Metastatic Clear Cell Renal Carcinoma Clinical Trial
Official title:
An Open Label, Randomised Phase II Study, Comparing AZD2014 Versus Everolimus With Advanced Metastatic Renal Cancer and Progression on VEGF Targeted Therapy
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 2 years
of the diagnosis.
Sunitinib and other related drugs (e.g. pazopanib) have become standard therapy for
untreated patients with metastatic kidney cancer. They target a growth factor known as VEGF
which is important in treating kidney cancer. Although the results with this drug are
impressive, patients develop resistance to the drug and stop therapy. It is currently
standard practice is to give everolimus when resistance to sunitinib occurs; this is
associated with clear clinical benefit.
However the average time to cancer regrowth with everolimus is only 5 months. It is thought
this might be because, everolimus only partially inhibits its target (TORC 1 and TORC 2).
Therefore further improvement in treating patients is required. AZD2014 is a promising new
drug which does inhibit both TORC 1 and TORC 2 and is therefore worthy of investigation in
renal cancer as it theoretically could may have advantages over everolimus. Therefore study
compares AZD2014 to everolimus in the setting where everolimus is used as standard of care.
(e.g. in patients who have failed drug like sunitinib). The study is a randomised trial
allowing us to quantify the benefit and potential for further development of AZD2014. Repeat
Xrays (CT scans) will be used to assess if the new drug delays tumour growth. Patients will
be closely followed up in clinic to ensure safety. A maximum of 122 patients will be
recruited into this multi centre national trial. The primary goal of the study is to
investigate if AZ2014 delays the time for cancer regrowth (time to progression) compared to
everolimus.
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, patients develop 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
benefit.
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:
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
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT05782400 -
Multiomics Approach in Metastatic Clear Renal Cell Carcnoma
|