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    Summary
    EudraCT Number:2015-002675-19
    Sponsor's Protocol Code Number:TMZ-CSF-001
    National Competent Authority:Austria - BASG
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2015-08-21
    Trial results View 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 ConcernedAustria - BASG
    A.2EudraCT number2015-002675-19
    A.3Full title of the trial
    Pharmacokinetics of temozolomide in cerebrospinal fluid in children with malignant brain tumors
    Pharmakokinetik von Temozolomide im Liquor von Kindern mit malignen Hirntumoren
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Pharmacokinetics of temozolomide in cerebrospinal fluid in children with malignant brain tumors
    Pharmakokinetik von Temozolomide im Liquor von Kindern mit malignen Hirntumoren
    A.4.1Sponsor's protocol code numberTMZ-CSF-001
    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 SponsorMedical University of Vienna, Department of Pediatrics
    B.1.3.4CountryAustria
    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 supportMedical University of Vienna, Department of Pediatrics
    B.4.2CountryAustria
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMedical University of Vienna, Department of Pediatrics
    B.5.2Functional name of contact pointMedical University of Vienna
    B.5.3 Address:
    B.5.3.1Street AddressSpitalgasse 23
    B.5.3.2Town/ cityVienna
    B.5.3.3Post code1090
    B.5.3.4CountryAustria
    B.5.4Telephone number+43140400 32320
    B.5.5Fax number+43140400 61028
    B.5.6E-mailandreas.peyrl@meduniwien.ac.at
    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 Temodal
    D.2.1.1.2Name of the Marketing Authorisation holderMerck Sharp & Dohme Limited
    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.3.1Product nameTemodal
    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 INNtemozolomide
    D.3.9.1CAS number 85622-93-1
    D.3.9.2Current sponsor codetemozolomide
    D.3.9.3Other descriptive nameTEMOZOLOMIDE
    D.3.9.4EV Substance CodeSUB10889MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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 malignant childhood central nervous system tumors
    Rezidivierte maligne ZNS-Tumoren des Kindes- und Jugendalters
    E.1.1.1Medical condition in easily understood language
    Recurrent malignant childhood central nervous system tumors
    Rezidivierte maligne ZNS-Tumoren des Kindes- und Jugendalters
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Measurement of CSF-levels of temozolomide in patients treated with temozolomide
    Messung der Konzentration von Temozolomid nach oraler Einnahme bei Kindern untschiedlichen Alters im Liquor
    E.2.2Secondary objectives of the trial
    Measurement of CSF-levels of temozolomide in patients treated with temozolomide
    Messung der Konzentration von Temozolomid nach oraler Einnahme bei Kindern untschiedlichen Alters im Liquor
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Female or male, aged between 0 and 19 years (at time of initial diagnosis)
    - Recurrent brain tumor with leptomeningeal dissemination or risk of leptomeningeal dissemination of any histology
    - Treatment with temozolomide for therapeutic reasons
    - Treatment with intrathecal administered chemotherapy for therapeutic reasons
    - Life expectancy of at least 8 weeks
    - Written informed consent of patients and/or parents
    - Serum creatinine < 1.5 mg/dL
    - Total serum bilirubin < 2.0 mg/dL and ALT less than 5 times upper limit of normal
    - Platelet count > 40.000/mm3 within 48 hours before intrathecal treatment
    - männlich oder weiblich, Alter zwischen 0 und 19 Jahren (bei Diagnose)
    - Rezidivierter Hirntumor mit leptomeningealer Dissemination oder Risiko einer leptomeningealen Dissemination
    - Therapie mit Temozolomid aus therapeutischen Gründen
    - Therapie mit intraventrikulärer Chemotherapie aus therapeutischen Gründen
    - Lebenserwartung von zumindest 8 Wochen
    - Schriftliche Einverständniserklärung des Patienten / der Eltern
    - Serum-Kreatinin < 1,5 mg/dl
    - Serum-Bilirubin < 2,0 mg/dl, Transaminasen weniger als 5-fach über oberem Grenzwert
    - Thrombozyten > 40.000/nl
    E.4Principal exclusion criteria
    - Treatment with temozolomide not indicated
    - Intrathecal therapy not indicated
    - Evidence of obstructive hydrocephalus or compartmentalization of CSF flow
    - Severe uncontrolled infection
    - Pregnancy or breast feeding
    - keine Therapie mit Temozolomid indiziert
    - keine Therapie mit intraventrikulärer Chemotherapie indiziert
    - unkontrollierte Infektion
    - Zeichen von obstruktivem Hydrocephalus
    - Schwangerschaft oder Stillen
    E.5 End points
    E.5.1Primary end point(s)
    CSF-levels of temozolomide identified
    Liquor-Spiegel von Temozolomid identifiziert
    E.5.1.1Timepoint(s) of evaluation of this end point
    CSF-levels of temozolomide identified
    Liquor-Spiegel von Temozolomid identifiziert
    E.5.2Secondary end point(s)
    -
    -
    E.5.2.1Timepoint(s) of evaluation of this end point
    -
    -
    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 No
    E.6.5Efficacy No
    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
    Pharmacokinetic pilot 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 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 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
    LVLS
    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 Yes
    F.1.1Number of subjects for this age range: 10
    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) Yes
    F.1.1.4.1Number of subjects for this age range: 1
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 5
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 4
    F.1.2Adults (18-64 years) No
    F.1.2.1Number of subjects for this age range: 0
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Pediatric population
    Kinder
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state10
    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)
    Routinely, patients remain under medical care after intrathecal and intravenous chemotherapy at the Department of Pediatrics, Medical University of Vienna.
    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 Decision2015-10-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-08-05
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2022-03-01
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