Spots Global Cancer Trial Database for A Study to Evaluate the Safety and Tolerability of Lenvatinib in Participants With Advanced or Unresectable Hepatocellular Carcinoma
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Trial Identification
Brief Title: A Study to Evaluate the Safety and Tolerability of Lenvatinib in Participants With Advanced or Unresectable Hepatocellular Carcinoma
Official Title: A Multicentre, Observational, Phase 4 Study to Evaluate the Safety and Tolerability of Lenvatinib in Patients With Advanced or Unresectable Hepatocellular Carcinoma (STELLAR)
Study ID: NCT04763408
Conditions
Study Description
Brief Summary: 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.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
California Liver Research Institute, Pasadena, California, United States
Montefiore Medical Center, Bronx, New York, United States
University of Texas Southwestern Medical Center, Dallas, Texas, United States
Royal Prince Alfred Hospital, Camperdown, New South Wales, Australia
Liverpool Hospital, Liverpool, New South Wales, Australia
Monash Health, Monash Medical Centre, Clayton, Victoria, Australia
Universitätsklinikum Innsbruck, Innsbruck, Tirol, Austria
Klinikum Klagenfurt Am Woerthersee, Klagenfurt Am Woerthersee, , Austria
Universitätsklinikum St. Pölten, St. Pölten, , Austria
Medizinische Universitat Wien (Medical University of Vienna), Vienna, , Austria
Eisai Trial Site #3, Köln, Nordrhein-Westfalen, Germany
Eisai Trial Site #5, Mainz, Rheinland-Pfalz, Germany
Eisai Trial Site #2, Berlin, , Germany
Eisai Trial Site #6, Munich, , Germany
Eisai Trial Site #1, Ulm, , Germany
Ospedale del Mare, Napoli, Campania, Italy
Fondazione PTV Policlinico Tor Vergata, Roma, Lazio, Italy
Azienda Ospedaliera San Camillo Forlanini, Roma, Lazio, Italy
Fondazione Policlinico Universitario A Gemelli, Roma, Lazio, Italy
Azienda Ospedaliero Universitaria Di Cagliari, Monserrato Cagliari, Sardegna, Italy
Azienda Ospedaliero Universitaria Di Bologna - Policlinico S Orsola Malpighi, Bologna, , Italy
Hospital Garcia de Orta, Almada, Setúbal, Portugal
Instituto Português de Oncologia Francisco Gentil Centro Regional de Oncologia de Coimbra EPE, Coimbra, , Portugal
Centro Hospitalar Lisboa Norte, E.P.E. - Hospital de Santa Maria, Lisboa, , Portugal
Centro Hospitalar Trás Os Montes E Alto Douro EPE, Vila Real, , Portugal
Budgetary Institution of the Chuvash Republic-The Republican Clinical Oncologic Dispensary-Cheboksar, Cheboksary, Chuvashskaya Respublika, Russian Federation
Corporacio Sanitaria Parc Tauli, Sabadell, Barcelona, Spain
Hospital Universitario Marques de Valdecilla, Santander, Cantabria, Spain
Hospital Universitario Virgen de La Arrixaca, El Palmar, Murcia, Spain
Hospital General Universitario de Alicante, Alicante, , Spain
C.H. Regional Reina Sofia - PPDS, Córdoba, , Spain
Hospital Universitario de Getafe, Getafe, , Spain
Hospital Universitario Ramon y Cajal, Madrid, , Spain
Hospital Regional Universitario de Malaga - Hospital General, Málaga, , Spain
CHUS - H. Clinico U. de Santiago, Santiago de Compostela, , Spain
Hospital Universitario Virgen del Rocio - PPDS, Sevilla, , Spain
Hospital Universitari i Politecnic La Fe de Valencia, Valencia, , Spain
Hospital Clinico Universitario Lozano Blesa, Zaragoza, , Spain
Hospital Universitario Miguel Servet, Zaragoza, , Spain
Karolinska Universitetssjukhuset Huddinge, Stockholm, , Sweden
University Hospitals Birmingham NHS Foundation Trust, Birmingham, , United Kingdom
Barts Health NHS Trust - Charterhouse Square, London, , United Kingdom
Royal Free London NHS Foundation Trust, London, , United Kingdom
Nottingham University Hospitals NHS Trust, Nottingham, , United Kingdom
Contact Details
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