Safety of Effivia®, a Bevacizumab Biosimilar

Last updated: October 8, 2024
Sponsor: Laboratorios Liomont
Overall Status: Completed

Phase

N/A

Condition

Cervical Cancer

Metastatic Cancer

Uterine Disorders

Treatment

Bevacizumab Biosimilar MB02

Clinical Study ID

NCT06313268
LT-02-20
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Male and female patients, 18 years and older.

  • Patients with metastatic colorectal cancer,unresectable, locally advanced, recurrentor metastatic non-squamous non-small cell lung cancer, metastatic renal cellcarcinoma, persistent, recurrent, or metastatic cervical cancer, or epithelialovarian, fallopian tube, or primary peritoneal cancer naive to bevacizumab therapy (Effivia®).

  • Provide written informed consent.

Exclusion

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 productshypersensitivity.

  • Other safety concerns or bevacizumab contraindications.

Study Design

Total Participants: 83
Treatment Group(s): 1
Primary Treatment: Bevacizumab Biosimilar MB02
Phase:
Study Start date:
August 11, 2022
Estimated Completion Date:
September 02, 2024

Connect with a study center

  • UMAE Hospital de Especialidades No. 1

    León, Guanajuato 37320
    Mexico

    Site Not Available

  • Hospital de Gineco-Obstetricia No. 3

    Azcapotzalco, Mexico City 02990
    Mexico

    Site Not Available

  • Hospital de Oncología, UMAE Centro Médico Nacional Siglo XXI

    Cuauhtémoc, Mexico City 06720
    Mexico

    Site Not Available

  • Instituto Nacional de Cancerología

    Tlalpan, Mexico City 14080
    Mexico

    Site Not Available

  • Hospital de Oncología IMSS Puebla

    Puebla, 07200
    Mexico

    Site Not Available

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