NO_LONGER_AVAILABLENot Applicable

Expanded Access to ONC201 for Patients With H3 K27M-mutant and/or Midline High Grade Gliomas

United States

Plain-language summary

The objective of this expanded access program is to provide ONC201 to eligible patients with previously-treated glioma that exhibits the H3 K27M mutation and/or that is located in the midline region of the brain.

Who can participate

Age range3 Years

SexALL

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Inclusion criteria

✓. Patient must have one type of diagnosis below:
✓. A glioma that is positive for the H3 K27M mutation (performed in a laboratory with CLIA certification);
✓. A grade III or IV glioma involving the thalamus, hypothalamus, brainstem, cerebellum, midbrain, or spinal cord;
✓. Diffuse intrinsic pontine glioma (DIPG), defined as tumors with a pontine epicenter and diffuse involvement of the pons. These patients are eligible with or without a tissue biopsy.
✓. Unequivocal evidence of progressive disease on as defined by RANO criteria or have documented recurrent glioma on diagnostic biopsy.
✓. Patient must have had previous therapy that includes radiotherapy.
✓. Interval of at least 90 days from the completion of radiotherapy to the first dose of ONC201. If patients are within 90 days of radiotherapy, they may still be eligible if they meet one or more of the following criteria.
✓. Progressive tumor is outside the original high-dose radiotherapy target volume as determined by the treating investigator, or

Exclusion criteria

✕. Qualifies for participation in an ongoing ONC201 clinical trial or is already participating in an ONC201 clinical trial.
✕. Current or planned participation in a study of an investigational agent or using an investigational device.
✕. Evidence of diffuse leptomeningeal disease or CSF dissemination.
✕. Any known systemic infection that, in the opinion of the investigator, could compromise the safety of the patient, while taking ONC201.

Trial details

NCT IDNCT03134131

SponsorJazz Pharmaceuticals

Sponsor typeINDUSTRY

Study typeEXPANDED_ACCESS

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