An Open Label, Randomised Phase II Study, Comparing AZD2014 Versus Everolimus With Advanced Metastatic Renal Cancer and Progression on VEGF Targeted Therapy
Renal cell cancer, also referred to as kidney cancer, is diagnosed in approximately 170,000
people worldwide annually, resulting in 82,000 deaths. Treatment for metastatic kidney
cancer is difficult. Almost all of the patients die from their disease.
In 2006 a new drug called sunitinib, a tyrosine kinase inhibitor, transformed treatment
options. It targets the development of new blood vessels within the cancer. Although the
results with this drug are impressive, patientsdevelop resistance a median after 11 months
to the drug, relapse and die of renal cancer. It is currently standard practice to switch to
everolimus when resistance to sunitinib occurs; this is associated with clear clinical
POTENTIAL RISKS FOR PATIENTS RECEIVING AZD2014:
The main risks and burdens to the patients participating in the study are the potential for
side effects of the AZD2014 drug. The phase I study using this drug has been completed,
therefore we know it is safe to administer to patients and we have a good idea of what side
effects the drug causes. But as the drug is given to larger numbers, additional side effects
may be discovered. The activity of the drug has not been evaluated in kidney cancer.
Therefore we are not sure if AZD2014 will work
POTENTIAL RISKS FOR PATIENTS RECEIVING EVEROLIMUS:
Everolimus is the current standard therapy for these patients so the risks associated with
study drug for these patients are the same as standard of care.
POTENTIAL RISKS FOR ALL PATIENTS:
Side effects will be closely monitored during and after the study. Patients are required to
attend clinic weekly for the first four weeks and then every 4 weeks whilst they are on
study medication where adverse events will be recorded.
The patient information sheet includes details on expected adverse events for patients to
look out for and also details that unexpected events may occur. Patients are provided with
the research nurse and principal investigator contact details should any adverse events
occur during the course of the study.
Other medical professionals are informed that patients are receiving an experimental drug
(through GP letter and labelling of hospital records). There will be an independent data
monitoring committee for the trial which will closely assess the side effects of the drugs
on a regular basis and the trial results to make sure there are no risk excess to patients.
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
To investigate if single agent AZD2014 delays progression free survival compared to everolimus using RESIST v1.1
Completion of study- approx 3 years
Queen Mary University of London, UK
United Kingdom: Medicines and Healthcare Products Regulatory Agency