Primary Outcomes:

Primary Outcome 1 - Measure: Recurrence-Free Survival (RFS)

Primary Outcome 1 - Time Frame: Up to 4 years

Condition:

• Urinary Bladder Neoplasms

Eligibility

Criteria:
Inclusion Criteria:

- Histologically confirmed, recurrent, non-muscle-invasive urothelial carcinoma of the
bladder. Variant pathology are allowed

- Tumor with specified fibroblast growth factor receptor (FGFR) mutations or fusions

- Bacillus Calmette- Guerin (BCG)-unresponsive after adequate BCG therapy or BCG
experienced participants

- Refuses or is not eligible for cystectomy (Cohort 1 and Cohort 2 only)

- Eastern Cooperative Oncology Group (ECOG) performance status Grade 0-1

- Must sign an informed consent form (ICF) (or their legally acceptable representative
must sign) indicating that he or she understands the purpose of, and procedures
required for, the study and is willing to participate in the study

- A woman of childbearing potential must have a negative pregnancy test (beta-hCG
[beta-human chorionic gonadotropin]) (urine or serum) within 7 days before
randomization (Cohort 1) or the first dose of study drug (Cohort 2 and Cohort 3)

- Adequate bone marrow, liver, and renal function as specified in the protocol

Exclusion Criteria:

- Histologically confirmed, muscle-invasive (T2 or higher stage) urothelial carcinoma of
the bladder

- Histopathology demonstrating any small cell component, pure adenocarcinoma, pure
squamous cell carcinoma, or pure squamous CIS of the bladder

- Prior treatment with an FGFR inhibitor

- Active malignancies other than the disease being treated under study. The only allowed
exceptions are: (a) skin cancer treated within the last 24 months that is considered
completely cured (b) adequately treated lobular carcinoma in situ (LCIS) and ductal
CIS (c) history of localized breast cancer and receiving antihormonal agents, or
history of localized prostate cancer (N0M0) and receiving androgen deprivation therapy

- Current central serous retinopathy or retinal pigment epithelial detachment of any
grade
Show More

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No