Cabozantinib PASS Study-F-FR-60000-001

• Research type

  Research Study

• Full title

  PROJECT TITLE: Cabozantinib PASS Study- F-FR-60000-001 Prospective non-interventional study of cabozantinib tablets in adults with advanced renal cell carcinoma following prior vascular endothelial growth factor (VEGF)-targeted therapy.

• IRAS ID

  237521

• Contact name

  Paul Nathan

• Contact email

  nathan.pd@gmail.com

• Sponsor organisation

  IPSEN PHARMA S.A.S

• Duration of Study in the UK

  3 years, 0 months, days

• Research summary

  Summary of Research
  This is a non-interventional study to be conducted at a number of locations in several countries around Europe. This study is not a condition of the marketing authorization and is voluntarily conducted by the Sponsor. The scope is to understand the utilization pattern of cabozantinib in subjects with advanced renal cell carcinoma (RCC) following prior VEGF-targeted therapy [Vascular endothelial growth factor] in real-life settings in terms of dose modifications due to adverse events when used as second line therapy or third and later line therapy. Visits will take place according to the study site’s clinical practice. The end of the study will be the date of the last study visit for the last subject in the study. A total of 680 subjects are to be included in the study in approximately 10 to 15 countries in Europe where CabometyxTM tablets is marketed at the time of the study. The total study duration will be 3 years.

  Summary of Results
  Not required as this is non-interventional study as per HRA guidelines

• REC name

  North West - Greater Manchester East Research Ethics Committee

• REC reference

  17/NW/0739

• Date of REC Opinion

  29 Dec 2017

• REC opinion

  Favourable Opinion