Ignite Creation Date:
2024-05-06 @ 4:45 PM
Last Modification Date:
2024-10-26 @ 2:15 PM
Study NCT ID:
NCT05080361
Status:
UNKNOWN
Last Update Posted:
2021-10-15
First Post:
2021-04-28
Brief Title:
Rechallenge of BRAF - MEK Inhibitors Following an Adverse Event in Patients With Cancer
Sponsor:
University Hospital Caen
Organization:
University Hospital Caen
Study Overview
Official Title:
Rechallenge of Rapidly Accelerated Fibrosarcoma B-type BRAF - Mitogen-activated Extracellular Signal-regulated Kinase MEK Inhibitors Following an Adverse Event in Patients With Cancer
Status:
UNKNOWN
Status Verified Date:
2021-04
Last Known Status:
ACTIVE_NOT_RECRUITING
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:
BRAFREC
Brief Summary:
Very little data are published on the safety of a rechallenge with a BRAF inhibitor or combination of BRAF and MEK inhibitor BRAFi and MEKi after an adverse event AE This study aimed at identifying the recurrence rate of the same AE after a BRAFi - MEKi rechallenge in patients with cancer and the factors associated to the recurrence
Detailed Description:
This is an observational cross-sectional pharmacovigilance cohort study AEs were extracted from safety reports from the World Health Organization database VigiBase to evaluate the safety of a rechallenge with a BRAF inhibitor or combination of BRAF and MEK inhibitor BRAFi and MEKi after an adverse event AE in patients with cancer
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?:
False
Is an FDA AA801 Violation?:
None