Multicenter, open label study using molecularly determined targeted therapies in children 3-18 years of age with DIPG (diffuse intrinsic pontine glioma- DIPG)- DIPGen
interventional
N/A
1 country
2
The aim of the study is to develop the optimal treatment for patients with DIPG by identifying molecular markers important for therapy, adjusting the type of medicinal product to the indicated markers and assessing the safety and efficacy of selected drugs (sirolimus, trametinib) in the treatment of DIPG 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)Overall survival (OS) from the time of diagnosis until last visit or death
Safety assessment of sirolimus administered during radiotherapy and in combination with trametinib as adjunctive treatment after irradiation
Progression free survival from diagnosis to progression
Response rate assessed at time points specified in the protocol (MRI every 2 months from commnecement of systemic treatment)
Quality of life assessment (using PedQoL- pediatric quality of life inventory) at time points specified in the protocol
Comparison of safety in 2 groups of patients; treated with sirolimus alone or in combination with trametinib
These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.
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 recordFormulated product
Mekinist 0.5 mg film-coated tablets
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
FILM-COATED TABLET
View registry recordFormulated product
Rapamune 1 mg coated tablets
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
COATED TABLET
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 recordMekinist 0.5 mg film-coated tablets
Named ingredient: trametinib
View registry recordRapamune 1 mg coated tablets
Named ingredient: Sirolimus
View registry recordInstytut Pomnik Centrum Zdrowia Dziecka
Warsaw, 04-730, Poland
Górnośląskie Centrum Zdrowia Dziecka
Katowice, 40-758, Poland
Monika Drogosiewicz
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.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved:
Biological Medicine for Diffuse Intrinsic Pontine Glioma (DIPG) Eradication
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