APPROVED_FOR_MARKETINGNot Applicable

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

United States

Plain-language summary

This is an intermediate-size expanded access protocol to provide ONC201 (dordaviprone) to patients with H3 K27M-mutant and/or midline gliomas who cannot access ONC201 (dordaviprone) through clinical trials.

Who can participate

Age range0 Years

SexALL

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Inclusion criteria

✓. Patient meets one or more of the criteria below:
✓. Patients with primary spinal glioma that is positive for the H3 K27M mutation (performed in a laboratory with Clinical Laboratory Improvement Amendments \[CLIA\] or equivalent certification). Primary spinal glioma must be documented in radiology reporting.
✓. Patients with diffuse glioma that is positive for the H3 K27M mutation (performed in a laboratory with CLIA or equivalent certification) AND radiographic evidence of leptomeningeal disease. Leptomeningeal disease must be documented in radiology reporting.
✓. Disease status:
✓. Prior radiotherapy:
✓. (Not applicable; criterion removed in Version 5).
✓. Patients must weigh at least 10 kg.
✓. Washouts:

Exclusion criteria

✕. Qualifies for participation in an ongoing ONC201 or ONC206 clinical trial.
✕. Arms B, C, and F: Previous or current enrollment in an ONC201 or ONC206 clinical study (including open-label and blinded studies) or expanded access protocol or previous exposure to ONC201 from any source for the treatment of CNS tumor.
✕. Current or planned participation in a study of an investigational agent (including ONC206) or using an investigational device.
✕. (Not applicable; criterion removed in Version 4).
✕. Any known systemic infection that, in the opinion of the Investigator, could compromise the safety of the patient while taking ONC201.
✕. Prolongation of QT/QTcF interval (QTc interval \>480 milliseconds) using Fridericia's QT correction formula on two electrocardiograms (ECGs) separated by at least 2 days.
✕. A history of Torsades de pointes or heart failure, hypokalemia, or family history of prolonged QT Syndrome.
✕. Concomitant use of medication(s) known to prolong the QT/QTc interval.

Trial details

NCT IDNCT04617002

SponsorJazz Pharmaceuticals

Sponsor typeINDUSTRY

Study typeEXPANDED_ACCESS

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