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

Status
Active
Cancer Type
Brain Cancer
Trial Phase
Phase I
Eligibility
2 - 18 Years, Male and Female
Study Type
Treatment
NCT ID
NCT03416530
Protocol IDs
ONC014 (primary)
NCI-2018-00193
Study Sponsor
Oncoceutics, Inc.

Summary

This is a multicenter, open-label, two 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.

Treatment Sites in Georgia

Emory University School of Medicine


1440 Clifton Road
Atlanta, GA 30322


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