A clinical trial intended to compare safety and efficacy of two formulations in patients with metastatic Colorectal Cancer (mCRC).

Intervention1: Bevacizumab
Biosimilar: Bevacizumab (5 mg/kg) will be administered initially as a 90-minute infusion
Control Intervention1: AVASTIN (Roche/Genentech: Avastin (5 mg/kg) will be administered initially as a 90-minute infusion
Primary outcome(s): To compare the PK profile of Bevacizumab and AvastinÂ, both administered in combination with FOLFOX (any) or FOLFIRI.Timepoint: Cycle 1:
0 h(pre-infusion), end of infusion; 1 h, 2 h, 6 h, 24 h (D2), 48h (D3),72h (D4), 120h (D6), 168 h (D8) & 240 h (D11) after end of infusion.Cycle 2- Cycle 5: 0 h(pre-infusion), end of infusion on D1 of Cycles 2 and 5
Cycle 7:
0h, end of infusion; 1 h, 2 h, 6 h after end of infusion on
D1 and thereafter one sample at 24 h (D2), 48 h (D3), 72 h (D4), 120 h
(D6), 168 h (D8), 240 h (D11) after end of infusion
(Cycle 7)and 336 h(D15, just before the start of the bevacizumab of Cycle 8
Study Design: Randomized, Parallel Group Trial
Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Centralized Blinding and masking:Open Label