EAP of RAD001 in Patients with Metastatic Carcinoma of the Kidney
Research type
Research Study
Full title
An open-label, multi-centre, expanded access study of RAD001 in patients with metastatic carcinoma of the kidney who are intolerant of or have progressed despite any available vascular endothelial growth factor receptor tyrosine kinase inhibitor therapy
IRAS ID
4659
Contact name
Simon Chowdhury
Sponsor organisation
Novartis Pharmaceuticals
Eudract number
2007-005460-28
Clinicaltrials.gov Identifier
Research summary
RAD001 is currently used to prevent organ rejection in patients with renal and cardiac transplantation. RAD001 is also being investigated as a anti-cancer agent, based on it??s potential to act as an inhibitor of cell division and cell growth.At present there is no licensed alternative drug treatment for patients with Metastatic Renal Cell Carcinoma (MRCC) who fail vascular endothelial growth factor receptor / tyrosine kinase inhibitor (VEGF/TKI) therapy. Results from Phase I and Phase II studies suggest that patients with MRCC can benefit from RAD001 by prolonging the time to progression of the disease. A Phase III study in MRCC was recently terminated early because it showed increased progression free survival. Novartis Pharmaceuticals is sponsoring a study to provide patients with continued access to treatment with RAD001 prior to becoming commercially available.Approximately 1000 patients will join in this study globally including multiple UK centres. All patients with MRCC will sign an informed consent and will then be screened for inclusion and exclusion criteria within five weeks prior to the first dose of RAD001. Baseline evaluations will be performed within two weeks of the first dose of RAD001. Then, patients will orally take a 10mg tablet of RAD001 continuously once daily. Patients will be asked to visit the clinic every month to check for safety (blood testing, vital signs, adverse events), other medications taken and drug accountability.Once the last dose of RAD001 is taken, or it becomes commercially available in the UK, no further safety or other data will be collected after the required 28 day safety interval.
REC name
London - South East Research Ethics Committee
REC reference
08/H1102/111
Date of REC Opinion
20 Jan 2009
REC opinion
Further Information Favourable Opinion