177Lu-IPN01072 - long term safety survelillance study

• Research type

  Research Study

• Full title

  A Multicentre Surveillance Study to Evaluate the Long-term Safety in Participants who Have Been Previously Treated with 177Lu-IPN01072 in an Ipsen-sponsored Clinical Study

• IRAS ID

  297709

• Contact name

  Ben Pais

• Contact email

  ct-application@ipsen.com

• Sponsor organisation

  Ipsen Pharma

• Eudract number

  2020-003640-88

• Duration of Study in the UK

  3 years, 6 months, 22 days

• Research summary

  The purpose of this safety surveillance study is to assess the long-term safety of 177Lu IPN01072 received in a previous study (protocol ID#OPS-C-001 – IRAS ID#192339) with the aim to determine the proportion of participants with neuroendocrine tumours who report a second primary malignancy during the study. Up to 40 enrolled participants (across this multicentre and the maximum study duration will be up to five years after the first dose of 177Lu-IPN01072 in Study OPS-C-001 or until withdrawal of consent or death, whichever occurs first. No study intervention will be administered in this proposed study. Visit Frequency to occur every three months (±4 weeks).

• REC name

  South Central - Oxford C Research Ethics Committee

• REC reference

  21/SC/0212

• Date of REC Opinion

  24 Aug 2021

• REC opinion

  Further Information Favourable Opinion