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A Study of Irinotecan With Dabrafenib Plus Trametinib and Anti-EGFR in the Second Line of Therapy in People With Metastatic Colorectal Cancer

NCT06967155 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2025-10-02

No results posted yet for this study

Summary

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

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

These participants will receive in the second line is irinotecan, dabrafenib + trametinib, cetuximab or panitumumab.

This trial is currently enrolling participants who will receive either irinotecan and dabrafenib plus cetuximab or panitumumab in the second 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

• Drug: Dabrafenib • Drug: Trametinib • Drug: Cetuximab • Drug: Рanitumumab • Drug: Oxaliplatin • Drug: Irinotecan • Drug: Leucovorin • Drug: 5-FU

Irinotecan + Dabrafenib + Trametinib and Cetuximab or Panitumumab in the second line of therapy Dabrafenib 150 mg twice orally daily Trametinib 2 mg orally once daily Cetuximab 500 mg/m2 (120-minute IV infusion) every two weeks or Panitumumab 6 mg/kg (60-minute IV infusion) every two weeks Irinotecan 90 mg/m2 (90-minute IV infusion) weekly. Second-line treatment is administered until disease progression or intolerable toxicity. It may be possible to switch to a regimen of dabrafenib, trametinib, cetuximab or panitumumab if irinotecan is intolerable.

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
Yes

Timeline & Regulatory

Start
2025-03-01
Primary Completion
2027-11-10
Completion
2028-06-10

Countries

  • Russia

Study Locations

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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 NCT06967155 on ClinicalTrials.gov