At a glance
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Phase II Study of Everolimus (RAD001) in Metastatic Transitional Cell Carcinoma of the Urothelium
In Brief
A Phase 2 clinical trial evaluating Everolimus for Bladder Cancer and Metastatic Transitional Cell Carcinoma. Completed, enrolled 46 participants across 1 site.
Detailed Summary
The purpose of this study is to learn what effects, good and/or bad, Everolimus has on advanced urothelial cancer. The goal of this clinical research study is to learn if the study drug Everolimus can shrink or slow the growth of urothelial cancer. The safety of this drug will also be studied. The patients physical state, changes in the size of the tumor, and laboratory findings taken while on-study will help us decide if Everolimus is safe and effective.
Study Details
Timeline
Interventions
Everolimus (RAD001) is a novel oral derivative of rapamycin. Everolimus will be administered orally as a once-daily dose of 10 mg (two 5 mg tablets) continuously from study day 1 until progression of disease or unacceptable toxicity. Patients will be instructed to take Everolimus in the morning, at the same time each day. Everolimus should be taken by the patient in a fasting state or with no more than a light fat-free meal.