A Pilot Study of BGJ398 in Patients with Recurrent Bladder Cancer that Has Not Invaded the Muscle Wall

Full Title

Pilot Study of BGJ398 in Non-Muscle-Invasive Urothelial Carcinoma of the Bladder

Purpose

Early-stage bladder cancer is often treated with anticancer drugs given directly inside the bladder (intravesical therapy). However, sometimes the cancer comes back. In this study, researchers are assessing the ability of an investigational drug called BGJ398 to shrink tumors in patients with cancer confined to the lining of the bladder ("non-invasive disease") and which came back despite intravesical therapy that included the drug BCG.

BGJ398 works by inhibiting the "fibroblast growth factor receptor" (FGFR) pathway. In many patients with non-invasive bladder cancer, there is a mutation in the FGFR gene. BGJ398 stops this mutated gene from working. It is taken orally (by mouth).

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have bladder cancer that is confined to the lining of the bladder and came back despite prior therapy that included intravesical BCG.
  • Patients must recover from the serious side effects of previous treatments before entering the study.
  • This study is for patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Jonathan Rosenberg at 646-422-4461.

Protocol

15-090

Phase

Pilot

Investigator

Co-Investigators

Locations