E7080-M000-508 (STELLAR)

Study identification

• EU PAS number:
  EUPAS36854
• Study ID:
  40736
• Official title and acronym:
  E7080-M000-508 (STELLAR)
• DARWIN EU® study:
  No
• Study countries:
  Australia

  Austria

  Belgium

  France

  Germany

  Italy

  Netherlands

  Portugal

  Russian Federation

  Sweden

  Switzerland

  United Kingdom

  United States
• Study description:
  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.
• Study status:
  Finalised

Research institutions and networks

Institutions

Eisai

Study timelines

Date when funding contract was signed

Planned: 26/10/2020

Actual: 26/10/2020

Study start date

Planned: 29/03/2021

Actual: 09/04/2021

Date of final study report

Planned: 30/03/2029

Actual: 14/06/2024

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Eisai

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 3 (required)