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    Summary
    EudraCT Number:2015-002727-25
    Sponsor's Protocol Code Number:UKM12_0017
    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:2017-03-16
    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 number2015-002727-25
    A.3Full title of the trial
    Controlled clinical trial to evaluate the safety and efficacy of stereotactical photodynamic therapy with 5-aminolevulinic acid (Gliolan®) in recurrent glioblastoma
    Klinisch kontrollierte Studie zur Evaluation der Sicherheit und Wirksamkeit der stereotaktischen, 5- Aminolävulinsäure (Gliolan)- gestützten, photodynamischen Therapie beim Rezidivglioblastom
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Evaluation of the efficacy and safety of stereotactical photodynamic therapy with 5-aminolevulinic acid (Gliolan®) in recurrent glioblastoma
    Untersuchung der Sicherheit und Wirksamkeit der stereotaktischen photodynamischen Therapie mit Gliolan® bei Patienten mit Rezidiv eines Glioblastoms
    A.3.2Name or abbreviated title of the trial where available
    NOA11
    NOA11
    A.4.1Sponsor's protocol code numberUKM12_0017
    A.5.3WHO Universal Trial Reference Number (UTRN)U1111-1182-8541
    A.5.4Other Identifiers
    Name:EUDAMED-NumberNumber:CIV-17-03-018624
    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 SponsorUniversitätsklinikum Münster
    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 supportDeutsche Krebshilfe
    B.4.2CountryGermany
    B.4.1Name of organisation providing supportmedac Gesellschaft für klinische Spezialpräparate mbH and photonamic GmbH & Co. KG
    B.4.2CountryGermany
    B.4.1Name of organisation providing supportLifePphotonic GmbH
    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, Gebäude A1
    B.5.3.2Town/ cityMünster
    B.5.3.3Post code48149
    B.5.3.4CountryGermany
    B.5.4Telephone number+491733802878
    B.5.6E-mailjuliane.schroeteler@ukmuenster.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 30 mg/ml powder for oral solution
    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.3.9.1CAS number 5451-09-2
    D.3.9.3Other descriptive nameAMINOLEVULINIC ACID HYDROCHLORIDE
    D.3.9.4EV Substance CodeSUB21578
    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
    Recurrent glioblastoma
    Glioblastom Rezidiv
    E.1.1.1Medical condition in easily understood language
    Recurrent glioblastoma
    Glioblastom Rezidiv
    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 PT
    E.1.2Classification code 10018336
    E.1.2Term Glioblastoma
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The study is initiated to compare the following treatment concepts of recurrent glioblastoma with respect to efficacy, safety and quality of life:
    • iPDT (interstitial photodynamic therapy) with 5-ALA and consecutive therapy at the investigator’s discretion
    • Therapy at the investigator’s discretion without iPDT.
    Ziel dieser Studie ist es, folgende Therapiekonzepte bei Patienten mit einem Glioblastomrezidiv im Hinblick auf ihre Wirksamkeit, Sicherheit und Lebensqualität zu untersuchen:
    • iPDT mit 5-ALA und anschließender Therapie nach Ermessen des Arztes
    • Therapie nach Ermessen des Arztes ohne iPDT.
    E.2.2Secondary objectives of the trial
    Not applicable
    nicht zutreffend
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Retrospective assessment of dosimetric data of iPDT.
    Translational investigation of iPDT immunological response.
    Retrospektive Bewertung der Dosimetriedaten der iPDT.
    Translationale Untersuchung der immunologischen Antwort auf iPDT.
    E.3Principal inclusion criteria
    1. Written informed consent
    2. Age 18 - 75 years
    3. Karnofsky Performance Score (KPS) of ≥60 %
    4. Radiologically suspected diagnosis (according to RANO criteria) of the first recurrence of a glioblastoma located in the cerebral hemisphere including insular lobe and diencephalon. Tumors in the brain stem are excluded.
    First MRI with signs of first recurrence (radiologic RANO criteria for disease progression) within 8 weeks prior to Informed Consent. Recurrent tumor must not necessarily be in the same location as primary tumor.
    5. Single or single progressive contrast-enhancing lesion on MRI, largest diameter not more than 2.5 cm
    6. For female and male patients of reproductive potential: Willingness to apply highly effective contraception (Pearl index <1) during the entire study
    1. Unterzeichnete Einwilligungserklärung
    2. Alter zwischen 18 und 75 Jahren
    3. Karnofsky Performance Score (KPS) von ≥60 %
    4. Radiologischer Verdacht (entsprechend der RANO Kriterien) auf das erste Rezidiv eines Glioblastoms. Lokalisation des Rezidivs in der Großhirnhemisphäre einschl. Inselregion und im Diencephalon. Tumore des Hirnstammes sind ausgeschlossen.
    Erstes MRT mit Anzeichen eines Rezidivs (entsprechend radiologischer RANO-Kriterien zur Progression) innerhalb von 8 Wochen vor Einwilligungserklärung. Die Läsion muss nicht zwingend an derselben Lokalisation wie der Ersttumor liegen.
    5. Singuläre neue oder eine progressive Kontrastmittel-anreichende Läsion im MRT mit einem Durchmesser von höchstens 2,5 cm
    6. Bei gebärfähigen Frauen oder Männern mit gebärfähigen Partnerinnen: Bereitschaft eine zuverlässige Verhütungsmethode (Pearl Index <1) über die Dauer der Studie anzuwenden
    E.4Principal exclusion criteria
    1. Multifocal disease in more than 2 locations
    2. Patients with significant non enhancing tumor portions
    3. Previous treatment of recurrence
    4. Other malignant disease except basalioma
    5. Hypersensitivity against porphyrins or Gliolan® or FEP (Fluorethylenpropylen)
    6. Porphyria
    7. HIV infection, active Hepatitis B or C infection
    8. Bone marrow reserve:
    white blood cell (WBC) count <2000/μl,
    platelets <100000/μl,
    9. Liver function:
    total bilirubin > 1.5 times above upper limit of normal range (ULN)
    alanine transaminase (ALT) and aspartate transaminase (AST) > 3 times ULN
    10. Renal function:
    creatinine > 1.5 times ULN
    11. Blood clotting:
    Quick/INR, PT or PTT out of acceptable limits
    12. Conditions precluding MRI (e.g. pacemaker)
    13. Past medical history of diseases with poor prognosis, e.g. severe coronary heart disease, heart failure (NYHA III/IV), severe poorly controlled diabetes, immune deficiency, residual deficits after stroke, severe mental retardation or other serious concomitant systemic disorders incompatible with the study (at the discretion of the investigator)
    14. Any active infection (at the discretion of the investigator)
    15. Any psychological, cognitive, familial, sociological or geographical condition that, in the investigator’s opinion, compromises the patient’s ability to understand the patient information, to give informed consent or to comply with the trial protocol
    16. Previous antiangiogenic treatment
    17. Participation in another interventional clinical trial during this trial or within 4 weeks before entry into this trial.
    18. Pregnancy or breastfeeding
    1. Multifokale Erkrankung mit mehr als 2 Herden
    2. Patienten, deren Tumor in weiten Teilen kein Kontrastmittel aufnimmt
    3. Frühere Behandlung des Rezidivs
    4. Anamnese eines Malignoms mit Ausnahme von Basalzellkarzinomen
    5. Bekannte Überempfindlichkeit gegen Porphyrine oder Gliolan® oder Fluorethylenpropylen (FEP)
    6. Porphyrien
    7. HIV Infektion, aktive Hepatitis B oder C Infektion
    8. Knochenmark-Reserve:
    Leukozyten <2000/μl,
    Thromboyzyten <100000/μl,
    9. Leberfunktion:
    Gesamtbilirubin > 1,5 x obere Normgrenze
    Alanin-Transaminase (ALT) und Aspartat-Transaminase (AST) > 3 x obere Normgrenze
    10. Nierenfunktion:
    Kreatinin > 1,5 x ULN
    11. Blutgerinnung:
    Quick/INR oder PTT ausserhalb akzeptabler Grenzen
    12. Kontraindikation für MRT-Untersuchungen (z.B. Herzschrittmacher)
    13. Patienten mit anamnestisch vorliegenden Nebenerkrankungen mit schlechter Prognose: z.B. schwere koronare Herzkrankheit, Herzinsuffizienz (NYHA III/IV), schlecht eingestellter schwerer Diabetes mellitus, Immundefizienz, schwere Beeinträchtigung nach Schlaganfall, schwere mentale Retardierung oder andere schwere systemische Begleiterkrankungen, welche die Teilnahme an der Studie verhindern (nach Ermessen des Prüfers)
    14. Jedwede aktive Infektion (im Ermessen des Prüfers)
    15. Psychologische, kognitive, familiäre, soziologische oder geographische Einschränkungen, die nach Einschätzung des Prüfers die Fähigkeit des Patienten beeinträchtigen, die Patienteninformation zu verstehen, seine Einwilligung zu erklären, das Protokoll zu befolgen
    16. Frühere antiangiogene Behandlung
    17. Teilnahme an einer anderen interventionellen klinischen Studie, gegenwärtig oder in den letzten 4 Wochen vor Eintritt in die Studie.
    18. Schwangerschaft oder Stillen
    E.5 End points
    E.5.1Primary end point(s)
    Progression free survival (PFS) measured as time from the day of randomization until diagnosis of progressive disease as determined by MRI according to RANO criteria or death from any cause
    Progressionsfreies Überleben gemessen an der Zeit ab Randomisierung bis zum Eintreten der Progression (mittels MRT bestätigt nach RANO Kriterien) oder des Todes
    E.5.1.1Timepoint(s) of evaluation of this end point
    At Visit 1 (1 month after randomization) and every second month after Visit 1 in the first 1.5 years of study participation and then every 3 months until disease progression or death
    Bei Visite 1 (1 Monat nach Randomisierung) und danach innerhalb der ersten 1,5 Jahre der Studienteilnahme jeden 2. Monat und dann alle 3 Monate bis zum Eintreten der Progression oder des Todes
    E.5.2Secondary end point(s)
    • 6-month PFS rate
    • Overall survival (OS) measured as time from the day of randomization until death
    • Progression free time as time from the day of randomization until progressive disease (death is regarded as censored)
    • 12-month OS rate
    • Absolute changes from baseline in contrast medium volume uptake from the MRI performed 48 hours after randomization on, and during any MRI performed thereafter to monitor for disease progression
    • 48h response rate on MRI (CR, PR, SD) after treatment with iPDT
    • If a PET was performed less than 2 weeks apart from an MRI: Consistency of both procedures with regard to the region of interest
    • Change in KPS, NIHSS, MMSE
    • Brain edema as assessed by MRI within 26 to 48 h after stereotactic surgery
    • Change from baseline in the EORTC QLQ-C30 score and the score assessed by means of the QLQ-BN20 module during study participation
    • Rate für das progressionsfreie Überleben nach 6 Monaten
    • Gesamtüberleben gemessen an der Zeit ab Randomisierung bis zum Eintreten des Todes
    • Gesamtüberleben gemessen an der Zeit ab Randomisierung bis zum Eintreten der Progression (Tod wird zensiert)
    • Gesamtüberlebensrate nach 12 Monaten
    • Absolute Änderungen im Volumen der Kontrastmittel-angereicherten Regionen der MRT Aufnahme 48 h nach der Randomisierung im Vergleich zu einem nachfolgenden MRT, zur Bestimmung der Progression.
    • 48 Std. Ansprechrate im MRT (Komplettes Ansprechen, partielles Ansprechen, stabiler Verlauf) nach der Behandlung mit der iPDT
    • Falls ein PET innerhalb der letzten 2 Wochen vor dem MRT durchgeführt wurde: Konsistenz der beiden Verfahren im Bezug auf die "region of interest" (ROI)
    • Veränderung im KPS, NIHSS; MMSE
    • Gehirnödeme beurteilt durch MRT innerhalb 26 bis 48 Std. nach stereotaktischer Intervention
    • Veränderung des Ergebnisses der Lebensqualitätsbögen QLQ-C30 und QLQ-BN20 während der Studienteilnahme
    E.5.2.1Timepoint(s) of evaluation of this end point
    At Visit 1 (1 month after randomization) and every second month after Visit 1 in the first 1.5 years of study participation and then every 3 months until disease progression or death
    Bei Visite 1 (1 Monat nach Randomisierung) und danach innerhalb der ersten 1,5 Jahre der Studienteilnahme jeden 2. Monat und dann alle 3 Monate bis zum Eintreten der Progression oder des Todes
    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 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 Yes
    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
    Therapie ohne iPDT nach Ermessen des Prüfers
    Therapy at the investigator’s discretion without iPDT
    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 concerned5
    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
    Planned end date is defined as the date when 73 patients had disease progression or died,
    or after interim analysis (performed when 37 patients had disease progression or died).
    Als Studienende ist der Zeitpunkt festgelegt, an dem bei 73 Patienten eine Krankheitsprogression aufgetreten ist oder der Tod eingetreten ist,
    oder nach der Zwischenauswertung (diese erfolgt, wenn bei 37 Patienten eine Krankheitsprogression aufgetreten ist oder der Tod eingetreten ist).
    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 months0
    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 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: 90
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 16
    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 state106
    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
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2017-10-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-11-16
    P. End of Trial
    P.End of Trial StatusOngoing
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