Ignite Creation Date:
2025-12-24 @ 3:53 PM
Ignite Modification Date:
2026-03-05 @ 10:45 AM
Study NCT ID:
NCT02525692
Status:
TERMINATED
Last Update Posted:
2024-12-24
First Post:
2015-08-14
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Oral ONC201 in Adult Recurrent Glioblastoma
Sponsor:
Jazz Pharmaceuticals
Organization:
Study Overview
Official Title:
Oral ONC201 in Adult Recurrent Glioblastoma
Status:
TERMINATED
Status Verified Date:
2024-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
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).
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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).
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).
* 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 Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: