NCT06463184

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

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• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: H. Lee Moffitt Cancer Center and Research Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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. Researchers 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, Researchers will engage in a phase I "window of opportunity" translational clinical trial in patients undergoing a clinically-indicated craniotomy for resection of recurrent tumors to evaluate the impact of treatment on rHGG.

Conditions

• Recurrent High-grade Glioma

Interventions

Type	Name	Description
DRUG	Xevinapant	Xevinapant is an investigational medication, taken orally, that promotes cancer cell death via apoptosis.

Timeline

• Start date: 2024-07-22
• Primary completion: 2027-06-01
• Completion: 2027-06-01
• First posted: 2024-06-17
• Last updated: 2024-12-04

Regulatory

• FDA-regulated drug study