Dosing and Effectiveness Study of Sorafenib and RAD001 in the Treatment of Patients With Advanced Kidney Cancer



Status:Archived
Conditions:Cancer, Cancer, Kidney Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:Any
Updated:7/1/2011

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Phase I/II Trial of Sorafenib (Nexavar) and RAD001 (Everolimus)in the Treatment of Patients With Advanced Clear Cell Renal Cell Carcinoma


This study is being done in 2 parts. The first part is to determine the dose of RAD001 that
should be used in combination with sorafenib. The second part is using the above determined
dose of RAD001 in combination with sorafenib to see how effective these 2 drugs are against
advanced kidney cancer.

Participants will be asked to keep a pill diary.


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.


We found this trial at
11
sites
2501 N Orange Ave # 235
Orlando, Florida 32804
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166 Stoneridge Drive
Columbia, South Carolina 29210
803-461-3000
South Carolina Oncology Associates, PA South Carolina Oncology Associates (SCOA) is the only comprehensive cancer...
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Columbia, SC
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Gainesville, Florida 30501
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Gainesville, FL
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5053 Wooster Rd
Cincinnati, Ohio 45226
(513) 751-2273
Oncology Hematology Care Our more than 60 physicians and advanced practice providers throughout neighborhood offices...
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Cincinnati, OH
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2316 E Meyer Blvd
Kansas City, Missouri 64132
(816) 276-4000
Research Medical Center Research Medical Center offers hospital and health clinic services across three Kansas...
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Kansas City, MO
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Louisville, Kentucky 40207
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Louisville, KY
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Louisville, Kentucky 40207
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Louisville, KY
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Marietta, Georgia 30060
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Marietta, GA
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Morristown, New Jersey 07960
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Morristown, NJ
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250 25th Ave N, Ste 100
Nashville, Tennessee 37023
615-320-5090
Tennessee Oncology, PLLC Since 1976 Tennessee Oncology has been providing quality cancer care. In 2013,...
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Nashville, TN
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Spartanburg, South Carolina 29303
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Spartanburg, SC
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