Status:
RECRUITING
A Study of Dabrafenib Plus Cetuximab/Panitumumab With FOLFOX in the First Line of Therapy in People With Metastatic Colorectal Cancer
Lead Sponsor:
Blokhin's Russian Cancer Research Center
Collaborating Sponsors:
City Clinical Oncology Hospital No 1
Moscow City Oncology Hospital No. 62
Conditions:
Neoplasms
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 ca...
Detailed Description
The purpose of the study is to evaluate the efficacy and toxicity of first-line FOLFOX with dabrafenib and cetuximab or panitumumab in patients with previously untreated metastatic inoperable colorect...
Eligibility Criteria
Inclusion
- Histologically confirmed colorectal adenocarcinoma that contains MSS and BRAF V600E mutation
- Metastatic inoperable colorectal cancer
- Adequate function of hematopoiesis and basic indicators of internal organs
- Has measurable or evaluable disease according to Response Evaluation Criteria In Solid Tumors (RECIST v1.1).
- Lacking antitumor systemic treatment for colorectal cancer.
- Patients with progression after adjuvant chemotherapy may be included if progression is recorded no earlier than 12 months after the last course of chemotherapy.
- The primary tumor is removed or asymptomatic.
- Absence of grade 2 or higher neuropathy.
- Absence of tumor MSI or dMMR.
- ECOG PS 0-2
Exclusion
- Participants having more than 2 lines of treatment (a progression of disease within 12 months of the completion of adjuvant and/or perioperative chemotherapy with oxaliplatin and fluoropyrimidines is acceptable).
- Presence of any other malignancy, except radically treated basal cell carcinoma, cervical cancer in situ, currently or within 5 years prior to enrolment.
- Pregnant and breastfeeding women.
- Male and female patients with preserved reproductive potential who refused to use adequate contraception throughout the study.
- HIV-infected patients.
- Patients with a life expectancy of less than 3 months.
- The presence of a disease or condition that, in the opinion of the investigator, prevents the patient from participating in the trial.
Key Trial Info
Start Date :
March 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 10 2028
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT06978400
Start Date
March 1 2025
End Date
July 10 2028
Last Update
May 18 2025
Active Locations (1)
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1
Blokhin's Russian Cancer Research Center
Moscow, Russia, 115193