Real World Multicenter National Study to Evaluate the Effectiveness and Safety of Biosimilar Bevacizumab Elovie
Recruiting · NCT06808685 · Observational (researchers observe without assigning treatment)
View the official record on ClinicalTrials.gov →What this trial is about
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.
Who can take part
Inclusion criteria
- Participants of both sexes aged 18 years or older at the start of treatment with bevacizumab;
- Participants diagnosed with metastatic colorectal cancer, clinical stage IV, unresectable, by clinical definition in medical records, according to the investigator's assessment at the initial consultation and before any type of palliative treatment;
- Participants who are undergoing first-line treatment with Elovie and who have completed at least 1 cycle of treatment or participants who have started first-line treatment with another bevacizumab (reference or another biosimilar other than Elovie) but who have currently switched to Elovie and completed at least 1 cycle of treatment with it, and whose data is available at the institution participating in the study;
- Participants with the capacity to understand and consent to their participation in the study through the Free and Informed Consent Form
Exclusion criteria
- Participants who use or have used bevacizumab in a manner different from that described in the current version of the Elovie® package insert;
- Participants who have been treated with Elovie for a period longer than 12 treatment cycles;
- Participants who have started first-line treatment with another bevacizumab (reference or another biosimilar other than Elovie) and have completed more than 2 treatment cycles with it;
- Participants with a concomitant diagnosis of another active malignant neoplasm other than metastatic colorectal cancer.
Where it is running
14 locations listed.
- 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