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

Pfizer

Overview

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.

Study Type

OBSERVATIONAL

Conditions

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

Interventions

ZirabevDRUG

Bevacizumab biosimilar

Eligibility

Sex: ALLMin age: 19 Years

Medical Language ↔ Plain English

\- Inclusion criteria Patients must meet all of the following inclusion criteria to be eligible for inclusion in the study: 1. Adults over 19 years old 2. 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. 3. Patients eligible for Zirabev dosage based on local product document, local treatment guidelines and clinical judgment of the medical team. 4. 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: 1. Any patients (or a legally acceptable representative) who does not agree that Pfizer and companies working with Pfizer use his/her information. 2. Patients for whom Zirabev is contraindicated according to the local product document.

Outcomes

Primary Outcomes

Safety profile

The following items that occurred from the baseline: 1. Adverse Events (AEs) 2. Serious Adverse Events (SAEs) 3. Expected Adverse Events (Expected AEs) 4. Unexpected Adverse Events (Unexpected AEs) 5. Adverse Drug Reactions (ADRs) 6. Serious Adverse Drug Reactions (SADRs) 7. Expected Adverse Drug Reactions (Expected ADR) 8. Unexpected Adverse Drug Reactions (Unexpected ADR)

Time frame: baseline up to approximately 4 years

Secondary Outcomes

Efficacy profile

OR CR SD PD 1. 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) 2. Glioblastoma multiforme patients • Four objective response categories: complete response (CR), partial response (PR), stable disease (SD), progressive disease (PD) (RANO-HGG)

Time frame: baseline up to approximately 4 years

Data from ClinicalTrials.gov

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