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    Summary
    EudraCT Number:2017-004689-93
    Sponsor's Protocol Code Number:207497
    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:2018-09-17
    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 number2017-004689-93
    A.3Full title of the trial
    A Phase I/II, Open-label, Dose Escalation and Expansion Study to Evaluate Safety, Tolerability, and Clinical Activity of the Antibody-Drug Conjugate GSK2857916 Administered in Combination with Lenalidomide Plus
    Dexamethasone (Arm A), or Bortezomib Plus Dexamethasone (Arm B) in Participants with Relapsed / Refractory Multiple Myeloma – dreaMM 6
    Estudio de fase I/II, abierto, de aumento gradual y expansión de la dosis para evaluar la seguridad, tolerabilidad y actividad clínica del conjugado anticuerpo-fármaco GSK2857916 administrado en combinación con lenalidomida más dexametasona (grupo A), o bortezomib más dexametasona (grupo B) en participantes con mieloma múltiple recidivante o resistente – (dreaMM 6)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    study to evaluate the safety of the study drug, GSK2857916, at different doses and how well it works to treat people with multiple myeloma when taken together with Lenalidomide Plus Dexamethasone (Treatment Arm A), or Bortezomib Plus Dexamethasone (Treatment Arm B).
    Estudio de aumento gradual de la dosis/expansión de la dosis de GSK2857916 administrado con lenalidomida más dexametasona (grupo A), o bortezomib más dexametasona (grupo B) en participantes con MMRR
    A.3.2Name or abbreviated title of the trial where available
    dreaMM 6
    A.4.1Sponsor's protocol code number207497
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT03544281
    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 SponsorGlaxoSmithKline Research & Development Ltd
    B.1.3.4CountryUnited Kingdom
    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 supportGlaxoSmithKline
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGlaxoSmithKline Research & Development Ltd
    B.5.2Functional name of contact pointGSK Clinical Support Help Desk
    B.5.3 Address:
    B.5.3.1Street Address1-3 Iron Bridge Road, Stockley Park West
    B.5.3.2Town/ cityUxbridge, Middlesex
    B.5.3.3Post codeUB11 1BT
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+349232913116
    B.5.6E-mailGSKClinicalSupportHD@gsk.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 Yes
    D.2.5.1Orphan drug designation numberEMA/OD/077/17
    D.3 Description of the IMP
    D.3.2Product code GSK2857916
    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 INNto be confirmed
    D.3.9.3Other descriptive nameGSK2857916
    D.3.9.4EV Substance CodeSUB130430
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin 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 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
    Relapsed / Refractory Multiple Myeloma
    mieloma múltiple recidivante o resistente
    E.1.1.1Medical condition in easily understood language
    Multiple Myeloma
    mieloma múltiple
    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 10028228
    E.1.2Term Multiple myeloma
    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
    Part 1 - To determine safety, tolerability, and to determine the RP2D dose of GSK2857916 administered in combination with either Len/Dex (Arm A) or Bor/Dex (Arm B) in subjects with RRMM.
    Part 2 - To assess the clinical activity after treatment with the RP2D of GSK2857916 administered in combination with Len/Dex (Treatment A) or Bor/Dex (Treatment B) in subjects with RRMM
    Parte 1 - Determinar la seguridad, tolerabilidad, y determinar la dosis DRF2 de GSK2857916 administrado en combinación con bien len/dex (grupo A) o bien bor/dex (grupo B) en sujetos con MMRR
    Parte 2 - Evaluar la actividad clínica tras el tratamiento con la DRF2 de GSK2857916 administrado en combinación con len/dex (grupo de tratamiento A) o bor/dex (grupo de tratamiento B) en sujetos con RRMM
    E.2.2Secondary objectives of the trial
    1. To evaluate the pharmacokinetic profile of GSK2857916 when administered in combination with Len/Dex (Treatment Arm A) or Bor/Dex (Treatment Arm B) in subjects with RRMM.
    2.To evaluate the pharmacokinetics profile of lenalidomide when administered in combination with GSK2857916 and dexamethasone
    3. To evaluate the pharmacokinetics profile of bortezomib when administered in combination with GSK2857916 and dexamethasone
    4. To assess anti-drug antibodies (ADAs) against GSK2857916
    5. To explore the effect of GSK2857916 in combination with Len/Dex
    (Treatment Arm A) or Bor/Dex (Treatment Arm B) on symptomatic adverse events in subjects with RRMM
    1. Evaluar el perfil farmacocinético de GSK2857916 cuando se administra en combinación con len/dex (grupo de tratamiento A) o bor/dex (grupo de tratamiento B) en sujetos con MMRR
    2. Evaluar el perfil farmacocinético de lenalidomida cuando se administra en combinación con GSK2857916 y dexametasona
    3. Evaluar el perfil farmacocinético de bortezomib cuando se administra en combinación con GSK2857916 y dexametasona
    4.Evaluar los anticuerpos antifármaco (AAF) contra GSK2857916
    5.Explorar el efecto de GSK2857916 en combinación con len/dex (grupo de tratamiento A) o bor/dex (grupo de tratamiento B) sobre los acontecimientos adversos sintomáticos en sujetos con MMRR
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
    2. Male or female, 18 years or older (at the time consent is obtained).
    3. Have confirmed diagnosis of Multiple Myeloma as defined by the International Myeloma Working Group (IMWG) (see Appendix 3, Section 13.3.1 of the Protocol).
    4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
    5. Have undergone stem cell transplant (STC), or are considered transplant ineligible.
    6. Have been previously treated with at least 1 prior line of MM therapy, and must have documented disease progression during or after their most recent therapy according to the IMWG criteria.
    7. Must have at least ONE aspect of measurable disease, defined as one the following:
    a. Urine M-protein excretion ≥200 mg/24h, or
    b. Serum M-protein concentration ≥0.5 g/dL (≥5.0 g/L), or
    c. Serum free light chain (FLC) assay: involved FLC level ≥10 mg/dL
    (≥100 mg/L) and an abnormal serum free light chain ratio (<0.26 or >1.65).
    8. Participants with a history of autologous stem cell transplant (SCT) are eligible for study participation provided the following eligibility criteria are met:
    a. Autologous SCT was >100 days prior to study enrollment
    b. No active bacterial, viral, or fungal infection(s) present
    c. Participant meets the remainder of the eligibility criteria outlined in this protocol
    9. All prior treatment-related toxicities (defined by National Cancer Institute Common Toxicity Criteria for Adverse Events [NCI-CTCAE], Version 4.03, 2010) must be ≤ Grade 1 at the time of enrollment, except for alopecia and Grade 2 neuropathy.
    10. Adequate organ system functions as defined by laboratory assessments (please refer to table 8 in the protocol).
    1. Ser capaz de dar su consentimiento informado firmado, lo que incluye el cumplimiento de los requisitos y restricciones enumerados en el formulario de consentimiento informado (FCI) y en este protocolo.
    2. Varones o mujeres de 18 años o mayores (en el momento de obtener el consentimiento).
    3. Tener un diagnóstico de mieloma múltiple según la definición de los criterios del Grupo internacional de trabajo sobre el mieloma (IMWG) (véase el Apéndice 3, Sección 13.3.1).
    4. Estado general de 0 a 2 según la escala del Grupo de Oncología Cooperativo del Este (ECOG) (Apéndice 4, Sección 13.4).
    5. Haberse sometido a un trasplante de células madre (TCM), o ser considerado no apto para el trasplante
    6. Haber sido tratado previamente con al menos 1 línea previa de tratamiento para el MM y debe tener progresión de la enfermedad documentada durante o después de su tratamiento más reciente, según los criterios del IMWG (véase el Apéndice 3, Sección 13.3.2).
    7. Debe tener al menos UN aspecto de enfermedad mensurable, definida como una de las siguientes características:
    a. Excreción de proteína M en orina ≥200 mg/24 h, o
    b. Concentración de proteína M en suero ≥0,5 g/dl (≥5,0 g/l), o
    c. Análisis de cadenas ligeras libres (free light chain, FLC) en suero: incluye nivel de FLC ≥10 mg/dl (≥100 mg/l) y una proporción de cadenas ligeras libres séricas anómala (<0,26 o >1,65).
    8. Los participantes con antecedentes de alotrasplante de células madre (ATCM) son aptos para la participación en el estudio siembre que se cumplan los siguientes criterios de aptitud:
    a. El ATCM fue >100 días antes de la inscripción en el estudio
    b. No presentar infecciones bacterianas, víricas o micóticas activas
    c. El participante cumple los restantes criterios de aptitud descritos en este protocolo
    9. Los participantes tras un ATCM previo son aptos si el alotrasplante se realizó ≥2 años antes del tratamiento del estudio, y si el participante no tiene enfermedad de injerto contra huésped (EICH) activa que requiera tratamiento, y cumplen los restantes criterios de aptitud.
    10. Todas las toxicidades relacionadas con el tratamiento previas (definidas por los criterios terminológicos comunes para los acontecimientos adversos del Instituto Nacional del Cáncer [CTCAE del NCI], versión 4.03, 2010) deben ser de grado ≤1 en el momento de la inscripción, exceptuando la alopecia y la neuropatía de grado 2.
    E.4Principal exclusion criteria
    1. Systemic anti-myeloma therapy (including systemic steroids) within ≤ 14 days, or plasmapheresis within 7 days prior to the first dose of study drug.
    2. Use of an investigational drug within 14 days or five half-lives (whichever is longer) preceding the first dose of study drug.
    3. Prior treatment with a monoclonal antibody within 30 days of receiving the first dose of study drugs.
    4. Prior allogenic stem cell transplant.
    5. Evidence of active mucosal or internal bleeding.
    6. Any major surgery within the last four weeks.
    7. Presence of active renal condition (infection, requirement for dialysis or any other condition that could affect participant’s safety). Participants with isolated proteinuria resulting from MM are eligible, provided they fulfill criteria given in Table 8 in the Protocol
    8. Any serious and/or unstable pre-existing medical, psychiatric disorder or other conditions (including lab abnormalities) that could interfere with participant’s safety, obtaining informed consent or compliance to the study procedures.
    9. Current active liver or biliary disease (with the exception of Gilbert’s syndrome or asymptomatic gallstones, or otherwise stable chronic liver disease per investigator’s assessment).
    10. Participants with previous or concurrent malignancies are allowed only if the second tumor is not contributing to the participant’s illness. The participant must not be receiving active therapy, other than hormonal therapy for this disease and the disease must be considered medically stable for at least 2 years.
    11. Evidence of cardiovascular risk including any of the following:
    a. QTc interval ≥470 msec. NOTE: the QTc is the QT interval corrected for heart rate according to Fridericia’s formula (QTcF).
    b. Evidence of current clinically significant uncontrolled arrhythmias, including clinically significant ECG abnormalities including 2nd degree (Type II) or 3rd degree atrioventricular (AV) block.
    c. History of myocardial infarction, acute coronary syndromes (including unstable angina), coronary angioplasty, or stenting or bypass grafting within six months of Screening.
    d. Class III or IV heart failure as defined by the New York Heart Association functional classification system (Appendix 6, Section 13.6 in the Protocol).
    e. Uncontrolled hypertension.
    12. Known immediate or delayed hypersensitivity reaction or idiosyncratic reaction to drugs chemically related to GSK2857916, or any of the components of the study treatment.
    13. Pregnant or lactating female.
    14. Active infection requiring treatment.
    15. Known HIV infection.
    16. Presence of hepatitis B surface antigen (HBsAg), or hepatitis B core antibody (HBcAb at Screening or within 3 months prior to first dose of study treatment)
    17. Positive hepatitis C antibody test result or positive hepatitis C RNA test result at screening or within 3 months prior to first dose of study treatment.
    NOTE: Participants with positive Hepatitis C antibody due to prior resolved disease can be enrolled, only if a confirmatory negative Hepatitis C RNA test is obtained. Hepatitis RNA testing is optional and participants with negative Hepatitis C antibody test are not required to also undergo Hepatitis C RNA testing
    18. Current corneal disease except for mild punctuate keratopathy (Appendix 10, Section 13.10 in the Protocol). Note: Patients with mild punctate keratopathy are allowed.

    Additional Exclusion Criteria for Participants Assigned to Treatment Arm A (GSK2857916 plus Len/Dex)
    19. Participants unable to tolerate antithrombotic prophylaxis must be excluded.
    20. Discontinuation of prior treatment with lenalidomide due to intolerable adverse events.

    Additional Exclusion Criteria for Participants Assigned to Treatment Arm B (GSK2857916 plus Bor/Dex)
    21. Unacceptable adverse effects from previous bortezomib treatment.
    22. Ongoing Grade 2 or higher peripheral neuropathy or neuropathic pain from previous bortezomib treatment.
    23. Intolerance or contraindications to anti-viral prophylaxis
    1. Tratamiento antimieloma sistémico (incluidos los corticosteroides sistémicos) en el plazo de 14 días, o plasmaféresis en los 7 días antes de la primera dosis del fármaco del estudio
    2. Uso de un fármaco en investigación en el plazo de los 14 días o cinco semividas (lo que sea más prolongado) previos a la primera dosis del fármaco del estudio.
    3. Tratamiento previo con un anticuerpo monoclonal en los 30 días previos a la primera dosis de los fármacos del estudio.
    4. Signos de hemorragia de mucosas o interna activa.
    5. Cualquier cirugía mayor en las últimas cuatro semanas.
    6. Presencia de una enfermedad renal activa (infección, necesidad de diálisis o cualquier otra enfermedad que pudiera afectar la seguridad del participante). Los participantes con proteinuria aislada resultado del MM son aptos, siempre que cumplan los criterios indicados en la Tabla 8.
    7. Cualquier trastorno médico, psiquiátrico o de otro tipo preexistente grave y/o inestable (incluidas las anomalías analíticas) que pudiera interferir con la seguridad del participante, con la obtención del consentimiento informado o con el cumplimiento de los procedimientos del estudio.
    8. Enfermedad hepática o biliar activa actual (con la excepción del síndrome de Gilbert o cálculos biliares asintomáticos, o cualquier otra enfermedad hepática crónica estable según la evaluación del investigador).
    9. Los participantes con neoplasias malignas previas o concurrentes son aptos solo si el segundo tumor no contribuye a la enfermedad del participante. El participante no debe estar recibiendo tratamiento activo, aparte del tratamiento hormonal para esta enfermedad, y la enfermedad debe considerarse médicamente estable durante al menos 2 años.
    10. Signos de riesgo cardiovascular, incluidos cualquiera de los siguientes:
    a. Intervalo QTc ≥470 ms.
    NOTA: el QTc es el intervalo QT corregido para la frecuencia cardíaca según la fórmula de Fridericia (QTcF).
    b. Signos de arritmias no controladas clínicamente significativas actuales, incluidas las anomalías de ECG clínicamente significativas que incluyen bloqueo auriculoventricular (AV) de 2o grado (tipo II) o 3r grado.
    c. Los antecedentes de infarto de miocardio, síndromes coronarios agudos (incluida la angina inestable), angioplastia coronaria, o colocación de endoprótesis o injerto de derivación en los seis meses previos a la selección.
    d. Insuficiencia cardíaca de clase III o IV definido por el sistema de clasificación funcional de la Asociación de Cardiología de Nueva York [New York Heart Association, NYHA] (Apéndice 6, Sección 13.6).
    e. Hipertensión no controlada.
    11. Reacción de hipersensibilidad inmediata o retrasada o reacción idiosincrática conocidas a los fármacos relacionados químicamente con GSK2857916, o a cualquiera de los componentes del tratamiento del estudio.
    12. Mujer embarazada o en período de lactancia.
    13. Infección activa que requiera tratamiento.
    14. Infección conocida por VIH.
    15. Presencia del antígeno de superficie de la hepatitis B (HbsAg) o anticuerpo nuclear de la hepatitis B (HbcAb en la selección o en los 3 meses antes de la primera dosis del tratamiento del estudio).
    16. Resultado positivo de la prueba del anticuerpo de la hepatitis C o resultado positivo de la prueba del ARN de la hepatitis C en la selección o en los 3 meses antes de la primera dosis del tratamiento del estudio.
    NOTA: se puede inscribir a participantes positivos para el anticuerpo de la hepatitis C debido a una enfermedad anterior resuelta, solo si se obtiene un resultado negativo en la prueba del ARN de la hepatitis C. Las pruebas de ARN de la hepatitis son opcionales y los participantes con una prueba negativa del anticuerpo de la hepatitis C no están obligados a someterse también a una prueba de ARN de la hepatitis C.
    17. Enfermedad actual de la córnea, excepto queratitis punteada leve (Apéndice 10, Sección 13.10).
    Nota: se permiten los pacientes con queratitis punteada leve.
    Criterios de exclusión adicionales para los pacientes asignados al tratamiento A
    (GSK2857916 más len/dex)
    18. Participantes con riesgo de trombosis, pero no puedan tolerar la profilaxis antitrombótica deben ser excluidos.
    19. Interrupción de un tratamiento previo con lenalidomida debido a acontecimientos adversos intolerables.
    Criterios de exclusión adicionales para los pacientes asignados al tratamiento B
    (GSK2857916 más bor/dex)
    20. Efectos adversos inaceptables de un tratamiento previo con bortezomib
    21. Neuropatía periférica de grado 2 o superior o dolor neuropático de un tratamiento previo con bortezomib.
    22. Intolerancia o contraindicaciones para la profilaxis antivírica
    23. Transplante alogénico de células madre previo.
    E.5 End points
    E.5.1Primary end point(s)
    Part 1
    Percentage (number) of Participants with adverse events (AEs), changes in clinical
    signs, electrocardiograms (ECGs) and laboratory parameters
    Percentage (%) of Participants with dose-limiting toxicities (DLTs)
    Part 2
    Complete Response Rate (CRR), defined as the percentage of participants
    with a confirmed complete response (CR) or better (i.e., CR and stringent
    complete response [sCR]), according to the International Myeloma Working
    Group (IMWG) Response Criteria (Rajkumar, 2016).
    Parte 1
    Porcentaje (número) de participantes con acontecimientos adversos (AA), cambios en los signos clínicos, electrocardiogramas (ECG) y parámetros analíticos
    Porcentaje (%) de participantes con toxicidades limitantes de la dosis (TLD)
    Parte 2
    Tasa de respuesta completa (TRC), definida como el porcentaje de participantes con una respuesta completa (RC) confirmada o mejor (es decir, RC y respuesta completa rigurosa [RCr]), según los criterios de respuesta del Grupo internacional de trabajo sobre el mieloma (International Myeloma Working Group, IMWG) (Rajkumar, 2016).
    E.5.1.1Timepoint(s) of evaluation of this end point
    All available data will be analyzed after all evaluable participants in the last cohort have completed at least one cycle of treatment, or have been withdrawn from the study due to toxicity
    Todos los datos disponibles se analizarán después de que todos los participantes evaluados en la última cohorte hayan completado al menos un ciclo de tratamiento, o han sido borrados del estudio debido a toxicidad
    E.5.2Secondary end point(s)
    1. GSK2857916 PK parameters, as data permit (e.g., area under the concentration time curve [AUC], maximum plasma concentration [Cmax], time to maximum plasma concentration [Tmax], half-life [t½]); pre-dose and end of infusion concentrations
    2. Lenalidomide PK parameters, as data permit (e.g., AUC, Cmax, Tmax, t½) in Cycle 1
    3. Bortezomib PK parameters, as data permit (e.g., AUC, Cmax, Tmax, t½) in Cycle 1
    4. Incidence and titers of ADAs against GSK2857916 pre-dose in Cycle 1 and selected subsequent cycles
    5. Changes from baseline in symptoms and related impacts as measured by OSDI, NEI-VFQ-25 and PRO-CTCAE
    1. Parámetros farmacocinéticos (FC) de GSK2857916, según lo permitan los datos (p. ej., ABC, Cmáx, Tmáx, t½); concentraciones antes de la dosis y al final de la infusión
    2. Parámetros FC de lenalidomida, según lo permitan los datos (p. ej., área bajo la curva de concentración-tiempo [ABC], concentración plasmática máxima [Cmáx], tiempo hasta la concentración plasmática máxima [Tmáx], semivida [t½]) en el ciclo 1
    3. Parámetros FC de lenalidomida, según lo permitan los datos (p. ej., área bajo la curva de concentración-tiempo [ABC], concentración plasmática máxima [Cmáx], tiempo hasta la concentración plasmática máxima [Tmáx], semivida [t½]) en el ciclo 1
    4. Incidencia y valores de AAF contra GSK2857916 antes de la dosis en el ciclo 1 y ciclos posteriores seleccionados
    5. Cambios desde el inicio en los síntomas y los impactos relacionados medidos por el Índice de la enfermedad de la superficie ocular (IESO), NEI-VFQ-25 y los resultados comunicados por el paciente, versión de los Criterios terminológicos comunes para acontecimientos adversos (PRO-CTCAE)
    E.5.2.1Timepoint(s) of evaluation of this end point
    All available data will be analyzed after all evaluable participants in the last cohort have completed at least one cycle of treatment, or have been withdrawn from the study due to toxicity
    Todos los datos disponibles se analizarán después de que todos los participantes evaluados en la última cohorte hayan completado al menos un ciclo de tratamiento, o han sido borrados del estudio debido a toxicidad
    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 Yes
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    tolerability
    tolerabilidad
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Yes
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    E.7.1.3.1Other trial type description
    Tolerability
    Tolerabilidad
    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 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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA12
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA 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
    Australia
    Canada
    France
    Spain
    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
    LVLS
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months2
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months2
    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: 32
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 58
    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 state4
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 33
    F.4.2.2In the whole clinical trial 90
    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 Decision2018-11-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-10-04
    P. End of Trial
    P.End of Trial StatusOngoing
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