NCT05007132

Trifluridine/ Tipiracil Plus Panitumumab Versus Trifluridine/ Tipiracil Plus Bevacizumab as First-line Treatment of Metastatic Colorectal Cancer

Prospective, Randomized, Open, Multicenter Phase II Trial to Investigate the Efficacy of Trifluridine/Tipiracil Plus Panitumumab Versus Trifluridine/Tipiracil Plus Bevacizumab as First-line Treatment of Metastatic Colorectal Cancer: FIRE-8; AIO-KRK/YMO-0519

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 153 (estimated)
• Sponsor: Dominik Paul Modest · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

FIRE-8 is a prospective, randomized, open label, multicenter phase II clinical trial. To evaluate the effecacy of trifluridine / tipiracil and panitumumab (Arm A) compared to trifluridine / tipiracil and bevacizumab (Arm B), participants will be randomly assigned to either Arm A or Arm B for the treatment of metastatic colorectal cancer. The primary objectives of this study is to compare the effecacy of treatment with trifluridine / tipiracil plus panitumumab versus trifluridine / tipiracil plus bevacizumab.

Conditions

• Metastatic Colorectal Cancer

Interventions

Type	Name	Description
BIOLOGICAL	Panitumumab 20 milligram/ML	Participants receive Panitumumab at 6mg/ kg intravenously (IV) on Day 1 and 15 of each 28-day cycle. Treatment is continued until occurrence of progression according to RECIST 1.1 criteria as evaluated by the investigator or unacceptable toxicity.
BIOLOGICAL	Bevacizumab	Participants receive bevacizumab at 5 mg/ kg intravenously (IV) on Day 1 and 15 of each 28-day cycle. Treatment is continued until occurrence of progression according to RECIST 1.1 criteria as evaluated by the investigator or unacceptable toxicity.
DRUG	Trifluridine/Tipiracil Hydrochloride	Participants receive Trifluridine/tipiracil at 35 mg/m² BSA, twice daily, orally on days 1-5 and 8-12

Timeline

• Start date: 2021-12-17
• Primary completion: 2029-12-01
• Completion: 2032-12-01
• First posted: 2021-08-16
• Last updated: 2024-02-15

Locations

1 site across 1 country: Germany