Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06640166
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-10-07
Brief Title:
Encorafenib Cetuximab Beyond Progression in Combination With FOLFIRI in Patients With BRAF V600E Mutated Metastatic Colorectal Cancer Progressing on Encorafenib Cetuximab
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Encorafenib Cetuximab Beyond Progression in Combination With FOLFIRI in Patients With BRAF V600E Mutated Metastatic Colorectal Cancer Progressing on Encorafenib Cetuximab
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ECLYPse
Brief Summary:
The aim of this study is to determine the activity of encorafenib plus cetuximab in combination with FOLFIRI in patients with BRAF V600E mutated metastatic colorectal cancer progressing on encorafenib plus cetuximab administered in second line
Detailed Description:
This is a prospective multicentre phase II single-arm trial evaluating encorafenib plus cetuximab beyond progression in combination with irinotecan-based doublet chemotherapy FOLFIRI in patients affected by BRAF V600E mutated metatstic colorectal cancer progressing on encorafenib plus cetuximab administered in second line
Eligible patients are
affected by BRAF V600E mutated metastatic colorectal cancer
progressing on encorafenib plus cetuximab administered in second line
achieved complete response or partial response or stable disease lasting more than 3 moths as best response to encorafenib plus cetuximab administered in second line
All patients eligible according to inclusion and exclusion criteria will receive encorafenib plus cetuximab beyond progression in combination with irinotecan-based doublet chemoterapy FOLFIRI as follows
encorafenib 300 mg 75 mgx4 hard capsules orally once daily
cetuximab 500 mgsqm iv every 14 days
FOLFIRI iv every 14 days Irinotecan 180 mgsqm Folinic Acid 400 mgsqm 5Fluorouracil 400 mgsqm iv bolus and 2400 mgsqm iv continuous infusion over 46-48 hours
Treatment will be administered until disease progression unacceptable toxic effects withdrawal of consent or death
The primary end point of this trial is investigator-assessed 6-month progression free survival rate and is defined as the proportion of patients alive and progression-free by the 6-month time point from start of investigational treatment encorafenib plus cetuximab beyond progression in combination with FOLFIRI
Eligible patients are
affected by BRAF V600E mutated metastatic colorectal cancer
progressing on encorafenib plus cetuximab administered in second line
achieved complete response or partial response or stable disease lasting more than 3 moths as best response to encorafenib plus cetuximab administered in second line
All patients eligible according to inclusion and exclusion criteria will receive encorafenib plus cetuximab beyond progression in combination with irinotecan-based doublet chemoterapy FOLFIRI as follows
encorafenib 300 mg 75 mgx4 hard capsules orally once daily
cetuximab 500 mgsqm iv every 14 days
FOLFIRI iv every 14 days Irinotecan 180 mgsqm Folinic Acid 400 mgsqm 5Fluorouracil 400 mgsqm iv bolus and 2400 mgsqm iv continuous infusion over 46-48 hours
Treatment will be administered until disease progression unacceptable toxic effects withdrawal of consent or death
The primary end point of this trial is investigator-assessed 6-month progression free survival rate and is defined as the proportion of patients alive and progression-free by the 6-month time point from start of investigational treatment encorafenib plus cetuximab beyond progression in combination with FOLFIRI
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None