ONC201 for the Treatment of Newly Diagnosed H3 K27M-mutant Diffuse Glioma Following Completion of Radiotherapy: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study (The ACTION Study)

Conditions

H3 K27M-mutant diffuse glioma

Brief summary

Overall survival, Progression-free survival using RANO-HGG criteria

Detailed description

Incidence of adverse events (AEs): overall, treatment-related, Grade 3 or higher in severity, serious, fatal, those resulting in treatment discontinuation, and events of special interest, Change from baseline in clinical laboratory parameters, Distribution of graded clinical laboratory parameters, Progression-free survival using RANO-HGG criteria for participants with measurable contrast-enhancing disease, Corticosteroid response; Time to first corticosteroid response; Duration of first corticosteroid response; Cumulative duration of corticosteroid responses; Corticosteroid dose and change from baseline over time; Time to corticosteroid use deterioration, Performance status response; Time to first performance status response; Duration of first performance status response; Cumulative duration of performance status responses; Performance status and change from baseline over time; Time to performance status deterioration, Change from baseline in QoL assessments: ≥18 years of age: EORTC-QLQ-C30, QLQ-BN20, and MDASI-BT; 2 to <18 years of age: PedsQL Brain Tumor Module, Change from baseline in Neurologic Assessment in Neuro Oncology (NANO) results

Related papers

No related papers found yet.

Interventions

DRUGPlacebo for ONC201

Eligibility

Sex/Gender

All

Age

0 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Overall survival, Progression-free survival using RANO-HGG criteria	—

Secondary

Measure	Time frame
Incidence of adverse events (AEs): overall, treatment-related, Grade 3 or higher in severity, serious, fatal, those resulting in treatment discontinuation, and events of special interest, Change from baseline in clinical laboratory parameters, Distribution of graded clinical laboratory parameters, Progression-free survival using RANO-HGG criteria for participants with measurable contrast-enhancing disease, Corticosteroid response; Time to first corticosteroid response; Duration of first corticosteroid response; Cumulative duration of corticosteroid responses; Corticosteroid dose and change from baseline over time; Time to corticosteroid use deterioration, Performance status response; Time to first performance status response; Duration of first performance status response; Cumulative duration of performance status responses; Performance status and change from baseline over time; Time to performance status deterioration, Change from baseline in QoL assessments: ≥18 years of age: EORTC-QL	—

Measure

Time frame

Incidence of adverse events (AEs): overall, treatment-related, Grade 3 or higher in severity, serious, fatal, those resulting in treatment discontinuation, and events of special interest, Change from baseline in clinical laboratory parameters, Distribution of graded clinical laboratory parameters, Progression-free survival using RANO-HGG criteria for participants with measurable contrast-enhancing disease, Corticosteroid response; Time to first corticosteroid response; Duration of first corticosteroid response; Cumulative duration of corticosteroid responses; Corticosteroid dose and change from baseline over time; Time to corticosteroid use deterioration, Performance status response; Time to first performance status response; Duration of first performance status response; Cumulative duration of performance status responses; Performance status and change from baseline over time; Time to performance status deterioration, Change from baseline in QoL assessments: ≥18 years of age: EORTC-QL

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Countries

Austria, Denmark, Germany, Italy, Netherlands, Spain

Outcome results

None listed