Clinical

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


ABSTRACT: 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

DISEASE(S): Patients With Metastatic Colorectal Cancer (mcrc)

PROVIDER: 2575730 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

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