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Table 2 Investigational medicinal products used in the FIRE-8 trial during first-line treatment

From: Study protocol of the FIRE-8 (AIO-KRK/YMO-0519) trial: a prospective, randomized, open-label, multicenter phase II trial investigating the efficacy of trifluridine/tipiracil plus panitumumab versus trifluridine/tipiracil plus bevacizumab as first-line treatment in patients with metastatic colorectal cancer

Study Arm

IMP

Dose

Dosing schedule (day of 28-day cycle)

Administration

A and B

Trifluridine/ tipiracil

35 mg/m2/dose BID

1–5 and 8–12

orally

A

Panitumumab

6 mg/kg body weight

1 and 15

i.v. over 30–60 mina

B

Bevacizumab

5 mg/kg body weight

1 and 15

i.v. over 60 ± 15 minb

  1. IMP Investigational medicinal product, i.v. intravenous infusion, BID twice daily
  2. afirst administration over 60 min; bfirst administration over 90 ± 15 min