COSAK

• Research type

  Research Study

• Full title

  A Randomised Phase II Study Evaluating Cediranib vs. Cediranib and Saracatanib in patients with relapsed metastatic clear cell renal cancer

• IRAS ID

  34050

• Contact name

  Thomas Powles

• Eudract number

  2009-018014-20

• ISRCTN Number

  ISRCTN56886343

• Research summary

  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. There is no standard treatment in the UK for patients once sunitinib has stopped working, therefore an improvement in this area is required.Metastatic clear cell renal cancer is usually considered to be an incurable disease and obtaining a remission of the disease with the hope of reducing disease symptoms, increasing time to progression of disease and increasing survival become important therapeutic goals. There is a need for new therapeutic strategies and/or new drugs to incorporate into such strategies.Previous trials have shown that cediranib has significant anti-tumoural activity and has shown clinical benefit in up to 80% of patients with renal cancer. giving drugs like sunitinib and cediranib sequentially in renal cancer is effective.Saracatanib is a cancer drug that works in a different way to cediranib and emerging evidence shows that it may help in preventing drug resistance. Saracatanib inhibits the Src protein tyrosine kinases and emerging studies show that Src is key in the development of drug resistance.This study is designed to see if there is more benefit from taking cediranib and saracatanib together than cediranib alone in patients who have previously been treated with and failed VEGF (vascular endothelial growth factor) targeted therapy such as sunitinib. This trial is a clinical phase II randomised study of 130 patients with relapsed metastatic clear cell renal cancer. Recruitment will take place over a period of two years. If the combination regimen proves more potent, it will be taken into a phase III study for this indication.

• REC name

  London - Dulwich Research Ethics Committee

• REC reference

  10/H0808/14

• Date of REC Opinion

  28 Jan 2010

• REC opinion

  Favourable Opinion