Safety of Effivia®, a Bevacizumab Biosimilar

NCT06313268 | Completed FDA Drug

• 1 other identifier: LT-02-20
• Study Type: observational
• Target: 83
• Locations: 1 country
• Sites: 5

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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)

Study Arms (1)

Test group

Bevacizumab (Effivia®)

Drug: Bevacizumab Biosimilar MB02

Interventions

Bevacizumab Biosimilar MB02 DRUG

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

Also known as: Effivia®

Test group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Naive to bevacizumab, adult patients with metastatic colorectal cancer, metastatic cervical cancer, non-squamous non-small cell lung cancer, and other cancer types where Bevacizumab therapy is indicated.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Laboratorios Liomont: lead
• Servicios Especializados en Ensayos Clínicos, S.C.: collaborator

Study Sites (5)

UMAE Hospital de Especialidades No. 1

León, Guanajuato, 37320, Mexico

Location

Hospital de Gineco-Obstetricia No. 3

Azcapotzalco, Mexico City, 02990, Mexico

Location

Hospital de Oncología, UMAE Centro Médico Nacional Siglo XXI

Cuauhtémoc, Mexico City, 06720, Mexico

Location

Instituto Nacional de Cancerología

Tlalpan, Mexico City, 14080, Mexico

Location

Hospital de Oncología IMSS Puebla

Puebla City, 07200, Mexico

Location

MeSH Terms

Conditions

Colorectal Neoplasms; Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 21, 2024
• First Posted: March 15, 2024
• Study Start: August 11, 2022
• Primary Completion: April 17, 2024
• Study Completion: September 2, 2024
• Last Updated: October 10, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

ME (5)