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    Summary
    EudraCT Number:2018-000727-13
    Sponsor's Protocol Code Number:MRG106-11-201
    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:2018-09-17
    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 number2018-000727-13
    A.3Full title of the trial
    SOLAR: A Phase 2, Randomized, Open-label, Parallel-group, Active Comparator, Multi-center Study to Investigate the Efficacy and Safety of Cobomarsen (MRG-106) in Subjects with Cutaneous T-Cell Lymphoma (CTCL), Mycosis Fungoides (MF) Subtype
    SOLAR: Una fase 2, aleatorizado, abierto, de grupos paralelos, con comparador activo, multi-centro de estudio para investigar la eficacia y seguridad de Cobomarsen (MRG-106) en sujetos con Cutáneo de Células T (CTCL), micosis fungoide (MF) Subtipo
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    SOLAR: Efficacy and Safety of Cobomarsen (MRG-106) vs. Active Comparator in Subjects with Mycosis Fungoides
    SOLAR: Eficacia y seguridad de Cobomarsen (MRG-106) en comparación a un comparador activo en pacientes con Micosis Fungoides
    A.3.2Name or abbreviated title of the trial where available
    SOLAR
    A.4.1Sponsor's protocol code numberMRG106-11-201
    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 SponsormiRagen 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 supportmiRagen Therapeutics, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationmiRagen Therapeutics, Inc.
    B.5.2Functional name of contact pointSOLAR Clinical Trial Information
    B.5.3 Address:
    B.5.3.1Street Address6200 Lookout Road
    B.5.3.2Town/ cityBoulder
    B.5.3.3Post codeCO 80301
    B.5.3.4CountryUnited States
    B.5.4Telephone number+34691765 107
    B.5.6E-mailSOLAR@miragen.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 numberEU/3/17/1872
    D.3 Description of the IMP
    D.3.1Product namecobomarsen
    D.3.2Product code MRG-106
    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 INNCOBOMARSEN
    D.3.9.1CAS number 1848257-52-2
    D.3.9.2Current sponsor codeMRG-106
    D.3.9.4EV Substance CodeSUB192820
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number141
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Zolinza
    D.2.1.1.2Name of the Marketing Authorisation holderMerck and Co., Inc.
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    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 namevorinostat
    D.3.4Pharmaceutical form Capsule
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNvorinostat
    D.3.9.1CAS number 149647-78-9
    D.3.9.3Other descriptive nameVORINOSTAT
    D.3.9.4EV Substance CodeSUB23356
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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
    Cutaneous T-Cell Lymphoma (CTCL), Mycosis Fungoides (MF) Subtype
    Cutáneo de Células T (CTCL), micosis fungoide (MF) Subtipo
    E.1.1.1Medical condition in easily understood language
    A cancer of the lymphatic system that affects the skin
    Cáncer del Sistema linfático que afecta a la piel
    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 10028483
    E.1.2Term Mycosis fungoides
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of the trial is to evaluate the efficacy of cobomarsen in subjects with MF.
    El objetivo primario del estudio es evaluar la eficacia de cobomarsen en sujetos con MF.
    E.2.2Secondary objectives of the trial
    • Investigate the safety and tolerability of cobomarsen in subjects with MF.
    • Characterize the population pharmacokinetics (PK) of cobomarsen in subjects with MF.
    • Investigar la seguridad y tolerabilidad de cobomarsen en sujetos con MF.
    • Caracterizar la farmacocinética de población (PK) de cobomarsen en sujetos con MF.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Must provide written informed consent (signed and dated) and any authorizations required by law and be able to comply with all study requirements.
    • Males or females, ≥ 18 years of age at the time of informed consent.
    • Biopsy-proven CTCL, MF subtype.
    • Clinical stage IB, II, or III, with staging based on Screening assessments. Subjects with large cell transformations may be enrolled.
    • Minimum mSWAT score of 10 at Screening.
    • Receipt of at least one prior therapy for CTCL (per the National Comprehensive Cancer Network [NCCN] guidelines for generalized skin involvement; e.g., topical, phototherapy, Total Skin Electron Beam Therapy [TSEBT] or systemic therapy).
    • Subjects of childbearing potential must agree to use highly effective methods of contraception as defined in the protocol.
    • Debe dar su consentimiento informado (firmado y fechado) y las autorizaciones requeridas por la ley escrita y ser capaz de cumplir con todos los requisitos del estudio.
    • Hombres o mujeres, ≥ 18 años de edad en el momento del consentimiento informado.
    • Comprobado por biopsia subtipo CTCL, MF.
    • El estadio clínico IB, II, o III, con la estadificación basan en Screening evaluaciones
    • mSWAT puntuación mínima de 10 en la selección.
    • La recepción de al menos una terapia previa para CTCL (por las directrices National Comprehensive Cancer Network [NCCN] para la participación de la piel generalizada; por ejemplo, tópica, la fototerapia, la piel total de haz de electrones Terapia [TSEBT] o terapia sistémica).
    • Los sujetos en edad fértil deben acordar el uso de métodos muy eficaces de anticoncepción como se define en el protocolo.
    E.4Principal exclusion criteria
    • Previous enrollment in a cobomarsen study.
    • Prior therapy with vorinostat or other HDAC inhibitors, or contraindication to an HDAC inhibitor.
    • Sézary syndrome or mycosis fungoides with B2 involvement.
    • B1 blood involvement at Screening,
    • Evidence of enlarged peripheral or lymph node(s) > 1.5 cm in the long diameter or > 1.0 cm in the short diameter by radiographical imaging at Screening.
    • Any palpable peripheral node, regardless of size, that on physical examination is firm, irregular, clustered, or fixed, unless histologically confirmed to be non-malignant.
    • Evidence of visceral involvement related to MF at Screening.
    • Receipt of any the following treatments:
    - Macrolide or tetracycline antibiotics within 28 days prior to Screening;
    - More than 3 short courses of prednisone equivalent > 10 mg per day within 8 weeks prior to Screening; however, a stable regimen of systemic prednisone equivalent to ≤ 10 mg per day (or steroid equivalent) is permitted;
    - Total skin electron beam therapy within 4 weeks prior to Screening;
    - Investigational small molecule drug within 5 half-lives prior to Screening;
    - Investigational biologic drug within 5 half-lives prior to Screening;
    - Phototherapy within 4 weeks prior to Screening;
    - Antibody-directed or immunoglobulin-based immune therapy or other monoclonal antibody therapies within 8 weeks prior to Screening;
    - Previous chronic (more than 20 days total) high potency topical corticosteroid use within 4 weeks of Screening. Stable doses of low to medium potency topical corticosteroids are allowed;
    - Previous chronic (more than 20 days total) use of topical MF treatments (not listed in the bullets above) within 4 weeks prior to Screening;
    - Previous systemic MF treatments (not listed in the bullets above) within 4 weeks prior to Screening;
    - Previous treatment with an oligonucleotide.
    • Clinically significant liver disease within 1 year prior to Screening.
    • Positivity for human immunodeficiency virus (HIV), Hepatitis B surface antigen, or Hepatitis C at the time of Screening,
    • Clinically significant anemia, neutropenia or thrombocytopenia at Screening.
    • Previous or concurrent malignancy with the following exceptions:
    - Adequately treated basal cell or squamous cell carcinoma of the skin (adequate wound healing is required prior to study entry),
    - In situ carcinoma of the cervix, treated curatively and without evidence of recurrence for at least 3 years prior to the study,
    - Or other solid tumor treated curatively, and without evidence of recurrence for at least 3 years prior to study entry.
    • Lactating or pregnant.
    • Currently active, clinically significant cardiovascular disease, such as uncontrolled arrhythmia or Class 3 or 4 congestive heart failure, as defined by the New York Heart Association Functional Classification; or a history of myocardial infarction, unstable angina, or acute coronary syndrome within 6 months prior to enrollment.
    • History of stroke or intracranial hemorrhage within 6 months prior to enrollment.
    • Clinically significant abnormalities which, in the opinion of the Investigator, would make subject unsuitable for inclusion in the study.
    • La inscripción previa en un estudio cobomarsen.
    • El tratamiento previo con vorinostat u otros inhibidores de HDAC, o contraindicación a un inhibidor de HDAC.
    • síndrome o micosis fungoide Sézary con la participación B2
    • implicación de sangre B1 en la selección
    • Evidencia de ganglio linfático periférico o central ampliada (s)> 1,5 cm en el diámetro largo o> 1.0 cm en el diámetro corto, por proyección de imagen radiográfica en el cribado.
    • Cualquier nodo periférico palpable, independientemente de su tamaño, que en el examen físico es firme, irregular, agrupado, o fijo, a menos que histológicamente confirmado para ser no maligno.
    • La evidencia de afectación visceral relacionada con MF en la selección.
    • La recepción de los siguientes tratamientos:
    - Macrólidos o tetraciclina antibióticos dentro de los 28 días anteriores a la selección;
    - Más de 3 ciclos cortos de prednisona equivalente> 10 mg por día dentro de las 8 semanas antes de la selección; sin embargo, un régimen estable de equivalente prednisona sistémica a ≤ está permitido 10 mg por día (o su equivalente esteroide);
    - terapia total con haz de electrones de la piel dentro de las 4 semanas antes de la selección;
    - Investigational fármaco de molécula pequeña dentro de los 5 vidas medias antes de la selección;
    - fármaco biológico en investigación dentro de los 5 vidas medias antes de la selección; La fototerapia dentro de las 4 semanas antes de la selección;
    - Dirigida por anticuerpos o inmunoglobulina-basado terapia inmune o otras terapias de anticuerpos monoclonales dentro de 8 semanas antes de la selección;
    - (Más de 20 días en total) de alta potencia tópica uso de corticosteroides crónica anterior dentro de las 4 semanas de la selección. se permiten dosis estables de potencia de baja a medio corticosteroides tópicos;
    - crónica Anterior uso (más de 20 días en total) de los tratamientos tópicos (MF no mencionados en los puntos anteriores) dentro de las 4 semanas antes de la selección;
    - Anterior tratamientos MF sistémicos (no mencionados en los puntos anteriores) dentro de las 4 semanas antes de la selección;
    - El tratamiento previo con un oligonucleótido.
    • enfermedad hepática clínicamente significativa dentro de 1 año antes de la selección.
    • La positividad para el virus de la inmunodeficiencia humana (VIH), antígeno de superficie de la hepatitis B o hepatitis C en el momento de la selección, por el laboratorio central.
    • anemia clínicamente significativa, neutropenia O trombocitopenia En la selección.
    • malignidad previo o simultáneo con las siguientes excepciones:
    - de células basales tratados adecuadamente o carcinoma de células escamosas de la piel (se requiere una adecuada cicatrización de la herida antes de la entrada en el estudio),
    - En el carcinoma in situ del cuello uterino, se trató curativa y sin evidencia de recurrencia durante al menos 3 años antes del estudio,
    - U otro tumor sólido tratado curativa, y sin evidencia de recurrencia durante al menos 3 años anteriores al ingreso al estudio.
    • En periodo de lactancia o embarazadas.
    • Actualmente activo, enfermedad cardiovascular clínicamente significativa, tales como arritmia no controlada o Clase 3 o 4 insuficiencia cardíaca congestiva, según lo definido por la clasificación funcional de la New York Heart Association; o una historia de infarto de miocardio, angina inestable,
    • Antecedentes de infarto o hemorragia intracraneal dentro de los 6 meses anteriores a la inscripción.
    • Anormales clínicamente significativos en la historia clínica, la exploración física o los valores de laboratorio, que, en opinión del investigador, podría hacer que el sujeto no aptos para su inclusión en el estudio.
    E.5 End points
    E.5.1Primary end point(s)
    Primary Efficacy Evaluation:
    Proportion of subjects achieving an objective response (complete response [CR] or partial response [PR]) of at least 4 months duration (ORR4) using composite global response criteria, including radiological imaging, flow cytometry, and the Modified Severity Weighted Assessment Tool (mSWAT) scoring.
    La evaluación primaria de eficacia:
    Proporción de sujetos que alcanzaron una respuesta objetiva (respuesta completa [CR] o respuesta parcial [PR]) de al menos 4 meses de duración (ORR4) usando criterios de compuestos respuesta global, incluyendo obtención de imágenes radiológicas, citometría de flujo, y la herramienta de evaluación de gravedad ponderado Modificado ( mSWAT) de puntuación.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Global response criteria collected 4 weeks after 4 months of sustained response (PR or CR) in the skin, and every 12 weeks thereafter.
    Criterio de respuesta global recogido 4 semanas después de 4 meses de respuesta mantenida (complete o parcial) en la piel y cada 12 semanas a partir de entonces.
    E.5.2Secondary end point(s)
    Efficacy measures
    • Key Secondary Endpoint: Progression-free survival (PFS).
    • Change from baseline and longitudinally during the study in Pruritus Numerical Rating Scale (NRS).
    • Change from baseline and longitudinally during the study in Skindex-29 total score.
    • Change from baseline and longitudinally during the study in Skindex-29 Subdomains (Symptoms, Emotion and Functionality).
    • Change from baseline and longitudinally during the study in Pain NRS.
    • Duration of composite global response for responding subjects.
    • Complete response rate (CRR).
    • Time to progression (TTP).
    • Time to maximal effect in mSWAT.
    • Proportion of subjects achieving ≥ 50% improvement in mSWAT of at least 4-months duration.
    • Proportion of subjects achieving ≥ 50% improvement in mSWAT of at least 28-days duration.
    • Percent of subjects achieving ≥ 50% improvement in mSWAT from baseline at 28 days and at 4 months.
    • Time to ≥ 50% improvement in mSWAT.
    • Duration of response in skin (no progression after achieving ≥ 50% improvement in mSWAT).
    • Change in pruritus medication utilization from baseline and incidence of pruritus medication utilization.
    • Overall survival.
    • Time to next treatment.

    Safety and Tolerability Evaluations:
    • Incidence and severity of clinically significant adverse events (AEs) (including grade 3 and 4 AEs, treatment-related AEs, serious adverse events [SAEs], and AEs requiring discontinuation), physical examination findings, changes in electrocardiograms (ECGs), changes in laboratory parameters and changes in vital signs.

    Pharmacokinetic Evaluation:
    • Population PK parameters.
    Las medidas de eficacia:
    • Clave criterio de valoración secundario: La supervivencia libre de progresión (SLP).
    • Cambio del valor inicial y longitudinalmente durante el estudio en el prurito Numerical Rating Scale (NRS).
    • Cambio del valor inicial y longitudinalmente durante el estudio en Skindex-29 puntuación total.
    • Cambio desde el inicio y longitudinalmente durante el estudio en Skindex-29 subdominios (síntomas, la emoción y funcionalidad).
    • Cambio del valor inicial y longitudinalmente durante el estudio en dolor NRS.
    • Duración de la respuesta global compuesta por responder temas. tasa de respuesta completa (CRR).
    • Tiempo hasta la progresión (TTP).
    • Tiempo para efecto máximo en mSWAT.
    • Proporción de sujetos lograr mejoría ≥ 50% en mSWAT de duración al menos de 4 meses.
    • Proporción de sujetos lograr mejoría ≥ 50% en mSWAT de al menos 28 días de duración.
    • Porcentaje de sujetos lograr mejoría ≥ 50% en mSWAT desde la línea base en 28 días y a los 4 meses.
    • Tiempo para ≥ 50% de mejora en mSWAT.
    • Duración de la respuesta en la piel (sin progresión después de lograr una mejora ≥ 50% en mSWAT).
    • Cambio en la utilización de medicamentos prurito de la línea de base y la incidencia de la utilización de medicamentos prurito.
    • Sobrevivencia promedio.
    • Tiempo hasta el siguiente tratamiento.

    Las evaluaciones de seguridad y tolerabilidad:
    • Incidencia y la gravedad de los acontecimientos adversos clínicamente significativos (AES) (incluyendo grado 3 y 4 AA, AES relacionados con el tratamiento, eventos adversos graves [AAG], y AES que requieren la interrupción), hallazgos del examen físico, los cambios en electrocardiogramas (ECG), cambios en parámetros de laboratorio y los cambios en los signos vitales.

    Evaluación farmacocinética:
    • Población parámetros PK.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Progression free survival, time to progression, overall survival, complete response rate: assessed throughout study
    Daily pruritus and pain score from Day 1 until follow up visit.
    Skindex-29, mSWAT: every 4 weeks to week 81, every 8 weeks thereafter
    Safety and tolerability: assessed throughout study
    PK: Days 1, 2, 3, 5, 8, 15, 29, every 4 weeks through week 81 and every 8 weeks thereafter.
    Supervivencia libre de Progresión, tiempo hasta progresión, supervivencia general, tipo de respuesta completa: evaluada durante todo el estudio.
    Puntuación de prurito y dolor desde el día 1 hasta visita de seguimiento.
    Skindex-29, mSWAT: cada 4 semanas hasta semana 81, cada 8 semanas a partir de entonces.
    Seguridad y tolerabilidad: determinado durante todo el estudio.
    Muestras PK: Días 1,2,3,5,8,15,29 cada 4 semanes hasta la semana 81 y cada 8 semanas a partir de entonces.
    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 No
    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) 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 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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA40
    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
    Austria
    Belgium
    Canada
    France
    Germany
    Italy
    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
    LVLS
    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 months10
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months0
    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: 63
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 63
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    F.3.3.3Pregnant women Information not present in EudraCT
    F.3.3.4Nursing women Information not present in EudraCT
    F.3.3.5Emergency situation Information not present in EudraCT
    F.3.3.6Subjects incapable of giving consent personally Information not present in EudraCT
    F.3.3.7Others Information not present in EudraCT
    F.4 Planned number of subjects to be included
    F.4.1In the member state15
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 102
    F.4.2.2In the whole clinical trial 126
    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)
    Subjects that have disease progression on the vorinostat arm can be assessed for eligibility for a cobomarsen open-label extension study.
    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 Decision2018-12-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-12-18
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2020-12-01
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