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    Summary
    EudraCT Number:2020-000640-64
    Sponsor's Protocol Code Number:MOU-2020-01
    National Competent Authority:Czechia - SUKL
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2020-04-21
    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 ConcernedCzechia - SUKL
    A.2EudraCT number2020-000640-64
    A.3Full title of the trial
    11C-METHIONIN IN DIAGNOSIS AND MANAGEMENT OF PATIENTS WITH AGGRESSIVE GLIOBLASTOM SHOWING A TIME POST-OPERATING PROGRESS BEFORE INITIATING ADJUVANT ONCOLOGICAL TREATMENT
    11C-METHIONIN V DIAGNOSTICE A MANAGEMENTU PACIENTŮ S AGRESIVNÍM GLIOBLASTOMEM VYKAZUJÍCÍM ČASNOU POOPERAČNÍ PROGRESI PŘED ZAHÁJENÍM ADJUVANTNÍ ONKOLOGICKÉ LÉČBY
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Diagnosis of early progression after glioblastoma surgery using 11C-methionine radiopharmaceutical
    Diagnostika časné progrese po operaci glioblastomu za použití radiofarmaka 11C-methionin
    A.3.2Name or abbreviated title of the trial where available
    GlioMET
    GlioMET
    A.4.1Sponsor's protocol code numberMOU-2020-01
    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 SponsorMasarykův onkologický ústav
    B.1.3.4CountryCzech Republic
    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 supportAGENTURA PRO ZDRAVOTNICKÝ VÝZKUM ČESKÉ REPUBLIKY
    B.4.2CountryCzech Republic
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMasarykův onkologický ústav
    B.5.2Functional name of contact pointRegina Demlová
    B.5.3 Address:
    B.5.3.1Street AddressŽlutý kopec 7
    B.5.3.2Town/ cityBrno
    B.5.3.3Post code65653
    B.5.3.4CountryCzech Republic
    B.5.6E-maildemlova@mou.cz
    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 nameMethionin (11C) methyl UJV 100 – 1500 MBq/ml injekční roztok
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    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 Yes
    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
    REP (rapid early progression) after glioblastoma operation
    REP (rapid early prgoression) po operaci glioblastomu
    E.1.1.1Medical condition in easily understood language
    REP (rapid early progression) after glioblastoma operation
    REP (rapid early prgoression) po operaci glioblastomu
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The aim of the study is to prove the potential of 11C-MET PET/CT optimized radiotherapy to prolong the progression free survival in the group of glioblastoma patients with rapid early progression (Arm A) if compared with respective historical retrospective cohort (Arm Ahist).
    Cílem je prokázat, že při optimalizaci radioterapie pomocí 11C-MET PET/CT se prodlouží čas do progrese (PFS) pacientů s časnou pooperační progresí GB (rameno A) ve srovnání s odpovídající historickou retrospektivní skupinou pacientů (rameno Ahist).
    E.2.2Secondary objectives of the trial
    • Prospective assessment of the incidence of REP on planning MRI in GB patients indicated to adjuvant chemoradiotherapy.
    • Evaluation of PFS in the group of patients with REP undergoing the MET PET optimized RT (Arm A) vs. PFS in the group of patients with no REP (Arm B).
    • Evaluation of overal survival (OS) in the group of patients with REP undergoing the MET PET optimized RT (Arm A) vs. OS in the respective historical retrospective cohort (Arm Ahist) vs. OS in the group of patients with no REP (Arm B).
    • Univariate and multivariate analysis of clinical factors and laboratory biomarkers in the whole group of prospectively enrolled GB patients, and in respective arms.
    • Identification of basic clinical and laboratory biomarkers of REP applicable to clinical practice.
    • Evaluation of spatial patterns of failure (central vs. in-field vs. marginal vs. distant) in MET PET cohort (Arm A) in comparison to retrospective REP cohort (Ahist.).
    • Prospektivní zhodnocení výskytu REP na plánovací MR u pacientů s GB indikovaných k adjuvantní chemoradioterapii.
    • Vyhodnocení PFS při optimalizaci RT pomocí MET PET pacientů s REP (rameno A) ve srovnání se skupinou pacientů bez REP (rameno B).
    • Vyhodnocení celkového přežití (OS) při optimalizaci RT pomocí MET PET pacientů s REP (rameno A) ve srovnání s historickou retrospektivní skupinou pacientů (rameno Ahist) a se skupinou pacientů bez REP (rameno B).
    • Univariační a multivariační analýza pro OS a PFS klinických charakteristik a laboratorních biomarkerů v celém souboru zařazených pacientů a v jednotlivých ramenech.
    • Identifikace základních klinických a laboratorních biomarkerů pacientů s REP, které lze aplikovat v klinické praxi.
    • Prostorové vyhodnocení recidiv (patterns of failure, PoF) u pacientů s REP (rameno A) ve srovnání s historickou retrospektivní skupinou pacientů (rameno Ahist).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. The subject is a person with a histologically proven diagnosis of glioblastoma (GB) according to WHO 2016.
    2. The subject is male or female, aged 18 years or older.
    3. Performance status (PS) according to ECOG (Eastern Cooperative Oncology Group) 0-2.
    4. Healed operation wound.
    5. Post-operative MR up to 72 hours.
    6. Indication to adjuvant chemoradiotherapy.
    7. Patient has to express his/her informed consent and sign the form before the screening period.
    8. Patient must achieve following values of laboratory parameters in the peripheral blood during the screening period:
    a. neutrophiles (total count) ≥1500/mm3
    b. platelets (total count) ≥100 000/mm3
    c. hemoglobin ≥ 9,0 g/dL
    d. serum creatinin ≤1,5x of upper limit of normal, ULN
    e. total bilirubin 1,5x ULN, unless documented Gilbert’s syndrome, for which bilirubin ≤ 3x ULN is permitted
    f. AST/ALT ≤3x ULN
    1. Pacientovi je diagnostikován glioblastom (GB) dle klasifikace WHO 2016.
    2. Pacient je ve věku ≥18 let.
    3. PS dle ECOG (Eastern Cooperative Oncology Group) 0-2.
    4. Zhojená operační rána.
    5. Pacient podstoupil pooperační MR do 72 hodin.
    6. Pacient je indikován k adjuvantní chemoradioterapii.
    7. Pacient chápe informovaný souhlas a podepíše ho.
    8. Pacient musí dosáhnout těchto hodnot laboratorních vyšetření:
    a. absolutní počet neutrofilů ≥1500/mm3
    b. počet krevních destiček ≥100 000/mm3
    c. hemoglobin ≥ 9,0 g/dL
    d. kreatinin v séru ≤1,5násobek maximálních normálních hodnot (upper limit of normal, ULN)
    e. celkový bilirubin ≤1,5násobek ULN; u pacientů s Gilbertovým syndromem je přípustá hodnota ≤3násobek ULN
    f. AST/ALT ≤3násobek ULN
    E.4Principal exclusion criteria
    1. Prior brain surgery.
    2. Prior radiotherapy targeting brain.
    3. The history of active/currently treated cancer (solid tumor); the exceptions are: non-melanoma skin cancer, in situ bladder carcinoma, in situ gastric cancer, in situ colorectal carcinoma, in situ cervical carcinoma, in situ breast cancer.
    4. Any systemic disease or health condition that might posses a risk at anticancer therapy and imaging techniques (MRI, MET PET).
    5. Patients must not have substance abuse disorders that would interfere with cooperation with the requirements of the trial.
    6. Patients must not have any evidence of ongoing (active) infection (HIV, hepatitis A, B, C).
    7. Pregnant and/or breastfeeding women.
    8. Patient who disagree and refuses to sign an Informed consent.
    1. Předchozí operace mozku.
    2. Předchozí radioterapie cílená na oblast mozku.
    3. Historie aktivního / aktuálně léčeného nádorového onemocnění (solidní tumor); výjimkami jsou nemelanomové kožní nádory, in situ karcinom močového měchýře, in situ karcinom žaludku, in situ kolorektální karcinom, in situ karcinom čípku děložního, in situ karcinom prsu.
    4. Jakékoli systémové onemocnění nebo obecně takový zdravotní stav pacienta, který by byl rizikem při podání onkologické léčby a provedení zobrazovacích metod (MRI, MET PET).
    5. Závislost na návykových látkách a další faktory, které by mohly interferovat se studijními procedurami.
    6. Aktivní infekční onemocnění (HIV, hepatitida A, B, C).
    7. Těhotenství, kojení.
    8. Pacient není schopen nebo odmítá podepsat informovaný souhlas.
    9. Pacienti, kteří nepodstoupili resekci GB, ale pouze biopsii.
    10. Známá kontraindikace k chemoradioterapii a/nebo MRI/MET PET zobrazování dle institucionálních standardů.
    E.5 End points
    E.5.1Primary end point(s)
    PFS in Arm A vs. PFS in arm Ahist (median PFS in Arm A > median PFS in arm Ahist for ≥3,1 months).
    PFS v rameni A vs. PFS v rameni Ahist
    (medián PFS v rameni A > medián PFS v rameni Ahist o ≥3,1 měsíce)
    E.5.1.1Timepoint(s) of evaluation of this end point
    This primary endpoint will be evaluated after all subjects are enrolled and reach the timepoint to evaluate PFS, i.e. progression of the disease.
    E.5.2Secondary end point(s)
    - Incidence of REP:
    PFS in arm A vs. PFS in arm B
    OS in arm A vs. OS in arm Ahist.
    - OS in arm A vs. OS in arm B
    - Characteristics of PoF in arm A vs. In arm Ahist.
    Pravděpodobnost REP
    PFS v rameni A vs. PFS v rameni B
    OS v rameni A vs. OS v rameni Ahist
    OS v rameni A vs. OS v rameni B
    Charakter PoF v rameni A vs. v rameni Ahist
    E.5.2.1Timepoint(s) of evaluation of this end point
    Incidence of REP could be evaluated after the enrollment is completed. Other characteristics could be evaluated after all subjects in all arms reach the respektive timepoints.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Yes
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy No
    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 Yes
    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 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 No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    historical cohort
    E.8.2.4Number of treatment arms in the trial3
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States No
    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 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 years3
    E.8.9.1In the Member State concerned months8
    E.8.9.1In the Member State concerned days
    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: 100
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 20
    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 state142
    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)
    none
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation CZECRIN
    G.4.3.4Network Country Czech Republic
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2020-05-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-05-19
    P. End of Trial
    P.End of Trial StatusOngoing
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