Ignite Creation Date:
2025-12-26 @ 10:57 AM
Ignite Modification Date:
2025-12-26 @ 10:57 AM
Study NCT ID:
NCT04763408
Status:
COMPLETED
Last Update Posted:
2024-07-18
First Post:
2021-02-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study to Evaluate the Safety and Tolerability of Lenvatinib in Participants With Advanced or Unresectable Hepatocellular Carcinoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006528', 'term': 'Carcinoma, Hepatocellular'}], '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': 'D008113', 'term': 'Liver Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D008107', 'term': 'Liver Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C531958', 'term': 'lenvatinib'}, {'id': 'D000077157', 'term': 'Sorafenib'}], 'ancestors': [{'id': 'D010671', 'term': 'Phenylurea Compounds'}, {'id': 'D014508', 'term': 'Urea'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009536', 'term': 'Niacinamide'}, {'id': 'D009539', 'term': 'Nicotinic Acids'}, {'id': 'D000147', 'term': 'Acids, Heterocyclic'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 335}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-04-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2023-12-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-07-17', 'studyFirstSubmitDate': '2021-02-17', 'studyFirstSubmitQcDate': '2021-02-17', 'lastUpdatePostDateStruct': {'date': '2024-07-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-02-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Hepatotoxicity Treatment-emergent Adverse Events (TEAEs) With Lenvatinib', 'timeFrame': 'Up to 7 years'}, {'measure': 'Number of Participants With SAEs With Lenvatinib', 'timeFrame': 'Up to 7 years'}, {'measure': 'Number of Participants With Grade 3 to 5 AEs With Lenvatinib', 'timeFrame': 'Up to 7 years', 'description': 'AEs are defined as undesirable events not present prior to medical treatment, or an already present event that worsens either in intensity or frequency following the treatment with lenvatinib. AEs will be graded using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE). Here Grade 3: severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care activity of daily living, Grade 4: life-threatening consequences; urgent intervention indicated and Grade 5: death related to AEs.'}, {'measure': 'Number of Participants with one or More TEAEs Leading to Dose Modifications and Treatment Discontinuations of Lenvatinib', 'timeFrame': 'Up to 7 years', 'description': 'Number of participants with one or more TEAEs Leading to Dose Modifications and Treatment Discontinuations of Lenvatinib will be collected at the discretion of the treating physician and in accordance with the prescribing information.'}], 'secondaryOutcomes': [{'measure': 'Duration of Lenvatinib and Sorafenib Treatment', 'timeFrame': 'Up to 7 years'}, {'measure': 'Number of Participants With Dose Interruption and Dose Reduction for Lenvatinib', 'timeFrame': 'Up to 7 years'}, {'measure': 'Relative Dose Intensity of Lenvatinib and Sorafenib', 'timeFrame': 'Up to 7 years', 'description': 'Relative Dose Intensity is defined as the amount of drug administered divided by the total dose specified by the corresponding standard regimen.'}, {'measure': 'Overall Survival (OS) For Lenvatinib and Sorafenib', 'timeFrame': 'Up to 7 years', 'description': 'OS is defined as the time from the start of lenvatinib and sorafenib treatment to date of death from any cause.'}, {'measure': 'Number of Participants With Dose Interruption and Dose Reduction for Sorafenib', 'timeFrame': 'Up to 7 years'}, {'measure': 'Number of Participants With Hepatotoxicity TEAEs With Sorafenib', 'timeFrame': 'Up to 7 years'}, {'measure': 'Number of Participants With SAEs With Sorafenib', 'timeFrame': 'Up to 7 years'}, {'measure': 'Number of Participants With Grade 3 to 5 AEs With Sorafenib', 'timeFrame': 'Up to 7 years', 'description': 'AEs are defined as undesirable events not present prior to medical treatment, or an already present event that worsens either in intensity or frequency following the treatment with sorafenib. AEs will be graded using NCI CTCAE. Here Grade 3: severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care activity of daily living, Grade 4: life-threatening consequences; urgent intervention indicated and Grade 5: death related to AEs.'}, {'measure': 'Number of Participants with one or More TEAEs Leading to Dose Modifications and Treatment Discontinuations of Sorafenib', 'timeFrame': 'Up to 7 years', 'description': 'Number of participants with one or more TEAEs Leading to Dose Modifications and Treatment Discontinuations of Sorafenib will be collected at the discretion of the treating physician and in accordance with the prescribing information.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Lenvatinib', 'Advanced or unresectable carcinoma hepatocellular', 'E7080'], 'conditions': ['Carcinoma, Hepatocellular']}, 'descriptionModule': {'briefSummary': 'The primary purpose of this study is to further characterise the hepatotoxicity in participants with advanced or unresectable hepatocellular carcinoma (HCC) treated with lenvatinib, and to further characterise the overall safety profile (serious adverse events \\[SAEs\\], grade 3 to 5 adverse events \\[AEs\\], dose modifications and discontinuations due to AEs) in participants with advanced or unresectable HCC treated with lenvatinib.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Participant with advanced or unresectable hepatocellular carcinoma.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Participants with advanced or unresectable HCC for whom a decision has been made by the treating physician (at their discretion) to initiate lenvatinib or sorafenib treatment, within the prescribing conditions of the approved product label\n2. Participants must provide signed informed consent to participate in the study within 31 days of initiating treatment with lenvatinib or sorafenib\n\nExclusion Criteria:\n\nNone'}, 'identificationModule': {'nctId': 'NCT04763408', 'acronym': 'STELLAR', 'briefTitle': 'A Study to Evaluate the Safety and Tolerability of Lenvatinib in Participants With Advanced or Unresectable Hepatocellular Carcinoma', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eisai Inc.'}, 'officialTitle': 'A Multicentre, Observational, Phase 4 Study to Evaluate the Safety and Tolerability of Lenvatinib in Patients With Advanced or Unresectable Hepatocellular Carcinoma (STELLAR)', 'orgStudyIdInfo': {'id': 'E7080-M000-508'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Lenvatinib', 'description': 'Participants with advanced or unresectable HCC will initiate treatment with lenvatinib capsules based on physicians decision and will be observed until withdrawal of consent, loss to follow-up, death or until the end of the study (up to 7 years) whichever occurs first.', 'interventionNames': ['Drug: Lenvatinib']}, {'label': 'Sorafenib', 'description': 'Participants with advanced or unresectable HCC will initiate treatment with sorafenib tablets based on physicians decision and will be observed until withdrawal of consent, loss to follow-up, death or until the end of the study (up to 7 years) whichever occurs first.', 'interventionNames': ['Drug: Sorafenib']}], 'interventions': [{'name': 'Lenvatinib', 'type': 'DRUG', 'otherNames': ['Lenvima', 'E7080'], 'description': 'Oral capsules.', 'armGroupLabels': ['Lenvatinib']}, {'name': 'Sorafenib', 'type': 'DRUG', 'description': 'Oral tablets.', 'armGroupLabels': ['Sorafenib']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91105', 'city': 'Pasadena', 'state': 'California', 'country': 'United States', 'facility': 'California Liver Research Institute', 'geoPoint': {'lat': 34.14778, 'lon': -118.14452}}, {'zip': '10467', 'city': 'The Bronx', 'state': 'New York', 'country': 'United States', 'facility': 'Montefiore Medical Center', 'geoPoint': {'lat': 40.84985, 'lon': -73.86641}}, {'zip': '75390-0001', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Texas Southwestern Medical Center', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '2050', 'city': 'Camperdown', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Royal Prince Alfred Hospital', 'geoPoint': {'lat': -33.88965, 'lon': 151.17642}}, {'zip': '1871', 'city': 'Liverpool', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Liverpool Hospital', 'geoPoint': {'lat': -33.91938, 'lon': 150.92588}}, {'zip': '3168', 'city': 'Clayton', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Monash Health, Monash Medical Centre', 'geoPoint': {'lat': -37.91667, 'lon': 145.11667}}, {'city': 'Innsbruck', 'state': 'Tyrol', 'country': 'Austria', 'facility': 'Universitätsklinikum Innsbruck', 'geoPoint': {'lat': 47.26266, 'lon': 11.39454}}, {'zip': '9020', 'city': 'Klagenfurt', 'country': 'Austria', 'facility': 'Klinikum Klagenfurt Am Woerthersee', 'geoPoint': {'lat': 46.62472, 'lon': 14.30528}}, {'zip': '3100', 'city': 'Sankt Pölten', 'country': 'Austria', 'facility': 'Universitätsklinikum St. Pölten', 'geoPoint': {'lat': 48.20762, 'lon': 15.63725}}, {'zip': '1090', 'city': 'Vienna', 'country': 'Austria', 'facility': 'Medizinische Universitat Wien (Medical University of Vienna)', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}, {'city': 'Cologne', 'state': 'North Rhine-Westphalia', 'country': 'Germany', 'facility': 'Eisai Trial Site #3', 'geoPoint': {'lat': 50.93333, 'lon': 6.95}}, {'city': 'Mainz', 'state': 'Rhineland-Palatinate', 'country': 'Germany', 'facility': 'Eisai Trial Site #5', 'geoPoint': {'lat': 49.98185, 'lon': 8.28008}}, {'city': 'Berlin', 'country': 'Germany', 'facility': 'Eisai Trial Site #2', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'city': 'Munich', 'country': 'Germany', 'facility': 'Eisai Trial Site #6', 'geoPoint': {'lat': 48.13743, 'lon': 11.57549}}, {'city': 'Ulm', 'country': 'Germany', 'facility': 'Eisai Trial Site #1', 'geoPoint': {'lat': 48.39841, 'lon': 9.99155}}, {'zip': '80147', 'city': 'Napoli', 'state': 'Campania', 'country': 'Italy', 'facility': 'Ospedale del Mare', 'geoPoint': {'lat': 40.87618, 'lon': 14.5195}}, {'zip': '00133', 'city': 'Rome', 'state': 'Lazio', 'country': 'Italy', 'facility': 'Fondazione PTV Policlinico Tor Vergata', 'geoPoint': {'lat': 41.89193, 'lon': 12.51133}}, {'zip': '00152', 'city': 'Rome', 'state': 'Lazio', 'country': 'Italy', 'facility': 'Azienda Ospedaliera San Camillo Forlanini', 'geoPoint': {'lat': 41.89193, 'lon': 12.51133}}, {'zip': '00168', 'city': 'Rome', 'state': 'Lazio', 'country': 'Italy', 'facility': 'Fondazione Policlinico Universitario A Gemelli', 'geoPoint': {'lat': 41.89193, 'lon': 12.51133}}, {'zip': '09042', 'city': 'Monserrato Cagliari', 'state': 'Sardinia', 'country': 'Italy', 'facility': 'Azienda Ospedaliero Universitaria Di Cagliari'}, {'zip': '40138', 'city': 'Bologna', 'country': 'Italy', 'facility': 'Azienda Ospedaliero Universitaria Di Bologna - Policlinico S Orsola Malpighi', 'geoPoint': {'lat': 44.49381, 'lon': 11.33875}}, {'zip': '2805-267', 'city': 'Almada', 'state': 'Setúbal District', 'country': 'Portugal', 'facility': 'Hospital Garcia de Orta', 'geoPoint': {'lat': 38.67902, 'lon': -9.1569}}, {'city': 'Coimbra', 'country': 'Portugal', 'facility': 'Instituto Português de Oncologia Francisco Gentil Centro Regional de Oncologia de Coimbra EPE', 'geoPoint': {'lat': 40.20686, 'lon': -8.41996}}, {'zip': '1649-035', 'city': 'Lisbon', 'country': 'Portugal', 'facility': 'Centro Hospitalar Lisboa Norte, E.P.E. - Hospital de Santa Maria', 'geoPoint': {'lat': 38.72509, 'lon': -9.1498}}, {'zip': '5000-508', 'city': 'Vila Real', 'country': 'Portugal', 'facility': 'Centro Hospitalar Trás Os Montes E Alto Douro EPE', 'geoPoint': {'lat': 41.3001, 'lon': -7.7432}}, {'zip': '428020', 'city': 'Cheboksary', 'state': 'Chuvashskaya Respublika', 'country': 'Russia', 'facility': 'Budgetary Institution of the Chuvash Republic-The Republican Clinical Oncologic Dispensary-Cheboksar', 'geoPoint': {'lat': 56.13218, 'lon': 47.246}}, {'city': 'Sabadell', 'state': 'Barcelona', 'country': 'Spain', 'facility': 'Corporacio Sanitaria Parc Tauli', 'geoPoint': {'lat': 41.54329, 'lon': 2.10942}}, {'zip': '39008', 'city': 'Santander', 'state': 'Cantabria', 'country': 'Spain', 'facility': 'Hospital Universitario Marques de Valdecilla', 'geoPoint': {'lat': 43.46589, 'lon': -3.80493}}, {'city': 'El Palmar', 'state': 'Murcia', 'country': 'Spain', 'facility': 'Hospital Universitario Virgen de La Arrixaca', 'geoPoint': {'lat': 37.93939, 'lon': -1.16095}}, {'zip': '03010', 'city': 'Alicante', 'country': 'Spain', 'facility': 'Hospital General Universitario de Alicante', 'geoPoint': {'lat': 38.34517, 'lon': -0.48149}}, {'zip': '14004', 'city': 'Córdoba', 'country': 'Spain', 'facility': 'C.H. Regional Reina Sofia - PPDS', 'geoPoint': {'lat': 37.89155, 'lon': -4.77275}}, {'city': 'Getafe', 'country': 'Spain', 'facility': 'Hospital Universitario de Getafe', 'geoPoint': {'lat': 40.30571, 'lon': -3.73295}}, {'zip': '28034', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Universitario Ramon y Cajal', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'city': 'Málaga', 'country': 'Spain', 'facility': 'Hospital Regional Universitario de Malaga - Hospital General', 'geoPoint': {'lat': 36.72016, 'lon': -4.42034}}, {'zip': '15706', 'city': 'Santiago de Compostela', 'country': 'Spain', 'facility': 'CHUS - H. Clinico U. de Santiago', 'geoPoint': {'lat': 42.88052, 'lon': -8.54569}}, {'city': 'Seville', 'country': 'Spain', 'facility': 'Hospital Universitario Virgen del Rocio - PPDS', 'geoPoint': {'lat': 37.38283, 'lon': -5.97317}}, {'zip': '46026', 'city': 'Valencia', 'country': 'Spain', 'facility': 'Hospital Universitari i Politecnic La Fe de Valencia', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}, {'city': 'Zaragoza', 'country': 'Spain', 'facility': 'Hospital Clinico Universitario Lozano Blesa', 'geoPoint': {'lat': 41.65606, 'lon': -0.87734}}, {'city': 'Zaragoza', 'country': 'Spain', 'facility': 'Hospital Universitario Miguel Servet', 'geoPoint': {'lat': 41.65606, 'lon': -0.87734}}, {'zip': '141 86', 'city': 'Stockholm', 'country': 'Sweden', 'facility': 'Karolinska Universitetssjukhuset Huddinge', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}, {'zip': 'B15 2PR', 'city': 'Birmingham', 'country': 'United Kingdom', 'facility': 'University Hospitals Birmingham NHS Foundation Trust', 'geoPoint': {'lat': 52.48142, 'lon': -1.89983}}, {'zip': 'EC1A 7BE', 'city': 'London', 'country': 'United Kingdom', 'facility': 'Barts Health NHS Trust - Charterhouse Square', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'NW3 2QG', 'city': 'London', 'country': 'United Kingdom', 'facility': 'Royal Free London NHS Foundation Trust', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'NG7 2UH', 'city': 'Nottingham', 'country': 'United Kingdom', 'facility': 'Nottingham University Hospitals NHS Trust', 'geoPoint': {'lat': 52.9536, 'lon': -1.15047}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': "Eisai's data sharing commitment and further information on how to request data can be found on our website http://eisaiclinicaltrials.com/."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eisai Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}