NCT04889495

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.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started May 2025

Shorter than P25 for all trials

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 12, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 17, 2021

Completed
4 years until next milestone

Study Start

First participant enrolled

May 16, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 16, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 16, 2025

Completed
Last Updated

March 19, 2025

Status Verified

March 1, 2025

Enrollment Period

3 months

First QC Date

May 12, 2021

Last Update Submit

March 14, 2025

Conditions

Non-small Cell Lung CancerMetastatic Colorectal CancerMetastatic Breast CancerMetastatic Kidney CancerCervical CancerEpithelial Ovarian CancerFallopian Tube CancerPrimary Peritoneal Cancer

Keywords

Zirabev

Outcome Measures

Primary Outcomes (1)

  • Safety profile

    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)

    baseline up to approximately 4 years

Secondary Outcomes (1)

  • Efficacy profile

    baseline up to approximately 4 years

Study Arms (1)

Participants receiving Zirabev

Participants receiving Zirabev

Drug: Zirabev

Interventions

ZirabevDRUG

Bevacizumab biosimilar

Participants receiving Zirabev

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

See below

You may qualify if:

  • Adults over 19 years old
  • 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.
  • Patients eligible for Zirabev dosage based on local product document, local treatment guidelines and clinical judgment of the medical team.
  • 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.

You may not qualify if:

  • Patients meeting any of the following criteria will not be included in the study:
  • Any patients (or a legally acceptable representative) who does not agree that Pfizer and companies working with Pfizer use his/her information.
  • Patients for whom Zirabev is contraindicated according to the local product document.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell LungColorectal NeoplasmsBreast NeoplasmsKidney NeoplasmsUterine Cervical NeoplasmsCarcinoma, Ovarian EpithelialFallopian Tube Neoplasms

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesUrologic NeoplasmsUrogenital NeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesKidney DiseasesUrologic DiseasesMale Urogenital DiseasesUterine NeoplasmsGenital Neoplasms, FemaleUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleGenital DiseasesCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeOvarian NeoplasmsEndocrine Gland NeoplasmsOvarian DiseasesAdnexal DiseasesEndocrine System DiseasesGonadal DisordersFallopian Tube Diseases

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR
0

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 12, 2021

First Posted

May 17, 2021

Study Start

May 16, 2025

Primary Completion

August 16, 2025

Study Completion

August 16, 2025

Last Updated

March 19, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.