Safety of Effivia®, a Bevacizumab Biosimilar

Laboratorios Liomont83 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Metastatic Colorectal Cancer Metastatic Cervical Cancer Non Squamous Non Small Cell Lung Cancer

Interventions

Bevacizumab Biosimilar MB02DRUG

5 mg/kg to 15 mg/kg in combination with chemotherapy.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (5)

UMAE Hospital de Especialidades No. 1

León, Guanajuato, Mexico

Hospital de Gineco-Obstetricia No. 3

Azcapotzalco, Mexico City, Mexico

Hospital de Oncología, UMAE Centro Médico Nacional Siglo XXI

Cuauhtémoc, Mexico City, Mexico

Instituto Nacional de Cancerología

Tlalpan, Mexico City, Mexico

Outcomes

Primary Outcomes

Adverse events

Frequency and characteristics of adverse events (serious and non serious)

Time frame: From date of patient inclusion to the end of Cycle 1 (each cycle is up to six months)

Data from ClinicalTrials.gov

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