Phase I/II Trial of RAD001 Plus Nexavar® For Patients With Metastatic Renal Cell Carcinoma
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.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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).
1 year
Yes
Robert J Amato, DO
Principal Investigator
The Methodist Hospital Research Institute
United States: Food and Drug Administration
RCC-06-102
NCT00448149
December 2006
Name | Location |
---|---|
The Methodist Hospital Research Institute | Houston, Texas 77030 |