Ignite Creation Date:
2024-05-06 @ 3:54 PM
Last Modification Date:
2024-10-26 @ 1:59 PM
Study NCT ID:
NCT04790448
Status:
COMPLETED
Last Update Posted:
2023-02-15
First Post:
2021-03-07
Brief Title:
Efficacy of VIC Regimen in BRAF Mutant Metastatic Colorectal Cancer
Sponsor:
Sun Yat-sen University
Organization:
Sun Yat-sen University
Study Overview
Official Title:
A Phase IaII Single Arm Trial on the Efficacy of Vemurafenib in Combination With Irinotecan and Cetuximab in BRAF V600E-Mutant Metastatic Colorectal Cancer
Status:
COMPLETED
Status Verified Date:
2023-02
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:
This prospective multicenter single arm clinical trial was designed to evaluate the efficacy and safety of Vemurafenib in combination with Irinotecan and Cetuximab in the treatment of BRAF V600E-Mutant Metastatic Colorectal Cancer
Detailed Description:
PRIMARY OBJECTIVES
To evaluate the Overall Response Rate ORR of v-raf murine sarcoma viral oncogene homolog B BRAF V600E mutant metastatic colorectal cancer patients treated with Vemurafenib in combination with Irinotecan and Cetuximab VIC regimen
SECONDARY OBJECTIVES
To evaluate the Progression Free Survival PFS Overall Survival OS safety and toxicity of VIC regimen in the treatment of BRAF V600E mutant colon cancer
EXPLORATORY OBJECTIVES
Mechanism of primary and secondary resistance to VIC regimen in the treatment of BRAF V600E mutant colon cancer
OUTLINE
Patients receive Cetuximab and Irinotecan intravenously on day 1 and Vemurafenib orally PO twice daily BID on days 1 to 14 Courses are repeated every 2 weeks in the absence of disease progression or unacceptable toxicity
To evaluate the Overall Response Rate ORR of v-raf murine sarcoma viral oncogene homolog B BRAF V600E mutant metastatic colorectal cancer patients treated with Vemurafenib in combination with Irinotecan and Cetuximab VIC regimen
SECONDARY OBJECTIVES
To evaluate the Progression Free Survival PFS Overall Survival OS safety and toxicity of VIC regimen in the treatment of BRAF V600E mutant colon cancer
EXPLORATORY OBJECTIVES
Mechanism of primary and secondary resistance to VIC regimen in the treatment of BRAF V600E mutant colon cancer
OUTLINE
Patients receive Cetuximab and Irinotecan intravenously on day 1 and Vemurafenib orally PO twice daily BID on days 1 to 14 Courses are repeated every 2 weeks in the absence of disease progression or unacceptable toxicity
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