Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   44195   clinical trials with a EudraCT protocol, of which   7329   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2020-003733-38
    Sponsor's Protocol Code Number:ORP-TMZ-I-b
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2020-10-06
    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 number2020-003733-38
    A.3Full title of the trial
    TEMOkids study (ORP-TMZ-I- b): A Population pharmacokinetic, acceptability and safety study for KIMOZO, a paediatric oral suspension of temozolomide
    TEMOkids Studie (ORP-TMZ-I-b): Populationspharmakokinetische Akzeptanz- und Sicherheitsstudie für Kimozo, einer pädiatrischen oralen Suspension von Temozolomid
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    TEMOkids study: Study of the fate in the body, acceptability and safety study of KIMOZO, a drinkable form of temozolomide adapted to children
    TEMOkids Studie: die Untersuchung der Aktion im Körper, Akzeptanz- und Sicherheitsstudie von KIMOZO, einer trinkbaren, an Kinder angepassten Form von Temozolomid
    A.3.2Name or abbreviated title of the trial where available
    TEMOkids study
    TEMOkids Studie
    A.4.1Sponsor's protocol code numberORP-TMZ-I-b
    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 SponsorORPHELIA Pharma
    B.1.3.4CountryFrance
    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 supportORPHELIA Pharma
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationORPHELIA Pharma
    B.5.2Functional name of contact pointContact
    B.5.3 Address:
    B.5.3.1Street Address85 boulevard Saint Michel
    B.5.3.2Town/ cityParis
    B.5.3.3Post code75005
    B.5.3.4CountryFrance
    B.5.4Telephone number33142770818
    B.5.6E-mailcontact@orphelia-pharma.eu
    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 Yes
    D.2.5.1Orphan drug designation numberEU/3/19/2188
    D.3 Description of the IMP
    D.3.1Product nameKIMOZO
    D.3.2Product code ORP-005
    D.3.4Pharmaceutical form Oral suspension
    D.3.4.1Specific paediatric formulation Yes
    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 INNTEMOZOLOMIDE
    D.3.9.1CAS number 85622-93-1
    D.3.9.3Other descriptive nameTEMOZOLOMIDE
    D.3.9.4EV Substance CodeSUB10889MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40
    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 Yes
    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
    Different pediatric cancers such as malignant glioma and also relapsed or refractory neuroblastoma, rhabdomyosarcoma, medulloblastoma, and Ewing sarcoma, for which treatment with the cytotoxic temozolomide is recommended as per treatment guidelines.
    Verschiedene pädiatrische Krebsarten wie malignes Gliom sowie rezidiviertes oder refraktäres Neuroblastom, Rhabdomyosarkom, Medulloblastom und Ewing-Sarkom, für die die Behandlung mit dem zytotoxischen Temozolomid gemäß den Behandlungsrichtlinien empfohlen wird.
    E.1.1.1Medical condition in easily understood language
    Different pediatric cancers for which treatment with the anticancer temozolomide is recommended as per treatment guidelines
    Verschiedene pädiatrische Krebsarten, für die eine Behandlung mit Temozolomid gemäß den Behandlungsrichtlinien empfohlen wird
    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 SOC
    E.1.2Classification code 10029104
    E.1.2Term Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10018337
    E.1.2Term Glioblastoma multiforme
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10029260
    E.1.2Term Neuroblastoma
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10039022
    E.1.2Term Rhabdomyosarcoma
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10027107
    E.1.2Term Medulloblastoma
    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
    Evaluate pharmacokinetic parameters of the oral suspension of temozolomide in the paediatric population aged 1 year and over
    Evaluation der PK-Parameter von Temozolomid als orale Suspension in der pädiatrischen Population ab 1 Jahr
    E.2.2Secondary objectives of the trial
    Evaluate the safety of the oral suspension of temozolomide,
    Evaluate the acceptability of the oral suspension of temozolomide.
    Describe the activity of the oral suspension of temozolomide over the course of a 6-month-treatment period (complete or partial response, disease progression, stable disease) according to the standard follow up exams and tests recommended for each indication
    •Beurteilung der Sicherheit von Temozolomid als orale Suspension
    •Beurteilung der Akzeptanz von Temozolomid als orale Suspension
    •Beschreibung der Aktivität von Temozolomid als orale Suspension im Laufe einer sechsmonatigen Behandlungsphase (komplette oder partielle Remission, Krankheitsprogression, stabile Erkrankung) gemäß der Standard-Nachbeobachtungsuntersuchungen und der für jede Indikation empfohlenen Tests
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Paediatric patients already receiving commercially available temozolomide-based treatment or naïve paediatric patients requiring temozolomide-based treatment as per investigator’s decision (all indications with 5-day treatment per 21- or 28-day cycle). Indications include those described in the Temodal SmPC (i.e. malignant glioma such as glioblastoma and anaplastic astrocytoma). For patients having no therapeutic alternatives, the IMP may be used in off-label indications in accordance with current treatment protocols recommended by European and International Medical Associations (e.g. SIOPEN, EPSSG, COG, European ITCC, SIOP,…). Such indications include but are not limited to primarily neuroblastoma, medulloblastoma and also rhabdomyosarcoma, or Ewing sarcoma
    • Male and female patients aged 1 to less than 18 years
    • Patients who have signed the informed consent or for which one, both parents or legal guardian (depending on local legislation) have signed the informed consent.
    • Patients having records of coverage by a health insurance
    • Life expectancy ≥ 3 months
    • Adequate haematological function:
    o haemoglobin ≥ 80 g/L (transfusion support authorized)
    o neutrophil count ≥ 1.0 x 10e9 cells/L
    o platelet count ≥ 100 x 10e9 cells/L (without transfusion support)
    o in case of bone marrow involvement: neutrophils ≥ 0.5 x 10e9 cells/L and platelets ≥75 x 10e9 cells/L
    • Adequate renal function:
    o Creatine clearance ≥ 60 mL/min.1.73m² according to the Schwartz formula [1] or its modified form [2]
    • Adequate hepatic function:
    o bilirubin ≤1.5 x ULN
    o AST and ALT ≤ 2.5 x ULN (AST, ALT 5xULN in case of liver metastases)
    • Lansky Score ≥ 70%
    • Pädiatrische Patienten, die bereits eine auf dem Markt erhältliche Behandlung auf Temozolomidbasis erhalten, oder naive pädiatrische Patienten, die eine Behandlung auf Temozolomidbasis gemäß der Entscheidung des Prüfers benötigen (alle Indikationen mit 5-tägiger Behandlung pro 21- oder 28-tägigem Zyklus). Indikationen schließen diejenigen ein, die in der Temodal SmPC beschrieben sind (d. h. malignes Gliom wie Glioblastom und anaplastisches Astrozytom). Für Patienten ohne therapeutische Alternativen kann das Prüfpräparat in Off-Label-Indikationen gemäß den aktuellen Behandlungsprotokollen verwendet werden, die von europäischen und internationalen medizinischen Verbänden empfohlen werden (z. B. SIOPEN, EPSSG, COG, European ITCC, SIOP,…). Solche Indikationen umfassen, ohne darauf beschränkt zu sein, hauptsächlich Neuroblastom, Medulloblastom und auch Rhabdomyosarkom oder Ewing-Sarkom
    • Männliche und weibliche Patienten im Alter zwischen 1 und unter 18 Jahren
    • Patienten, die die Einverständniserklärung unterzeichnet haben oder für die beide Elternteile oder Erziehungsberechtigten (abhängig von der lokalen Gesetzgebung) die Einverständniserklärung unterzeichnet haben.
    • Patienten mit Krankenversicherungsnachweis
    • Lebenserwartung ≥ 3 Monate
    • Angemessene hämatologische Funktion:
    o Hämoglobin ≥ 80 g/l (Transfusionsunterstützung zulässig)
    o Neutrophilenzahl ≥ 1,0 x 109 Zellen/l
    o Thrombozytenzahl ≥ 100 x 109 Zellen/l (ohne Transfusionsunterstützung)
    o bei Knochenmarkbeteiligung: Neutrophile ≥ 0,5 x 109 Zellen/l und Blutplättchen ≥ 75 x 109 Zellen/l
    • Angemessene Nierenfunktion:
    o Kreatin-Clearance ≥ 60 ml/min, 1,73 m² nach der Schwartz-Formel [1] oder ihrer modifizierten Form [2]
    • Angemessene Leberfunktion:
    o Bilirubin ≤ 1,5 x ULN
    o AST und ALT ≤ 2,5 x ULN (AST, ALT 5xULN bei Lebermetastasen)
    •Lansky Score ≥ 70%
    E.4Principal exclusion criteria
    • Patient treated with sodium valproate within two weeks prior to receiving Kimozo or Patients who are co-administrated on day one of Kimozo administration with sodium valproate as it decreases the clearance of temozolomide.
    • Patients with (naso)gastric tube administration of temozolomide
    • Patients already enrolled in studies investigating temozolomide or other investigational new drugs
    • A post-menarche female with a positive blood/urine pregnancy test at inclusion
    • Known contraindication or hypersensitivity to temozolomide or any chemically close substance
    •Persons who are living in a facility by order of a court or an administrative order.
    •Patients infected by a SARS-CoV-2 variant.
    • Patient, der innerhalb von zwei Wochen vor Erhalt von Kimozo mit Natriumvalproat behandelt wurde, oder Patienten, die am ersten Tag der Kimozo-Verabreichung gleichzeitig Natriumvalproat verabreicht bekommen, da dies die Clearance von Temozolomid verringert.
    • Verabreichung von Temozolomid über eine (naso)gastrale Magensonde.
    • Laufende Teilnahme an anderen Temozolomid-Studien.
    • Frauen im gebärfähigen Alter mit einem positiven Blut- oder Urinschwangerschaftstest bei Aufnahme.
    • Bekannte Kontraindikation oder Überempfindlichkeit gegen Temozolomid oder ein anderes chemisch verwandtes Molekül.
    • Personen, die auf Anordnung eines Gerichts oder einer Verwaltungsverordnung in einer Einrichtung leben.
    • Patienten, die mit einer SARS-CoV-2-Variante infiziert sind.
    E.5 End points
    E.5.1Primary end point(s)
    Primary endpoint:
    Investigated PK parameters will be TMZ apparent clearance (CL/F), distribution volume (V/F) and absorption rate constant (Ka). These PK parameters will be used to derive key estimates of exposure such as TMZ area under the curve between 2 intakes (AUC0-t) and, if feasible, maximum concentration (Cmax) for each included subject and elimination half-life (t1/2), and the total AUC0-∞.
    Population PK parameters will be estimated by a population analysis performed with NONMEM (7.4). Individual Bayesian estimates of the PK parameters will be used to calculate individual AUC24, Cmax, and t1/2.
    Primäre Endpunkte:
    Die untersuchten PK-Parameter sind: die scheinbare Clearance (CL/F) von Temozolomid (TMZ), das Verteilungsvolumen (V/F) und die Absorptionsratenkonstante (Ka). Diese PK-Parameter werden verwendet, um die wesentlichen Expositionsabschätzung vorzunehmen. Dazu gehören die Fläche unter der TMZ-Kurve zwischen zwei Einnahmen (AUC0-t) und, falls möglich, die maximale Plasmakonzentration (Cmax) bei jedem eingeschlossenen Teilnehmer sowie die Eliminationshalbwertszeit (t1/2) und die die gesamte AUC0-∞.
    Die Parameter der Populationspharmakokinetik werden mithilfe einer Populationsanalyse mit NONMEM (7.4) geschätzt. Individuelle Bayes-Schätzer der PK-Parameter werden zur Berechnung der individuellen AUC24, Cmax und t1/2 herangezogen.
    E.5.1.1Timepoint(s) of evaluation of this end point
    A total of 6 blood samples of 1 ml will be drawn per patient in a single daytime hospitalisation. Blood samples will be collected in prechilled K2-EDTA tubes prior to Kimozo administration and at 0.10-0.20 (6-12 min), 0.33-0.66 (20-40 min), 0.75-1.5 (45-90 min), 2.0-3.0 and 6.0-8.0 hours post-dose. The administered dose and exact time for each sample will be recorded. Should a patient be naïve to any prior treatment with TMZ, the pre-treatment sample is not necessary.
    Insgesamt werden jedem Patienten pro Tag der stationären Behandlung 6 Blutproben von 1 ml* entnommen. Die Blutproben werden in vorgekühlten K2-EDTA Röhrchen vor der Kimozo-Verabreichung und 0,10–0,20 (6-12 min), 0,33–0,66 (20-40 min), 0,75–1,5 (45-90 min), 2,0–3,0 und 6,0–8,0 Stunden nach der Verabreichung genommen. Die verabreichte Dosis und die genaue Uhrzeit jeder Probe werden aufgezeichnet. Sollte der Patient zuvor noch kein TMZ erhalten haben, ist die Vorbehandlungsprobe nicht erforderlich.
    E.5.2Secondary end point(s)
    Secondary endpoints:
    • Acceptability
    The acceptability of the oral suspension of temozolomide will be scored with a standardized assessment tool: CAST - ClinSearch Acceptability Score Test. This tool measures 9 observational drivers of medicine acceptability.
    • Safety
    All Safety events will be collected throughout the study, including buccal tolerance
    • Activity
    The clinical activity of the oral suspension of temozolomide during the optional treatment extension phase will be described according to the standard follow-up exams and tests (i.e. complete or partial response, disease progression, stable disease)
    Sekundäre Endpunkte:
    • Akzeptanz
    Die Akzeptanz der oralen Temozolomid-Suspension wird mit einem standardisierten Bewertungsverfahren gemessen: CAST - ClinSearch Acceptability Score Test®. Dieses Verfahren berücksichtigt 9 objektive Parameter, die die Akzeptanz von Medikamenten widerspiegeln.
    • Sicherheit
    Alle Sicherheitsereignisse werden während der gesamten Studie erfasst, einschließlich der bukkalen Verträglichkeit
    • Aktivität
    Die klinische Aktivität der oralen Temozolomid-Suspension während der optionalen Verlängerungsphase der Behandlung wird gemäß den Standard-Nachuntersuchungen und -Tests (d.h. vollständiges oder teilweises Ansprechen, Fortschreiten der Krankheit, stabile Krankheit) beschrieben.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Secondary endpoints:
    • Acceptability
    A paper diary will be filled-in to assess palatability/acceptability of the oral suspension of temozolomide.
    • Safety
    Safety events recorded by the caregiver in the patient diary will be medically controlled on a monthly basis by the principal investigator.
    Safety follow-up during the 1st cycle : 21 or 28 days, including buccal tolerance at day 5 and until day 21 or 28
    Safety follow-up during the optional treatment extension phase for 5 potential additional treatment cycles.
    • Activity
    The clinical activity during the optional treatment extension phase will be assessed when planned for the standard follow-up exams and tests
    Sekundäre Endpunkte:
    • Akzeptanz
    Ein Papiertagebuch wird ausgefüllt, um die Schmackhaftigkeit/Akzeptanz der oralen Temozolomid-Suspension zu beurteilen.
    • Sicherheit
    Unerwünschte Ereignisse, die von der betreuenden Person im Patiententagebuch aufgezeichnet werden, werden vom Prüfarzt jeden Monat aus medizinischer Sicht bewertet.
    Sicherheitsnachbeobachtung während des ersten Zyklus: 21 oder 28 Tage, einschließlich bukkaler Verträglichkeit (am 5. Behandlungstag und bis zu 21 oder 28 Tagen).
    Sicherheitsnachbeobachtung während der optionalen Verlängerungsphase der Behandlung für 5 zusätzliche Behandlungszyklen
    • Aktivität
    Die klinische Aktivität während der optionalen Verlängerungsphase der Behandlung wird gemäß den Standard-Nachuntersuchungen und -Tests beschrieben.
    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) Yes
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    E.7.1.3.1Other trial type description
    population pharmacokinetic study
    E.7.2Therapeutic exploratory (Phase II) No
    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.8.2.4Number of treatment arms in the trial1
    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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA16
    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 years
    E.8.9.1In the Member State concerned months12
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months18
    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: 40
    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: 30
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 10
    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
    paediatric patients from the age of 1 year to be included, thus incapable of giving consent personnally
    pädiatrische Patienten ab 1 Jahr, die ihre persönliche Einwilligung nicht erteilen können, werden eingeschlossen
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state6
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 40
    F.4.2.2In the whole clinical trial 40
    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)
    Already included in the protocol, an optional treatment extension phase of up to 5 additional treatment cycles after the main study period made of 1 cycle of treatment with the oral suspension of the cytotoxic drug temozolomide
    Bereits im Protokoll enthalten. Es gibt eine nachfolgende optionale Verlängerungsphase der Behandlunge von bis zu 5 zusätzlichen Behandlungszyklen nach der Hauptstudienperiode, die aus einem Behandlungszyklus mit der oralen Temozolomid-Suspension Temozolomid besteht
    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 Decision2021-03-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-07-16
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2023-07-03
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Thu Oct 24 16:48:37 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA