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Protocol No. UW16102

Principal Investigator Kyriakopoulos, Christos

Phase II

Age Group Adult

Scope National

Sponsor Type Industry

Title A Phase 2, Open-Label, Single-Agent, Multicenter Study to Evaluate the Efficacy and Safety of INCB054828 in Subjects With Metastatic or Surgically Unresectable Urothelial Carcinoma Harboring FGF/FGFR Alterations

Objective The primary purpose of this research study is to assess how metastatic or surgically unresectable Urothelial Carcinoma with FGF/FGFR alterations responds to treatment with INCB054828. The other goals of the study are to determine how safe and well tolerated the study drug, INCB054828, is, and to obtain data to try and identify subjects who would benefit most from INCB054828.

Treatment INCB054828 is an oral medicine (taken by mouth) which has not been approved by U.S. Food and Drug Administration (FDA) for the treatment of people with your medical condition. As part of this study, you are being invited to provide a tumor sample that will be used to conduct genetic testing. The sponsor needs to know if you have a specific genetic abnormality that may work with the study drug. The FGFR/FGF clinical trial assay used at the central laboratory is an investigational (not approved) test.

Description This is an "open label" study. This means that you and the study research staff will know that you are receiving INCB054828 (study drug). INCB054828 is an oral medicine (taken by mouth) which has not been approved by U.S. Food and Drug Administration (FDA) for the treatment of people with your medical condition.The treatment regimen is INCB054828 once a day by mouth for 2 consecutive weeks and then 1 week off-therapy for every 3 weeks or 21 day cycle. The estimated time you might be in the study is about 24 months.

Key Eligibility
  • Histologically documented metastatic or surgically unresectable urothelial carcinoma Stage IIIB or IV
  • Radiographically measurable or evaluable disease
  • Known FGF/FGFR alteration from the sponsor's central laboratory and have failed at least 1 previous treatment for their metastatic or surgically unresectable urothelial carcinoma or have not received chemotherapy for metastatic or surgically unresectable urothelial carcinoma due to poor performance status and insufficient renal function
  • Archival tumor specimen or willingness to undergo a pretreatment tumor biopsy
  • Patients who have received treatment with other investigational study drug for any indication for any reason, or receipt of anticancer medications within 28 days before first dose of study drug are ineligible
  • Patients with untreated brain or central nervous system (CNS) metastases or brain/CNS metastases that have progressed are ineligible
  • Women who are pregnant or lactating are ineligible
  • Patients with current evidence of corneal disorder/keratopathy are ineligible
  • Subjects who require hemodialysis are ineligible
  • Patients who have prior receipt of a selective FGFR inhibitor are ineligible
  • Patients with a history of human immunodeficiency virus infection, hepatitis B virus or hepatitis C virus are ineligible

Applicable Disease Sites Bladder; Genitourinary cancers, other

Therapies Involved Other

Drugs Involved INCB054828

Status Open

Participating Institutions UW Hospital and Clinics