Ignite Creation Date:
2025-12-24 @ 2:07 PM
Ignite Modification Date:
2026-02-25 @ 7:55 PM
Study NCT ID:
NCT04889495
Status:
WITHDRAWN
Last Update Posted:
2025-03-19
First Post:
2021-05-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Post-marketing Surveillance to Assess the Safety and Effectiveness of Zirabev in Domestic Patients With Various Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}, {'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D007680', 'term': 'Kidney Neoplasms'}, {'id': 'D002583', 'term': 'Uterine Cervical Neoplasms'}, {'id': 'D000077216', 'term': 'Carcinoma, Ovarian Epithelial'}, {'id': 'D005185', 'term': 'Fallopian Tube Neoplasms'}], 'ancestors': [{'id': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial Neoplasms'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D014571', 'term': 'Urologic Neoplasms'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D014594', 'term': 'Uterine Neoplasms'}, {'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D002577', 'term': 'Uterine Cervical Diseases'}, {'id': 'D014591', 'term': 'Uterine Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D010051', 'term': 'Ovarian Neoplasms'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D010049', 'term': 'Ovarian Diseases'}, {'id': 'D000291', 'term': 'Adnexal Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D006058', 'term': 'Gonadal Disorders'}, {'id': 'D005184', 'term': 'Fallopian Tube Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'The study was withdrawn due to global supply chain issue. Zirabev was not launching in Korea.', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2025-05-16', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2025-08-16', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-14', 'studyFirstSubmitDate': '2021-05-12', 'studyFirstSubmitQcDate': '2021-05-12', 'lastUpdatePostDateStruct': {'date': '2025-03-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-05-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-08-16', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety profile', 'timeFrame': 'baseline up to approximately 4 years', 'description': 'The following items that occurred from the baseline:\n\n1. Adverse Events (AEs)\n2. Serious Adverse Events (SAEs)\n3. Expected Adverse Events (Expected AEs)\n4. Unexpected Adverse Events (Unexpected AEs)\n5. Adverse Drug Reactions (ADRs)\n6. Serious Adverse Drug Reactions (SADRs)\n7. Expected Adverse Drug Reactions (Expected ADR)\n8. Unexpected Adverse Drug Reactions (Unexpected ADR)'}], 'secondaryOutcomes': [{'measure': 'Efficacy profile', 'timeFrame': 'baseline up to approximately 4 years', 'description': 'OR CR SD PD\n\n1. 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\n\n • Four objective response categories: complete response (CR), partial response (PR), stable disease (SD), progressive disease (PD) (RECIST 1.1)\n2. Glioblastoma multiforme patients • Four objective response categories: complete response (CR), partial response (PR), stable disease (SD), progressive disease (PD) (RANO-HGG)'}]}, 'conditionsModule': {'keywords': ['Zirabev'], 'conditions': ['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']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'See below', 'healthyVolunteers': False, 'eligibilityCriteria': '\\- Inclusion criteria\n\nPatients must meet all of the following inclusion criteria to be eligible for inclusion in the study:\n\n1. Adults over 19 years old\n2. 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.\n3. Patients eligible for Zirabev dosage based on local product document, local treatment guidelines and clinical judgment of the medical team.\n4. 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.\n\n * Exclusion criteria\n\nPatients meeting any of the following criteria will not be included in the study:\n\n1. Any patients (or a legally acceptable representative) who does not agree that Pfizer and companies working with Pfizer use his/her information.\n2. Patients for whom Zirabev is contraindicated according to the local product document.'}, 'identificationModule': {'nctId': 'NCT04889495', 'briefTitle': 'A Post-marketing Surveillance to Assess the Safety and Effectiveness of Zirabev in Domestic Patients With Various Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': '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.', 'orgStudyIdInfo': {'id': 'B7391012'}, 'secondaryIdInfos': [{'id': 'NCT04889495', 'type': 'REGISTRY', 'domain': 'ClinicalTrials.gov'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Participants receiving Zirabev', 'description': 'Participants receiving Zirabev', 'interventionNames': ['Drug: Zirabev']}], 'interventions': [{'name': 'Zirabev', 'type': 'DRUG', 'description': 'Bevacizumab biosimilar', 'armGroupLabels': ['Participants receiving Zirabev']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Pfizer CT.gov Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pfizer'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', '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."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pfizer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}