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

Study Overview
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Brief Summary
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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.

Official Title
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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.

Conditions
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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

Intervention / Treatment
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* Drug: Zirabev


Participation Criteria
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Eligibility Criteria
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- 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.

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Participants receiving Zirabev<br>Participants receiving Zirabev | Drug: Zirabev<br>* Bevacizumab biosimilar<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety profile | 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) | baseline up to approximately 4 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy profile | 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) | baseline up to approximately 4 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Zirabev