OPEN LABEL RANDOMIZED BIOEQUIVALENCE STUDY TO EVALUATE THEPHARMACOKINETIC (PK) AND SAFETY PROFILE OF BEVACIZUMABBIOSIMILAR (BEVZ92) IN COMBINATION WITH FOLFOX ORFOLFIRI VERSUS BEVACIZUMAB (AVASTIN) IN COMBINATIONWITH FOLFOX OR FOLFIRI AS FIRST-LINE TREATMENT IN PATIENTSWITH METASTATIC COLORECTAL CA

Interventions: BEVZ92 (5 mg/kg) will be administered initially as a 90-minute
infusion. If well tolerated, the next infusion will be given over a 60-
minute period. Thereafter, the drug will be given as a 30-minute IV
infusion.
Study Design: This is a multicenter, open label, randomized bioequivalence study of
BEVZ92 (bevacizumab biosimilar) and Avastin with 2 parallel arms
to compare the PK profile of BEVZ92 and Avastin in combination
with FOLFOX (any) or FOLFIRI chemotherapy.
FOLFOX (any) or FOLFIRI will be chosen as per investigator criteria
based on the hospital standard of care.
A cut off will be made after the cycle 2 achieving for the first 20
patients (10 per arm) for a Safety Data Review by an Independent Data
Safety Monitoring Review Board (DSMB) in order to ensure the safety
of the subjects participant in the study and to ensure the validity of the
data. Nevertheless, this DSMB will review safety data on each two
months as regular basis throughout the study.
Recruitment will continue until reaching the target of 100 patients (88
evaluable).
A parallel group design is proposed because a cross-over design is not<