Non-Interventional Study of Renal Cell Cancer Targeted Therapy V1
Research type
Research Study
Full title
A real world retrospective database study of patients diagnosed with metastatic and/or advanced renal cell carcinoma and treated with sunitinib and/or axitinib in a specialist United Kingdom oncology centre.
IRAS ID
266899
Contact name
Michael Moran
Contact email
Sponsor organisation
Pfizer Pharma GmbH
Duration of Study in the UK
0 years, 3 months, 29 days
Research summary
Metastatic renal cell carcinoma (mRCC) is a global health problem, resulting in the deaths of more than 14,000 patients every year. Over the past 20 years, there has been a shift from cytokine based therapy towards agents targeting vascular endothelial growth factor (VEGF) receptors due to evidence of increased efficacy.
Pfizer have two VEGF targeted medicines to treat mRCC, both TKIs (tyrosine kinase inhibitors): sunitinib and axitinib, which are used in first and second line respectively. It is important that we have a clear understanding of the real world use and efficacy of our medicines.
The Christie Hospital has been building a detailed database of information regarding patients with mRCC, and now has over 3000 patients’ details included. The collated information includes prognostic scoring criteria, patient outcomes, grading systems and therapy details.
The Food and Drug Authorization (FDA), European Medicines Agency (EMA) and the National Institute for Health and Care Excellence (NICE) have approved several TKIs over the years. It is important that first-line therapies are strategically chosen to devoid the need for sequential therapy lines. In order for HCPs to select the optimal first-line TKI, head-to-head RCT comparison studies are undertaken.
This study presents an opportunity to investigate TKI therapies used for the treatment of renal cell carcinoma, using a high quality real world evidence database, which was developed and has been maintained at the Christie Hospital, Manchester.REC name
London - Surrey Research Ethics Committee
REC reference
19/LO/1041
Date of REC Opinion
21 Jun 2019
REC opinion
Favourable Opinion