Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06578559
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-29
Brief Title:
Phase II Study of ctDNA-guided Encorafenib Plus Cetuximab Retreatment in Patients BRAF V600E Mutated mCRC
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Single Arm Phase II Study of ctDNA-guided Encorafenib Plus Cetuximab Retreatment in Patients With BRAF V600E Mutated mCRC BRICKET
Status:
RECRUITING
Status Verified Date:
2024-07
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:
BRICKET
Brief Summary:
The aim of this study is to evaluate the activity in terms of best response according to RECIST criteria 11 as assessed by the local investigator of the ctDNA-guided retreatment with encorafenib plus cetuximab in BRAFV600E mutated mCRC patients experiencing benefit from previous exposure to encorafenib plus cetuximab - chemotherapy and with BRAFV600E mutated KRAS NRAS and MAP2K1 wild-type and MET not amplified status on ctDNA at the time of study entry
Detailed Description:
This is a proof-of-concept multicenter open-label single arm one-stage phase II trial of a ctDNA-guided retreatment with encorafenib plus cetuximab for mCRC patients bearing the BRAFV600E mutation and with the key following characteristics
initial benefit and then secondary resistance to a previous exposure to encorafenib and cetuximab with or without chemotherapy
only one subsequent intervening anti-BRAF and anti-EGFR-free line of therapy
confirmed BRAFV600E mutated status and no detectable mutations in KRAS NRAS MAP2K1 and no amplification of MET in ctDNA at the time of retreatment
Eligible patients will receive Encorafenib 300 mg once daily four 75 mg oral capsules and Cetuximab 500 mgsqm iv infusion every 14 daysTreatment will be delivered in 28-day cycles until disease progression unacceptable toxic effects withdrawal of consent initiation of subsequent anticancer therapy or death
initial benefit and then secondary resistance to a previous exposure to encorafenib and cetuximab with or without chemotherapy
only one subsequent intervening anti-BRAF and anti-EGFR-free line of therapy
confirmed BRAFV600E mutated status and no detectable mutations in KRAS NRAS MAP2K1 and no amplification of MET in ctDNA at the time of retreatment
Eligible patients will receive Encorafenib 300 mg once daily four 75 mg oral capsules and Cetuximab 500 mgsqm iv infusion every 14 daysTreatment will be delivered in 28-day cycles until disease progression unacceptable toxic effects withdrawal of consent initiation of subsequent anticancer therapy or death
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