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

Not yet recruiting

• Conditions: Metastatic Kidney Cancer; Epithelial Ovarian Cancer; Non-small Cell Lung Cancer; Metastatic Colorectal Cancer; Cervical Cancer; Metastatic Breast Cancer; Fallopian Tube Cancer; Primary Peritoneal Cancer
• Interventions: Drug: Zirabev

• Registration Number: NCT04889495
• Lead Sponsor: Pfizer

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study First Submitted: 2021-05-12
• Study First Submitted QC: 2021-05-12
• Study First Posted: 2021-05-17
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-31
• Last Update Posted: 2024-11-04
• Study Start: 2025-05-16
• Primary Completion: 2025-08-16
• Study Completion: 2025-08-16

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Participants receiving Zirabev	Zirabev	Participants receiving Zirabev

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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)