Clinical trial · Observational

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

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.

NCT04889495CI-TRIAL-00087386withdrawnClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Why stopped (as posted): The study was withdrawn due to global supply chain issue. Zirabev was not launching in Korea.

Summary

Brief summary (as posted)

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.

Conditions

Conditions (8)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Cervical Cancer	Malignant Cervical Neoplasm	CURATED_EXACT	0.92
Epithelial Ovarian Cancer	Ovarian Carcinoma	ALIAS	0.90
Fallopian Tube Cancer	Malignant Fallopian Tube Neoplasm	ALIAS	0.90
Metastatic Breast Cancer	Malignant Breast Neoplasm	CURATED_BROADER	0.78
Metastatic Colorectal Cancer	Malignant Colorectal Neoplasm	CURATED_BROADER	0.80
Metastatic Kidney Cancer	Malignant Kidney Neoplasm	CURATED_BROADER	0.78
Non-small Cell Lung Cancer	Lung Non-Small Cell Carcinoma	ALIAS	0.90

Interventions

Interventions (1)

Intervention	Type	Mapped drug	Match
Zirabev	Drug	Bevacizumab	ALIAS

Design

Arms and outcomes

Arms (1)

label
Participants receiving Zirabev
description
Participants receiving Zirabev
interventionNames
1. Drug: Zirabev

Primary outcomes (1)

measure
Safety profile
timeFrame
baseline up to approximately 4 years
description
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 (1)

measure
Efficacy profile
timeFrame
baseline up to approximately 4 years

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 19 Years

Show eligibility criteria text

\- 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.

References

Publications (0)

Data not yet available

No reference posted for this study.