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Spots Global Cancer Trial Database for Bioequivalence Study Bevacizumab Biosimilar (BEVZ92) Versus Bevacizumab (AVASTIN®) in First-line Treatment mCRC Patients

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Trial Identification

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

Study Description

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.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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

Contact Details

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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