Observational Study on the Safety and Effectiveness of Sotorasib in South Korea (20200009)

Study identification

• EU PAS number:
  EUPAS104428
• Study ID:
  105849
• Official title and acronym:
  Observational Study on the Safety and Effectiveness of Sotorasib in South Korea (20200009)
• DARWIN EU® study:
  No
• Study countries:
  Korea, Republic of
• Study description:
  The primary objective is to describe safety of sotorasib in post-marketing clinical practice within ; the approved indication by estimating the incidence of adverse events, serious adverse events, adverse drug reactions, serious adverse drug reactions, unexpected adverse events, unexpected serious adverse events, unexpected adverse drug reactions, unexpected serious adverse drug ; reactions, leading to discontinuation of sotorasib, and fatal events; as required by the Ministry of Food and Drug Safety (MFDS). The secondary objective is to describe effectiveness of sotorasib in clinical practice within the approved indication by estimating overall response rate (ORR) and clinical outcome measure by the investigator.
• Study status:
  Ongoing

Research institutions and networks

Institutions

Amgen

United States

Study timelines

Date when funding contract was signed

Planned: 31/10/2022

Actual: 06/03/2023

Study start date

Planned: 18/08/2023

Actual: 13/09/2024

Data analysis start date

Planned: 05/01/2027

Date of final study report

Planned: 13/04/2027

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Amgen

Regulatory

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