MedTrace Logo

A Study of Dabrafenib Plus Cetuximab/Panitumumab With FOLFOX in the First Line of Therapy in People With Metastatic Colorectal Cancer

NCT06978400 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2025-05-18

No results posted yet for this study

Summary

The purpose of this study is to evaluate the efficacy and toxicity of FOLFOX regimen with dabrafenib and cetuximab/panitumumab in the first line of therapy for the potential treatment of colorectal cancer that: has a metastatic, inoperable; has a mutation in the BRAF gene and MSS.

Participants in this study will receive one of the following study treatments:

These participants will receive FOLFOX regimen with dabrafenib and cetuximab or panitumumab in the first line of therapy This study is currently enrolling participants who will receive either FOLFOX regimen with dabrafenib and cetuximab or panitumumab in the first line of therapy.

The study team will monitor how each participant responds to the study treatment for up to about 3 years.

Conditions

  • Neoplasms

Interventions

DRUG

mFOLFOX6 + dabrafenib and cetuximab or panitumumab in the first line of therapy

Dabrafenib 150 mg twice orally daily Cetuximab 500 mg/m2 (120-minute IV infusion) every two weeks or Panitumumab 6 mg/kg (60-minute IV infusion) every two weeks Oxaliplatin 85 mg/m2 (120-minute IV infusion) every two weeks, Сalcium folinate 400 mg/m2 (120-minute IV infusion) every two weeks 5-FU 400 mg/m2 IV bolus, then 5-FU 2400 mg/m2 continuous IV infusion over 46-48 hours every two weeks.

Sponsors & Collaborators

  • City Clinical Oncology Hospital No 1

    collaborator OTHER_GOV

  • Moscow City Oncology Hospital No. 62

    collaborator OTHER_GOV

  • The Loginov MCSC MHD

    collaborator UNKNOWN

  • MMCC Kommunarka MHD

    collaborator UNKNOWN

  • Blokhin's Russian Cancer Research Center

    lead OTHER

Principal Investigators

  • Mikhail Fedyanin MD · Blokhin's Russian Cancer Research Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-03-01
Primary Completion
2027-11-10
Completion
2028-07-10

Countries

  • Russia

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06978400 on ClinicalTrials.gov