Cervical Cancer, Epithelial Ovarian Cancer, Fallopian Tube Cancer, Metastatic Breast Cancer, Metastatic Colorectal Cancer, Metastatic Kidney Cancer, Non-small Cell Lung Cancer, Primary Peritoneal Cancer
Conditions
Keywords
Zirabev
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.
Interventions
DRUGZirabev
Bevacizumab biosimilar
Sponsors
Pfizer
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
\- 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety profile | baseline up to approximately 4 years | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy profile | baseline up to approximately 4 years | 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) |
Outcome results
None listed