Urinary Bladder Neoplasms, Urologic Neoplasms, Receptor, Fibroblast Growth Factor, Type 3
Conditions
Brief 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.
Interventions
DRUGVepugratinib
Administered orally
Sponsors
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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 chemotherapy, Bacillus Calmette-Guerin, Jelmyto) therapy within 8 weeks of the first day of treatment. * Cohort A * Have synchronous UTUC disease. * Have presence of, or history of, high-grade urothelial carcinoma within 3 years of the first day of treatment, or presence of, or history of, carcinoma in situ. * Cohort B * Have presence of bladder tumors at the time of enrollment. * Have presence of, or history of, high-grade urothelial carcinoma or carcinoma in situ.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants with LG IR NMIBC with Complete Response | Baseline, 2 Years | Complete response rate is defined as negative cystoscopy and negative cytology . |
| Number of Participants with LG UTUC with Complete Response | Baseline, 2 Years | Complete response rate is defined as negative uterorenoscopy or nephroscopy assessment and negative cytology, per investigator assessment. |
Secondary
| Measure | Time frame |
|---|---|
| Duration of Response | Baseline, 5 Years |
| Time to Recurrence | Baseline, 5 Years |
Countries
United States
Contacts
CONTACTTrial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
CONTACTPhysicians interested in becoming principal investigators please contact
STUDY_DIRECTOR1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST)
Eli Lilly and Company
Outcome results
None listed