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Brief Title: Bioequivalence Study Bevacizumab Biosimilar (BEVZ92) Versus Bevacizumab (AVASTIN®) in First-line Treatment mCRC Patients
Official Title: Open Label Randomized Bioequivalence Study to Evaluate the Pharmacokinetic and Safety Profile of Bevacizumab Biosimilar (BEVZ92) vs Bevacizumab (AVASTIN®), Both With FOLFOX or FOLFIRI, in First-line Treatment for mCRC Patients
Study ID: NCT02069704
Brief 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.
Detailed Description: Planned enrolment duration: 12 months. Pre-treatment period (included in enrolment period): 1 month. Treatment period: Patients will continue treatment until disease progression or unacceptable toxicity, or withdrawal of consent.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Hospital de Gastroenterologia "Dr. Carlos Bonorino Udaondo", Buenos Aires, , Argentina
Instituto Oncológico de Rosario, Rosario, , Argentina
Fundaçáo Pio XII - Hospital do Cancer de Barretos, Barretos, , Brazil
Hospital Caridade, Ijui, , Brazil
Hospital Sao Lucas da Pucrs, Porto Alegre, , Brazil
Centro de Pesquisa do Instituto Brasileiro de Controle do Câncer - IBCC, São Paulo, , Brazil
Hosp. A.C Camargo, São Paulo, , Brazil
Instituto do Cancer del estado de S. Paulo (ICEPS ), São Paulo, , Brazil
M S Patel Cancer Centre- Shree Krishna Hospital, Karamsad, Gujarat, India
Sri Ramachandra Hospital, Chennai, , India
Tata Hospital, Mumbai, , India
Central India Canter Research Institute, Nagpur, , India
Curie Manavta Cancer Center, Nashik, , India
Regional Cancer Center & Medical College, Thiruvananthapuram, , India
Centro Oncológico Clara Campal, Madrid, , Spain
Dnipropetrovsk City Multiple-discipline Clinical Hospital №4, Dnipropetrovsk, , Ukraine
Kharkiv Regional Clinical Oncology Center, Kharkiv, , Ukraine
Danylo Halytskiy Lviv National Medical University, Lviv, , Ukraine