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

Non-small Cell Lung Cancer Clinical Trial

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.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04889495
• Other study ID #: B7391012
• Status: Not yet recruiting
• Start date: September 1, 2024
• Est. completion date: May 16, 2025

Study information

• Verified date: August 2023
• Source: Pfizer
• Contact: Pfizer CT.gov Call Center
• Phone: 1-800-718-1021
• Email: ClinicalTrials.gov_Inquiries[@]pfizer.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 400
• Est. completion date: May 16, 2025
• Est. primary completion date: May 16, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

• 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.

Related Conditions & MeSH terms

• Breast Neoplasms
• Carcinoma, Non-Small-Cell Lung
• Carcinoma, Ovarian Epithelial
• Carcinoma, Renal Cell
• Cervical Cancer
• Colorectal Neoplasms
• Epithelial Ovarian Cancer
• Fallopian Tube Cancer
• Fallopian Tube Neoplasms
• Kidney Neoplasms
• Lung Neoplasms
• Metastatic Breast Cancer
• Metastatic Colorectal Cancer
• Metastatic Kidney Cancer
• Non-small Cell Lung Cancer
• Ovarian Neoplasms
• Primary Peritoneal Cancer
• Uterine Cervical Neoplasms

Intervention

Drug:
• Zirabev
Bevacizumab biosimilar

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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