Ignite Creation Date:
2024-05-06 @ 5:19 PM
Last Modification Date:
2024-10-26 @ 2:26 PM
Study NCT ID:
NCT05267106
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-06-27
First Post:
2022-02-15
Brief Title:
Study to Evaluate the Efficacy and Safety of Pemigatinib in Participants With Previously Treated Glioblastoma or Other Primary Central Nervous System Tumors Harboring Activating FGFR1-3 Alterations
Sponsor:
Incyte Corporation
Organization:
Incyte Corporation
Study Overview
Official Title:
A Phase 2 Open-Label Single-Arm Multicenter Study to Evaluate the Efficacy and Safety of Pemigatinib in Participants With Previously Treated Glioblastoma or Other Primary Central Nervous System Tumors Harboring Activating FGFR1-3 Alterations FIGHT-209
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FIGHT-209
Brief Summary:
This is an open-label monotherapy study of pemigatinib in participants with recurrent glioblastoma GBM or other recurrent gliomas circumscribed astrocytic gliomas and glioneuronal and neuronal tumors with an activating FGFR1-3 mutation or fusionrearrangement This study consists of 2 cohorts Cohorts A and B and will enroll approximately 82 participants into each cohort Participants will receive pemigatinib 135 mg QD on a 2-week on-therapy and 1-week off-therapy schedule as long as they are receiving benefit and have not met any criteria for study withdrawal
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