A Study to Evaluate the Safety and Tolerability of Lenvatinib in Participants With Advanced or Unresectable Hepatocellular Carcinoma
Completed
Conditions studied: Carcinoma, Hepatocellular
In brief
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.
Key facts
- Study ID
- NCT04763408
- Run by
- Eisai Inc.
- People needed
- 335
- Starts
- 2021-04-09
- Expected to finish
- 2023-12-13
- Last updated by the study team
- 2024-07-18
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- None
Where it is running
- California Liver Research Institute — Pasadena, California, United States
- Montefiore Medical Center — The 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, Tyrol, Austria
- Klinikum Klagenfurt Am Woerthersee — Klagenfurt, Austria
- Universitätsklinikum St. Pölten — Sankt Pölten, Austria
- Medizinische Universitat Wien (Medical University of Vienna) — Vienna, Austria
- Eisai Trial Site #3 — Cologne, North Rhine-Westphalia, Germany
- Eisai Trial Site #5 — Mainz, Rhineland-Palatinate, Germany
- Eisai Trial Site #2 — Berlin, Germany
- Eisai Trial Site #6 — Munich, Germany
- Eisai Trial Site #1 — Ulm, Germany
- Ospedale del Mare — Naples, Campania, Italy
- Fondazione PTV Policlinico Tor Vergata — Rome, Lazio, Italy
- Azienda Ospedaliera San Camillo Forlanini — Rome, Lazio, Italy
- Fondazione Policlinico Universitario A Gemelli — Rome, Lazio, Italy
- Azienda Ospedaliero Universitaria Di Cagliari — Monserrato Cagliari, Sardinia, Italy
- Azienda Ospedaliero Universitaria Di Bologna - Policlinico S Orsola Malpighi — Bologna, Italy
- Hospital Garcia de Orta — Almada, Setúbal District, 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 — Lisbon, Portugal
- Centro Hospitalar Trás Os Montes E Alto Douro EPE — Vila Real, Portugal
Full record on ClinicalTrials.gov
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