RecruitingNCT06808685

Real World Multicenter National Study to Evaluate the Effectiveness and Safety of Biosimilar Bevacizumab Elovie

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


Sponsor

Libbs Farmacêutica LTDA

Enrollment

133 participants

Start Date

Jun 1, 2025

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is tracking how well a biosimilar version of bevacizumab (brand name Elovie) works for people with advanced colorectal cancer that has spread. Biosimilars are medications that work essentially the same as an already-approved drug. This is a real-world observational study — researchers are collecting data from patients already receiving this treatment. **You may be eligible if...** - You are 18 years or older - You have been diagnosed with stage IV (metastatic) colorectal cancer that cannot be surgically removed - You are currently receiving Elovie as your first-line treatment, or you recently switched to Elovie from another bevacizumab and have completed at least 1 treatment cycle - You are able to give informed consent **You may NOT be eligible if...** - You have been treated with Elovie for more than 12 cycles already - You previously received another bevacizumab for more than 2 cycles before switching to Elovie - You have another active cancer in addition to colorectal cancer - You used bevacizumab in a way not described in the official Elovie prescribing information Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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

View Full Details on ClinicalTrials.gov

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NCT06808685


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