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Clinical Trials/NCT04889495
NCT04889495
Withdrawn
Not Applicable

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.

Pfizer0 sites400 target enrollmentMay 16, 2025

Overview

Phase
Not Applicable
Intervention
Zirabev
Conditions
Non-small Cell Lung Cancer
Sponsor
Pfizer
Enrollment
400
Primary Endpoint
Safety profile
Status
Withdrawn
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 16, 2025
End Date
August 16, 2025
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Sponsor
Pfizer
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Arms & Interventions

Participants receiving Zirabev

Participants receiving Zirabev

Intervention: Zirabev

Outcomes

Primary Outcomes

Safety profile

Time Frame: 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 Outcomes

  • Efficacy profile(baseline up to approximately 4 years)

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