RAD001 compared to Sunitinib in Patients with Renal Cancer.

• Research type

  Research Study

• Full title

  An open-label, multicenter phase II study to compare the efficacy and safety of RAD001 as first-line followed by second-line sunitinib versus sunitinib as first-line followed by second-line RAD001 in the treatment of patients with metastatic renal cell carcinoma.

• IRAS ID

  27773

• Contact name

  Amit Bahl

• Sponsor organisation

  Novartis Pharma Services AG

• Eudract number

  2009-011055-21

• Clinicaltrials.gov Identifier

  NCT00903175

• Research summary

  The purpose of this study is to see whether Everolimus (Afinitor©) in comparison to sunitinib (Sutent©), as a first line or second-line treatment, is as effective and safe for people who have not received prior treatment for their advanced kidney cancer. Sunitinib is marketed in the USA and Europe for the treatment of kidney cancer. Everolimus is currently marketed for the prevention of organ transplantation and has received approval in the UK for the treatment of kidney cancer from September 2009. Everolimus works by stopping certain proteins in the body that cause the cancer cells to grow and divide. Everolimus has shown effects on kidney cancer in both laboratory and human studies, by slowing the growth of the cancer. Patients will receive either Everolimus or Sunitinib on a daily basis, Sunitinib will be stopped for 2 weeks after every 4-weeks. This is an open label study, which means that both the patient and the doctor will know which medication the patient is taking. If it is found that treatment is not working, the patient will switch to the other study medication. Patients will visit the study hospital twice every cycle (six weeks) for routine check-ups and they will have scans every 12 weeks to determine the tumour status. Each participant will receive study medication until disease progression, unacceptable side effects or withdrawal of consent. Patients will then be contacted every two months for up to three years to see how they are. Approximately 390 patients will take part in this study in over 100 centres around the world (Europe, Asia, North and South America and Australia). This study is being organised by Novartis Pharmaceuticals Corporation of Florham Park, New Jersey 07932 USA.

• REC name

  London - Hampstead Research Ethics Committee

• REC reference

  09/H0720/117

• Date of REC Opinion

  18 Nov 2009

• REC opinion

  Further Information Favourable Opinion