Safety of Effivia®, a Bevacizumab Biosimilar

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.

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Key information

Conditions

Metastatic Colorectal Cancer Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Gastrointestinal Diseases Gastrointestinal Neoplasms Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Intestinal Diseases Intestinal Neoplasms Metastatic Cervical Cancer Neoplasms Neoplasms by Site Non Squamous Non Small Cell Lung Cancer Rectal Diseases Urogenital Diseases Urogenital Neoplasms Uterine Cervical Diseases Uterine Cervical Neoplasms Uterine Diseases Uterine Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

UMAE Hospital de Especialidades No. 1, León, Guanajuato, Mexico

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Bevacizumab Biosimilar MB02

Drug

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

Other names: Effivia®

Primary outcomes

Adverse events

Time frame: 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)

Sponsors and collaborators

Lead sponsor

Laboratorios Liomont

Industry

Collaborators

Servicios Especializados en Ensayos Clínicos, S.C.

Registry information

Official study title

Post-marketing Safety of Effivia®, a Bevacizumab Biosimilar: Phase IV, Observational, Multicenter Clinical Study in Mexican Population

Important dates

Study start: 2022
Primary completion: 2024
Study completion: 2024
First posted: Mar 15, 2024
Registry last updated: Oct 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Active, Not Recruiting