Incidence and Resolution of Eribulin-induced peripheral Neuropathy (IRENE)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/50054
• EU PAS number:
  EUPAS14118
• Study ID:
  50054
• Official title and acronym:
  Incidence and Resolution of Eribulin-induced peripheral Neuropathy (IRENE)
• DARWIN EU® study:
  No
• Study countries:
  Germany
• Study description:
  To characterize and determine the incidence of eribulin-induced peripheral neuropathy (PN), and frequency and time to resolution of eribulin-induced PN in patients treated with eribulin in a real life setting for locally advanced or metastatic breast cancer (MBC), following one or two prior chemotherapeutic regimens for advanced disease.
• Study status:
  Finalised

Research institutions and networks

Institutions

Eisai

Multiple centres: 60 centres are involved in the study

Study timelines

Date when funding contract was signed

Planned: 05/05/2016

Actual: 05/05/2016

Study start date

Planned: 08/08/2016

Actual: 12/08/2016

Date of interim report, if expected

Planned: 02/12/2019

Actual: 15/11/2019

Date of final study report

Planned: 31/12/2023

Actual: 18/04/2023

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Eisai

Study protocol

Initial protocol

Halaven_Beobachtungsplan_PASS_1.0_ 06 May 2016 clean_FINAL_160602_signed

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)

Other study registration identification numbers and links

E7389-M044-504