Everolimus (RAD001) in Metastatic Transitional Cell Carcinoma of the Urothelium

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.

Timeline

Start

2008-12-05

Primary completion

2021-12-15

Completion

2021-12-15

Outcome

Missed primary endpoint

paper Although everolimus did not meet its primary endpoint, one partial response, one near-complete response and twelve minor regressions were observed. PMID 23551593 ↗

Publications

• Milowsky MI, Iyer G, Regazzi AM, Al-Ahmadie H, Gerst SR, Ostrovnaya I, Gellert LL, Kaplan R, Garcia-Grossman IR, Pendse D, Balar AV, Flaherty AM, Trout A, Solit DB, Bajorin DF. Phase II study of everolimus in metastatic urothelial cancer. BJU Int. 2013 Aug;112(4):462-70. doi: 10.1111/j.1464-410X.2012.11720.x. Epub 2013 Apr 3.
• Iyer G, Hanrahan AJ, Milowsky MI, Al-Ahmadie H, Scott SN, Janakiraman M, Pirun M, Sander C, Socci ND, Ostrovnaya I, Viale A, Heguy A, Peng L, Chan TA, Bochner B, Bajorin DF, Berger MF, Taylor BS, Solit DB. Genome sequencing identifies a basis for everolimus sensitivity. Science. 2012 Oct 12;338(6104):221. doi: 10.1126/science.1226344. Epub 2012 Aug 23.

Drugs

Indications