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    Summary
    EudraCT Number:2014-005669-54
    Sponsor's Protocol Code Number:UKM2013_0034
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2019-12-03
    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 ConcernedGermany - BfArM
    A.2EudraCT number2014-005669-54
    A.3Full title of the trial
    Clinical safety study on 5-Aminolevulinic acid (5-ALA) in children and adolescents with supratentorial brain tumours
    Klinische Prüfung zur Bewertung der Sicherheit von 5-Aminolävulinsäure (5-ALA) bei Kindern und Jugendlichen mit supratentoriellen Hirntumoren
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    5-Aminolevulinic acid (5-ALA) in children and adolescents with differnt types of brain tumours
    5-Aminolävulinsäure (5-ALA) bei Kindern und Jugendlichen mit Hirntumoren
    A.3.2Name or abbreviated title of the trial where available
    5-ALA in children and adolescents
    5-ALA bei Kindern und Jugendlichen
    A.4.1Sponsor's protocol code numberUKM2013_0034
    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 SponsorWestfälische Wilhelms-Universität Münster c/o Universitätsklinikum Münster, Geschäftsbereich Recht u. Drittmittel
    B.1.3.4CountryGermany
    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 supportmedac Gesellschaft für klinische Spezialpräparate mbH
    B.4.2CountryGermany
    B.4.1Name of organisation providing supportphotonamic GmbH & Co. KG
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversitätsklinikum Münster
    B.5.2Functional name of contact pointKlinik für Neurochirurgie
    B.5.3 Address:
    B.5.3.1Street AddressAlbert-Schweitzer-Campus 1, Geb. A1
    B.5.3.2Town/ cityMünster
    B.5.3.3Post code48149
    B.5.3.4CountryGermany
    B.5.4Telephone number+4925183 5555
    B.5.5Fax number+492518347479
    B.5.6E-mail5-ala-in-children.study@uni-muenster.de
    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.2.1.1.1Trade name Gliolan 30mg/ml
    D.2.1.1.2Name of the Marketing Authorisation holdermedac Gesellschaft für klinische Spezialpräparate mbH
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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.3.4Pharmaceutical form Powder for oral solution
    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 INN5-AMINOLEVULINIC ACID
    D.3.9.1CAS number 106-60-5
    D.3.9.4EV Substance CodeSUB12853MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number30
    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
    supratentorial intra-axial brain tumor (malignant glioma, astrocytoma, malignant ependymoma, AT/RT, Oligodendroglioma, etc.)
    Supratentorielle intraaxiale Hirntumore (malignes Gliom, Astrozytom, malignes Ependymom, atypischer teratoider Rhabdoidtumor, Oligodendrogliom etc.)
    E.1.1.1Medical condition in easily understood language
    different types of brain tumors
    verschiedene Typen von Hirntumoren
    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 10006154
    E.1.2Term Brain tumor NOS
    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
    To determine the safety of 5-ALA for fluorescence-guided resections in children and adolescents with supratentorial, intra-axial brain tumors
    Bestimmung der Sicherheit fluoreszenzgestützter Resektion mit 5-ALA bei supratentoriellen, intra-axialen Hirntumoren bei Kindern und Jugendlichen
    E.2.2Secondary objectives of the trial
    1. To determine whether fluorescing tissue truly signifies tumor (positive predictive value)
    2. To determine extent of tumor resection on early post-operative MRI
    3. Pharmacokinetics of 5-ALA in children and adolescents
    1. Ermittlung, ob fluoreszierendes Gewebe Tumorgewebe entspricht.
    2. Bestimmung des Resektionsausmaßes im Kontrastmittel-MRT nach Tumor-OP
    3. Untersuchung der Pharmakokinetik von 5-ALA bei Kindern und Jugendlichen
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Age 3 - <18 years
    • First radiological diagnosis of intra-axial, supratentorial contrast-enhancing tumor on MRI or recurrent supratentorial intra-axial brain tumor (malignant glioma, astrocytoma, malignant ependymoma, AT/RT, Oligodendroglioma, etc.)
    • Resection is part of therapeutic strategy with an emphasis on neurological safety
    • Informed consent by the parents or guardians and if possible assent of the patient after education of purpose and risks of study. Patients that are able to understand should provide assent to participate in the trial
    • Female adolescents: not pregnant (pregnancy test required for adolescents of childbearing age) and not breast-feeding.
    Female patients of childbearing potential and male patients who are sexually active must be practising a highly effective method of birth control up to 6 weeks after the tumor operation consistent with local regulations regarding the use of birth control methods for subjects participating in clinical trials.
    •Alter 3 - < 18 Jahre
    •Radiologische Erstdiagnose eines intra-axialen supratentoriellen Kontrastmittel-aufnehmenden Hirntumor im MRT oder Rezidiv eines supratentoriellen intra-axialen Hirntumors (malignes Gliom, Astrozytom, malignes Ependymom, atypischer teratoider Rhabdoidtumor, Oligodendrogliom etc.)
    •Geplante Resektion des Tumors mit dem Ziel das umgebende gesunde Gewebe nicht zu schädigen, um zusätzliche neurologische Ausfälle zu vermeiden
    •Unterzeichnete Einwilligungserklärung der Eltern oder des/der Sorgeberechtigten und sofern möglich die Zustimmung des Patienten nach Aufklärung über die Ziele und die Risiken der Studie. Der Wille des Patienten sollte berücksichtigt werden.
    •Weibliche Studienteilnehmerinnen: nicht schwanger (ein Schwangerschaftstest wird für Jugendliche im gebärfähigen Alter benötigt) und nicht stillend (mindestens 24h nach Einnahme von Gliolan).
    Bei gebärfähigen Frauen oder Männern mit gebärfähigen Partnerinnen: Bereitschaft eine zuverlässige Verhütungsmethode (Pearl-Index <1) bis zu 6 Wochen nach der Tumor-Operation anzuwenden.
    E.4Principal exclusion criteria
    • Posterior fossa tumors
    • Extra-axial tumors such as craniopharyngeoma
    • Germ cell tumor or entities precluding surgical resection
    • Acute or chronic porphyria
    • Hypersensitivity to 5-ALA or porphyrins
    • Renal insufficiency: serum creatinine > 2x upper limit of normal
    • Hepatic insufficiency: serum bilirubine > 2x upper limit of normal, serum γ-GT > 2,5 x upper limit of normal, alanine transaminase (ALT) and aspartate transaminase (AST)> 2,5 upper limit of normal
    • Blood clotting: INR out of acceptable limits
    • Other malignant disease
    • Patients with pre-existing cardiovascular diseases
    • Co-administration with other potentially phototoxic substances (e.g. tetracyclines, sulfonamides, fluoroquinolones, hypericin extracts)
    • Planned administration of potentially hepatotoxic substances within 24 hours after 5-ALA administration
    •Hirntumore der Fossa posterior (hintere Schädeldecke)
    •Extra-axiale Tumoren, wie z.B. Craniopharyngeome
    •Keimzelltumoren oder inoperable Tumoren
    •Akute oder chronische Porphyrie
    •Bekannte Überempfindlichkeit gegen Porphyrine oder 5-ALA/Gliolan
    •Nierenfunktion: Kreatinin > 2 x obere Normgrenze (ULN)
    •Leberfunktion: Gesamtbilirubin > 2 x ULN, serum γ-GT > 2,5 ULN, alanin transaminase (ALT) und apspartat transaminase (ALT)> 2,5 ULN
    •Blutgerinnung: INR außerhalb akzeptablem Limit
    •Sonstige maligne Erkrankungen
    •Bestehende kardiovaskuläre Erkrankungen
    •Gleichzeitige Gabe mit anderen potentiell phototoxischen Substanzen (z.B. Tetrazykline, Sulfonamide, Fluorochinolone, Hypericinextrakte (z.B. Johanniskraut)
    •Geplante Gabe von potentiell hepatotoxischen Substanzen im Zeitraum von 24h nach 5-ALA Gabe
    E.5 End points
    E.5.1Primary end point(s)
    Toxicological and clinical safety by measuring the incidence of adverse events of CTCAE grade III, IV or V (excluding chemotherapy-associated toxicities) during and after 5-ALA fluorescence-guided resections in children and adolescents with unifocal, supratentorial, contrast-enhancing intra-axial brain tumors (first diagnosis with unknown history, recurrent with malignant neuroepithelial histology)

    Toxikologische und klinische Sicherheit gemessen als Inzidenz von unerwünschten Ereignissen CTCAE Grad III, IV, V (mit Ausnahme von Chemotherapie-assoziierten Nebenwirkungen) nach 5-ALA fluoreszenz-gestützter Tumorresektion bei Kindern und Jugendlichen mit supratentoriellen Kontrastmittel-aufnehmenden intra-axialen Hirntumoren (Primärdiagnose oder Rezidiv)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Adverse events will be documented continuously from day of operation to 6 weeks afterwards.
    Unerwünschte Ereignisse werden kontinuierlich erfasst vom Tag der Operation bis 6 Wochen danach.
    E.5.2Secondary end point(s)
    1. True positive rate of fluorescence for indicating tumor

    2. Extent of resection as assessed on early post-operative MRI

    3. Pharmacokinetics (determination of protoporphyrin IX 3 times within 12h after 5-ALA-administration)
    1. Ermittlung, ob fluoreszierendes Gewebe Tumorgewebe entspricht.

    2. Bestimmung des Resektionsausmaßes im Kontrastmittel-MRT nach Tumor-OP.

    3. Untersuchung der Pharmakokinetik von 5-ALA bei Kindern und Jugendlichen (Messung von Protoporphyrin IX 3x innerhalb von 12 Stunden nach 5-ALA-Gabe)
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. Biopsies are taken during the resection of the tumor
    2. MRI is done until max. 72h post-OP
    3. Samples for protoporphyrine IX analysis will be taken 3-6h, 6-9h, 9-12h after 5-ALA administration
    1. Biopsien werden während der Resektion des Tumors entnommen
    2. MRT bis zu 72 Stunden nach der OP
    3. Blutproben zur Messung von Protoporphyrin IX werden in den Zeiträumen 3-6 Stunden, 6-9 Stunden und 9-12 Stunden nach 5-ALA-Gabe entnommen
    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 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 concerned7
    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
    letzte Visite des letzten Patienten
    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 months11
    E.8.9.1In the Member State concerned days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 80
    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) Yes
    F.1.1.5.1Number of subjects for this age range: 40
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 40
    F.1.2Adults (18-64 years) No
    F.1.3Elderly (>=65 years) No
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Children age 3 to < 18 years
    Kinder im Alter von 3 bis 17 Jahren
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state80
    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)
    After the end of the study, patients will be treated according to the normal treatment of their condition
    Nach Studienende erhalten die Patienten die gängige Behandlung für ihre Erkrankung.
    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 Decision2020-02-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-06-02
    P. End of Trial
    P.End of Trial StatusOngoing
    The status of studies in GB is no longer updated from 1.1.2021
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