Prospective non interventional study of cabozantinib tablets in adults with advanced renal cell carcinoma following prior vascular endothelial growth factor (VEGF)-targeted therapy (Cassiope)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/48986
• EU PAS number:
  EUPAS19464
• Study ID:
  48986
• Official title and acronym:
  Prospective non interventional study of cabozantinib tablets in adults with advanced renal cell carcinoma following prior vascular endothelial growth factor (VEGF)-targeted therapy (Cassiope)
• DARWIN EU® study:
  No
• Study countries:
  Austria

  Belgium

  Czechia

  France

  Germany

  Greece

  Italy

  Netherlands

  Poland

  Spain

  United Kingdom
• Study description:
  For this prospective non-interventional study, the objective is to understand the utilisation of cabozantinib in subjects with advanced Renal Cell Carcinoma following prior VEGF-targeted therapy in real life settings in terms of dose modifications due to AEs (Adverse Events) when used as a second line therapy or third and later line therapy. Other patterns of use of cabozantinib will also be described.
• Study status:
  Finalised

Research institutions and networks

Institutions

Ipsen Pharma

Multiple centres: 103 centres are involved in the study

Study timelines

Date when funding contract was signed

Planned: 16/03/2017

Actual: 16/03/2017

Study start date

Planned: 05/01/2018

Actual: 24/04/2018

Data analysis start date

Planned: 01/09/2022

Actual: 08/09/2022

Date of interim report, if expected

Planned: 30/12/2020

Actual: 30/12/2020

Date of final study report

Planned: 31/03/2023

Actual: 19/12/2022

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Ipsen Pharma

Study protocol

Initial protocol

f-fr-60000-001-protocol

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 3 (required)