Have you or your loved ones been diagnosed with diffuse intrinsic pontine glioma?

You may be eligible to participate in a diffuse intrinsic pontine glioma clinical trial.

Have you or your loved ones been diagnosed with diffuse intrinsic pontine glioma? You may be eligible to participate in a diffuse intrinsic pontine glioma clinical trial.

What is a clinical trial? Is participating in a clinical trial right for you? Learn more

H3 K27M-mutant High-Grade Glioma incl. DIPG
NCT03416530 | Phase 1 | Interventional
Chimerix
Sponsored by
Chimerix

Have you or your loved ones been diagnosed with diffuse intrinsic pontine glioma?

You may be eligible to participate in a diffuse intrinsic pontine glioma clinical trial.

Have you or your loved ones been diagnosed with diffuse intrinsic pontine glioma? You may be eligible to participate in a diffuse intrinsic pontine glioma clinical trial.

Recruiting

Male & Female

2 - 18

Years old

This study is looking to recruit 130 Participants

This is a multicenter, open-label, seven arm, dose escalation, phase I study of oral ONC201 in pediatric patients with newly diagnosed Diffuse Intrinsic Pontine Glioma (DIPG) and recurrent/refractory H3 K27M gliomas. Arm A will define the RP2D for single agent ONC201 in pediatric patients with glioma who are positive for the H3 K27M mutation (positive testing in CLIA laboratory) and have completed at least one line of prior therapy. This will allow for recurrent patients and also patients who have not yet recurred, but have completed radiation and will inevitably recur based on prior clinical experience and the literature. Arm B will define the RP2D for ONC201 in combination with radiation in pediatric patients with newly diagnosed DIPG. Arm C will determine intratumoral drug concentrations and biomarker expression in pediatric patients with midline gliomas. Arm D will determine H3 K27M DNA levels and drug concentrations in the CSF of pediatric H3 K27M-mutant glioma patients. Arm E will determine the RP2D for single agent ONC201 administered as a liquid formulation in Ora-Sweet to patients with DIPG and/or H3 K27M glioma. Arm F is a dose expansion cohort to confirm the safety and estimate the efficacy in recurrent H3 K27M-mutant glioma population at the RP2D. Arm G will define the RP2D for single agent ONC201 given on two consecutive days of each week in pediatric patients with glioma who are positive for the H3 K27M mutation and have completed at least one line of prior therapy.