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    Summary
    EudraCT Number:2017-000123-28
    Sponsor's Protocol Code Number:IJB-MULTI-MIME-A-2017
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2019-04-02
    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 ConcernedFrance - ANSM
    A.2EudraCT number2017-000123-28
    A.3Full title of the trial
    Multiorgan Metabolic imaging response assessment of Abemaciclib: the MiMe-A trial
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Multiorgan Metabolic imaging response assessment of Abemaciclib: the MiMe-A trial
    A.3.2Name or abbreviated title of the trial where available
    MIME-A
    A.4.1Sponsor's protocol code numberIJB-MULTI-MIME-A-2017
    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 SponsorInstitut Jules Bordet
    B.1.3.4CountryBelgium
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportEli Lilly
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationInstitut Jules Bordet
    B.5.2Functional name of contact pointCTSU
    B.5.3 Address:
    B.5.3.1Street AddressBoulevard de Waterloo 121
    B.5.3.2Town/ cityBruxelles
    B.5.3.3Post code1000
    B.5.3.4CountryBelgium
    B.5.6E-mailctsu.trials@bordet.be
    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 Yes
    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 nameabemaciclib
    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 INNabemaciclib
    D.3.9.1CAS number 1231929-97-7
    D.3.9.2Current sponsor codeAbemaciclib_50mg_IJB
    D.3.9.3Other descriptive nameABEMACICLIB
    D.3.9.4EV Substance CodeSUB171907
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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
    esophageal ADC, esophageal SCC, Cholangiocarcinoma, urothelial cancer (progressive after immunotherapy), or endometrial cancer
    E.1.1.1Medical condition in easily understood language
    esophageal ADC, esophageal SCC, Cholangiocarcinoma, urothelial cancer (progressive after immunotherapy), or endometrial cancer
    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 10055458
    E.1.2Term Esophageal adenocarcinoma
    E.1.2System Organ Class 100000004864
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10055476
    E.1.2Term Esophageal squamous cell carcinoma
    E.1.2System Organ Class 100000004864
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10008595
    E.1.2Term Cholangiocarcinoma NOS
    E.1.2System Organ Class 100000004864
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10064467
    E.1.2Term Urothelial carcinoma
    E.1.2System Organ Class 100000004864
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10014735
    E.1.2Term Endometrial cancer NOS
    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 anti-tumour activity of abemaciclib in the five tumour types studied in this trial using the combination of FDG-PET/CT during the first cycle of therapy (early FDG- PET/CT) and RECIST v1.1 after 2 cycles of therapy as a screening tool.
    E.2.2Secondary objectives of the trial
    In each tumour type population:
    • To evaluate Progression-free survival (PFS define as the time from treatment start until disease progression or death) and Overall Survival (OS defined as the time from treatment start until death) at 24 weeks from treatment start,
    • To evaluate median progression-free survival (PFS) and median overall survival (OS)
    • To evaluate safety/toxicity profile
    • To evaluate the correlation of early metabolic response using FDG-PET/CT with morphological response to treatment assessed by RECIST
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Age ≥ 18 years old
    2. Female or Male
    3. ECOG performance status ≤ 1
    4. Life expectancy of greater than 12 weeks
    5. Must have histologically confirmed cancer corresponding to the predefined tumour subtypes (esophageal adenocarcinoma, esophageal squamous cell carcinoma, cholangiocarcinoma, urothelial cancer (progressive after immunotherapy), endometrial cancer) that are metastatic or non-resectable and refractory to standard platinum regimens (and progressive after immunotherapy for urothelial cancer if available).
    6. Presence of at least one metabolically measurable tumour lesion on FDG-PET/CT, according to PERCIST. If previously irradiated, must have been more than 2 months before the baseline FDG PET/CT.
    7. Measurable disease according to RECIST v1.1
    8. Negative serum pregnancy test (for subjects of childbearing potential).
    9. Women of childbearing potential must agree to the use of 1 highly effective method of contraception prior to study entry, during the course of the study and at least 3 months after the last administration of study treatment.
    10. Men with childbearing potential partner must agree to use a condom during the course of this study and for at least 3 months after the last administration of the study treatment.
    11. Adequate coagulation: International Normalized Ratio (INR) ≤ 1.5 x ULN unless subject is receiving anticoagulant therapy as long as INR and activated partial thromboplastin time [aPTT] are within therapeutic range of intended use of anticoagulants
    12. Adequate bone marrow function as defined below:
    • Hemoglobin ≥ 10g/dl
    • Absolute neutrophil count ≥ 1500/µL or 1.5x109/L
    • Platelets ≥ 100000/µL or 100x109/L
    • Leukocytes ≥ 3,000/mcL
    13. Adequate liver function as defined below:
    • Serum total bilirubin within 1.5 × normal institutional limits (except for Gilbert syndrome where direct bilirubin should be <1.5 institutional ULN)
    • AST/ALT/ALP) levels < 3 × institutional upper normal limit (or ALT and AST <5 times upper limit of normal if liver metastases are present).
    14. Adequate renal function as defined below:
    • Cockcroft-Gault creatine clearance >50ml/min
    15. Completion of all necessary screening procedures
    16. Ability to swallow capsules
    17. Grade ≤ 1 toxicity due to any previous cancer therapy according to the National Cancer Institute Common Terminology Criteria of Adverse Events (NCI-CTCAE v 5.0). Grade 2 is allowed in case of alopecia and peripheral sensory neuropathy.
    18. If primary archived tumour tissue block available, it must be provided. (1 FFPE tumour tissue or 20 unstained slides)
    19. Signed Informed Consent form (ICF) obtained prior to any study related procedure
    E.4Principal exclusion criteria
    1. Have had chemotherapy, radiotherapy, immunotherapy, or targeted therapy within 3 weeks prior study enrolment
    2. Receiving concomitantly any other experimental agents
    3. Have received prior therapy with other CDK4/6 inhibitors
    4. Known brain metastasis; unless the metastasis are asymptomatic and have been stable since at least 2 months prior to treatment start.
    5. Have meningeal carcinomatosis
    6. Have had major surgery within 28 days prior to the start of the treatment to allow for post-operative healing of the surgical wound
    7. History of allergic reactions attributed to compounds of similar chemical or biologic composition
    8. Bleeding diathesis, thromboembolic event, history of cardiovascular ischemic disease or cerebrovascular incident within the last six months
    9. Uncontrolled concurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia
    10. Substance abuse, psychiatric illness/social situations, any psychological, familial, sociological, geographical condition, significant medical or surgical condition currently uncontrolled by treatment that would limit compliance with study requirements or interfere with the patient’s ability to understand informed consent and participation in the study
    11. Pregnant and/or lactating women
    12. Uncontrolled Diabetes
    13. Known history of HIV infection, or active hepatitis B or C requiring treatment with anti-viral therapy
    14. Have received recent (within 28 days prior the enrolment) yellow fever vaccination
    15. Individuals with a history of a different malignancy are ineligible except for the following circumstances. Individuals with a history of other malignancies are eligible if they have been disease-free and are deemed by the investigator to be at low risk for recurrence of that malignancy.
    E.5 End points
    E.5.1Primary end point(s)
    Therapy success rate defined as:
    • PERCIST 15%-assessed Metabolic Response at early FDG-PET/CT (D12-D16)
    and
    • RECIST v1.1-assessed Disease Control (DC) after 2 treatment cycles (CR or PR or SD)
    E.5.1.1Timepoint(s) of evaluation of this end point
    end of the study
    E.5.2Secondary end point(s)
    In each tumour type population:

    • RECIST v1.1-based radiological response assessment performed at 24 weeks from the treatment start to determine the PFS and OS.
    • Progression Free Survival
    • Overall Survival
    • Safety/Toxicity profile according to CTCAE version 5.0
    E.5.2.1Timepoint(s) of evaluation of this end point
    end of the study
    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 No
    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 No
    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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA15
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    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
    · All cohorts have been closed for recruitment.
    · 18 months after the enrolment of the last patient in each cohort.
    · The trial is mature for the analysis of the endpoints as defined in the protocol, if the trial reaches its endpoints
    · The database has been fully cleaned and frozen for all analyses
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    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 years5
    E.8.9.2In all countries concerned by the trial months9
    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: 185
    F.1.3Elderly (>=65 years) No
    F.1.3.1Number of subjects for this age range: 0
    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 state50
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 185
    F.4.2.2In the whole clinical trial 185
    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)
    At the discretion of the physician according to local practice / 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 Decision2019-05-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-05-23
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2023-12-11
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