Ignite Creation Date:
2025-12-24 @ 11:41 PM
Ignite Modification Date:
2025-12-25 @ 9:32 PM
Study NCT ID:
NCT05061251
Status:
WITHDRAWN
Last Update Posted:
2022-01-11
First Post:
2021-09-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Surgical Window of Opportunity Study of Orally Administered BAY 2402234 in Recurrent Glioma
Sponsor:
University of Texas Southwestern Medical Center
Organization:
Study Overview
Official Title:
An Open-Label Surgical Window of Opportunity Study Evaluating Pharmacodynamic Response of Orally Administered BAY 2402234 in Subjects With Recurrent Glioma, IDH Mutant, Grade 3 or 4
Status:
WITHDRAWN
Status Verified Date:
2021-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Drug availability
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study aims to look at how BAY 2402234 responds in body in patients with recurrent glioma.
Detailed Description:
To characterize the biological activity of BAY 2402234 in recurrent glioma, IDH-mutant, Grade 3/4 using liquid chromatography-mass spectrometry (LC-MS). The tissue orotate:carbamoyl aspartate ratio will serve as the primary pharmacodynamic biomarker and will be characterized via LC-MS.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?: