Study to Assess Xevinapant in Preoperative Subjects With Recurrent High-Grade Glioma (rHGG)

Recurrent High-grade Glioma Clinical Trial

Official title: A Phase 1, Open-Label Window-of-Opportunity Study to Assess the Pharmacokinetics, Pharmacodynamics and Central Nervous System (CNS) Penetration of Xevinapant in Preoperative Subjects With Recurrent High-Grade Glioma (rHGG)

Status Not yet recruiting

Clinical Trial Summary

Researchers will investigate the ability of Xevinapant to cross the blood-brain barrier and exert anti-tumor effects on rHGG through activation of apoptosis. We hypothesize that oral administration of Xevinapant has acceptable safety and tolerability in patients with recurrent HGG and demonstrate pharmacokinetic and pharmacodynamic effects in HGG tumors. To that end, we will engage in a phase I "window of opportunity" translational clinical trial in patients undergoing a clinically-indicated craniotomy for resection of their recurrent tumors to evaluate the impact of treatment on rHGG.

Clinical Trial Description

n/a

Related Conditions & MeSH terms

• Glioma
• Recurrence
• Recurrent High-grade Glioma

• NCT number: NCT06463184
• Study type: Interventional
• Source: H. Lee Moffitt Cancer Center and Research Institute
• Contact: Sebastian Matzza
• Phone: 813-745-1158
• Email: Sebastian.Matzza@moffitt.org
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: June 2024
• Completion date: June 2027