Status:
ACTIVE_NOT_RECRUITING
A Study of Irinotecan With Dabrafenib Plus Trametinib and Anti-EGFR in the Second 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 irinotecan with dabrafenib, cetuximab/panitumumab in the second line of treatment for the potential treatment of colorectal cancer...
Detailed Description
The purpose of the study is to evaluate the efficacy and toxicity of irinotecan in combination with dabrafenib + trametinib and cetuximab or panitumumab in second-line treatment of patients with metas...
Eligibility Criteria
Inclusion
- Histologically confirmed metastatic inoperable colorectal adenocarcinoma
- The tumour has a BRAF mutation
- 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).
- Absence of grade 2 or higher toxicity from previous line of treatment.
- It is possible to include patients with MSI or dMMR if they have received first-line immune checkpoint therapy.
- ECOG PS 0-1
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 :
June 10 2028
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT06967155
Start Date
March 1 2025
End Date
June 10 2028
Last Update
October 2 2025
Active Locations (1)
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1
Blokhin's Russian Cancer Research Center
Moscow, Moscow, Russia, 115478