An Efficacy and Safety Study of JNJ-42756493 in Participants With Urothelial Cancer

Status:

Recruiting

Clinicaltrials.gov identifier:

Participating centers:

United States (several centers), France, United Kingdom, Belgium, Germany, Italy, Korea, Russia, Spain, Taiwan, Germany, Austria, Romania, Moldova

Accrual:

estimated 165

Study Design:

A Phase 2, Two-arm Multicenter, Open-Label Study to Determine the Efficacy and the Safety of Two Different Dose Regimens of a Pan-FGFR Tyrosine Kinase Inhibitor JNJ-42756493 in Subjects With Metastatic or Surgically Unresectable Urothelial Cancer With FGFR Genomic Alterations. Patients who have failed first line chemotherapy for metastatic disease or unresectable urothelial cancer or patients who are ineligible for cisplatin based chemotherapy (GFR < 60 mL/min) will be included.

Rationale:

JNJ-42756493 is a selective and potent orally administered pan-fibroblast growth factor receptor (FGFR) tyrosine kinase inhibitor with demonstrated activity in patients with solid tumors with alterations in the FGFR pathway including urothelial carcinoma (Tabernero J et al., ASCO 2015), indicating the potential to be a new therapeutic option for these patients. Thus far no molecularly targeted agents have been approved for the treatment of this disease. However, recent advances in genomic profiling of urothelial carcinomas have identified potential therapeutic molecular targets in 69% of tumors (The Cancer Genome Atlas Project Nature 2014). Of the molecular alterations identified, FGFR signaling in particular is altered in a high proportion of bladder tumors in both muscle invasive (15–20%) and non-invasive tumors (70–80%).