Primary Outcome Measures:
- Phase I: To establish the maximally tolerated dose (MTD) and safety profile of RAD001 in combination with Nexavar® in patients with metastatic renal cell carcinoma (MRCC). [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
- Phase II: Study the anti-tumor effects of RAD001 plus Nexavar® [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Phase II: Response rate [ Time Frame: restaging every 8 weeks ] [ Designated as safety issue: No ]
- Duration of tumor response [ Time Frame: restaging every 8 weeks ] [ Designated as safety issue: No ]
- Progression free survival [ Time Frame: restaging every 8 weeks ] [ Designated as safety issue: No ]
- Overall survival [ Time Frame: restaging every 8 weeks ] [ Designated as safety issue: No ]
- Study the safety of RAD001 plus Nexavar® given at MTD. [ Time Frame: AEs as occur ] [ Designated as safety issue: Yes ]
Despite significant progress in understanding the biology of renal cell carcinoma (RCC), it is estimated that over 35, 000 people in the United States will be diagnosed and approximately 12, 000 have died from this disease in 2005. Renal cell carcinoma presently ranks tenth as the leading cause of cancer death and constitutes 3% of all solid neoplasms.
In contrast to many other malignancies, treatment for RCC is limited. Treatment remains a highly difficult and perplexing challenge due to its resistance to both chemotherapy and hormone therapy and limited response to cytokines. Despite recent advances in our fundamental knowledge of RCC biology and development of molecular therapeutics, more clinical research will be required to best guide our use of these exciting new agents in combination regimens.
The combination of RAD001 and Nexavar®, in current clinical trials with minimal toxicity, represents a treatment regimen which should be investigated for tolerance and toxicity as well as initial phase II efficacy. The study is designed to evaluate the MTD. Following the completion of the phase I, utilizing the MTD, Phase II study is designed to evaluate the anti-tumor activity.