Bioequivalence Study Bevacizumab Biosimilar (BEVZ92) Versus Bevacizumab (AVASTIN®) in First-line Treatment mCRC Patients
Status:
Completed
Trial end date:
2017-06-01
Target enrollment:
Participant gender:
Summary
This is a multicenter, open label, randomized bioequivalence study of BEVZ92 (bevacizumab
biosimilar) and Avastin® with 2 parallel arms to compare the pharmacokinetic (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.
Phase:
Phase 1
Details
Lead Sponsor:
mAbxience S.A
Collaborators:
Laboratorio Elea Phoenix S.A. Laboratorio Elea S.A.C.I.F. y A. Libbs Farmacêutica LTDA