Post-marketing surveillance of Lenvima in patients with unresectable thyroid cancer in Japan (LEN01T)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/33058
• EU PAS number:
  EUPAS14555
• Study ID:
  33058
• Official title and acronym:
  Post-marketing surveillance of Lenvima in patients with unresectable thyroid cancer in Japan (LEN01T)
• DARWIN EU® study:
  No
• Study countries:
  Japan
• Study description:
  All patients with unresectable thyroid cancer administered Lenvima in Japan will be registered and monitored for safety, and efficacy (overall survival at one year and response rate)
• Study status:
  Finalised

Research institutions and networks

Institutions

Eisai

Multiple centres: 40 centres are involved in the study

Study timelines

Date when funding contract was signed

Actual: 01/04/2016

Study start date

Actual: 20/05/2016

Date of final study report

Planned: 31/12/2017

Actual: 17/10/2019

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Eisai Inc

Regulatory

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

Other study registration identification numbers and links

E7080-M081-501