ONC201 in Newly Diagnosed Diffuse Intrinsic Pontine Glioma and Recurrent/Refractory Pediatric H3 K27M Gliomas

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions:
    Diagnosed Diffuse Intrinsic Pontine Glioma And Recurrent/refractory Pediatric H3 K27m Gliomas
  • Age: Between 2 - 18 Years
  • Gender: Male or Female
  • Other Inclusion Criteria:
    1. Patients are 2 to 18 years of age. 2. Patient body weight must be above the minimum necessary for the patient to receive the ONC201 dose indicated for the currently enrolling dose le el. The minimum body weight ranges from 10 to 35kg depending on the dose level. 3. Arm A: Patients with glioma who are positive for the H3 K27M mutation and have completed at least one line of prior therapy. OR Arm B: Patients with newly diagnosed diffuse intrinsic pontine glioma (DIPG), defined as tumors with a pontine epicenter and diffuse involvement of the pons, are eligible with or without histologic confirmation.

You may not be eligible for this study if the following are true:

  • 1. Current or planned participation in a study of another investigational agent or using an investigational device. 2. History of allergic reactions attributed to compounds of similar chemical or biologic composition to ONC201 or its excipients. 3. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection or psychiatric illness/social situations that would limit compliance with study requirements.


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