Clinical trial

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.

Name
B7391012
Description
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.
Trial arms
Trial start
2024-09-01
Estimated PCD
2025-05-16
Trial end
2025-05-16
Status
Not yet recruiting
Treatment
Zirabev
Bevacizumab biosimilar
Arms:
Participants receiving Zirabev
Size
400
Primary endpoint
Safety profile
baseline up to approximately 4 years
Eligibility 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.
Protocol
{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'CASE_ONLY', 'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'count': 400, 'type': 'ESTIMATED'}}
Updated at
2023-08-30

1 organization

1 product

8 indications

Organization
Pfizer
Product
Zirabev
Indication
Lung Cancer
Indication
Breast Cancer
Indication
Cervical Cancer
Indication
Ovarian Cancer