NCT06808685 Real World Multicenter National Study to Evaluate the Effectiveness and Safety of Biosimilar Bevacizumab Elovie
| NCT ID | NCT06808685 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Libbs Farmacêutica LTDA |
| Condition | Metastatic Colorectal Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 133 participants |
| Start Date | 2025-06-01 |
| Primary Completion | 2027-11-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 133 participants in total. It began in 2025-06-01 with a primary completion date of 2027-11-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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.
Frequently Asked Questions
Who can join the NCT06808685 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Metastatic Colorectal Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06808685 currently recruiting?
Yes, NCT06808685 is actively recruiting participants. Visit ClinicalTrials.gov or contact Libbs Farmacêutica LTDA to inquire about joining.
Where is the NCT06808685 trial being conducted?
This trial is being conducted at Vitória, Brazil, Curitiba, Brazil, Londrina, Brazil, Recife, Brazil and 10 additional locations.
Who is sponsoring the NCT06808685 clinical trial?
NCT06808685 is sponsored by Libbs Farmacêutica LTDA. The trial plans to enroll 133 participants.
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