GDC-0980 vs Everolimus in MRCC patients who failed anti - VEGF therapy

• Research type

  Research Study

• Full title

  A phase II, open-label, randomised study of GDC-0980 versus everolimus in patients with metastatic renal cell carcinoma who have progressed on or following VEGF-targeted therapy.

• IRAS ID

  75606

• Contact name

  Thomas Powles

• Sponsor organisation

  Genentech Inc

• Eudract number

  2011-000493-56

• ISRCTN Number

  N/A

• Research summary

  Renal cancer is the 8th most common cancer in the UK. When Kidney cancer spreads beyond the kidney (metastatic disease) it is invariably fatal despite effective systemic therapy. Over the last 5 years 2 new classes of drugs have been shown be effective in treating metastatic kidney cancer. These include the vascular endothelial growth factor tyrosine kinase inhibitors (VEGFTKIs) which target the development of blood supply to cancers, and drugs which target the mammalian target of rapamycin inhibitors (mTOR) which inhibit proteins involved with kidney cancer cell development. The VEGFTKIs are usually given as first line therapy in metastatic kidney cancer. Once this class of drugs fail mTOR inhibitors are used. The oral mTOR inhibitor, everolimus, has randomised data to support its use in this setting. Therefore everolimus is used in patients with metastatic renal cancer who have failed VEFGTKI therapy. It is standard therapy in this setting throughout the world. Everolimus is an oral drug, taken once a day. It is continued until the cancer starts to grow. This growth is assessed by regular x-ray imaging with CT scans (about every 2 months). Although the side effects of everolimus are tolerable, it only delays the growth of the cancer by an average of 4-5 months. Everolimus may not be as effective as initially hoped because it only inhibits a small proportion of the proteins involved in cancer cell growth. Therefore there is a need to improve drugs in this setting. GDC0980 is a drug which inhibits mTOR as well as different group of related proteins (PI3K). These PI3K related proteins are thought to be important in kidney cancer. Therefore, it is hoped that this drug will turn out to be superior to everolimus in renal cancer patients who have failed initial VEGF TKI therapy. For this reason the proposed study presented here is planned. This randomised study will compare everolimus with 0890 in 80 patients who have failed VEFG TKI therapy. Half of the patients will receive everolimus and the other half will receive the study drug. The study will compare how long these drugs are effective in controlling cancer growth in these patients. Xrays (CT scans) will be used to assess cancer growth. If the study is positive larger trials with 0980 in renal cancer, with potentially hundreds of patients will occur. We hope this will change the way renal cancer, and other cancer are treated.0980 has already been given to over 50 patients with advanced cancer to test the safety (phase I study). The drug is well tolerated and safe. However safety will be closely scrutinised in this study.

• REC name

  London - South East Research Ethics Committee

• REC reference

  11/LO/1405

• Date of REC Opinion

  25 Oct 2011

• REC opinion

  Further Information Favourable Opinion