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    Summary
    EudraCT Number:2018-002896-17
    Sponsor's Protocol Code Number:ME-401-003
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2019-02-13
    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 ConcernedUK - MHRA
    A.2EudraCT number2018-002896-17
    A.3Full title of the trial
    A Multicenter, Open-Label, Single-Arm, Phase 2 Study of ME-401 in Subjects with Follicular Lymphoma After Failure of Two or More Prior Systemic Therapies
    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
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Follicular lymphoma (FL)
    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.
    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 21.0
    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
    To evaluate the objective response rate (ORR) of ME-401 in relapsed or refractory FL, based on the Modified Lugano Response Criteria (Appendix 5), and determined by an Independent Response Review Committee (IRRC)
    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)
    o Complete response (CR) rate
    o Progression-free survival (PFS)
    o Time to treatment failure (TTF)
    o Recapture of response
    o Duration of recaptured response (DORR)
    2. To evaluate the efficacy of ME-401 as assessed by the Investigator:
    o Objective response rate (ORR)
    o Duration of response (DOR)
    o Complete response (CR) rate
    o Progression-free survival (PFS)
    o Time to treatment failure (TTF)
    o Recapture of response
    o Duration of recaptured response (DORR)
    3. To evaluate the overall survival (OS)
    4.To evaluate the safety profile of ME-401
    o Overall incidence of treatment-emergent adverse events (TEAEs)
    o Incidence of adverse events of special interest (AESIs)
    o Time to occurrence of AESIs
    5.To evaluate the PK of 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. Subjects with relapsed or refractory FL who received ≥2 prior therapy regimens. A previous regimen is defined as one of the following: at least
    two months of single-agent therapy or at least two consecutive cycles of polychemotherapy, autologous transplant, or radioimmunotherapy. Prior therapy must include rituximab and an alkylating agent(s). Relapsed or refractory disease defined as:
    a. Relapsed disease: disease progression after a response (CR or PR) lasting ≥6 months
    b. Refractory disease: no response to therapy (no CR or PR) or response lasting <6 months
    E.4Principal exclusion criteria
    1. Histologically confirmed FL Grade 3b, or transformed disease (assessed by the Investigator):
    a. Histological confirmation of transformation, or
    b. Clinical and laboratory signs: rapid disease progression, high
    standardized uptake value (>12) by positron emission tomography (PET) at baseline
    2. Known lymphomatous involvement of the central nervous system.
    3. Major surgical procedure within 4 weeks prior to study Day 1.
    4. Prior therapy with PI3K inhibitors.
    5. Any uncontrolled clinically significant illness including, but not limited to, active infections requiring systemic antimicrobial therapy,
    hypertension, angina, arrhythmias, pulmonary disease, or autoimmune dysfunction.
    6. Subjects who have tested positive for hepatitis B surface antigen and/or hepatitis B core antibody plus have a positive hepatitis B polymerase chain reaction (PCR) assay; subjects who have previously tested positive with a negative PCR assay are permitted with appropriate
    anti-viral prophylaxis.
    7. Positive hepatitis C virus antibody (HCV Ab); subjects with positive HCV Ab are eligible if they are negative for HCV by PCR.
    8. Known history of, or active HIV infection.
    9. Ongoing or history of drug-induced pneumonitis.
    10. Previous or concurrent cancer that is distinct in primary site or histology from indolent B-cell NHL within 3 years before start of study
    treatment except for curatively treated cervical cancer in situ, nonmelanoma skin cancer, and superficial bladder tumors (Ta [non-invasive
    tumor], Tis [carcinoma in situ], and T1 [tumor invades lamina propria]).
    11. History of clinically significant cardiovascular abnormalities such as congestive heart failure (New York Heart Association classification ≥ II
    [NYHA 1994]), myocardial infarction within 6 months of study entry.
    12. History of clinically significant gastrointestinal (GI) conditions, particularly:
    a. Known GI condition that would interfere with swallowing or the oral absorption or tolerance of study drug
    b. Pre-existing malabsorption syndrome or other clinical situation that would affect oral absorption
    13. Females who are pregnant; females who plan to breastfeed during study treatment through 90 days after ending treatment.
    14. Psychiatric illness/social situations that would interfere with study compliance.
    15. Hypersensitivity or other clinically significant reaction to the study drug or its inactive ingredients.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint is ORR, defined as the proportion of subjects achieving the best response rating of CR or PR based on the Modified Lugano Classification.
    E.5.1.1Timepoint(s) of evaluation of this end point
    The primary analysis will be triggered after the last subject enrolled in the study is followed for at least 6 months.
    E.5.2Secondary end point(s)
    1. Duration of Response (DOR) and Duration of Recaptured Response (DORR)
    Duration of response (DOR) will be evaluated as a secondary endpoint and is defined as the time from documentation of the first CR or PR to the time of first disease progression based on the Modified Lugano Response Criteria. To evaluate the duration of response for subjects who had recapture of response on the CS dosing, duration of recaptured response (DORR) is defined as the time from recapture of response to the time of second disease progression.
    2. Progression-free survival (PFS)
    Progression-free survival (PFS) will be assessed as a secondary endpoint and is defined as the time from initiation of treatment (Day 1) until first
    disease progression or death from any cause. Disease progression criteria are defined per Modified Lugano Response Criteria and will be
    assessed by the IRRC and Investigator independently.
    3. Time to treatment Failure (TTF)
    Time to treatment failure will be assessed as a secondary endpoint and is defined as the time from first dose of study drug to treatment failure.
    Treatment failure is defined as any treatment discontinuation due to disease progression, toxicity, or death.
    4. Recapture of Response
    Recapture of response is defined as achieving a second documented CR or PR after experiencing the first PD.
    Recapture of response rate will be assessed as a secondary endpoint, and is defined as the proportion of subjects who achieved a CR or PR
    followed by a PD during IS dosing and subsequently switched to CS dosing and achieved a second documented CR or PR.
    Time to recapture of response will be assessed as a secondary endpoint, and is defined as the time from the first PD until the second documented
    CR or PR.
    5. Overall Survival (OS) OS will be assessed as a secondary endpoint and is defined as the 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.
    E.5.2.1Timepoint(s) of evaluation of this end point
    The primary analysis will be triggered after the last subject enrolled in the study is followed for at least 6 months.
    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 No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.3 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 concerned13
    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
    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: 70
    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 state26
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 90
    F.4.2.2In the whole clinical trial 120
    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
    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 Decision2019-03-31
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-04-08
    P. End of Trial
    P.End of Trial StatusOngoing
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