Ignite Creation Date:
2024-05-06 @ 3:57 PM
Last Modification Date:
2024-10-26 @ 2:00 PM
Study NCT ID:
NCT04810585
Status:
RECRUITING
Last Update Posted:
2021-03-23
First Post:
2021-03-09
Brief Title:
Plasma Biomarker for Aflibercept in Advanced Colorectal Cancer
Sponsor:
Yonsei University
Organization:
Yonsei University
Study Overview
Official Title:
Efficacy and Biomarker Exploration of 2nd Line Aflibercept in Combination With FOLFIRI in Advanced Colorectal Cancer
Status:
RECRUITING
Status Verified Date:
2021-03
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:
None
Brief Summary:
Based on the pervious data aflibercept in combination with FOLFIRI is one of the effective 2nd line treatment option in advanced colorectal cancer In this study we prospectively assess the efficacy of 2nd line aflibercept in combination with FOLFIRI in advanced colorectal cancer in terms of progression-free survival We further assess the efficacy according to the type of 1st line treatment plasma biomarker study HGF VEGF-A VEGF-D IFN-γ Angiopoietin-2 sICAM-1 sVCAM-1 TIMP-1 PIGF HS IL-6 HS IL-8 HS sNeuropilin-1 Thrombospondin-2 Osteopontin sVEGFR1 sVEGFR2 sVEGFR3 overall survival OSOS objective response rate ORR and safety are also assessed as the 2ndary objectives
Detailed Description:
This is a prospective multicenter open-label single arm study Patients will be considered on study upon signing the written informed consent form ICF The study consists of a baseline period followed by a treatment period consisting of 14-day treatment cycles which will end by a 30-day Follow-up visit which in turn will be followed by a post-treatment follow-up period
Patients will be evaluated for PFS then be followed on study until death or until cut-off date for final analysis of OS has been reached whichever comes first
During the 21-day baseline period all baseline procedures will have to be performed within defined timelines including review of eligibility criteria During the treatment period the study treatment aflibercept combined with FOLFIRI will be administered every 2 weeks unless a definitive treatment discontinuation criterion is met Cycle lengths may be extended in case of unresolved toxicity
Imaging to document tumor response and progressive disease will take place every 6 weeks and will continue to be done during the follow-up period in case of early study treatment discontinuation ie prior to documented progression Once disease progression is documented patients will be followed every 2 months for survival status and collection of data regarding further anticancer therapy until death or until the study cutoff date whichever comes first
The patients will be followed for safety for a minimum of 30 days following the last administration of the study treatment 30-day Follow-up visit Beyond this date all study drug related AEs and all SAEs should be followed until resolutionstabilization Study drug-related AEs brought to the attention of the investigator at any time after the 30-day Follow-up visit should be recorded in the case report form CRF
Patients will be evaluated for PFS then be followed on study until death or until cut-off date for final analysis of OS has been reached whichever comes first
During the 21-day baseline period all baseline procedures will have to be performed within defined timelines including review of eligibility criteria During the treatment period the study treatment aflibercept combined with FOLFIRI will be administered every 2 weeks unless a definitive treatment discontinuation criterion is met Cycle lengths may be extended in case of unresolved toxicity
Imaging to document tumor response and progressive disease will take place every 6 weeks and will continue to be done during the follow-up period in case of early study treatment discontinuation ie prior to documented progression Once disease progression is documented patients will be followed every 2 months for survival status and collection of data regarding further anticancer therapy until death or until the study cutoff date whichever comes first
The patients will be followed for safety for a minimum of 30 days following the last administration of the study treatment 30-day Follow-up visit Beyond this date all study drug related AEs and all SAEs should be followed until resolutionstabilization Study drug-related AEs brought to the attention of the investigator at any time after the 30-day Follow-up visit should be recorded in the case report form CRF
Study Oversight
Has Oversight DMC:
None
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?:
None