Safety of Effivia®, a Bevacizumab Biosimilar

Liomont

Status

Completed

Conditions

Metastatic Cervical Cancer

Metastatic Colorectal Cancer

Non Squamous Non Small Cell Lung Cancer

Treatments

Drug: Bevacizumab Biosimilar MB02

Study type

Observational

Funder types

Industry

Other

Identifiers

NCT06313268

LT-02-20

Details and patient eligibility

About

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.

Enrollment

83 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.