NCT04790448

Efficacy of VIC Regimen in BRAF Mutant Metastatic Colorectal Cancer

A Phase Ia/II, Single Arm Trial on the Efficacy of Vemurafenib in Combination With Irinotecan and Cetuximab in BRAF V600E-Mutant Metastatic Colorectal Cancer

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 37 (actual)
• Sponsor: Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Colorectal Cancer Metastatic

Interventions

Type	Name	Description
DRUG	Cetuximab	Route of administration: Intravenous
DRUG	Irinotecan	Route of administration: Intravenous
DRUG	Vemurafenib	Route of administration: Oral

Timeline

• Start date: 2020-07-27
• Primary completion: 2021-12-31
• Completion: 2021-12-31
• First posted: 2021-03-10
• Last updated: 2023-02-15

Locations

1 site across 1 country: China