A Post-marketing Surveillance to Assess the Safety and Effectiveness of Zirabev in Domestic Patients With Various Cancer

Sponsor

Pfizer (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT04889495

Collaborator

(none)

400

Enrollment

26.5

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

This is a prospective, single-arm, open-label, non-interventional, multicenter, post-marketing surveillance to assess the safety and effectiveness of Zirabev(Bevacizumab biosimilar) in domestic patients with non-small cell lung cancer, metastatic colorectal cancer, metastatic breast cancer, advanced or metastatic kidney cancer, cervical cancer, epithelial ovarian cancer, fallopian tube cancer, primary peritoneal cancer or glioblastoma multiforme.

Condition or Disease	Intervention/Treatment	Phase
Non-small Cell Lung Cancer Metastatic Colorectal Cancer Metastatic Breast Cancer Metastatic Kidney Cancer Cervical Cancer Epithelial Ovarian Cancer Fallopian Tube Cancer Primary Peritoneal Cancer	Drug: Zirabev

Study Design

Study Type:

Observational

Anticipated Enrollment :

400 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

Official Title:

A Prospective, Single-arm, Open-label, Non-interventional, Multicenter, Post-marketing Surveillance to Assess the Safety and Effectiveness of Zirabev in Domestic Patients With Non-small Cell Lung Cancer, Metastatic Colorectal Cancer, Metastatic Breast Cancer, Advanced or Metastatic Kidney Cancer, Cervical Cancer, Epithelial Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Cancer or Glioblastoma Multiforme.

Anticipated Study Start Date :

May 31, 2023

Anticipated Primary Completion Date :

Aug 1, 2024

Anticipated Study Completion Date :

Aug 16, 2025

Arms and Interventions

Arm	Intervention/Treatment
Participants receiving Zirabev Participants receiving Zirabev	Drug: Zirabev Bevacizumab biosimilar

Arm

Intervention/Treatment

Participants receiving Zirabev

Drug: Zirabev

Bevacizumab biosimilar

Outcome Measures

Primary Outcome Measures

Safety profile [baseline up to approximately 4 years]
The following items that occurred from the baseline: Adverse Events (AEs) Serious Adverse Events (SAEs) Expected Adverse Events (Expected AEs) Unexpected Adverse Events (Unexpected AEs) Adverse Drug Reactions (ADRs) Serious Adverse Drug Reactions (SADRs) Expected Adverse Drug Reactions (Expected ADR) Unexpected Adverse Drug Reactions (Unexpected ADR)

Secondary Outcome Measures

Efficacy profile [baseline up to approximately 4 years]
OR CR SD PD Non-small cell lung cancer, metastatic colorectal cancer, metastatic breast cancer, advanced or metastatic kidney cancer, cervical cancer, epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer • Four objective response categories: complete response (CR), partial response (PR), stable disease (SD), progressive disease (PD) (RECIST 1.1) Glioblastoma multiforme patients • Four objective response categories: complete response (CR), partial response (PR), stable disease (SD), progressive disease (PD) (RANO-HGG)

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion criteria

Patients must meet all of the following inclusion criteria to be eligible for inclusion in the study:

Adults over 19 years old
Patients with non-small cell lung cancer, metastatic colorectal cancer, metastatic breast cancer, advanced or metastatic kidney cancer, cervical cancer, epithelial ovarian cancer, fallopian tube cancer, primary peritoneal cancer or glioblastoma multiforme.
Patients eligible for Zirabev dosage based on local product document, local treatment guidelines and clinical judgment of the medical team.
Evidence of a signed and dated informed consent document indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study.

Exclusion criteria

Patients meeting any of the following criteria will not be included in the study:

Any patients (or a legally acceptable representative) who does not agree that Pfizer and companies working with Pfizer use his/her information.
Patients for whom Zirabev is contraindicated according to the local product document.