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

NCT06463184 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2024-12-04

No results posted yet for this study

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

DRUG

Xevinapant

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

Sponsors & Collaborators

  • EMD Serono Research & Development Institute, Inc.

    collaborator INDUSTRY

  • H. Lee Moffitt Cancer Center and Research Institute

    lead OTHER

Principal Investigators

  • Arnold Etame, MD, PhD · Moffitt Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-07-22
Primary Completion
2027-06-30
Completion
2027-06-30
FDA Drug
Yes

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06463184 on ClinicalTrials.gov