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5FU/LV + Regorafenib in 3rd-Line Metastatic Colorectal Cancer
NCT06887218Phase 2
Key facts
- Status
- Recruiting
- Start
- May 2025
- Primary completion
- Dec 2028
- Countries
- 1
- Sponsor
- Houston Methodist Research Institute
- Modality
- Small Molecules
- Drugs
- regorafenib
- Conditions
- colorectal cancer (CRC)
01
Overview
Phase 2, randomised, open-label trial of regorafenib in colorectal cancer (CRC) (2 arms), sponsored by Houston Methodist Research Institute. Primary endpoint: Efficacy at 18 months. Started May 2025; status: recruiting.
02
Design
2 arms- Study design
- RandomizedOpen-label
5FU/LV + Regorafenib
5FU/LV (2-week cycles) + Regorafenib (80-120 mg/day, 3 weeks on / 1 week off)
FTD-TPI + Bevacizumab
FTD-TPI (days 1-5, 8-12 every 28 days) + Bevacizumab (days 1 and 15)
03
Who it enrols
Adults with metastatic colorectal cancer who failed second-line therapy, have measurable disease, ECOG 0-2, adequate organ function, and no severe cardiac, bleeding, or infectious comorbidities.
04
Endpoints
Primary
Efficacy
Secondary
Progression-free survival rate
Duration of response
Safety and tolerability
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