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

Recruiting for this study? Get access to patient recruitment tools.
H3 K27M-mutant High-Grade Glioma incl. DIPG in Ann Arbor MI
NCT03416530 | Phase 1 | Interventional
Oncoceutics Inc
Sponsored by
Oncoceutics Inc

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 90 Participants

This is a multicenter, open-label, five 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. All patients must be 2-12 weeks from completion of first-line radiation.

Where you'll go

Selected location

University of Michigan Cancer Center

University of Michigan Cancer Center Change

1500 East Medical Center Drive, Ann Arbor, MI, USA 48109 Map | Learn more
Available locations
Cincinnati Children's Hospital Medical Center

Cincinnati Children's Hospital Medical Center

Recruiting 3333 Burnet Avenue, Cincinnati, OH, USA 45229

M D Anderson Cancer Center

M D Anderson Cancer Center

Recruiting 1515 Holcombe Boulevard, Houston, TX, USA 77030

Miami Cancer Institute

Miami Cancer Institute

Recruiting 8900 North Kendall Drive, Miami, FL, USA 33176

New York University

New York University

Recruiting New York, NY, USA 10016

Interested in participating?
Selected location

University of Michigan Cancer Center

1500 East Medical Center Drive, Ann Arbor, MI, USA 48109

Krystal Merdinger +12159666244
krystal.merdinger@oncoceutics.com


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