ASPEN study in Metastatic Non-Clear Cell Renal Cell Carcinoma
Research type
Research Study
Full title
A Randomized Phase II Study of Afinitor (RAD001) vs. Sutent (Sunitinib) in Patients with Metastatic Non-Clear Cell Renal Cell Carcinoma (ASPEN)
IRAS ID
56781
Contact name
Robert (Rob) Jones
Contact email
Sponsor organisation
Duke University
Eudract number
2010-019966-95
Clinicaltrials.gov Identifier
00903175
Research summary
Renal cell carcinoma (RCC) affects approximately 210 000 people worldwide causing 100 000 deaths annually. Around 85% of RCCs are of dominant clear cell histology (clear cell RCC (ccRCC)). The majority of the remaining non-clear cell renal cell cancers (nccRCC) are of papillary or chromophobe histologies. The overall clinical course of metastatic RCC is variable, with approximately 50% of subjects surviving <1 year and 10% surviving for over 5 years. Cytotoxic chemotherapy (such as that used in other common cancers) has consistently been shown to be an ineffective form of treatment for RCC, and, until recently, the only effective treatment for metastatic disease was immunotherapy with interferon or interleukin-2 (IL-2), the benefits of which were modest. Recent advances in understanding the biology and genetics of RCC have lead to several new drugs for the treatment of metastatic RCC, with higher response rates and improved survival times compared to immunotherapy. Most of this work has focused on patients with ccRCC. This study is designed to provide information which may improve the way nccRCC is treated in the future. It will compare two drugs (RAD001 aka everolimus (Afinitor) and sunitinib (Sutent))that have both been approved to treat RCC (although the trials included only ccRCC patients). As both work in different ways, new information will be collected to better understand if some patients respond more favourably to one or other treatment. In addition, samples will be collected to try and find out if we can predict which patients may or may not benefit from either drug in the future.
REC name
West of Scotland REC 1
REC reference
10/S0703/58
Date of REC Opinion
17 Nov 2010
REC opinion
Further Information Favourable Opinion