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

Sponsor
Libbs Farmacêutica LTDA
Study ID
NCT06808685
Status
Recruiting
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Conditions

  • Metastatic Colorectal Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Study Details

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.

Key Dates

First listed
Feb 5, 2025
Start date
Jun 1, 2025
Status verified
Dec 2025
Primary completion
Nov 30, 2027
Completion
Nov 30, 2027

Study Design

Enrollment
133 participants (estimated)

Primary Outcome Measure

Evaluate the effectiveness of treatment with bevacizumab [ Time Frame: 24 months ]

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