Efficacy of VIC Regimen in BRAF Mutant Metastatic Colorectal Cancer

Sponsor
Sun Yat-sen University
Study ID
NCT04790448
Phase
PHASE1/PHASE2
Status
Completed

Conditions

  • Colorectal Cancer Metastatic

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Cetuximab — DRUG
    Route of administration: Intravenous
  • Irinotecan — DRUG
    Route of administration: Intravenous
  • Vemurafenib — DRUG
    Route of administration: Oral

Study Details

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.

Key Dates

Start date
Jul 27, 2020
Status verified
Feb 2023
Primary completion
Dec 31, 2021
Completion
Dec 31, 2021

Study Design

Enrollment
37 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: VIC regimen
    Patients will receive VIC regimen every 2 weeks: Cetuximab 500mg/m2 IV on Day 1; Irinotecan 180mg/m2 IV on Day 1 (If patient carries UGT\*28 7/7 or UGT\*6 A/A or UGT\*28 6/7 and UGT\*6 A/G variants, use Irinotecan IV 150mg/m2 instead); Vemurafenib PO BID on Days 1 to 14 (Dosage: 480mg; 720mg; 960mg, determined by the maximum tolerated dose (MTD) in Phase Ia trial).

Primary Outcome Measure

Overall response rate from the date of first drug administration until the date of first documented progression or date of death, whichever came first. [ Time Frame: up to 17 months ]

Related Studies