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Brief Title: Buparlisib in Metastatic Transitional Cell Carcinoma of the Urothelium
Official Title: Phase II Study of Buparlisib in Metastatic Transitional Cell Carcinoma of the Urothelium
Study ID: NCT01551030
Brief Summary: The purpose of this study is to learn what effects, good and/or bad, Buparlisib has on advanced urothelial cancer. Buparlisib is a pill that works by shutting down some of the signals in cancer cells that make tumors grow. It is being tested in patients in research studies such as this one. As of 2010, more than 80 patients with various types of cancer have received treatment with Buparlisib in research studies. This clinical research study is divided into two parts. The goal of the first part of this study is to learn if the study drug Buparlisib can shrink or slow the growth of cancer in patients with urothelial tumors. The goal of the second part of this study is to learn if the study drug Buparlisib can shrink or slow the growth of urothelial tumors in patients known to have certain genetic alterations that cause these types of tumors. The study doctor will inform the patient which part of the study is currently enrolling participants. Participants in both parts of the study will receive the same treatment and tests. The safety of this drug will also be studied in both parts. The physical state, changes in the size of the tumor, and laboratory findings taken while on-study will help us decide if Buparlisib is safe and effective.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Memorial Sloan-Kettering at Basking Ridge, Basking Ridge, New Jersey, United States
Memorial Sloan-Kettering Cancer Center @ Suffolk, Commack, New York, United States
Memorial Sloan Kettering Cancer Center, New York, New York, United States
Memorial Sloan-Kettering Cancer Center at Mercy Medical Center, Rockville Centre, New York, United States
Memoral Sloan Kettering Cancer Center@Phelps, Sleepy Hollow, New York, United States
Name: Dean Bajorin, MD
Affiliation: Memorial Sloan Kettering Cancer Center
Role: PRINCIPAL_INVESTIGATOR