Infigratnib in Invasive UC - PROOF 302 (Urothelial Carcinoma) - Clinical Trial

What is the Purpose of this Study?

We are doing this study to learn more about the study drug (infagratinib) in patients who have undergone surgery for urothelial carcinoma.

What is the Condition Being Studied?

Urothelial carcinoma, cancer

Who Can Participate in the Study?

Adults, 18+ who:
-Have invasive urothelial carcinoma
-Are planning to have or have had nephroureterectomy, distal ureterectomy, or cystectomy in the past 4 months
-Are not pregnant
-Do not have additional health conditions like GI, kidney, or heart disease

Age Group

What is Involved?

If you choose to join this study, you will:
- Be randomized (a fair 50/50 chance) to 1 of 2 treatment groups: 
--- Group 1 will get the study drug infigratinib
--- Group 2 will get a placebo (harmless pill that does not have medicine in it)

All participants will:
-Take the study drug or placebo in 28 day cycles (3 weeks on, 1 week off) for 13 cycles.
-Have blood and urine tests
-Have tumor samples taken
-Have physical exams
-Have images taken (x-rays, CT scans etc.)

Participation in this study lasts approximately 4 years

Study Details

Full Title
Phase 3, Multicenter, Double-Blind, Randomized, Placebo-Controlled Trial of Infigratinib for the Adjuvant Treatment of Subjects with Invasive Urothelial Carcinoma with Susceptible FGFR3 Genetic Alterations (PROOF 302)
Principal Investigator
Surgical Oncologist
Protocol Number
IRB: PRO00105440
NCT: NCT04197986
Phase III
Enrollment Status
Open for Enrollment
Contact the Duke Recruitment Innovation Center