A Study to Evaluate the Safety and Tolerability of Lenvatinib in Participants With Advanced or Unresectable Hepatocellular Carcinoma
- Registration Number
- NCT04763408
- Lead Sponsor
- Eisai Inc.
- 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
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 335
- 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
- Participants must provide signed informed consent to participate in the study within 31 days of initiating treatment with lenvatinib or sorafenib
None
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Lenvatinib Lenvatinib 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. Sorafenib Sorafenib 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.
- Primary Outcome Measures
Name Time Method Number of Participants With SAEs With Lenvatinib Up to 7 years Number of Participants With Hepatotoxicity Treatment-emergent Adverse Events (TEAEs) With Lenvatinib Up to 7 years Number of Participants With Grade 3 to 5 AEs With Lenvatinib Up to 7 years 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.
Number of Participants with one or More TEAEs Leading to Dose Modifications and Treatment Discontinuations of Lenvatinib Up to 7 years 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.
- Secondary Outcome Measures
Name Time Method Number of Participants With Hepatotoxicity TEAEs With Sorafenib Up to 7 years Number of Participants With SAEs With Sorafenib Up to 7 years Number of Participants With Grade 3 to 5 AEs With Sorafenib Up to 7 years 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.
Number of Participants with one or More TEAEs Leading to Dose Modifications and Treatment Discontinuations of Sorafenib Up to 7 years 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.
Duration of Lenvatinib and Sorafenib Treatment Up to 7 years Number of Participants With Dose Interruption and Dose Reduction for Lenvatinib Up to 7 years Relative Dose Intensity of Lenvatinib and Sorafenib Up to 7 years Relative Dose Intensity is defined as the amount of drug administered divided by the total dose specified by the corresponding standard regimen.
Number of Participants With Dose Interruption and Dose Reduction for Sorafenib Up to 7 years Overall Survival (OS) For Lenvatinib and Sorafenib Up to 7 years OS is defined as the time from the start of lenvatinib and sorafenib treatment to date of death from any cause.
Trial Locations
- Locations (44)
California Liver Research Institute
🇺🇸Pasadena, California, United States
Eisai Trial Site #2
🇩🇪Berlin, Germany
Eisai Trial Site #6
🇩🇪Munich, Germany
Azienda Ospedaliero Universitaria Di Cagliari
🇮🇹Monserrato Cagliari, Sardegna, Italy
Budgetary Institution of the Chuvash Republic-The Republican Clinical Oncologic Dispensary-Cheboksar
🇷🇺Cheboksary, Chuvashskaya Respublika, Russian Federation
Hospital Universitario Virgen de La Arrixaca
🇪🇸El Palmar, Murcia, Spain
Hospital General Universitario de Alicante
🇪🇸Alicante, Spain
Hospital Regional Universitario de Malaga - Hospital General
🇪🇸Málaga, Spain
Hospital Universitario de Getafe
🇪🇸Getafe, Spain
Hospital Universitario Virgen del Rocio - PPDS
🇪🇸Sevilla, Spain
Hospital Universitari i Politecnic La Fe de Valencia
🇪🇸Valencia, Spain
Hospital Universitario Miguel Servet
🇪🇸Zaragoza, Spain
Barts Health NHS Trust - Charterhouse Square
🇬🇧London, United Kingdom
Nottingham University Hospitals NHS Trust
🇬🇧Nottingham, United Kingdom
Karolinska Universitetssjukhuset Huddinge
🇸🇪Stockholm, Sweden
Monash Health, Monash Medical Centre
🇦🇺Clayton, Victoria, Australia
Universitätsklinikum Innsbruck
🇦🇹Innsbruck, Tirol, Austria
Medizinische Universitat Wien (Medical University of Vienna)
🇦🇹Vienna, Austria
Eisai Trial Site #3
🇩🇪Köln, Nordrhein-Westfalen, Germany
Klinikum Klagenfurt Am Woerthersee
🇦🇹Klagenfurt Am Woerthersee, Austria
Eisai Trial Site #5
🇩🇪Mainz, Rheinland-Pfalz, Germany
Eisai Trial Site #1
🇩🇪Ulm, Germany
Fondazione PTV Policlinico Tor Vergata
🇮🇹Roma, Lazio, Italy
Azienda Ospedaliera San Camillo Forlanini
🇮🇹Roma, Lazio, Italy
Hospital Garcia de Orta
🇵🇹Almada, Setúbal, Portugal
Azienda Ospedaliero Universitaria Di Bologna - Policlinico S Orsola Malpighi
🇮🇹Bologna, Italy
Centro Hospitalar Lisboa Norte, E.P.E. - Hospital de Santa Maria
🇵🇹Lisboa, Portugal
Corporacio Sanitaria Parc Tauli
🇪🇸Sabadell, Barcelona, Spain
Hospital Universitario Marques de Valdecilla
🇪🇸Santander, Cantabria, Spain
C.H. Regional Reina Sofia - PPDS
🇪🇸Córdoba, Spain
Hospital Universitario Ramon y Cajal
🇪🇸Madrid, Spain
CHUS - H. Clinico U. de Santiago
🇪🇸Santiago de Compostela, Spain
Hospital Clinico Universitario Lozano Blesa
🇪🇸Zaragoza, Spain
University Hospitals Birmingham NHS Foundation Trust
🇬🇧Birmingham, United Kingdom
Universitätsklinikum St. Pölten
🇦🇹St. Pölten, Austria
Fondazione Policlinico Universitario A Gemelli
🇮🇹Roma, Lazio, Italy
Centro Hospitalar Trás Os Montes E Alto Douro EPE
🇵🇹Vila Real, Portugal
Instituto Português de Oncologia Francisco Gentil Centro Regional de Oncologia de Coimbra EPE
🇵🇹Coimbra, Portugal
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
Ospedale del Mare
🇮🇹Napoli, Campania, Italy
Royal Free London NHS Foundation Trust
🇬🇧London, United Kingdom
Montefiore Medical Center
🇺🇸Bronx, New York, United States