Trials / Completed
CompletedNCT04763408
A Study to Evaluate the Safety and Tolerability of Lenvatinib in Participants With Advanced or Unresectable Hepatocellular Carcinoma
A Multicentre, Observational, Phase 4 Study to Evaluate the Safety and Tolerability of Lenvatinib in Patients With Advanced or Unresectable Hepatocellular Carcinoma (STELLAR)
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 335 (actual)
- Sponsor
- Eisai Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Lenvatinib | Oral capsules. |
| DRUG | Sorafenib | Oral tablets. |
Timeline
- Start date
- 2021-04-09
- Primary completion
- 2023-12-13
- Completion
- 2023-12-13
- First posted
- 2021-02-21
- Last updated
- 2024-07-18
Locations
44 sites across 10 countries: United States, Australia, Austria, Germany, Italy, Portugal, Russia, Spain, Sweden, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04763408. Inclusion in this directory is not an endorsement.