Oral Infigratinib for the Adjuvant Treatment of Subjects With Invasive Urothelial Carcinoma With Susceptible FGFR3 Genetic Alterations
Stopped early · Phase 3 · Has a placebo group
Conditions studied: Upper Tract Urothelial Carcinomas, Urothelial Bladder Cancer
In brief
This is a Phase 3 multicenter, double-blind, randomized, placebo-controlled study to evaluate the efficacy of infigratinib (an oral targeted FGFR1-3 inhibitor) versus placebo, as adjuvant treatment following surgery in adult subjects with invasive urothelial carcinoma and susceptible FGFR3 genetic alterations (mutations, and gene fusions or rearrangements) who have disease that is considered at high risk for recurrence with surgery alone. The study enrolls subjects with either bladder cancer post radical cystectomy or upper tract urothelial cancer post distal ureterectomy and/or nephrectomy. Study treatment is randomized 1:1 between infigratinib or placebo with treatment up to 1 year or until invasive local, distal, or metastatic disease recurrence confirmed by independent imaging reviewer.
Key facts
- Study ID
- NCT04197986
- Run by
- QED Therapeutics, a BridgeBio company
- People needed
- 39
- Starts
- 2020-03-11
- Expected to finish
- 2023-02-28
- Last updated by the study team
- 2024-03-13
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- City of Hope - Duarte — Duarte, California, United States
- City of Hope — Duarte, California, United States
- Loma Linda University Faculty Medical Clinics — Loma Linda, California, United States
- USC Norris Comprehensive Cancer Center — Los Angeles, California, United States
- University of Colorado Cancer Center — Aurora, Colorado, United States
- The Urology Center of Colorado — Denver, Colorado, United States
- Georgetown University Medical Center — Washington D.C., District of Columbia, United States
- Urological Research Network CORP — Hialeah, Florida, United States
- Mayo Clinic - Jacksonville — Jacksonville, Florida, United States
- Lakeland Regional Health Hollis Cancer Center — Lakeland, Florida, United States
- Emory University — Atlanta, Georgia, United States
- Winship Cancer Institute of Emory University — Atlanta, Georgia, United States
- Northwestern University Feinberg School of Medicine — Chicago, Illinois, United States
- UChicago Medicine Duchossois Center for Advanced Medicine (DCAM) - Hyde Park — Chicago, Illinois, United States
- DuPage Medical Group - Warrenville Road — Lisle, Illinois, United States
- Indiana University Melvin and Bren Simon Cancer Center — Indianapolis, Indiana, United States
- Tulane University/Southeastern Louisiana VA Health Care — New Orleans, Louisiana, United States
- Johns Hopkins Hospital — Baltimore, Maryland, United States
- Saint Louis University- SLUCare Academic Pavilion — St Louis, Missouri, United States
- University of Nebraska Medical Center — Omaha, Nebraska, United States
- Dartmouth-Hitchcock Medical Center — Lebanon, New Hampshire, United States
- John Theurer Cancer Center at Hackensack University Medical Center — Hackensack, New Jersey, United States
- New Jersey Urology - Saddle Brook — Saddle Brook, New Jersey, United States
- New Jersey Urology — Voorhees Township, New Jersey, United States
- Arizona Oncology Associates — Tucson, Arizona, United States
Full record on ClinicalTrials.gov
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