Comparative Study of RAD001 in Metastatic Carcinoma of the Kidney

• Research type

  Research Study

• Full title

  A randomised, open label, multi-centre phase II study to compare bevacizumab plus RAD001 versus interferon alfa- 2a plus bevacizumab for the first-line treatment of patients with metastatic clear cell carcinoma of the kidney

• IRAS ID

  4655

• Sponsor organisation

  Novartis Pharmaceuticals

• Eudract number

  2008-000077-38

• Clinicaltrials.gov Identifier

  NCT00719264

• Research summary

  RAD001 is currently used to prevent organ rejection in patients with kidney and cardiac transplantation. RAD001 is also being investigated as an anti-cancer agent, based on its potential to act as an inhibitor of cell division and cell growth. Results from previous studies suggest that patients with metastatic renal cell carcinoma (MRCC) can benefit from RAD001 by prolonging the time to progression of the disease. A previous study in MRCC was recently terminated early because it showed increased patient free survival. Novartis Pharmaceuticals is sponsoring a study to determine if the study drug RAD001 in combination with bevacizumab (a licensed drug for treatment of MRCC) can slow the progression of kidney cancer compared to bevacizumab combined with interferon alfa-2a (a licensed drug for treatment of MRCC)About 360 patients from approximately 100 centres around the world will be randomly (by chance) assigned to one of two treatment groups:
  Group 1 - Bevacizumab and interferon alfa-2a. Patients will be asked to inject themselves with interferon alfa-2a three times a week and have fortnightly infusion of bevacizumab
  Group 2 - Bevacizumab and RAD001. Patients will be asked to take 2 tablets of RAD001 every day and have fortnightly infusion of bevacizumab
  Study site visits will occur approximately every two weeks to check for safety (blood testing, vital signs, adverse events), other medications taken, quality of life and drug accountability. Imaging scans to evaluate the size of the tumour(s) in the body will be carried out every 3 months from the second site visit and as often as medically necessary.Patients with available archival tumour tissue will be asked to donate a sample for biomarker analysis. If the patient consents to this optional sub study, a blood sample will be collected for DNA analysis.

• REC name

  London - Hampstead Research Ethics Committee

• REC reference

  09/H0720/5

• Date of REC Opinion

  12 Mar 2009

• REC opinion

  Further Information Favourable Opinion