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Real World Multicenter National Study to Evaluate the Effectiveness and Safety of Biosimilar Bevacizumab Elovie
Sponsor: Libbs Farmacêutica LTDA
Summary
Colorectal cancer is one of the most common tumors and is the second most prevalent cause of cancer death, leading to almost 1 million deaths per year.Elovie is a bevacizumab biosimilar medicine marketed by Libbs Farmacêutica, which had its registration approved by ANVISA in May 2022.At the time of registration a robust evidence package was presented that included, for example, pharmacokinetic bioequivalence studies in patients with metastatic RCC (mRCC) and a phase III study in participants with non-small cell lung cancer .Conducting a real-world study to evaluate the effectiveness and safety of bevacizumab biosimilar Elovie in patients with mCRC is crucial to provide relevant information on how this therapy behaves in real-world clinical conditions in brazilian population.
Official title: Real-world Multicenter National Study to Evaluate the Effectiveness and Safety of Biosimilar Bevacizumab Elovie in First-line Treatment in Participants With Unresectable Metastatic Colorectal Cancer
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
133
Start Date
2025-06-01
Completion Date
2027-11-30
Last Updated
2026-06-01
Healthy Volunteers
No
Conditions
Locations (14)
Unimed Vitória
Vitória, Espírito Santo, Brazil
Centro de Oncologia do Paraná (COP)
Curitiba, Paraná, Brazil
Centro de Pesquisa Unimed Londrina
Londrina, Paraná, Brazil
Instituto Dor de Pesquisa E Ensino
Recife, Pernambuco, Brazil
Centro de Ensino e Pesquisa - Hospital São Marcos
Teresina, Piauí, Brazil
Centro de Pesquisa Unimed Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil
Associação Hospitalar Moinhos de Vento
Porto Alegre, Rio Grande do Sul, Brazil
Unidade de Ensino e Pesquisa UEP-COHM
Santo Ângelo, Rio Grande do Sul, Brazil
OncoJaraguá
Jaraguá do Sul, Santa Catarina, Brazil
Hospital Vera Cruz
Campinas, São Paulo, Brazil
CEON+ Pesquisas
São Caetano do Sul, São Paulo, Brazil
COE Ensino e Pesquisa
São José dos Campos, São Paulo, Brazil
Centro Paulista de Oncologia
São Paulo, São Paulo, Brazil
Instituto Dor de Pesquisa E Ensino
São Paulo, São Paulo, Brazil