Actively Recruiting
Real World Multicenter National Study to Evaluate the Effectiveness and Safety of Biosimilar Bevacizumab Elovie
Led by Libbs Farmacêutica LTDA · Updated on 2025-12-16
133
Participants Needed
1
Research Sites
130 weeks
Total Duration
On this page
AI-Summary
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.
CONDITIONS
Official Title
Real World Multicenter National Study to Evaluate the Effectiveness and Safety of Biosimilar Bevacizumab Elovie
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants of both sexes aged 18 years or older at the start of treatment with bevacizumab
- Diagnosed with unresectable metastatic colorectal cancer, clinical stage IV, confirmed by medical records
- Receiving first-line treatment with Elovie and completed at least 1 treatment cycle, or switched to Elovie after starting another bevacizumab and completed at least 1 cycle with Elovie
- Able to understand and provide informed consent through the Free and Informed Consent Form
You will not qualify if you...
- Using bevacizumab differently than described in the current Elovie package insert
- Treated with Elovie for more than 12 treatment cycles
- Started first-line treatment with another bevacizumab and completed more than 2 treatment cycles with it
- Having another active malignant cancer besides metastatic colorectal cancer
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Instituto Dor de Pesquisa E Ensino
São Paulo, São Paulo, Brazil
Actively Recruiting
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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