumor tissue available for correlative studies. Fresh tumor biopsy is preferred. Archival tissue must meet the following criteria: archival sections within 4 months of sectioning that have been stored at 2° to 8° C in the dark or archival tumor blocks within 5 years of collection. Subjects without tissues meeting the aforementioned archived tissue criteria must undergo a fresh biopsy.
    1. Edad ≥ 18 años.
    2. Tener enfermedad evaluable.
    2a. Para la parte 2, al menos una lesión mensurable que pueda valorarse de forma exacta en el momento basal mediante TAC (o resonancia magnética [RM] cuando la TAC esté contraindicada) y se preste a valoración repetida de acuerdo con los RECIST v1.1.
    3.Tipo de cáncer:
    Parte 1 del estudio:
    Tiene cualquier tipo de tumor sólido maligno resistente, excepto linfoma, que es metastásico o irresecable, y ha recibido previamente opciones de tratamiento habituales o no era elegible para recibirlas, incluyendo terapias apropiadas dirigidas molecularmente (e.d. pacientes con cáncer de pulmón no microcítico (CPNM) con mutaciones del receptor de factor de crecimiento epidérmico (EGFR) o con cáncer de pulmón no microcítico con reordenación del gen de cinasa del linfoma anaplásico (ALK)
    Parte 2 del estudio:
    Diagnóstico confirmado histológica o citológicamente de uno de los tumores sólidos malignos en estadio III o IV irresecables siguientes, y ha recibido previamente opciones de tratamiento habituales o no era elegible para recibirlas, incluyendo terapias apropiadas dirigidas molecularmente (e.d. pacientes con CPNM con mutaciones del receptor de factor de crecimiento epidérmico (EGFR) o con CPNM con reordenación del gen ALK:
    • CPNM
    • Cáncer de vejiga (carcinoma urotelial)
    • Carcinoma de células renales
    • Carcinoma gástrico/esofágico
    • Melanoma
    • CPM
    4. Presentar un estado funcional del Eastern Cooperative Oncology Group [ECOG] de 0 ó 1 .
    5. Tener las características de la función orgánica y de la médula ósea sin el apoyo de hemoderivados.
    6. Tiene valores analíticos de función tiroidea dentro del intervalo normal. Nota: Aunque la tirotropina (TSH) no esté dentro de los límites normales, el sujeto puede ser elegible si la T3 total o la T3 y la T4 libres están dentro de los límites normales.
    7. Las mujeres en edad fértil deberán dar negativo en una prueba de embarazo en suero en la selección usando una prueba de embarazo muy sensible.
    8. Estar dispuesta a utilizar métodos anticonceptivos acordes con la normativa local para sujetos que participen en estudios clínicos durante y después del estudio hasta 5 meses después de la última dosis de fármaco del estudio.
    a. Las mujeres en edad fértil deberán comprometerse a utilizar 2 métodos anticonceptivos muy eficaces acordes con la normativa local (con una tasa de fracaso <1 % al año cuando se usen de forma constante y correcta).
    b. Un varón sexualmente activo con una mujer en edad fértil y que no se haya sometido a vasectomía deberá comprometerse a emplear un método anticonceptivo de barrera.
    c. Mujeres y varones deberán comprometerse a no donar semen ni óvulos (ovocitos), respectivamente, durante el estudio y en los 5 meses siguientes a la última dosis de fármaco del estudio.
    9. Estar dispuestos a respetar las prohibiciones y las restricciones especificadas en este protocolo.
    10. Cada sujeto (o su representante legal) deberán firmar un documento de consentimiento informado (DCI) que indique que entiende el objetivo del estudio y los procedimientos que exige y que está dispuesto a participar en él. El consentimiento tiene que obtenerse antes de iniciar las pruebas o procedimientos relacionados con el estudio que no formen parte de la asistencia habitual para la enfermedad del sujeto.
    11. Deberá haber tejido tumoral disponible de los sujetos incluidos en la parte 2 para estudios correlativos. Es preferible una biopsia tumoral reciente. El tejido archivado deberá cumplir los criterios siguientes: cortes archivados en los 4 meses siguientes a su realización que se hayan conservado a 2-8°C en la oscuridad, o bloques tumorales archivados dentro de los 5 años siguientes a su obtención. Los sujetos de quienes no existan tejidos que cumplan los criterios anteriores para el tejido archivado deberán someterse a una nueva biopsia.
    E.4Principal exclusion criteria
    1. Has uncontrolled intercurrent illness, including but not limited to ongoing or active infection requiring IV antibiotics, symptomatic congestive heart failure (New York Heart Association class III-IV; Attachment 2), unstable angina pectoris, cardiac arrhythmia, poorly controlled hypertension or diabetes, or psychiatric illness/social situation that would limited compliance with study requirements
    2. Has had prior treatment with an anti-PD-1 antibody, anti-PD-L1 antibody or anti-PD-L2 antibody
    3. Treatment with any local or systemic anti-neoplastic therapy, radiotherapy (excluding limited palliative radiation), or investigational anticancer agent within 14 days or 4 half-lives, whichever is longer, up to a maximum wash-out period of 28 days prior to the initiation of study drug administration.
    4. Has symptomatic brain or leptomeningeal metastases
    5. Has not recovered (ie, ≤Grade 1 or baseline) from AEs except alopecia, peripheral neuropathy related to prior anticancer therapy and stable anemia (ie, untransfused Hb ≥8.5 g/dL without the need for supportive transfusion within 2 weeks of screening) at the time of treatment allocation
    6. Has an active autoimmune disease or a documented history of autoimmune disease.
    7. Grade 3 or higher toxicity effects from previous treatment with immunotherapy
    8. Known allergies, hypersensitivity, or intolerance to protein-based therapies or with a history of any significant drug allergy (such as anaphylaxis, hepatotoxicity, or immune-mediated thrombocytopenia or anemia), or to JNJ-63723283 excipients (refer to Investigator's Brochure)
    9. Has taken immunosuppressive doses of systemic medications, such as corticosteroids (doses >10 mg/day prednisone or equivalent), within 2 weeks before the planned first dose of study drug
    10. A woman who is pregnant, breast-feeding, or planning to become pregnant while enrolled in this study or within 5 months after the last dose of study drug
    11. A man who plans to father a child while enrolled in this study or within 5 months after the last dose of study drug.
    12. Has any condition for which, in the opinion of the investigator, participation would not be in the best interest of the subject (eg, compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments
    13. Had major surgery (eg, requiring general anesthesia) within 4 weeks before dosing, or will not have fully recovered from surgery, or has surgery planned during the time the subject is expected to participate in the study or within 4 weeks after the last dose of study drug administration.
    14. Has a history of hepatitis B surface antigen (HBsAg) or hepatitis C antibody (anti-HCV) positive, or other clinically active liver disease, or tests positive for HBsAg or anti-HCV at screening. If positive, further testing of quantitative levels to rule out positivity is required.
    15. Has a history of human immunodeficiency virus (HIV) antibody positive, or tests positive for HIV at Screening
    16. Vaccinated with a live vaccine within 28 days (with the exception of the annual inactivated influenza vaccine) prior to the first dose of study drug
    1. Enfermedad intercurrente no controlada incluidas, entre otras, infección en curso o activa que precise antibióticos IV, insuficiencia cardíaca congestiva sintomáticas (clase III-IV de la New York Heart Association; anexo 2), angina de pecho inestable, arritmia cardíaca, hipertensión o diabetes mal controlada, o enfermedad psiquiátrica/situación social que limitaría el cumplimiento de los requisitos del estudio.
    2. Ha recibido tratamiento previo con un anticuerpo anti-PD-1, anticuerpo anti-PD-L1 o anticuerpo anti-PD-L2.
    3. Tratamiento con cualquier terapia antineoplásica local o sistémica, radioterapia (excepto radiación paliativa limitada) o fármaco contra el cáncer en investigación en los 14 días o 4 semividas previos, lo que sea más largo, hasta un periodo máximo de lavado de 28 días antes del inicio de la administración del fármaco del estudio.
    4. Tiene metástasis cerebrales o leptomeníngeas sintomáticas.
    5. No se ha recuperado (es decir, grado ≤1 o estado basal) de los AA excepto alopecia, neuropatía periférica relacionada con tratamiento previo del cáncer y anemia estable (es decir, Hb sin transfusiones ≥8.5 g/dl sin necesidad de transfusión de apoyo en las 2 semanas siguientes a la selección) en el momento de asignarse el tratamiento
    6. Tiene una enfermedad autoinmunitaria activa o antecedentes comprobados de enfermedad autoinmunitaria.
    7. Efectos tóxicos de grado 3 o superior de una inmunoterapia previa.
    8. Alergias conocidas, hipersensibilidad o intolerancia a los tratamientos basados en proteínas o antecedentes de cualquier alergia a fármacos importante (como anafilaxia, hepatotoxicidad o trombocitopenia o anemia inmunomediada) o a los excipientes de JNJ-63723283 (véase el Manual del investigador).
    9. Ha recibido dosis inmunodepresoras de medicación sistémica, como corticosteroides (dosis >10 mg/día de prednisona o su equivalente) en las 2 semanas previas a la primera dosis prevista del fármaco del estudio.
    10. El sujeto es una mujer embarazada, en lactancia materna o que planea quedarse embarazada durante su participación en este estudio o en los 5 meses siguientes a la última dosis de fármaco del estudio.
    11. El sujeto es un varón que planea engendrar un hijo durante su participación en este estudio o en los 5 meses siguientes a la última dosis de fármaco del estudio.
    12. Presenta cualquier circunstancia o proceso para el que, en opinión del investigador, la participación no sería lo mejor para el sujeto (p. ej., comprometería su bienestar) o que podría impedir, limitar o genera confusión en las valoraciones especificadas en el protocolo.
    13. Se ha sometido a una intervención de cirugía mayor (p. ej., que exigió anestesia general) en las 4 semanas previas a la administración, o no se habrá recuperado totalmente de la operación, o está previsto operarle durante el período previsto de participación en el estudio o en las 4 semanas siguientes a la última dosis de la administración del fármaco del estudio.
    14. Tiene antecedentes de resultados positivos del antígeno de superficie de la hepatitis B (HBsAg) o del anticuerpo contra el virus de la hepatitis C (anti-HCV), otra hepatopatía clínicamente activa o resultados positivos del HBsAg o el anti-HCV en la selección. Si los resultados son positivos, son necesarios análisis de los niveles cuantitativos para descartar la positividad
    15. Tiene antecedentes de un resultado positivo de la prueba de anticuerpos contra el virus de la inmunodeficiencia humana (VIH) o da positivo en la prueba del VIH en la selección
    16. Ha recibido una vacuna con microorganismos vivos (excepto la vacuna anual contra la gripe inactivada) en los 28 días previos a la primera dosis de fármaco del estudio.
    E.5 End points
    E.5.1Primary end point(s)
    • Frequency and severity of dose-limiting toxicity (DLT)
    • Overall response rate (ORR) per the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 in subjects with selected advanced solid tumors
    • Frecuencia y gravedad de la toxicidad limitante de la dosis (TLD).
    • Tasa de respuesta global (TRG) según los Criterios de evaluación de la respuesta de tumores sólidos (RECIST), versión 1.1, en sujetos con tumores sólidos avanzados seleccionados.
    E.5.1.1Timepoint(s) of evaluation of this end point
    - The DLT evaluation period is defined as 2 weeks from the start of the first JNJ-63723283 infusion.
    - Every 8 weeks (+/-2 weeks window) until Week 24 then every 12 weeks (+/-2 weeks window) relative to the date of first dose, and regardless of dose or schedule.
    - El periodo de evaluación del TLD se define como 2 semanas desde el inicio de la primera infusión de JNJ-63723283.
    - Cada 8 semanas (+/- 2 semanas de ventana) hasta la semana 24 y luego cada 12 semanas (+/- 2 semanas de ventana) con relación a la fecha de la primera dosis, y con independencia de la dosis o el calendario.
    E.5.2Secondary end point(s)
    • Safety profile of JNJ-63723283 (safety parameters include but are not limited to the frequency and severity of adverse events [AEs] and immune-related AEs [irAEs], vital signs measurements, clinical laboratory values, and electrocardiograms [ECGs])
    • Serum JNJ-63723283 pharmacokinetic parameters including but not limited to maximum observed serum concentration (Cmax), area under the concentration-time curve between 2 defined sampling points, t1 and t2 (AUCt1-t2), half-life (T1/2), total systemic clearance of drug after IV administration (CL), volume of distribution at steady-state (Vss), and accumulation ratio (R)
    • Presence of anti-JNJ-63723283 antibodies and effect on serum JNJ-63723283 concentrations
    • ORR per the Immune-Related Response Criteria (irRC), duration of response (DOR), progression-free survival (PFS) by both RECIST v.1.1 and irRC, and OS
    • Perfil de seguridad de JNJ-63723283 (los parámetros de seguridad son, entre otros, la frecuencia y la intensidad de los AA (Acontecimientos Adversos) y de los AAri (Acontecimientos Adversos relacionados con la inmunidad), las determinaciones de las constantes vitales, los valores del laboratorio clínico y los electrocardiogramas [ECG]).
    • Parámetros farmacocinéticos de JNJ-63723283 incluidos, entre otros, la concentración sérica máxima observada (Cmáx), el área bajo la curva concentración-tiempo entre dos puntos de muestreo definidos, t1/1 y t2 (AUCt1-t2), la semivida (T1/2), la depuración sistémica total del fármaco tras administración IV (CL), el volumen de distribución en estado de equilibrio (Vee) y el cociente de acumulación (R).
    • Presencia de anticuerpos anti-JNJ-63723283 y efecto en las concentraciones séricas de JNJ-63723283.
    • TRG (Tasa de Respuesta Global) según los Criterios de respuesta relacionados con la inmunidad (CRri), la duración de la respuesta (DR) y la supervivencia sin progresión (SSP) tanto mediante los RECIST v.1.1 como los CRri y la SG.
    E.5.2.1Timepoint(s) of evaluation of this end point
    - The Safety profile of JNJ-63723283 will be evaluated throughout the whole study
    - Serum pharmacokinetic parameters defined above will be evaluated throughout the whole study.
    - The presence of anti-JNJ-63723283 antibodies and effect on serum concentrations will be evaluated throughout the whole study.
    - OSS, DOR, PFS and OS will be evaluated at the end of the study
    - El perfil de seguridad de JNJ-63723283 se evaluará a lo largo de todo el estudio.
    - Los parámetros farmacocinéticos de suero definidos anteriormente serán evaluados a lo largo de todo el estudio.
    - La presencia de anticuerpos anti-JNJ-63723283 y efecto sobre las concentraciones de suero será evaluada a lo largo de todo el estudio.
    - TGR (Tasa de Respuesta Global), DR (Duración de la Respuesta), SSP (Supervivencia Sin Progresión) y SG (Supervivenvia Global) serán evaluados al final del estudio.
    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 Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Yes
    E.7.1.1First administration to humans Yes
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E. 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.8.3 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 concerned10
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA26
    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
    Russian Federation
    United Kingdom
    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 is defined as last study assessment for the last subject on study or anytime the sponsor terminates the study, whichever comes first.
    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 months7
    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 months7
    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: 101
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 68
    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 state32
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 99
    F.4.2.2In the whole clinical trial 169
    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)
    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 Decision2016-11-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-11-11
    P. End of Trial
    P.End of Trial StatusOngoing
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