A Phase II study of RAD001 in advanced papillary renal cell cancer

• Research type

  Research Study

• Full title

  RAPTOR: A single arm, multicentre phase II trial of RAD001(everolimus) as monotherapy in the treatment of advanced papillary renal cell cancer

• IRAS ID

  18622

• Sponsor organisation

  Novartis Pharma services AG

• Eudract number

  2008-006181-28

• ISRCTN Number

  requested

• Research summary

  This clinical research study is a Phase II study to investigate the effects of RAD001 (everolimus) as monotherapy in patients with metastatic papillary renal cell cancer. RAD001 (everolimus) acts directly on the tumour cells, preventing cell growth and spread of the tumour to other areas of the body. The rationale for this study is that there is a need for first line chemotherapy agents in this patient population as there are few alternatives available. There are preclinical and clinical data to support the use of drugs such as RAD001 (everolimus) in papillary renal cell cancer. The study design is open label, non-randomised, single arm and multicentre. This means that there is only one drug being used, RAD001 (everolimus), and all patients on the trial will receive this. They will all be told that they are receiving RAD001 (everolimus). The study will take place in 4 different sites* across the UK recruiting a total of 12 patients. This represents part of a larger European study in France, Germany, Spain, Italy and Poland, where 44 patients will be recruited in total. Patients who are over 18 and have been diagnosed with metastatic papillary renal cell cancer will be eligible. The study is expected to last until patients show signs of disease progression. They will then be followed for a further 2 years for monitoring of their disease and general health. The primary research objective is to evaluate the percentage of patients whose disease hasn't progressed at 6 months. Patients will receive radiological scans to monitor for disease progression. Other procedures that will be used for this study are blood and urine tests and a complete physical examination.The study will also be evaluating the following secondary endpoints; disease control rate, objective response rate, duration of response, median progression free survival and overall survival. *3 sites are currently open in the UK ?? one site has been closed due to non-recruitment of patients.

• REC name

  London - West London & GTAC Research Ethics Committee

• REC reference

  09/H0803/74

• Date of REC Opinion

  22 May 2009

• REC opinion

  Further Information Favourable Opinion