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


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The purpose of this study is to see if ONC201 is effective in treating participants with glioma when given following radiation therapy, how safe and tolerable ONC201 as compared to using placebo (a capsule that looks like ONC201 but does not contain any active drug), and to see how well ONC201 can improve quality of life and brain functioning in patients with glioma. ONC201 is a new drug that is being developed for treating people with glioma. ONC201 may help to remove tumor cells without affecting normal cells of the body. ONC201 is a first-in-class drug, which means it is a new drug having unique action, and it is not approved by the U.S. Food and Drug Administration (FDA) for treating glioma.

Are you Eligible? (Inclusion Criteria)

  • Must be 18 years old or older. - Must have completed standard frontline radiotherapy within 2 to 6 weeks before to randomization. - Must not have a primary spinal tumor. - Must not be pregnant, breastfeeding, or planning to become pregnant while receiving the study intervention or within 3 months after the last dose.

Specialty Area(s)

Principal Investigator

Trial Location(s)

CUIMC/Herbert Irving Pavilion
161 Fort Washington Avenue
New York, NY 10032