Ignite Creation Date:
2025-12-24 @ 7:43 PM
Ignite Modification Date:
2026-01-01 @ 3:45 PM
Study NCT ID:
NCT04555603
Status:
WITHDRAWN
Last Update Posted:
2023-11-21
First Post:
2020-09-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Axitinib Therapy Management Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002292', 'term': 'Carcinoma, Renal Cell'}], 'ancestors': [{'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D007680', 'term': 'Kidney Neoplasms'}, {'id': 'D014571', 'term': 'Urologic Neoplasms'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077784', 'term': 'Axitinib'}, {'id': 'C000609138', 'term': 'avelumab'}, {'id': 'C582435', 'term': 'pembrolizumab'}], 'ancestors': [{'id': 'D001549', 'term': 'Benzamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001565', 'term': 'Benzoates'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D007191', 'term': 'Indazoles'}, {'id': 'D011720', 'term': 'Pyrazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'Failed at data quality assurance process before any analyses would be performed', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2020-09-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2021-02-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-11-20', 'studyFirstSubmitDate': '2020-09-14', 'studyFirstSubmitQcDate': '2020-09-14', 'lastUpdatePostDateStruct': {'date': '2023-11-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-09-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-02-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To describe type of immune related adverse events and adverse events related to axitinib', 'timeFrame': 'during treatment period', 'description': 'describe type of immune related adverse events and adverse events related to axitinib'}, {'measure': 'To describe the percentage of patients with documentation of dose modifications', 'timeFrame': 'during treatment period', 'description': 'describe dose modifications'}, {'measure': 'To describe the percentage of patients with usage of concomitant high-dose corticosteroid', 'timeFrame': 'during treatment period', 'description': 'descriptive assessment'}, {'measure': 'To describe the percentage of patients alive at pre-specified time points (6 months, 12 months, 18 months, 24 months) from start of the index therapy', 'timeFrame': 'during study period', 'description': 'calculation of overall survival time'}, {'measure': 'To estimate the best overall response (partial response, complete response, progressive disease, or stable disease', 'timeFrame': 'during treatment period', 'description': 'description of overall response'}, {'measure': 'To estimate time to treatment discontinuation', 'timeFrame': 'during treatment period', 'description': 'calculation of duration of treatment'}, {'measure': 'To estimate PFS', 'timeFrame': 'during treatment period', 'description': 'calculation of progression free survival'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Renal Cell Carcinoma']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://pmiform.com/clinical-trial-info-request?StudyID=A4061096', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'The objectives of the study is to describe axitinib therapy management through use of the data to be generated by ConcertAI', 'detailedDescription': 'not mandatory'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'academic and community centers', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Confirmed diagnosis of aRCC (Stage III, Stage IV (M0) or Stage IV (M1)) at any point\n* Age 18 years or older at the time of aRCC diagnosis\n* Received a qualifying IO-containing combination (nivolumab and ipilimumab, axitinib and pembrolizumab, or axitinib and avelumab) in the first regimen after aRCC diagnosis or axitinib monotherapy in any line\n\nExclusion Criteria:\n\n* none'}, 'identificationModule': {'nctId': 'NCT04555603', 'briefTitle': 'Axitinib Therapy Management Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'Retrospective Analysis of Axitinib Treatment Optimization and Management of Selected Immune Related Adverse Events of Checkpoints Inhibitors', 'orgStudyIdInfo': {'id': 'A4061096'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Inlyta', 'type': 'DRUG', 'otherNames': ['Axitinib as prescribed in the real world'], 'description': 'axitinib'}, {'name': 'Bavencio', 'type': 'DRUG', 'otherNames': ['Avelumab as prescribed in the real world'], 'description': 'avelumab'}, {'name': 'Keytruda', 'type': 'DRUG', 'otherNames': ['Pembrolizumab as prescribed in the real world'], 'description': 'Pembrolizumab'}]}, 'contactsLocationsModule': {'locations': [{'zip': '10017', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Pfizer Inc.', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], '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'}}}}