Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 3:53 PM
Ignite Modification Date:
2025-12-24 @ 3:53 PM
NCT ID:
NCT02525692
Brief Summary:
This was a Phase 2, open-label, 6-arm, multi-center study of dordaviprone (ONC201) in patients with recurrent glioblastoma (Arms A, B, and C), H3 K27M-mutant diffuse glioma (Arm D), or diffuse midline glioma (Arms E and F).
The primary objective of this study was the assessment of dordaivprone (ONC201) anti-tumor activity through progression-free survival at 6 months using Response Assessment in Neuro-Oncology (RANO) criteria for high-grade glioma (HGG).
Detailed Description:
This study included 6 arms:
* Patients in Arm A received 625 mg oral dordaviprone (ONC201) every 3 weeks.
* Patients in Arms B, C, D, E, and F received 625 mg oral dordaviprone (ONC201) every 1 week (Days 1, 8 and 15 of each cycle).
* Patients in Arms C and E received salvage surgical resection of their brain tumor 1 day after the second (or more) dose of dordaviprone (ONC201).
All patients underwent clinical evaluation after each cycle (defined as every 3 weeks).
Neuroimaging studies (contrast-enhanced brain magnetic resonance imaging or computed tomography for patients unable to undergo MRI) were performed at baseline, 8 weeks from treatment initiation, and then every 8 weeks thereafter.
Assessments of dordaviprone (ONC201) anti-tumor activity were assessed through progression-free survival at 6 months using RANO-HGG criteria. Safety was assessed through the reporting of adverse events, measurement of vital signs, electrocardiograms, and clinical laboratory results.
This study was terminated by an administrative protocol amendment (17 January 2023). The decision to terminate the study was not related to any safety concerns with dordaviprone (ONC201). Before the study was terminated, a total of 84 patients were enrolled and received at least 1 dose of dordaviprone (ONC201).
Study:
NCT02525692
Study Brief:
Protocol Section:
NCT02525692