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

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ClinicalTrials.gov Identifier: NCT04889495
Recruitment Status : Not yet recruiting
First Posted : May 17, 2021
Last Update Posted : May 17, 2021
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Non-small Cell Lung Cancer Metastatic Colorectal Cancer Metastatic Breast Cancer Metastatic Kidney Cancer Cervical Cancer Epithelial Ovarian Cancer Fallopian Tube Cancer Primary Peritoneal Cancer Drug: Zirabev

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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Case-Only
Time Perspective: Prospective
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, Etc.
Estimated Study Start Date : May 31, 2021
Estimated Primary Completion Date : August 1, 2024
Estimated Study Completion Date : May 30, 2025


Group/Cohort Intervention/treatment
Participants receiving Zirabev
Participants receiving Zirabev
Drug: Zirabev
Bevacizumab biosimilar




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Efficacy profile [ Time Frame: 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)



Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
See below
Criteria

- 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04889495


Contacts
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Contact: Pfizer CT.gov Call Center 1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com

Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT04889495    
Other Study ID Numbers: B7391012
First Posted: May 17, 2021    Key Record Dates
Last Update Posted: May 17, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: 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.
Keywords provided by Pfizer:
Zirabev
Additional relevant MeSH terms:
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Breast Neoplasms
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Colorectal Neoplasms
Fallopian Tube Neoplasms
Carcinoma, Ovarian Epithelial
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Ovarian Neoplasms
Endocrine Gland Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Neoplasms, Female
Urogenital Neoplasms