Ignite Creation Date:
2024-05-06 @ 2:07 AM
Last Modification Date:
2024-10-26 @ 11:14 AM
Study NCT ID:
NCT01975701
Status:
COMPLETED
Last Update Posted:
2019-12-04
First Post:
2013-10-28
Brief Title:
A Phase 2 Study of BGJ398 in Patients With Recurrent GBM
Sponsor:
Novartis Pharmaceuticals
Organization:
Novartis
Study Overview
Official Title:
A Phase 2 Multicenter Open-label Study of BGJ398 in Patients With Recurrent Resectable or Unresectable Glioblastoma
Status:
COMPLETED
Status Verified Date:
2019-11
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:
None
Brief Summary:
This is an open-label non-randomized multicenter phase II study of BGJ398 administered to adult patients with histologically confirmed GBM andor other glioma subtypes with FGFR1-TACC1 FGFR3-TACC3 fusion andor activating mutation in FGFR1 2 or 3
Detailed Description:
Patients were enrolled in two groups Group 1 enrolled patients who are not candidates for surgery Group 2 was planned to enroll patients who are surgical candidates Patients from both groups were evaluated for tumor response and progression by MRI every 8 weeks until disease progression or discontinuation from study using RANO criteria
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