ONC201 for the Treatment of Newly Diagnosed H3 K27M-mutant Diffuse Glioma Following Completion of Radiotherapy: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study
Categories (click each to see list of all clinical trials associated with that category): Pediatric (PEDONC)
Current Status: Open
Phase: III
Principal Investigator: Raulji, Chittalsinh
Eligibility: https://clinicaltrials.gov/study/NCT05580562?term=NCT05580562&rank=1
Summary
Primary
To evaluate the efficacy of ONC201 administered following radiotherapy in participants with H3 K27M-mutant diffuse glioma
Secondary
- To evaluate the safety and tolerability of ONC201 versus placebo
- To evaluate the efficacy of ONC201 administered following radiotherapy using RANO-HGG criteria in participants with H3 K27M-mutant diffuse glioma
- To evaluate clinical benefits of treatment with ONC201
- To evaluate the impact of ONC201 on health-related QoL and neurological function
Exploratory
- To assess plasma concentrations and estimate PK parameters for ONC201
- To evaluate the exposure-response relationship
- To evaluate the efficacy of ONC201 using RANO-LGG criteria
- To evaluate the impact of molecular profile on outcomes
- To compare outcomes among selected subgroups
- To evaluate the impact of ONC201 treatment on healthcare resource utilization