An open randomized phase II clinical trial evaluating the safety and efficacy of rapamycin in the treatment of gliomas high-grade malignant gliomas in children as part of the establishment management of rare and ultra rare diseases of the central nervous system associated with mTOR pathway activation: BraimTOR- ONKO
interventional
N/A
1 country
3
The primary objective of the study is to determine safety and tolerability of rapamycin in the treatment of high grade glioma in children
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
Not reported
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 16, 2024
Actual (reported)The primary safety endpoint of rapamycin will be the assessment of the incidence of 3 and 4 grade adverse reactions (according to the CTCAE classification) during the treatment phase and follow-up.
OS (overall survival) after 15 months, 24 months, 3 years, 5 years
EFS (event free survival) after 15 months, 24 months, 3 years, 5 years
PFS (progression free survival) after 15 months, 24 months, 3 years, 5 years
ORR ( overall response rate) according RAPNO (CR, PR, SD, PD) criteria
Evaluation of adverse event seriousness according CTCAE
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Formulated product
Rapamune 1 mg/mL oral solution
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
ORAL SOLUTION
View registry recordThe registry names these ingredients. The formulation’s exact chemical form has not been confirmed.
Rapamune 1 mg/mL oral solution
Named ingredient: Sirolimus
View registry recordUniwersytet Medyczny W Lodzi
Lodz, 90-419, Poland
Instytut Pomnik Centrum Zdrowia Dziecka
Warsaw, 04-730, Poland
Górnośląskie Centrum Zdrowia Dziecka
Katowice, 40-758, Poland
Anna Drużdżel
First Submitted
October 16, 2024
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Source: European Medicines Agency (EMA), Clinical Trials Information System (CTIS). Original record and public documents are available on CTIS.
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