ONC201 in Adults With Recurrent H3 K27M-mutant Glioma (NCT03295396) | Clinical Trial Compass
TerminatedPhase 2
ONC201 in Adults With Recurrent H3 K27M-mutant Glioma
Stopped: The Sponsor terminated the study to prioritize enrollment in a randomized Phase 3 trial of ONC201 in an earlier setting. This decision was unrelated to any safety concerns with dordaviprone (ONC201).
United States73 participantsStarted 2017-10-30
Plain-language summary
This was a Phase 2, open-label, 2-arm study of dordaviprone (ONC201) in patients with recurrent H3 K27M- mutant glioma.
The primary assessment of dordaviprone (ONC201) involved evaluating its anti-tumor activity through the overall response rate according to the Response Assessment in Neuro-Oncology (RANO) criteria for high-grade glioma (HGG).
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Had histologically confirmed diagnosis of high-grade glioma (HGG) in any tumor sample and presence of histone H3 K27M mutation detected in a Clinical Laboratory Improvement Amendment (CLIA) certified laboratory by immunohistochemistry or DNA sequencing test on any glioma tumor sample.
✓. Had unequivocal evidence of progressive disease on contrast-enhanced brain computed tomography (CT) or magnetic resonance imaging (MRI) as defined by Response Assessment in Neuro-Oncology (RANO)-HGG criteria, or have documented recurrent glioma on diagnostic biopsy.
✓. Had measurable disease by RANO-HGG criteria.
✓. Patients must have had previous therapy with at least radiotherapy.
✓. Had no more than two prior episodes of recurrence from radiotherapy and/or chemotherapy. Use of bevacizumab solely for treatment of radiation necrosis, pseudoprogression, or treatment effect was not considered a recurrence.
✓. Had an interval of at least 90 days from the completion of radiotherapy to the first dose of dordaviprone (ONC201). If patients were within 90 days of radiotherapy, they may have still been eligible if they met 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
What they're measuring
1
Number of Patients With Overall Response
Timeframe: From first dose of study treatment through study completion, an average of 1 year
. Histologic confirmation of tumor through biopsy or resection, or
Exclusion criteria
✕. Arm B: Had a primary malignant lesion located in the pons or spinal cord.
✕. Arm B: Had atypical non-astrocytic histologies such as ependymoma, ganglioma and pleomorphic xanthoastrocytoma, or pilocytic astrocytoma and subependymal giant cell astrocytoma (SEGA).
✕. Arm B: Had prior bevacizumab treatment of \>4 doses of \>7.5 mg/kg
✕. Had a history of allergic reactions attributed to compounds of similar chemical or biologic composition to dordaviprone (ONC201) or its excipients.
✕. Had current or planned participation in a study of an investigational agent or using an investigational device.
✕. Had presence of diffuse leptomeningeal disease or evidence of cerebrospinal fluid (CSF) dissemination.
✕. Had uncontrolled intercurrent illness including, but not limited to, ongoing or active infection or psychiatric illness/social situations that would limit compliance with study requirements.
✕. Had an active infection requiring systemic therapy.