DEVELOP
Research type
Research Study
Full title
A Phase I study investigating Everolimus and Dovitnib in metastatic clear cell renal cancer
IRAS ID
54711
Contact name
Thomas Powles
Sponsor organisation
Queen Mary University Of Medicine / Barts And The London NHS Trust
Eudract number
2010-021250-19
Clinicaltrials.gov Identifier
Research summary
When kidney cancer spreads beyond the kidney, it is known as metastatic kidney cancer. This is very difficult to treat and almost all patients will die of their disease within 3 years. Sunitinib has become standard therapy for untreated patients with metastatic clear cell renal (kidney) cancer. It targets a growth factor known as VEGF which is important in treating renal cancer. Although the results with this drug are impressive, patients develop resistance to the drug, relapse and die of renal cancer. It is currently standard practice is to treat patients with everolimus when resistance to sunitinib occurs; this is associated with clear clinical benefit. However the median time to progression with everolimus is 4.9 months in previously treated patients therefore further improvement in treating patients required. The optimal way of achieving this is to increase the efficacy of everolimus by adding agents which directly target the cause of resistance to sunitinib. Dovitinib is a promising new drug in renal cancer. Dovitinib blocks cellular functions such as activation of downstream signalling molecules, cell proliferation and survival. Combining dovitinib and everolimus is very attractive. This trial is aimed to establish the maximum tolerated dose for the combination of dovitinib and everolimus in clear call renal cancer, which can then be taken into a randomised phase II study. A maximum of 30 patients will be recruited into this multi centre national trial.
REC name
West of Scotland REC 1
REC reference
10/S0703/64
Date of REC Opinion
20 Dec 2010
REC opinion
Favourable Opinion