CABOZANTINIB IN PATIENTS WITH ADVANCED RENAL CELL CARCINOMA
Research type
Research Study
Full title
A NON-INTERVENTIONAL RETROSPECTIVE STUDY TO DESCRIBE EARLY CLINICAL EXPERIENCE WITH CABOZANTINIB IN PATIENTS WITH ADVANCED RENAL CELL CARCINOMA IN THE UK
IRAS ID
253198
Contact name
Balaji Venugopal
Contact email
Sponsor organisation
Ipsen Group
Clinicaltrials.gov Identifier
NA, NA
Duration of Study in the UK
0 years, 9 months, 31 days
Research summary
This is a multicentre, retrospective non-interventional research study to be conducted in 5-6 specialist centres in the UK.
Cabozantinib is indicated for the treatment of advanced RCC in adults following prior vascular endothelial growth factor (VEGF)-targeted therapy and is one of a number of targeted therapies approved as second line treatment in advanced renal cell carcinoma (RCC). Since its licence was granted in 2016 it has been available to patients in the UK via a managed access programme (MAP).Data to describe treatment pathways, clinical outcomes and baseline characteristics will be collected from the hospital medical records of all eligible (estimated 100) adult patients prescribed cabozantinib for advanced RCC as part of the MAP in the participating centres. There will be no changes to patient management for the purposes of any part of this retrospective study; all evaluations and assessments will have been in accordance with routine care.
REC name
North of Scotland Research Ethics Committee 1
REC reference
18/NS/0112
Date of REC Opinion
28 Sep 2018
REC opinion
Favourable Opinion