Ignite Creation Date:
2025-12-24 @ 6:26 PM
Ignite Modification Date:
2025-12-30 @ 12:46 PM
Study NCT ID:
NCT06313268
Status:
COMPLETED
Last Update Posted:
2024-10-10
First Post:
2024-02-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety of Effivia®, a Bevacizumab Biosimilar
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D002583', 'term': 'Uterine Cervical Neoplasms'}], 'ancestors': [{'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': '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': 'D014594', 'term': 'Uterine Neoplasms'}, {'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D002577', 'term': 'Uterine Cervical Diseases'}, {'id': 'D014591', 'term': 'Uterine Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 83}, 'targetDuration': '2 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-08-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2024-09-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-10-08', 'studyFirstSubmitDate': '2024-02-21', 'studyFirstSubmitQcDate': '2024-03-08', 'lastUpdatePostDateStruct': {'date': '2024-10-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-03-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-04-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adverse events', 'timeFrame': 'From date of patient inclusion to the end of Cycle 1 (each cycle is up to six months)', 'description': 'Frequency and characteristics of adverse events (serious and non serious)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Metastatic Colorectal Cancer', 'Metastatic Cervical Cancer', 'Non Squamous Non Small Cell Lung Cancer']}, 'descriptionModule': {'briefSummary': 'This is a post-marketing observational study aimed to evaluated the safety profile of Effivia®, a biosimilar of bevacizumab, in mexican patients with different types of cancer.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Naive to bevacizumab, adult patients with metastatic colorectal cancer, metastatic cervical cancer, non-squamous non-small cell lung cancer, and other cancer types where Bevacizumab therapy is indicated.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male and female patients, 18 years and older.\n* Patients with metastatic colorectal cancer,unresectable, locally advanced, recurrent or metastatic non-squamous non-small cell lung cancer, metastatic renal cell carcinoma, persistent, recurrent, or metastatic cervical cancer, or epithelial ovarian, fallopian tube, or primary peritoneal cancer naive to bevacizumab therapy (Effivia®).\n* Provide written informed consent.\n\nExclusion Criteria:\n\n* History of recent surgery or wound healing complications.\n* History of gastrointestinal perforations or fistula.\n* History of renal injury and proteinuria.\n* Recent surgical intervention.\n* Pregnant or nursing women.\n* History of bevacizumab, monoclonal antibodies, or CHO cells-derived products hypersensitivity.\n* Other safety concerns or bevacizumab contraindications.'}, 'identificationModule': {'nctId': 'NCT06313268', 'briefTitle': 'Safety of Effivia®, a Bevacizumab Biosimilar', 'organization': {'class': 'INDUSTRY', 'fullName': 'Laboratorios Liomont'}, 'officialTitle': 'Post-marketing Safety of Effivia®, a Bevacizumab Biosimilar: Phase IV, Observational, Multicenter Clinical Study in Mexican Population', 'orgStudyIdInfo': {'id': 'LT-02-20'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Test group', 'description': 'Bevacizumab (Effivia®)', 'interventionNames': ['Drug: Bevacizumab Biosimilar MB02']}], 'interventions': [{'name': 'Bevacizumab Biosimilar MB02', 'type': 'DRUG', 'otherNames': ['Effivia®'], 'description': '5 mg/kg to 15 mg/kg in combination with chemotherapy.', 'armGroupLabels': ['Test group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '37320', 'city': 'León', 'state': 'Guanajuato', 'country': 'Mexico', 'facility': 'UMAE Hospital de Especialidades No. 1', 'geoPoint': {'lat': 21.12908, 'lon': -101.67374}}, {'zip': '02990', 'city': 'Azcapotzalco', 'state': 'Mexico City', 'country': 'Mexico', 'facility': 'Hospital de Gineco-Obstetricia No. 3', 'geoPoint': {'lat': 19.48698, 'lon': -99.18594}}, {'zip': '06720', 'city': 'Cuauhtémoc', 'state': 'Mexico City', 'country': 'Mexico', 'facility': 'Hospital de Oncología, UMAE Centro Médico Nacional Siglo XXI', 'geoPoint': {'lat': 19.44506, 'lon': -99.14612}}, {'zip': '14080', 'city': 'Tlalpan', 'state': 'Mexico City', 'country': 'Mexico', 'facility': 'Instituto Nacional de Cancerología', 'geoPoint': {'lat': 19.29513, 'lon': -99.16206}}, {'zip': '07200', 'city': 'Puebla City', 'country': 'Mexico', 'facility': 'Hospital de Oncología IMSS Puebla', 'geoPoint': {'lat': 19.04778, 'lon': -98.20723}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Laboratorios Liomont', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Servicios Especializados en Ensayos Clínicos, S.C.', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}