This is an intermediate-size expanded access protocol to provide ONC201 to patients with H3 K27M-mutant and/or midline gliomas who cannot access ONC201 through clinical trials.
Name: ONC201
There is one SNP
Intermediate-size Expanded Access to ONC201 for Patients With H3 K27M-mutant and/or Midline Gliomas. --- K27M ---
Intermediate-size Expanded Access to ONC201 for Patients With H3 K27M-mutant and/or Midline Gliomas This is an intermediate-size expanded access protocol to provide ONC201 to patients with H3 K27M-mutant and/or midline gliomas who cannot access ONC201 through clinical trials. --- K27M ---
Intermediate-size Expanded Access to ONC201 for Patients With H3 K27M-mutant and/or Midline Gliomas This is an intermediate-size expanded access protocol to provide ONC201 to patients with H3 K27M-mutant and/or midline gliomas who cannot access ONC201 through clinical trials. --- K27M --- --- K27M ---
Inclusion Criteria: 1. Patient meet one or more of the criteria below: Arm A 1. Central nervous system tumor that is positive for the H3 K27M mutation (performed in a laboratory with CLIA or equivalent certification); 2. Central nervous system tumor involving the thalamus, hypothalamus, basal ganglia, brainstem, cerebellum, cerebellar peduncle, midline cortex, corpus callosum, pineal region, optic tract, or optic chiasm. --- K27M ---
H3 K27M status does not have to be known or positive for this arm. --- K27M ---
7. A history of Torsades de Pointes or heart failure, hypokalemia, or family history of prolonged QT Syndrome 8. Concomitant use of medication(s) known to prolong the QT/QTc interval Inclusion Criteria: 1. Patient meet one or more of the criteria below: Arm A 1. Central nervous system tumor that is positive for the H3 K27M mutation (performed in a laboratory with CLIA or equivalent certification); 2. Central nervous system tumor involving the thalamus, hypothalamus, basal ganglia, brainstem, cerebellum, cerebellar peduncle, midline cortex, corpus callosum, pineal region, optic tract, or optic chiasm. --- K27M ---
7. A history of Torsades de Pointes or heart failure, hypokalemia, or family history of prolonged QT Syndrome 8. Concomitant use of medication(s) known to prolong the QT/QTc interval Glioma H3 K27M Glioma null --- K27M ---