NCT04424966

Infigratinib in Recurrent High-Grade Glioma Patients

A Phase 0 Study of Infigratinib in Recurrent High-Grade Glioma Participants Scheduled for Resection to Evaluate Central Nervous System (CNS) Penetration With PK Triggered Expansion Cohort

• Status: Terminated
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: Nader Sanai · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This trial is an open-label, multicenter, Phase 0 trial that will enroll up to 20 participants with recurrent high-grade glioma with FGFR1 K656E or FGFR3 K650E mutation or FGFR3-TACC3 translocation which are scheduled for resection. In the lead-in cohort, a total of 20 participants will be enrolled into the proposed phase 0 clinical trial. Participants will be administered infigratinib prior to surgical resection of their tumor.

Conditions

• Glioma
• Glioblastoma
• GBM

Interventions

Type	Name	Description
DRUG	Infigratinib	The Phase 0 study will include treatment of recurrent high-grade glioma participants with 125 mg of infigratinib 7 days prior to surgical resection. Participants with tumors demonstrating PK-response will continue treatment with the same dose continuously for 21 days in 28-day cycles after surgery.

Timeline

• Start date: 2020-07-21
• Primary completion: 2023-01-31
• Completion: 2024-02-19
• First posted: 2020-06-11
• Last updated: 2025-10-24
• Results posted: 2025-10-24

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study