Ignite Creation Date:
2024-05-06 @ 2:48 PM
Last Modification Date:
2024-10-26 @ 1:37 PM
Study NCT ID:
NCT04424966
Status:
TERMINATED
Last Update Posted:
2024-03-27
First Post:
2020-05-27
Brief Title:
Infigratinib in Recurrent High-Grade Glioma Patients
Sponsor:
Nader Sanai
Organization:
St Josephs Hospital and Medical Center Phoenix
Study Overview
Official Title:
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
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study drug no longer available
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 20-500-092-34-38 | OTHER | SJHMC | None |