Safety of Effivia®, a Bevacizumab Biosimilar

March 14, 2024 updated by: Laboratorios Liomont

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

95

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Mexico
      • Puebla, Mexico, 07200
        • Recruiting
        • Hospital de Oncología IMSS Puebla
        • Contact:
          • José Gustavo Núñez Cerrillo, M.D.
          • Phone Number: +522222230690
        • Principal Investigator:
          • José Gustavo Núñez Cerrillo, M.D.
    • Guanajuato
      • León, Guanajuato, Mexico, 37320
        • Recruiting
        • UMAE Hospital de Especialidades No. 1
        • Contact:
          • David Suárez García, M.D.
          • Phone Number: +524777174000
        • Principal Investigator:
          • David Suárez García, M.D.
    • Mexico City
      • Azcapotzalco, Mexico City, Mexico, 02990
        • Recruiting
        • Hospital de Gineco-Obstetricia No. 3
        • Contact:
          • Eliseo Neftalí de la Cruz Escobar, M.D.
          • Phone Number: +525557821088
        • Principal Investigator:
          • Eliseo Neftalí de la Cruz Escobar, M.D.
      • Cuauhtémoc, Mexico City, Mexico, 06720
        • Recruiting
        • Hospital de Oncología, UMAE Centro Médico Nacional Siglo XXI
        • Contact:
          • Alberto Alfonso Pimentel Rentería, M.D.
          • Phone Number: +525556276900
        • Principal Investigator:
          • Alberto Alfonso Pimentel Rentería, M.D.
      • Tlalpan, Mexico City, Mexico, 14080
        • Recruiting
        • Instituto Nacional de Cancerologia
        • Contact:
          • David Francisco Cantú de León, M.D., Ph.D.
          • Phone Number: +525556280400
        • Principal Investigator:
          • David Francisco Cantú de León, M.D., Ph.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Test group
Bevacizumab (Effivia®)
Drug: Bevacizumab Biosimilar MB02
5 mg/kg to 15 mg/kg in combination with chemotherapy.
Other Names:
  • Effivia®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse events
Time Frame: 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)
From date of patient inclusion to the end of Cycle 1 (each cycle is up to six months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Laboratorios Liomont

Collaborators

Servicios Especializados en Ensayos Clínicos, S.C.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 21, 2022

Primary Completion (Actual)

February 20, 2024

Study Completion (Estimated)

June 30, 2024

Study Registration Dates

First Submitted

February 21, 2024

First Submitted That Met QC Criteria

March 8, 2024

First Posted (Actual)

March 15, 2024

Study Record Updates

Last Update Posted (Actual)

March 15, 2024

Last Update Submitted That Met QC Criteria

March 14, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LT-02-20

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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