Metastatic Cervical Cancer, Metastatic Colorectal Cancer, Non Squamous Non Small Cell Lung Cancer
Conditions
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.
Interventions
DRUGBevacizumab Biosimilar MB02
5 mg/kg to 15 mg/kg in combination with chemotherapy.
Sponsors
Servicios Especializados en Ensayos Clínicos, S.C.
Laboratorios Liomont
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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) |
Countries
Mexico
Outcome results
None listed