drugset / Trial / NCT06967155
A Study of Irinotecan With Dabrafenib Plus Trametinib and Anti-EGFR in the Second Line of Therapy in People With Metastatic Colorectal Cancer
Phase 2
Active not recruiting
23 enrolled
Blokhin's Russian Cancer Research Center
City Clinical Oncology Hospital No 1 · collabMoscow City Oncology Hospital No. 62 · collabMoscow Multidisciplinary Clinical Center "Kommunarka" · collabThe Loginov MCSC MHD · collab
NaSingle-groupOpen-labelTreatment
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.
Timeline
- Start
- 2025-03-01
- Primary completion
- 2027-11-10
- Completion
- 2028-06-10
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cetuximab | Monoclonal antibody | 500 mg/m2 | Intravenous |
| Subject | Dabrafenib | Small molecule | 150 mg | Oral |
| Subject | Irinotecan | Small molecule | 90 mg/m2 | Intravenous |
| Subject | Panitumumab | Monoclonal antibody | 6 mg/kg | Intravenous |
| Subject | Trametinib | Small molecule | 2 mg | Oral |
| Background | Leucovorin | Small molecule | — | — |
| Background | Oxaliplatin | Small molecule | — | — |
| Background | fluorouracil | Small molecule | — | — |