Phase I/II Trial of Sorafenib (Nexavar) and RAD001 (Everolimus)in the Treatment of Patients With Advanced Clear Cell Renal Cell Carcinoma
The drugs used in this trial are called targeted drugs as they target specific activities
that are carried out by cancer cells that make them grow and spread. Sorafenib is an
approved drug for the treatment of advanced kidney cancer. RAD001 is an experimental drug
that has been used in other research studies with other types of cancer. In this trial, the
use of RAD001 and sorafenib together for the treatment of kidney cancer is experimental. In
the Phase I portion of this study 13-16 patients will be treated with the same dose of
sorafenib and different doses of RAD001. The purpose is to see what is a safe dose of
RAD001 when combined with sorafenib in the treatment of kidney cancer. Once this dose of
RAD001 is determined, about 65 more patients will be treated to see how effective this
combination of drugs is against this kidney cancer.
Both of these drugs are taken by mouth. Sorafenib will be taken twice a day. RAD001 is
taken by mouth weekly. Patients will be able to continue treatment as long as their disease
does not worsen or side effects become intolerable.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To define the optimal dose of RAD001 and sorafenib when used in combination
18 Months
No
John D Hainsworth, MD
Principal Investigator
Sarah Cannon Research Institute
United States: Food and Drug Administration
SCRI GU 44
NCT00392821
January 2007
December 2013
Name | Location |
---|---|
Florida Hospital Cancer Institute | Orlando, Florida 32804 |
Northeast Georgia Medical Center | Gainesville, Georgia 30501 |
Spartanburg Regional Medical Center | Spartanburg, South Carolina 29303 |
Research Medical Center | Kansas City, Missouri 64132 |
South Carolina Oncology Associates, PA | Columbia, South Carolina 29210 |
Tennessee Oncology, PLLC | Clarksville, Tennessee 37043 |
Wellstar Cancer Research | Marietta, Georgia 30060 |
Oncology Hematology Care | Cincinnati, Ohio 45242 |
Baptist Hospital East | Louisville, Kentucky 40207 |
Norton Cancer Institute | Louisville, Kentucky 40207 |
Hematology Oncology Associates of Northern NJ | Morristown, New Jersey 07960 |