A Phase III Study of ONC201 for Newly Diagnosed H3 K27M-Mutant Diffuse Glioma

Cancer
Xiao-Tang Kong
ONC201 for the Treatment of Newly Diagnosed H3 K27M-mutant Diffuse Glioma Following Completion of Radiotherapy: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study
Brain and Nervous System

Study Description

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

Eligibility

  • Able to understand the study procedures and agree to participate in the study by providing written informed consent (by participant or legally authorized representative), and assent when applicable.
  • Body weight >10 kg at time of randomization

-Stable or decreasing dose of corticosteroids and anti-seizure medications for 7 days prior to randomization, if applicable. Stable steroid dose is defined as ≤ 2 mg/day increase (based on dexamethasone dose or equivalent dose of an alternative steroid).

-Primary spinal tumor.

  • New lesion(s) outside of the radiation field.
  • Received whole-brain radiotherapy.
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