ZEBRA

• Research type

  Research Study

• Full title

  AN OPEN LABEL RANDOMISED PHASE II STUDY COMPARING AZD2014 VERSUS EVEROLIMUS IN PATIENTS WITH ADVANCED METASTATIC RENAL CANCER AND PROGRESSION ON VEGF TARGETED THERAPY

• IRAS ID

  99465

• Contact name

  Thomas Powles

• Sponsor organisation

  Queen Mary University of London

• Eudract number

  2012-002874-30

• ISRCTN Number

  N/a

• 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 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 X-rays (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.

• REC name

  London - City & East Research Ethics Committee

• REC reference

  12/LO/1717

• Date of REC Opinion

  10 Dec 2012

• REC opinion

  Further Information Favourable Opinion