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    Summary
    EudraCT Number:2016-000807-99
    Sponsor's Protocol Code Number:4SC-201-6-2015
    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:2016-08-05
    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 number2016-000807-99
    A.3Full title of the trial
    A multicentre, double blind, randomised, placebo controlled, Phase II trial to evaluate Resminostat for maintenance treatment of patients with advanced stage (Stage IIB-IVB) mycosis fungoides (MF) or Sézary Syndrome (SS) that have achieved disease control with systemic therapy – the RESMAIN Study
    Estudio multicéntrico, doble ciego, aleatorizado, controlado con placebo, de fase II para evaluar Resminostat para el tratamiento de mantenimiento de pacientes con estadio avanzado (estadio IIB-IVB) de micosis fungoide (MF) o Síndrome de Sézary (SS) que
    hayan logrado el control de la enfermedad con la terapia sistémica – Estudio
    RESMAIN
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The purpose of this research study is to determine if the new drug resminostat will be able to delay or prevent worsening of disease in patients with advanced stage mycosis fungoides or Sézary Syndrome that have achieved disease control with previous systemic therapy, recently
    El propósito de este estudio de investigación es determinar si el nuevo fármaco Resminostat será capaz de retrasar o prevenir el empeoramiento de la enfermedad en pacientes con estadio avanzado de micosis fungoide o síndrome de Sézary que han logrado el control de la enfermedad con la terapia sistémica. El objetivo de esta investigación es determinar si el nuevo fármaco Resminostat será capaz de retrasar o prevenir el empeoramiento de la enfermedad en pacientes con micosis fungoide.
    A.3.2Name or abbreviated title of the trial where available
    RESMAIN Study
    Estudio RESMAIN
    A.4.1Sponsor's protocol code number4SC-201-6-2015
    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 Sponsor4SC AG
    B.1.3.4CountryGermany
    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 support4SC AG
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationHospital Universitario 12 de Octubre
    B.5.2Functional name of contact pointPablo Ortiz Romero
    B.5.3 Address:
    B.5.3.1Street AddressAvenida de Córdoba sn
    B.5.3.2Town/ cityMadrid
    B.5.3.3Post code28041
    B.5.3.4CountrySpain
    B.5.4Telephone number0034917792252
    B.5.6E-mailpablo.ortiz@salud.madrid.org
    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 nameResminostat
    D.3.4Pharmaceutical form Film-coated tablet
    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 INNResminostat
    D.3.9.1CAS number 864814-88-0
    D.3.9.2Current sponsor code4SC-201
    D.3.9.3Other descriptive nameBYK 408740
    D.3.9.4EV Substance CodeSUB120712
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboFilm-coated tablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Advanced stage (Stage IIB-IVB) mycosis fungoides (MF) or Sézary Syndrome (SS) that have achieved disease control with systemic therapy
    Estadio avanzado (estadio IIB-IVB) de micosis fungoide (MF) o Síndrome de Sézary (SS) que hayan logrado el control de la enfermedad con la terapia sistémica
    E.1.1.1Medical condition in easily understood language
    Specific type of lymphoma affecting the skin (Mycosis fungoides or Sézary Syndrome) which has treated recently with systemic therapy, responded to this treatment and has been stabilized
    Tipo específico de linfoma que afecta a la piel (micosis fungoide o síndrome de Sézary ), que ha sido tratado recientemente con terapia sistémica, respondido a este tratamiento y estabilizado
    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 10028508
    E.1.2Term Mycosis fungoides/Sezary syndrome
    E.1.2System Organ Class 100000004864
    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 is to determine if maintenance treatment with resminostat increases progression free survival (PFS) compared to placebo in patients with advanced stage (Stage IIB-IVB) MF or SS that have achieved disease control (complete response [CR], partial response [PR] or stable disease [SD]) with previous systemic therapy.
    El objetivo principal es determinar si el tratamiento de mantenimiento con resminostat aumenta la supervivencia sin progresión (PFS) en comparación con el placebo en pacientes con estadio avanzado (estadio IIB-IVB) de MF o SS que hayan logrado el control de la enfermedad (remisión completa [CR], parcial [PR] o enfermedad estable [SD]) con una terapia sistémica previa.
    E.2.2Secondary objectives of the trial
    Key Secondary Objective
    •To determine if maintenance treatment with resminostat increases time to symptom (pruritus) worsening (TTSW) compared to placebo.
    Objetivo secundario clave
     Determinar si el tratamiento de mantenimiento con resminostat aumenta el tiempo transcurrido hasta el empeoramiento del síntoma (prurito) (TTSW) en comparación con el placebo.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Patients with histologically confirmed MF (Stage IIB-IVB) or SS in an ongoing CR, PR or SD after at least one prior systemic therapy according to local standards (including but not limited to α-interferon, bexarotene, total skin electron beam irradiation, chemotherapy)
    othe most recent systemic therapy must have been completed as planned or stopped due to unacceptable toxicity 2-8 weeks prior to randomisation
    2.Male or female ≥ 18 years
    3.Written informed consent obtained prior to any trial specific procedure
    4.Eastern Cooperative Oncology Group (ECOG) status score 0-2
    5.Adequate haematological, hepatic and renal function, as demonstrated by:
    a)haemoglobin ≥ 9.0 g/dl (International System [SI] of Units: 5.6 mmol/L)
    b)absolute neutrophil count ≥ 1,000/mm3
    c)platelets ≥ 75 × 109/L
    d)alanine aminotransferase and aspartate amino-transferase ≤ 2 times upper limit of normal
    e)total bilirubin ≤ 2 mg/dL (SI units: 0.117 µmol/L) (unless known Gilbert syndrome)
    f)serum creatinine ≤ 1.5 mg/dL (SI units: 132 µmol/L)
    g)prothrombin time International Normalised Ratio ≤ 2.3
    6.Women of childbearing potential (not post-menopausal for 1 year and not surgically sterile) and males with partners of childbearing potential must be sexually abstinent or must use effective double contraception (at least two of the following: hormonal contraceptives [e.g., injection, implant, patch], diaphragm, intrauterine device, and condoms [for the male partner]) from the time of screening to 30 days (female patients) or 3 months (male patients) after the last dose of trial treatment
    7.Adequate recovery from precedent non-haematological toxicities, excluding alopecia, to ≤ National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Grade 1
    8.Able to comply with all the requirements of the protocol
    Criterios de inclusión
    1. Pacientes con MF (estadio IIB-IVB) o SS confirmados por histología con CR, PR o SD en curso tras al menos una terapia sistémica previa según las pautas locales (entre las que se incluyen, sin ánimo de exhaustividad, interferón α, bexaroteno, radioterapia con haz de electrones de toda la piel, quimioterapia)
    o la terapia sistémica más reciente debe haberse completado según lo programado o haberse interrumpido por toxicidad inaceptable 2-8 semanas antes de la aleatorización
    2. Personas de ambos sexos ≥ 18 años
    3. Consentimiento informado por escrito obtenido previa realización de cualquier procedimiento específico del estudio
    Estado funcional del Eastern Cooperative Oncology Group (ECOG) 0-2
    5. Función renal, hepática y hematológica satisfactorias, demostrado por:
    a) hemoglobina ≥ 9,0 g/dl (Sistema internacional [SI] de unidades: 5,6 mmol/l)
    b) cifra absoluta de neutrófilos ≥ 1000/mm3
    c) plaquetas ≥ 75 × 109/l
    d) alanina-aminotransferasa y aspartato-aminotransferasa ≤ 2 veces el límite superior de la normalidad
    e) bilirrubina total ≤ 2 mg/dl (unidades del SI: 0,117 μmol/l) (salvo con síndrome de Gilbert demostrado)
    f) creatinina sérica ≤ 1,5 mg/dl (unidades del SI: 132 μmol/l)
    g) tiempo de protrombina según el índice internacional normalizado ≤ 2,3
    6. Las mujeres con posibilidad de quedarse embarazadas (no posmenopáusicas durante 1 año ni esterilizadas quirúrgicamente) y los varones con parejas que tengan la posibilidad de quedarse embarazadas deben abstenerse de mantener relaciones sexuales o bien utilizar un método anticonceptivo doble efectivo (como mínimo, dos de los métodos siguientes: anticonceptivos hormonales [p. ej., inyección, implante, parche], diafragma, dispositivo intrauterino y preservativos [para la pareja de sexo masculino]) desde el momento de la selección hasta 30 días (pacientes femeninas) o 3 meses (pacientes masculinos) después de la última dosis del tratamiento del estudio
    7. Recuperación satisfactoria de toxicidades no hematológicas precedentes, salvo la alopecia, a ≤ grado 1 de los criterios de terminología común para los acontecimientos adversos (CTCAE) del Instituto Nacional del Cáncer (NCI)
    8. Capacidad de cumplir todos los requisitos del protocolo
    E.4Principal exclusion criteria
    1.Patients with PD
    2.Known central nervous system involvement
    3.History and current cardiovascular complications, including unstable angina pectoris, uncontrolled hypertension, congestive heart failure (New York Heart Association [NYHA] Class III or IV) related to primary cardiac disease, a condition requiring anti arrhythmic therapy, ischemic or severe valvular heart disease, or a myocardial infarction within 6 months prior to randomisation
    4.Baseline corrected QT (QTc) interval > 500 milliseconds
    5.History of additional risk factors for Torsade de Pointes (e.g., heart failure, hypokalaemia, family history of Long QT Syndrome)
    6.Use of concomitant medications that are known to prolong the QT/QTc interval
    7.Concurrent use of any other specific anti tumour therapy including psoralen photo chemotherapy (PUVA), chemotherapy, immunotherapy, hormonal therapy, radiation therapy, or experimental medications
    8.Previous or concurrent cancer that is distinct in primary site or histology from CTCL, except cervical carcinoma in situ, treated basal cell carcinoma, superficial bladder tumours (Ta, Tis and T1); any cancer curatively treated > 3 years prior to randomisation will be allowed
    9.Current evidence of any uncontrolled clinically significant internal, psychiatric or neurologic disease
    10.Altered mental status precluding understanding of the informed consent process and/or completion of the necessary trial procedures
    11.Pregnant or breast feeding women
    12.History of allergic reactions attributed to compounds of similar chemical or biological composition to the trial drugs
    13.Active alcohol and/or drug abuse
    14.Any other acute or chronic condition that, in the investigator’s opinion, would limit the patient’s ability to complete or participate in this trial
    Criterios de exclusión
    1. Pacientes que presenten PD
    2. Afectación del sistema nervioso central demostrada
    3. Complicaciones cardiovasculares previas y actuales, como angina de pecho inestable, hipertensión no controlada, insuficiencia cardíaca congestiva (clase III o IV de la New York Heart Association [NYHA]) relacionada con una cardiopatía primaria, un trastorno que precise terapia antiarrítmica, valvulopatía isquémica o grave, o un infarto de miocardio en los 6 meses previos a la aleatorización
    4. Valor del intervalo QT corregido (QTc) en el momento basal > 500 milisegundos
    5. Antecedentes de factores de riesgo adicionales de taquicardia ventricular en entorchado (p. ej., insuficiencia cardíaca, hipopotasiemia, antecedentes familiares de síndrome de QT largo)
    6. Uso de medicamentos concomitantes que prolonguen el intervalo QT/QTc
    7. Uso concomitante de cualquier otra terapia antitumoral específica, como, por ejemplo: fotoquimioterapia con psoralenos (PUVA), quimioterapia, inmunoterapia, terapia hormonal, radioterapia o medicamentos experimentales
    8. Se permitirá cualquier cáncer previo o concurrente que sea distinto, en cuanto a su localización primaria o histología, del CTCL, excepto el carcinoma de cuello uterino in situ, carcinoma de células basales tratado, tumores superficiales de vejiga (Ta, Tis y T1) o cualquier cáncer tratado de forma curativa > 3 años antes de la aleatorización
    9. Constancia actual de cualquier trastorno interno, psiquiátrico o neurológico no controlado de importancia clínica
    10. Alteración del estado mental que impida la comprensión del proceso de consentimiento informado y/o la culminación de los procedimientos necesarios del estudio
    11. Mujeres embarazadas o en período de lactancia
    12. Antecedentes de reacciones alérgicas atribuidas a compuestos de composición química o biológica similar a la de los fármacos del estudio
    13. Alcoholismo o drogadicción activos
    14. Cualquier otra enfermedad crónica o aguda que, a juicio del investigador, limitaría la capacidad del paciente de completar o participar en el presente estudio.
    E.5 End points
    E.5.1Primary end point(s)
    Progression free survival (PFS) is defined as the time from date of randomisation to first date that criteria for PD have been met according to the global response score or death due to any cause in the absence of documented PD.
    Se entiende por PFS el tiempo transcurrido desde la fecha de la aleatorización hasta la fecha en la que se cumplieron por primera vez los criterios de PD, conforme a la puntuación de la respuesta global o, si no existe PD documentada, a la muerte por cualquier causa.
    E.5.1.1Timepoint(s) of evaluation of this end point
    PFS (progression free survival) is defined as the time from date of
    randomisation to first date that criteria for progressive disease (PD)
    have been met according to the global response score or death due to
    any cause in the absence of documented PD.
    Se entiende por PFS el tiempo transcurrido desde la fecha de la aleatorización hasta la fecha en la que se cumplieron por primera vez los criterios de PD, conforme a la puntuación de la respuesta global o, si no existe PD documentada, a la muerte por cualquier causa.
    E.5.2Secondary end point(s)
    Key Secondary Endpoint
    •TTSW (pruritus)

    Secondary Endpoints
    •TTP
    •TTNT
    •PFS2
    •PFS3
    •ORR (CR, PR)
    •DOR
    •OS
    •HrQoL
    oVAS (itching)
    oFACT-G
    oSkindex-29
    •PK analysis (peripheral blood)
    Criterio de valoración secundario clave
     TTSW (prurito)
    Criterios de valoración secundarios
     TTP
     TTNT
     PFS2
     PFS3
     ORR (CR, PR)
     DOR
     OS
     HrQoL
    o VAS (picor)
    o FACT-G
    o Skindex-29
     Análisis de la PK (sangre periférica)
    E.5.2.1Timepoint(s) of evaluation of this end point
    TTSW (pruritus), the key secondary endpoint, is defined as the time from date of randomisation to first date that criteria for symptom (pruritus) worsening have been met.
    TTSW (prurito), el criterio de valoración secundario clave se entiende como el
    tiempo transcurrido desde la fecha de aleatorización hasta la fecha en la que se
    cumplió por primera vez el criterio de empeoramiento del síntoma (prurito).
    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 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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Fase abierta seguida de fase ciega, vease el protocolo para mas detalles
    open label phase to follow the blinded phase, see protocol for details
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    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 EEA48
    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
    Austria
    Belgium
    France
    Germany
    Italy
    Netherlands
    Poland
    Spain
    Switzerland
    United Kingdom
    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
    LSLV
    UPUV
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    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 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: 75
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 75
    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 state15
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 140
    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)
    Standard of Care
    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 Decision2016-10-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-09-21
    P. End of Trial
    P.End of Trial StatusOngoing
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