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    Summary
    EudraCT Number:2017-000625-12
    Sponsor's Protocol Code Number:CTMX-M-2009-001
    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:2017-08-08
    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 number2017-000625-12
    A.3Full title of the trial
    A Phase 1-2, Open-Label, Dose-Finding, Proof of Concept, First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of CX-2009 in Adults with Metastatic or Locally Advanced Unresectable Solid Tumors (PROCLAIM-CX-2009)
    Estudio preliminar de eficacia, en abierto, de determinación de la dosis, en fase I-II y llevado a cabo en humanos por primera vez para evaluar la seguridad, la tolerabilidad, la farmacocinética y la farmacodinámica de CX-2009 en adultos con tumores sólidos irresecables metastásicos o localmente avanzados (PROCLAIM-CX-2009)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Open label, First in human study for CX-2009 in adults with metastatic or locally advanced unresectable solid tumors
    Estudio en abierto, llevado a cabo en humanos para el CX-2009 en adultos con tumores sólidos irresecables metastásicos o localmente avanzados
    A.3.2Name or abbreviated title of the trial where available
    PROCLAIM-CX-2009
    A.4.1Sponsor's protocol code numberCTMX-M-2009-001
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT03149549
    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 SponsorCytomX Therapeutics, Inc
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportCytomX Therapeutics, Inc
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCytomX Therapeutics, Inc
    B.5.2Functional name of contact pointClinical Trial Team
    B.5.3 Address:
    B.5.3.1Street Address151 Oyster Point Boulevard, Suite 400
    B.5.3.2Town/ citySouth San Francisco
    B.5.3.3Post codeCA 94080
    B.5.3.4CountryUnited States
    B.5.4Telephone number001650763-9501
    B.5.5Fax number001650515-3185
    B.5.6E-mailclinicaltrials@cytomx.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 nameCX-2009
    D.3.2Product code CX-2009
    D.3.4Pharmaceutical form Powder 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 INNNot established
    D.3.9.2Current sponsor codeCX-2009
    D.3.9.3Other descriptive nameCX-2009
    D.3.9.4EV Substance CodeSUB186901
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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) 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 Yes
    D.3.11.13.1Other medicinal product typeProbody Drug Conjugate
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Metastatic or locally advanced unresectable solid tumors in following indications: breast carcinoma, castration-resistant prostate carcinoma, non-small cell lung carcinoma, epithelial ovarian carcinoma, endometrial carcinoma, head and neck squamous cell carcinoma, or cholangiocarcinoma
    Tumores sólidos irresecables metastásicos o localmente avanzados ( en las indicaciones siguientes: carcinoma de mama, carcinoma de próstata resistente a la castración, carcinoma de pulmón no microcítico, carcinoma ovárico epitelial, carcinoma endometrial, carcinoma de cabeza y cuello epidermoide o colangiocarcinoma.
    E.1.1.1Medical condition in easily understood language
    Cancer
    Cancer
    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 LLT
    E.1.2Classification code 10065147
    E.1.2Term Malignant solid tumor
    E.1.2System Organ Class 100000020935
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of the study is to determine the safety profile of CX-2009, the maximum tolerated dose (MTD) / Recommended Phase 2 Dose (RP2D), and the dose-limiting toxicities (DLTs) of CX-2009, when administered intravenously (IV) every 21 days as monotherapy to subjects with selected advanced or recurrent solid tumors.
    El objetivo principal del estudio es determinar el perfil de seguridad de CX-2009, la dosis máxima tolerada (DMT)/dosis recomendada para la fase II (DRFII) y las toxicidades limitantes de la dosis (TLD) de CX-2009 cuando se administra por vía intravenosa (i.v.) cada 21 días en monoterapia a pacientes con tumores sólidos seleccionados en estadio avanzado o recidivantes.
    E.2.2Secondary objectives of the trial
    Evaluate preliminary efficacy in subjects treated with CX-2009 as monotherapy
    Characterize the pharmacokinetics (PK) of CX-2009
    Assess the incidence of anti-drug antibody (ADA) formation to CX-2009
    Evaluar la eficacia preliminar en pacientes tratados con CX-2009 en monoterapia
    Caracterizar la farmacocinética (FC) de CX-2009
    Evaluar la incidencia de la formación de anticuerpos contra el fármaco (AAF) contra CX-2009
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Histologically confirmed diagnosis of any active metastatic or locally advanced unresectable solid tumor. Subjects with advanced or metastatic solid tumors who have disease progression after treatment with available therapies that are known to confer clinical benefit, or who are intolerant to treatment in following indications: breast carcinoma, castration-resistant prostate cancer, non-small cell lung cancer (incl adenocarcinoma and squamous cell subtypes), overian carcinoma, endometrial carcinoma, head and neck squamous cell carcinoma, cholangiocarcinoma
    2. Agrees to provide tumor tissue, archival, new or recent acquisition confirmed to be available prior to initiation of study drug for performance of correlative tissue and cellular studies from a tumor site not previously irradiated
    3. Evaluable or measurable disease for dose escalation part A and measurable disease required for dose expansion cohorts part B
    4. Subjects with treated brain metastases are eligible if brain metastases are stable and subject does not require radiation therapy or steroids. Active screening for brain metastases is not required.
    5. At least 18 y of age
    6. Eastern Cooperative Oncology Group performance status of 0 or 1
    7. Anticipated life expectancy of at least 3 months
    8. screening lab values must meet following criteria: absolute neutrophil count >=1500µl; platelet count >= 100 x 10³/µl (must not have been transfused within prev. 10 days); hemoglobin >=9.0 g/dL (may have been transfused); serum creatinine <= 1.5 x institution upper limit of normal (ULN); aspartate aminotransferase (AST) <= 2.5xinstitution's ULN; alanine aminotransferase (ALT) <= 2.5x institution's ULN (AST, ALT <5 x ULN if liver metastases); and serum total bilirubin <= 1.5x institutional ULN (total bilirubin must be <=3x institution's ULN in subjects with Gilbert's syndrome)
    9. Women of childbearing potential and males must agree to use a highly effective method of contraception prior to study entry, while on study drug and for a period of 50 days following the last treatment; highly effective methods of contraception which result in a low failure rate (ie <1 % per year) when used consistently and correctly include implants, injectables, combined hormonal contraceptives, some IUD's, sexual abstinence or a vasectomized partner - True abstinence, when in line with the preferred and usual lifestyme of the subjects is considered a highly effective method only if defined as refraining from heterosexual intercourse during the entire period of risk associated with the study treatments. (periodic abstinence and withdrawal are not acceptable methods of contraception)
    10. The ability to understand and the willingness to sign a written informed consent document and adhere to study schedule and prohibitions
    1. Diagnóstico confirmado histológicamente de cualquier tumor sólido activo no resecable, metastásico o localmente avanzado. Los sujetos con tumores sólidos avanzados o metastásicos que tienen progresión de la enfermedad después del tratamiento con terapias disponibles que se sabe que confieren beneficio clínico o que son intolerantes al tratamiento en las siguientes indicaciones: carcinoma de mama, cáncer de próstata resistente a la castración y cáncer de pulmón de células no pequeñas (Incluyendo adenocarcinoma y subtipos de células escamosas), carcinoma de ovario, carcinoma de endometrio, carcinoma de células escamosas de cabeza y cuello, colangiocarcinoma.
    2. Se acuerda proporcionar tejido tumoral, archivo, adquisición nueva o reciente confirmada para estar disponible antes del inicio del fármaco del estudio para la realización de tejido correlativo y estudios celulares de un sitio de tumor no irradiado previamente
    3. Enfermedad evaluable o mensurable para la parte A de la escalada de dosis y enfermedad mensurable necesaria para las cohortes de expansión de dosis, parte B
    4. Los sujetos con metástasis cerebrales tratadas son elegibles si las metástasis cerebrales son estables y el sujeto no requiere radioterapia o esteroides. La detección activa de las metástasis cerebrales no es necesaria.
    5. Al menos 18 años de edad
    6. Estatus de desempeño del Grupo de Oncología Cooperativa Oriental de 0 ó 1
    7. Esperanza de vida anticipada de al menos 3 meses
    8. Los valores del laboratorio de screening deben cumplir los siguientes criterios: recuento absoluto de neutrófilos> = 1500μl; Recuento de plaquetas> = 100 x 10³ / μl (no debe haber sido transfundido dentro de los 10 días previos); Hemoglobina> = 9,0 g / dl (puede haber sido transfundido); Creatinina sérica <= 1,5 x institución límite superior de la normalidad (LSN); Aspartato aminotransferasa (AST) <= 2,5 x LSN de la institución; Alanina aminotransferasa (ALT) <= 2,5x LSN de la institución (AST, ALT <5 x LSN si metástasis hepáticas); Y la bilirrubina total del suero <= 1.5x ULN institucional (la bilirrubina total debe ser <= 3x LSN de la institución en sujetos con síndrome de Gilbert)
    9. Las mujeres en edad fértil y los varones deben estar de acuerdo en utilizar un método altamente eficaz de anticoncepción antes del ingreso al estudio, mientras que en el medicamento del estudio y durante un período de 50 días después del último tratamiento; Métodos anticonceptivos altamente efectivos que resultan en una baja tasa de fracaso (es decir, <1% al año) cuando se usan consistentemente y correctamente incluyen implantes, inyectables, anticonceptivos hormonales combinados, algunos DIU, abstinencia sexual o un compañero vasectomizado. Con la preferencia y la vida habitual de los sujetos se considera un método altamente eficaz sólo si se define como abstenerse de relaciones heterosexuales durante todo el período de riesgo asociado con los tratamientos del estudio. (La abstinencia periódica y la retirada no son métodos aceptables de anticoncepción)
    10. La capacidad de comprender y la voluntad de firmar un documento de consentimiento informado por escrito y cumplir con el calendario del estudio y las prohibiciones
    E.4Principal exclusion criteria
    1. Neuropathie > grade 1
    2. Active chronic corneal disorder, including but not limited to the following: sjogren's syndrome, Fuchs corneal dystropathy (requiring treatment), history of corneal transplantation, active herpetic keratitis, and also active ocular conditions requiring ongoing treatment/monitoring such as wet age-related macular degeneration requiring intravitreal injections, active diabetic retinopathy with macular edema, presensce of papilledema and acquired monocular vision
    3. Serious concurrent illness, including, but not limited to following:
    - clinically relevant active infection including known active hepatitis B or C. HIV infection or CMV infection or any other known concurrent infectious disease requiring IV antibiotics within 2 weeks of study enrollment
    - history of or current active autoimmune diseases, including but not limited to inflammatory bowel diseases, RA, autoimmune thyroiditis, autoimmune hepatitis, systemic sclerosis, systemic lupus erythematosus, autoimmune vasculitis, autoimmune neuropathies or type 1 insuline dependent diabetes mellitus
    - significant cardiac disease such as recent MI (<= 6 months prior to day 1), unstable angina pectoris, uncontrolled congestive heart failure (NY Heart association >class II), uncontrolled hypertension (NCI CTCAE v.4.03 grade 3 or higher), uncontrolled cardiac arrythmias, severe aortic stenosis or >= grade 3 cardiac toxicity following prior chemotherapy
    - History of multiple sclerosis or other demyelinating disease, Eaton-Lambert syndrome (para-neoplastic syndrome), history of hemorrhagic or ischemic stroke within the last 6 months, or alcoholic liver disease
    - Non-healing wound(s) or ulcer(s) except for ulcerative lesions caused by the underlying neoplasm
    - Psychiatric illness/social situations that would limit compliance with study requirements
    - Interstitial lung disease irrespective of etiology
    4. Advanced or metastatic Stage IV NSCLC subjects with epidermal growth factor receptor or anaplastic lymphoma kinase genomic alterations unless they have progressed on treatment with appropriate targeted therapy, including osimertinib for T790M mutation-positive NSCLC
    5. Any other anti-cancer treatment such as chemotherapy, immunotherapy, biochemotherapy, radiotherapy, investigative therapy, or high-dose steroids within 30 days of receiving study drug. Low-dose steroids, luteinizing hormone-releasing hormone, aromatase inhibitors (eg, anastrozole), at doses that have been stable for 30 days are permitted for subjects with CRPC
    6. History of severe allergic or anaphylactic reactions to previous monoclonal antibody therapy
    7. Prior treatment with maytansinoid-containing drug conjugates
    8. Subjects with a previously documented absence of thiol-S-purine methyltransferase activity
    9. Unresolved acute toxicity NCI CTCAE v4.03 Grade >1 (or baseline, whichever is greater) from prior anti-cancer therapy. Alopecia and other non-acute toxicities are acceptable
    10. History of malignancy that is active within the previous 2 years except for localized cancers that are not related to the current cancer being treated, are considered to have been cured and in the opinion of the Investigator, present a low risk for recurrence, including basal or squamous cell skin cancer, superficial bladder cancer or carcinoma in situ of the prostate, cervix or breast
    11. Currently receiving anticoagulation therapy with warfarin
    12. The subject has undergone major surgery (requiring general anesthesia) within 3 months prior to dosing. Subjects who have undergone major surgery within this time period may be enrolled, if, in the Investigator’s judgment, wound healing has largely resolved
    13. Subjects who have received a live vaccine within 1 week prior to the planned first dose of CX-2009 will be excluded
    14. Participating in an ongoing clinical study involving treatment with medications, radiation, or surgery
    15. Women who are pregnant or breast feeding
    1. Neuropathie > grade 1
    2. Active chronic corneal disorder, including but not limited to the following: sjogren's syndrome, Fuchs corneal dystropathy (requiring treatment), history of corneal transplantation, active herpetic keratitis, and also active ocular conditions requiring ongoing treatment/monitoring such as wet age-related macular degeneration requiring intravitreal injections, active diabetic retinopathy with macular edema, presensce of papilledema and acquired monocular vision
    3. Serious concurrent illness, including, but not limited to following:
    - clinically relevant active infection including known active hepatitis B or C. HIV infection or CMV infection or any other known concurrent infectious disease requiring IV antibiotics within 2 weeks of study enrollment
    - history of or current active autoimmune diseases, including but not limited to inflammatory bowel diseases, RA, autoimmune thyroiditis, autoimmune hepatitis, systemic sclerosis, systemic lupus erythematosus, autoimmune vasculitis, autoimmune neuropathies or type 1 insuline dependent diabetes mellitus
    - significant cardiac disease such as recent MI (<= 6 months prior to day 1), unstable angina pectoris, uncontrolled congestive heart failure (NY Heart association >class II), uncontrolled hypertension (NCI CTCAE v.4.03 grade 3 or higher), uncontrolled cardiac arrythmias, severe aortic stenosis or >= grade 3 cardiac toxicity following prior chemotherapy
    - History of multiple sclerosis or other demyelinating disease, Eaton-Lambert syndrome (para-neoplastic syndrome), history of hemorrhagic or ischemic stroke within the last 6 months, or alcoholic liver disease
    - Non-healing wound(s) or ulcer(s) except for ulcerative lesions caused by the underlying neoplasm
    - Psychiatric illness/social situations that would limit compliance with study requirements
    - Interstitial lung disease irrespective of etiology
    4. Advanced or metastatic Stage IV NSCLC subjects with epidermal growth factor receptor or anaplastic lymphoma kinase genomic alterations unless they have progressed on treatment with appropriate targeted therapy, including osimertinib for T790M mutation-positive NSCLC
    5. Any other anti-cancer treatment such as chemotherapy, immunotherapy, biochemotherapy, radiotherapy, investigative therapy, or high-dose steroids within 30 days of receiving study drug. Low-dose steroids, luteinizing hormone-releasing hormone, aromatase inhibitors (eg, anastrozole), at doses that have been stable for 30 days are permitted for subjects with CRPC
    6. History of severe allergic or anaphylactic reactions to previous monoclonal antibody therapy
    7. Prior treatment with maytansinoid-containing drug conjugates
    8. Subjects with a previously documented absence of thiol-S-purine methyltransferase activity
    9. Unresolved acute toxicity NCI CTCAE v4.03 Grade >1 (or baseline, whichever is greater) from prior anti-cancer therapy. Alopecia and other non-acute toxicities are acceptable
    10. History of malignancy that is active within the previous 2 years except for localized cancers that are not related to the current cancer being treated, are considered to have been cured and in the opinion of the Investigator, present a low risk for recurrence, including basal or squamous cell skin cancer, superficial bladder cancer or carcinoma in situ of the prostate, cervix or breast
    11. Currently receiving anticoagulation therapy with warfarin
    12. The subject has undergone major surgery (requiring general anesthesia) within 3 months prior to dosing. Subjects who have undergone major surgery within this time period may be enrolled, if, in the Investigator’s judgment, wound healing has largely resolved
    13. Subjects who have received a live vaccine within 1 week prior to the planned first dose of CX-2009 will be excluded
    14. Participating in an ongoing clinical study involving treatment with medications, radiation, or surgery
    15. Women who are pregnant or breast feeding 1. Neuropatía> grado 1
    2. Trastorno activo crónico de la córnea, incluyendo pero no limitado a: síndrome de sjogren, distrofia corneal de Fuchs (que requiere tratamiento), historia de trasplante de córnea, queratitis herpética activa y también condiciones oculares activas que requieren tratamiento / Relacionada con la degeneración macular que requiere inyecciones intravítreas, la retinopatía diabética activa con edema macular, presencia de papiledema y la visión adquirida monocular
    3. Enfermedad concurrente grave, incluyendo pero no limitado a siguiente:
    - infección activa clínicamente relevante incluyendo hepatitis B activa o C. infección por VIH o infección por CMV o cualquier otra enfermedad infecciosa concurrente conocida que requiera antibióticos intravenosos dentro de las 2 semanas de la inscripción en el estudio
    4. Pacientes con CPNM de estadio IV avanzado o metastásico con alteración genómica del receptor del factor de crecimiento epidérmico o de la linfoma quinasa anaplásica (...)
    E.5 End points
    E.5.1Primary end point(s)
    Dose-limiting toxicities
    Study-drug related AEs and AEs leading to discontinuation
    Changes from baseline in clinical laboratory results and vital signs
    Toxicidad limitante de la dosis
    AE relacionados con el estudio y AEs que conducen a la discontinuación
    Cambios desde la línea de base en los resultados de laboratorio clínico y signos vitales
    E.5.1.1Timepoint(s) of evaluation of this end point
    Administrative interim analyses on safety and efficacy or on PK, immunogenicity, and selected biomarkers may be performed at several times prior to completion of the study in order to facilitate program decisions and to support study presentations or publications
    Los análisis intermedios administrativos sobre seguridad y eficacia o sobre PK, inmunogenicidad y biomarcadores seleccionados pueden realizarse varias veces antes de la finalización del estudio para facilitar las decisiones del programa y apoyar las presentaciones o publicaciones del estudio
    E.5.2Secondary end point(s)
    Objective Response Rate (ORR) is the primary efficacy endpoint
    Duration of response (DOR)
    Time To Tumor Response (TTR)
    Progression-free survival (PFS)
    Overall survival (OS)
    Characterize the pharmacokinetics (PK) of CX-2009, including the
    following analytes:
    o Intact CX-2009 (referring to the prodrug form of CX-2009 ± DM4);
    o Total CX-2009 (intact and activated forms of CX-2009 ± DM4);
    o Total CX-2009-conjugated DM4 (antibody conjugated-DM4);
    o Free DM4; and
    o S-methyl DM4 (DM4-Me) - a DM4 metabolite with potent cytotoxic
    activity
    La Tasa de Respuesta Objetiva (ORR) es el punto final de eficacia primario
    Duración de la respuesta (DOR)
    Tiempo Hasta La Respuesta Del Tumor (TTR)
    La supervivencia sin progresión (PFS)
    Supervivencia global (SO)
    Caracterizar la farmacocinética (PK) de CX-2009, incluyendo la
    siguiente analitica:
    O intacto CX-2009 (referido a la forma de profármaco de CX-2009 ± DM4);
    O Total CX-2009 (formas intactas y activadas de CX-2009 ± DM4);
    E.5.2.1Timepoint(s) of evaluation of this end point
    Administrative interim analyses on safety and efficacy or on PK, immunogenicity, and selected biomarkers may be performed at several times prior to completion of the study in order to facilitate program decisions and to support study presentations or publications
    Administrative interim analyses on safety and efficacy or on PK, immunogenicity, and selected biomarkers may be performed at several times prior to completion of the study in order to facilitate program decisions and to support study presentations or publications
    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 No
    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.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 trial1
    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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA16
    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
    Germany
    Netherlands
    Spain
    United Kingdom
    United States
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LPLV
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years4
    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: 100
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 50
    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 state25
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 70
    F.4.2.2In the whole clinical trial 150
    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 Decision2017-10-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-09-14
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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