Safety of Effivia®, a Bevacizumab Biosimilar

Metastatic Colorectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06313268
• Other study ID #: LT-02-20
• Status: Recruiting
• Start date: April 21, 2022
• Est. completion date: June 30, 2024

Study information

• Verified date: March 2024
• Source: Laboratorios Liomont
• Contact: Livan Delgado-Roche, Ph.D.
• Phone: +525558141200
• Email: ldelgado[@]liomont.com.mx
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 95
• Est. completion date: June 30, 2024
• Est. primary completion date: February 20, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Colorectal Neoplasms
• Metastatic Cervical Cancer
• Metastatic Colorectal Cancer
• Non Squamous Non Small Cell Lung Cancer
• Uterine Cervical Neoplasms

Intervention

Drug:
• Bevacizumab Biosimilar MB02
5 mg/kg to 15 mg/kg in combination with chemotherapy.

Locations

Country	Name	City	State
Mexico	Hospital de Gineco-Obstetricia No. 3	Azcapotzalco	Mexico City
Mexico	Hospital de Oncología, UMAE Centro Médico Nacional Siglo XXI	Cuauhtémoc	Mexico City
Mexico	UMAE Hospital de Especialidades No. 1	León	Guanajuato
Mexico	Hospital de Oncología IMSS Puebla	Puebla
Mexico	Instituto Nacional de Cancerología	Tlalpan	Mexico City

Sponsors (2)

Lead Sponsor	Collaborator
Laboratorios Liomont	Servicios Especializados en Ensayos Clínicos, S.C.

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse events	Frequency and characteristics of adverse events (serious and non serious)	From date of patient inclusion to the end of Cycle 1 (each cycle is up to six months)