NCT05061251

Surgical Window of Opportunity Study of Orally Administered BAY 2402234 in Recurrent Glioma

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• Status: Withdrawn
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University of Texas Southwestern Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Glioma
• IDH Mutation

Interventions

Type	Name	Description
DRUG	BAY 2402234	Patients will receive 3 doses of 5mg each of BAY 2402234. Drug will be given Day 1 and Day 2 prior to standard-of-care craniotomy for tumor resection and 1 dose on the morning of surgery.

Timeline

• Start date: 2021-12-01
• Primary completion: 2022-12-01
• Completion: 2023-12-01
• First posted: 2021-09-29
• Last updated: 2022-01-11

Regulatory

• FDA-regulated drug study