FORAY: A Phase 2, Randomized, Open-Label Study Evaluating Vepugratinib in Adults With FGFR3 Altered Low Grade, Intermediate Risk, Non-muscle Invasive Bladder Cancer and Low Grade Upper Tract Urothelial Carcinoma

Eli Lilly and Company

Summary

The main purpose of this study is to see how well vepugratinib works in adults with low grade, intermediate risk, non-muscle invasive bladder cancer (LG IR NMIBC) or low-grade upper tract urothelial carcinoma (LG UTUC). Safety tests will also be conducted. For each participant, the study will last up to 5 years.

Eligibility

Age range: 18+ years
Sex: All
Healthy volunteers: No

Detailed criteria

Inclusion Criteria: * All Participants: * Have a PS of 0 to 2 on the Eastern Cooperative Oncology Group Performance Status (ECOG PS) scale * Cohort A * Have histologically confirmed LG NMIBC. * Have LG IR NMIBC at time of screening * Have a documented qualifying fibroblast growth factor receptor 3 protein (FGFR3) mutation or fusion * Cohort B * Have histologically confirmed LG UTUC. Exclusion Criteria: * All Participants * Have had a prior positive urine cytology within 6 weeks of first day of treatment. * Have received prior local instillation (for example, intravesical c…

Interventions

Drug
Vepugratinib
Administered orally

Location

Carolina Urologic Research Center, LLC
Myrtle Beach, South Carolina

FORAY: A Phase 2, Randomized, Open-Label Study Evaluating Vepugratinib in Adults With FGFR3 Altered Low Grade, Intermediate Risk, Non-muscle Invasive Bladder Cancer and Low Grade Upper Tract Urothelial Carcinoma

Summary

Eligibility

Interventions

Location

Run this study?

Details

Conditions