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    Summary
    EudraCT Number:2018-002896-17
    Sponsor's Protocol Code Number:ME-401-003
    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:2019-05-31
    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 number2018-002896-17
    A.3Full title of the trial
    A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Two-Arm, Phase 2 Study of ME-401 in Subjects with Follicular Lymphoma After Failure of Two or More Prior Systemic Therapies
    Estudio de fase II, multicéntrico, aleatorizado, doble ciego, controlado con placebo y de dos brazos, de ME-401 en sujetos con linfoma folicular tras el fracaso de dos o más terapias sistémicas anteriores
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Phase 2 Study of ME-401 in Subjects with Follicular Lymphoma
    Estudio de fase II de ME-401 en sujetos con linfoma folicular
    A.4.1Sponsor's protocol code numberME-401-003
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT03768505
    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 SponsorMEI Pharma, 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 supportMEI Pharma Inc
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMEI Pharma Inc
    B.5.2Functional name of contact pointErika Coleman
    B.5.3 Address:
    B.5.3.1Street Address3611 Valley Centre Drive, Suite 500
    B.5.3.2Town/ citySan Diego
    B.5.3.3Post codeCA 92130
    B.5.3.4CountryUnited States
    B.5.4Telephone number1858369-7121
    B.5.6E-mailecoleman@meipharma.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.3.2Product code ME-401
    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 INNME-401
    D.3.9.1CAS number 1401436-95-0
    D.3.9.2Current sponsor codeME-401
    D.3.9.3Other descriptive nameME-401
    D.3.9.4EV Substance CodeSUB178477
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number60
    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 placeboCapsule
    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
    Follicular lymphoma (FL)
    Linfoma folicular (LF)
    E.1.1.1Medical condition in easily understood language
    Follicular lymphoma is a type of blood cancer. It is the most common of the indolent (slow-growing) non-Hodgkin's lymphomas, and the second-most-common form of non-Hodgkin's lymphomas overall.
    El linfoma folicular es un tipo de cancer de la sangre. Es el más común de los linfomas no Hodgkin indolentes (crecimiento lento) y la segunda forma más común de los linfomas de Hodgkin en general.
    E.1.1.2Therapeutic area Diseases [C] - Blood and lymphatic diseases [C15]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10029473
    E.1.2Term Nodular (follicular) lymphoma
    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
    1. To evaluate the objective response rate (ORR) of ME-401 in relapsed FL, defined as the best response rating of complete response (CR) or partial response (PR) according to the Lugano Response Criteria , as determined by an Independent Response Review Committee (IRRC)
    2. To evaluate the tolerability of ME-401, defined as the rate of AEs requiring modified dosing schedule or study drug discontinuation (AERDM)
    1. Evaluar la tasa de respuesta objetiva (TRO) de ME-401 en el LF recidivante, definida como la mejor tasa de respuesta completa (RC) o respuesta parcial (RP) según los criterios de respuesta de Lugano, tal y como lo determine un comité de revisión de respuestas independiente (IRRC, por sus siglas en inglés).
    2. Evaluar la tolerabilidad de ME-401, que se define como la tasa de acontecimientos adversos (AA) que requieren una modificación de la pauta posológica o la interrupción de la administración del fármaco (AARMD).
    E.2.2Secondary objectives of the trial
    1. To evaluate the efficacy of ME-401 as assessed by an IRRC:
    o Duration of response (DOR) among subjects with an objective response
    o Complete response (CR) rate
    o Progression-free survival (PFS)
    2.To evaluate the efficacy of ME-401 as assessed by the Investigator:
    o Objective response rate (ORR)
    o Duration of response (DOR) among subjects with an objective response
    o Complete response (CR) rate
    o Progression-free survival (PFS)
    3.To evaluate overall survival (OS)
    4.To evaluate the safety profile of ME-401
    o Overall incidence of AEs
    o Time to occurrence of AERDM
    5.To evaluate the PK of ME-401
    1. Evaluar la eficacia de ME-401, según la evaluación de un IRCC:
    o Duración de la respuesta (DR) entre los sujetos con una respuesta objetiva
    o Tasa de respuesta completa (RC)
    o Supervivencia libre de progresión (SLP)
    2. Evaluar la eficacia de ME-401, según la evaluación de un investigador:
    o TRO
    o DR entre los sujetos con una respuesta objetiva
    o Tasa de RC
    o SLP
    3. Evaluar la supervivencia global (SG)
    4. Evaluar el perfil de seguridad de ME-401
    o Incidencia global de los AA
    o Momento en el que aparecen los AARMD
    5. Evaluar la farmacocinética (FC) de ME-401
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Age ≥ 18 years (or age of majority)
    2. Histologically confirmed diagnosis of FL as defined in the WHO classification scheme, limited to Grade 1, 2, or 3a
    3. Progression of disease after at least 2 prior systemic therapies for FL. Subjects must have received an anti-CD20 antibody (minimum of 4 doses) and chemotherapy (minimum of 2 doses, which must have included an alkylating agent or a purine analogue), whether administered together or as successive treatments; radioimmunotherapy, high dose therapy and autologous stem cell transplantation, and CAR T-cell therapy are considered as one line of therapy
    1. Edad ≥ 18 años (o mayoría de edad)
    2. Diagnóstico del LF confirmado histológicamente tal y como se define en el esquema de clasificación de la Organización Mundial de la Salud (OMS), limitado a los grados 1, 2 o 3a (Swerdlow, 2016).
    3. Progresión de la enfermedad después de un mínimo de 2 tratamientos sistémicos anteriores del LF. Los sujetos deben haber recibido un tratamiento de anticuerpos anti-CD20 (un mínimo de 4 dosis) y quimioterapia (un mínimo de 2 ciclos, que deben haber incluido un agente alquilante o un análogo de la purina), tanto si se administró de manera conjunta o como tratamientos sucesivos. La radioinmunoterapia, el tratamiento de dosis alta, el trasplante autólogo de células madre y el tratamiento de linfocitos T con CAR se consideran una línea de tratamiento.
    E.4Principal exclusion criteria
    1. Known active histological transformation from FL to an aggressive lymphoma: biopsy documentation of the absence or presence of transformation is not required and left to the Investigator’s discretion
    2. Major surgical procedure within 4 weeks of Day 1
    3. Any uncontrolled clinically significant illness including, but not limited to, active infections, hypertension, angina, arrhythmias, pulmonary disease, or autoimmune dysfunction
    4. Subjects who have tested positive for hepatitis B surface antigen and/or hepatitis B core antibody plus have a positive hepatitis B PCR assay; subjects with a negative PCR assay are permitted with appropriate anti-viral prophylaxis
    5. Positive HCV Ab; subjects with positive hepatitis C antibody are eligible if they are negative for HCV by PCR
    6. Ongoing or history of drug-induced pneumonitis
    7. Other diagnosis of cancer that is likely to require treatment in the next 2 years, with the exception of the following:
    a. Curatively treated basal cell carcinoma or squamous cell carcinoma of the skin
    b. Curatively treated carcinoma in situ of the cervix
    c. Hormonal therapy for prostate cancer
    1. Transformación histológica activa conocida del LF a linfoma agresivo. La documentación de la biopsia sobre la ausencia o la presencia de la transformación no es necesaria y se deja a discreción del investigador.
    2. Intervención quirúrgica mayor en las 4 semanas anteriores al día 1 del estudio.
    3. Cualquier enfermedad de importancia clínica sin controlar, incluidas, entre otras, infecciones activas, hipertensión, angina, arritmias, neumopatía o disfunción autoinmunitaria.
    4. Sujetos que hayan dado positivo en la prueba del antígeno de superficie de la hepatitis B y/o del anticuerpo central de la hepatitis B y que además hayan dado positivo en el análisis de reacción en cadena de la polimerasa (RCP) de la hepatitis B. Se permite la participación de sujetos que den negativo en el análisis de RCP que reciban la profilaxis antivírica adecuada.
    5. Anticuerpos positivos contra el virus de la hepatitis C (Ac VHC). Los sujetos con anticuerpos positivos contra la hepatitis C son aptos si dan negativo al VHC en la RCP.
    6. Neumonitis inducida por fármacos anterior o en curso.
    7. Otros diagnósticos de cáncer que probablemente requieran tratamiento en los próximos 2 años, a excepción de los siguientes:
    a. Carcinoma de células basales o carcinoma de células escamosas de la piel tratado de forma curativa.
    b. Carcinoma in situ de cuello uterino tratado de forma curativa.
    c. Hormonoterapia para el cáncer de prostate
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoints are: 1) ORR defined as the best response of CR + PR as determined by an IRRC, and 2) the proportion of subjects requiring a modified dosing schedule or study drug discontinuation for CTCAE v5.0 Grade ≥ 2 AEs thought to be related or possibly related to the study drug.
    Las variables principales son: 1) la TRO, definida como la mejor respuesta de RC + RP, según lo determinado por un CRRI y 2) la proporción de sujetos que requieren una pauta posológica modificada o la interrupción del fármaco del estudio por AA de grado ≥2 según los CTCAE v5.0 que se consideren relacionados o posiblemente relacionados con el fármaco del estudio.
    E.5.1.1Timepoint(s) of evaluation of this end point
    TBC: 1. meetings by IRRC for ORR 2. After the last patient has been on the study for 6 months.
    Pendiente de confirmar: 1. Reuniones del CRRI para la TRO 2. Después de que el último paciente haya estado en el estudio durante 6 meses.
    E.5.2Secondary end point(s)
    1. Duration of Response (DOR)
    DOR will be evaluated as a secondary endpoint and is defined as time from documentation of the first CR or PR to the time of disease progression or relapse (based on the Lugano Response Criteria) independently from study period or dosing schedule.
    2.Progression-Free Survival (PFS)
    PFS will be assessed as a secondary endpoint and is defined as time from initiation of treatment (Day 1) until disease progression or death from any cause independently from the study period or dosing schedule. PFS time will be censored at the last disease assessment date indicating the absence of progression or recurrence for subjects who have not demonstrated objective progression and are still alive. For subjects who withdraw consent for any reason before demonstrating evidence of progression or recurrence, PFS time will be censored at the last date for which disease assessment indicated the absence of progression or recurrence. Subjects are censored at the date of first dose of study treatment if no additional follow-up data are obtained.
    3. Overall Survival (OS)
    OS will be assessed as a secondary endpoint and is defined as time from initiation of treatment (Day 1) until death from any cause independently from the study period or dosing schedule. OS time will be censored at the last date the subject is known to be alive when the confirmation of death is absent or unknown.
    1. Duración de la respuesta (DR)
    La DR se evaluará como un criterio de valoración secundario y se define como el tiempo transcurrido desde la documentación de la primera RC o RP hasta el momento de la progresión de la enfermedad o recidiva (en función de los criterios de respuesta de Lugano) independientemente del periodo del estudio o la pauta posológica.
    2. Supervivencia libre de progresión (SLP)
    La SLP se evaluará como una variable secundaria y se define como el tiempo transcurrido desde el inicio del tratamiento (día 1) hasta la progresión de la enfermedad o la muerte por cualquier causa independientemente del periodo del estudio o la pauta posológica. El tiempo de SLP se censurará en la fecha de la última evaluación de la enfermedad que indique ausencia de progresión o recurrencia para los sujetos que no hayan mostrado progresión objetiva y sigan vivos. En el caso de los sujetos que retiren su consentimiento por cualquier motivo antes de mostrar signos de progresión o recurrencia, el tiempo de SLP se censurará en la última fecha en la que la evaluación de la enfermedad indicó la ausencia de progresión o recurrencia. Los sujetos se censurarán en la fecha de la primera dosis del tratamiento del estudio si no se obtienen datos de seguimiento adicionales.
    3. Supervivencia global (SG)
    La SG se evaluará como una variable secundaria y se define como el tiempo transcurrido desde el inicio del tratamiento (día 1) hasta la muerte por cualquier causa independientemente del periodo del estudio o la pauta posológica. El tiempo de SG se censurará en la última fecha en que se sepa que el sujeto está vivo cuando no se disponga de confirmación de la muerte o se desconozca.
    E.5.2.1Timepoint(s) of evaluation of this end point
    After the last patient has been on the study for 6 months.
    Después de que el último paciente haya estado en el estudio durante 6 meses.
    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 No
    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 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) 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 concerned12
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA59
    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
    Korea, Republic of
    New Zealand
    Poland
    Spain
    Switzerland
    Taiwan
    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
    Última visita del ultimo paciente
    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 months6
    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: 115
    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 state5
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 90
    F.4.2.2In the whole clinical trial 165
    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)
    Patients will be treated according to the standard of care
    Los pacientes serán tratados de acuerdo a la práctica médica habitual
    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 Decision2019-05-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-04-25
    P. End of Trial
    P.End of Trial StatusOngoing
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