Safety of Effivia®, a Bevacizumab Biosimilar

Completed

• Conditions: Metastatic Colorectal Cancer; Metastatic Cervical Cancer; Non Squamous Non Small Cell Lung Cancer
• Interventions: Drug: Bevacizumab Biosimilar MB02

• Registration Number: NCT06313268
• Lead Sponsor: Laboratorios Liomont

Brief Summary

This is a post-marketing observational study aimed to evaluated the safety profile of Effivia®, a biosimilar of bevacizumab, in mexican patients with different types of cancer.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-08-11
• Study First Submitted: 2024-02-21
• Study First Submitted QC: 2024-03-08
• Study First Posted: 2024-03-15
• Primary Completion: 2024-04-17
• Study Completion: 2024-09-02
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-08
• Last Update Posted: 2024-10-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 83

Inclusion Criteria

• Male and female patients, 18 years and older.
• Patients with metastatic colorectal cancer,unresectable, locally advanced, recurrent or metastatic non-squamous non-small cell lung cancer, metastatic renal cell carcinoma, persistent, recurrent, or metastatic cervical cancer, or epithelial ovarian, fallopian tube, or primary peritoneal cancer naive to bevacizumab therapy (Effivia®).
• Provide written informed consent.

Exclusion Criteria

• History of recent surgery or wound healing complications.
• History of gastrointestinal perforations or fistula.
• History of renal injury and proteinuria.
• Recent surgical intervention.
• Pregnant or nursing women.
• History of bevacizumab, monoclonal antibodies, or CHO cells-derived products hypersensitivity.
• Other safety concerns or bevacizumab contraindications.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Test group	Bevacizumab Biosimilar MB02	Bevacizumab (Effivia®)

Primary Outcome Measures

Name	Time	Method
Adverse events	From date of patient inclusion to the end of Cycle 1 (each cycle is up to six months)	Frequency and characteristics of adverse events (serious and non serious)

Trial Locations

Locations (5)

Hospital de Oncología, UMAE Centro Médico Nacional Siglo XXI; 🇲🇽 Cuauhtémoc, Mexico City, Mexico

Instituto Nacional de Cancerología; 🇲🇽 Tlalpan, Mexico City, Mexico

Hospital de Oncología IMSS Puebla; 🇲🇽 Puebla, Mexico

UMAE Hospital de Especialidades No. 1; 🇲🇽 León, Guanajuato, Mexico

Hospital de Gineco-Obstetricia No. 3; 🇲🇽 Azcapotzalco, Mexico City, Mexico