Massachusetts General Hospital / Dana Farber Cancer Institute / Miami Cancer Institute:
Phase II – Adults with recurrent Glioblastoma (GBM) (NCT02525692)
This Phase II clinical trial is investigating the use of ONC201 in patients with relapsed or refractory glioblastoma multiforme (GBM) as well as a specific cohort of patients with H3 K27M mutant gliomas. Isabel Arrillaga-Romany, MD, PhD, Associate Clinical Director of Neuro-Oncology at Massachusetts General Hospital, Patrick Wen, MD, Director of the Center for Neuro-Oncology at the Dana Farber Cancer Institute, and Yazmin Odia, MD at the Miami Cancer Institute are the Principal Investigators for the trial. The interim results from this Phase II study, including the first H3 K27M patient, can be found here.
New York University School of Medicine / Levine Cancer Institute:
Phase II – Adults with Recurrent H3 K27M High-grade Glioma (NCT03295396)
The primary objective of this phase II trial is to determine the efficacy and safety of ONC201 in adult patients with recurrent high-grade glioma that have the H3 K27M mutation. Andrew S. Chi, MD PhD, Chief of Neuro-Oncology and the Codirector of the Brain Tumor Center at NYU Langone, is the Principal Investigator for the trial.
New York University / University of Michigan / MD Anderson:
Phase I – Pediatric Patients with H3 K27M High-Grade Gliomas Including Diffuse Intrinsic Pontine Gliomas (DIPG) (NCT03416530)
The primary objective of this phase I trial is to determine the efficacy and safety of ONC201 in pediatric patients with newly diagnosed or recurrent high-grade gliomas that exhibit the H3 K27M mutation. Sharon Gardner, MD, pediatric hematologist/oncologist at the Stephen D. Hassenfeld Children Center for Cancer and Blood Disorders, is the Principal Investigator for this trial.
Recurrent Histone H3 Mutant Glioma (NCT03134131)
The objective of this expanded access program is to provide ONC201 on a single patient compassionate use basis to eligible patients with recurrent gliomas that exhibit a missense histone H3 mutation and are unable to participate in the clinical trials listed above. The expanded access program is open to both adult and pediatric patients.