Ignite Creation Date:
2025-12-24 @ 6:33 PM
Ignite Modification Date:
2026-01-06 @ 2:12 AM
Study NCT ID:
NCT05904457
Status:
RECRUITING
Last Update Posted:
2023-06-15
First Post:
2023-06-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Phase II Stydy of Bevacizumab Plus Erlotinib in Patients for Krebs Cycle Altered Cancer
Sponsor:
Asan Medical Center
Organization:
Study Overview
Official Title:
A Phase II Clinical Trial of Bevacizumab Plus eRlotinIb in patientS With Advanced Cancer Having Genetic Alterations in Krebs Cycle (BRISK, KCSG AL22-16)
Status:
RECRUITING
Status Verified Date:
2023-06
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:
BRISK
Brief Summary:
A national, prospective, multi-center, open-label, single arm phase II trial investigating the efficacy and safety of bevacizumab plus erlotinib in patients with advanced cancers which harbors genomic alterations in Krebs cycle
Detailed Description:
The BRISK study will recruit patients with locally advanced or metastatic solid tumor harboring the genomic alterations in Krebs cycle (e.g. fumarate hydratase, isocitrate dehydrogenase, succinate dehydrogenase) who had disease progression on standard systemic treatment and/or has no standard treatment option, and investigate the efficacy and safety of bevacizumab plus erlotinib.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
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?: