LCI-GU-URO-CRI-001: Crizotinib in Patients With c-MET or RON-Positive Metastatic Urothelial Cancer
Status:
Terminated
Trial end date:
2019-11-21
Target enrollment:
Participant gender:
Summary
This is a single arm two-stage phase II study with crizotinib (Xalkori®) in the treatment of
subjects with metastatic urothelial cancer of the bladder, upper (ureter or renal pelvis) or
lower (urethra) urinary tracts. The purpose of this study is to see if this experimental drug
has a potential benefit in subjects with stage 4 urothelial cancer.
This study tests crizotinib used alone in subjects with urothelial cancer, previously treated
with chemotherapy, and whose tumors have certain proteins. Proteins are complex natural
substances essential to the structure and function of all living cells. These proteins, c-MET
or RON, may trigger molecular pathways that are involved in the growth and spread of bladder
or upper urinary tract cancer. Crizotinib is a drug taken by mouth that blocks these
pathways. Early laboratory research suggests that crizotinib may benefit patients with
urothelial and other cancers with these molecular pathways.