Ignite Creation Date:
2024-05-06 @ 2:25 PM
Last Modification Date:
2024-10-26 @ 1:31 PM
Study NCT ID:
NCT04317599
Status:
COMPLETED
Last Update Posted:
2024-07-15
First Post:
2020-03-18
Brief Title:
A Retrospective Non Interventional Study on First Line Treatment for Patients With BRAFV600E Mutant Metastatic Colorectal Cancer mCRC
Sponsor:
Pierre Fabre Medicament
Organization:
Pierre Fabre Medicament
Study Overview
Official Title:
A Retrospective Non Interventional Study on First Line Treatment for Patients With BRAFV600E Mutant Metastatic Colorectal Cancer mCRC
Status:
COMPLETED
Status Verified Date:
2023-03
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:
CAPSTAN CRC
Brief Summary:
The presence of a BRAFV600E mutation is considered a marker of poor prognosis in patients with mCRC and findings from clinical trials have largely remained inconclusive regarding the efficacy of first line treatments for BRAF-mutant mCRC patients In the absence of targetedspecific treatment for BRAF-mutant mCRC treatment practices can vary based on local practices and guidelines There is therefore an unmet need to document the current practices for first-line treatment of BRAF-mutant mCRC and their effectiveness and safety in a real-world setting
This real-world multicenter non-interventional study NIS will describe the treatment patterns effectiveness and safety of current treatment regimens in BRAFV600E mutant mCRC patients in Europe with the aim to put the clinical study findings of the ongoing Phase 2 single-arm open label trial ANCHOR into context of the current treatment landscape excluding investigational therapies Additionally the NIS output may be used to support future health technology assessment submissions and publications
This real-world multicenter non-interventional study NIS will describe the treatment patterns effectiveness and safety of current treatment regimens in BRAFV600E mutant mCRC patients in Europe with the aim to put the clinical study findings of the ongoing Phase 2 single-arm open label trial ANCHOR into context of the current treatment landscape excluding investigational therapies Additionally the NIS output may be used to support future health technology assessment submissions and publications
Detailed Description:
This retrospective multi-center longitudinal study on BRAFV600E mutant mCRC patients will be conducted in Europe to characterize the first-line treatment patterns All BRAFV600E mutant patients having initiated a first-line treatment for mCRC between January 1st 2016 and December 31st 2018 both days inclusive with drugs registered for mCRC in respective country will be eligible to participate The study will not provide or recommend any treatment or procedure all decisions regarding treatment are made at the sole discretion of the treating physician in accordance with their usual practices and all eligible patients will be considered for enrollment
The target countries for patient enrollment will include Germany France Italy United Kingdom Spain Belgium Austria and the Netherlands Approximately 300 adult patients 18 years from a mix of academic and non-academic sites up to 65 sites will be enrolled
The target countries for patient enrollment will include Germany France Italy United Kingdom Spain Belgium Austria and the Netherlands Approximately 300 adult patients 18 years from a mix of academic and non-academic sites up to 65 sites will be enrolled
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