Everolimus (RAD001) in Metastatic Transitional Cell Carcinoma of the Urothelium
|ClinicalTrials.gov Identifier: NCT00805129|
Recruitment Status : Active, not recruiting
First Posted : December 9, 2008
Last Update Posted : January 3, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Bladder Cancer Metastatic Transitional Cell Carcinoma||Drug: Everolimus||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||46 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study of Everolimus (RAD001) in Metastatic Transitional Cell Carcinoma of the Urothelium|
|Study Start Date :||December 2008|
|Estimated Primary Completion Date :||December 2018|
|Estimated Study Completion Date :||December 2018|
Everolimus will be administered at a dose of 10 mg orally once daily continuously.
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.
- To measure the two-month PFS rate of Everolimus (RAD001) as determined by RECIST. [ Time Frame: conclusion of the study ]
- To determine the safety and toxicity of Everolimus (RAD001) in this patient population. [ Time Frame: conclusion of the study ]
- To determine the response rate of Everolimus in patients with progressive urothelial cancer who have received prior cytotoxic chemotherapy. [ Time Frame: conclusion of the study ]
- To assess markers for activated mTOR pathway (including phospho-S6 and phospho-4E BP1) in all pre-treatment tissue specimens and correlate with response to treatment and PFS. [ Time Frame: conclusion of the study ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00805129
|United States, New York|
|Memorial Sloan Kettering Cancer Center|
|New York, New York, United States, 10065|
|Principal Investigator:||Dean Bajorin, MD||Memorial Sloan Kettering Cancer Center|