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

Sponsor
Dominik Paul Modest
Study ID
NCT05007132
Phase
PHASE2
Status
Recruiting
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Conditions

  • Metastatic Colorectal Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Panitumumab 20 milligram/ML — BIOLOGICAL
    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.
  • Bevacizumab — BIOLOGICAL
    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.
  • Trifluridine/Tipiracil Hydrochloride — DRUG
    Participants receive Trifluridine/tipiracil at 35 mg/m² BSA, twice daily, orally on days 1-5 and 8-12

Study Details

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.

Key Dates

First listed
Aug 16, 2021
Start date
Dec 17, 2021
Status verified
Feb 2024
Primary completion
Dec 31, 2029
Completion
Dec 31, 2032

Study Design

Enrollment
153 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm A
    Trifluridine/tipiracil, 35 mg/m² body surface area (BSA), twice daily, orally on days 1-5 and 8-12 Panitumumab at 6 mg/kg bodyweight, intravenous infusion on days 1 and 15
  • Active Comparator: Arm B
    Trifluridine/tipiracil, 35 mg/m² body surface area, twice daily, orally on days 1-5 and 8-12 Bevacizumab at 5 mg/kg bodyweight, intravenous infusion on days 1 and 15

Primary Outcome Measure

Objective response rate [ Time Frame: 36 months ]

Central Contacts

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