Oral Infigratinib for the Adjuvant Treatment of Subjects With Invasive Urothelial Carcinoma With Susceptible FGFR3 Genetic Alterations
Public ClinicalTrials.gov record NCT04197986. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official 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)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT04197986
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 39 participants
Conditions and interventions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Mar 11, 2020 (Actual)
- Primary completion
- Feb 28, 2023 (Actual)
- Completion
- Feb 28, 2023 (Actual)
- Last update posted
- Mar 13, 2024
2020 – 2023
United States locations
- U.S. sites
- 47
- U.S. states
- 24
- U.S. cities
- 42
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Arizona Oncology Associates | Tucson | Arizona | 85711 | — |
| City of Hope - Duarte | Duarte | California | 91010 | — |
| City of Hope | Duarte | California | 91010 | — |
| Loma Linda University Faculty Medical Clinics | Loma Linda | California | 92350 | — |
| USC Norris Comprehensive Cancer Center | Los Angeles | California | 90033 | — |
| University of Colorado Cancer Center | Aurora | Colorado | 80045 | — |
| The Urology Center of Colorado | Denver | Colorado | 80211 | — |
| Georgetown University Medical Center | Washington D.C. | District of Columbia | 20007 | — |
| Urological Research Network CORP | Hialeah | Florida | 33016 | — |
| Mayo Clinic - Jacksonville | Jacksonville | Florida | 32224 | — |
| Lakeland Regional Health Hollis Cancer Center | Lakeland | Florida | 33805 | — |
| Emory University | Atlanta | Georgia | 30322 | — |
| Winship Cancer Institute of Emory University | Atlanta | Georgia | 30322 | — |
| Northwestern University Feinberg School of Medicine | Chicago | Illinois | 60611 | — |
| UChicago Medicine Duchossois Center for Advanced Medicine (DCAM) - Hyde Park | Chicago | Illinois | 60637 | — |
| DuPage Medical Group - Warrenville Road | Lisle | Illinois | 60532 | — |
| Indiana University Melvin and Bren Simon Cancer Center | Indianapolis | Indiana | 46202 | — |
| Tulane University/Southeastern Louisiana VA Health Care | New Orleans | Louisiana | 70112 | — |
| Johns Hopkins Hospital | Baltimore | Maryland | 21287 | — |
| Saint Louis University- SLUCare Academic Pavilion | St Louis | Missouri | 63110 | — |
| University of Nebraska Medical Center | Omaha | Nebraska | 68198 | — |
| Dartmouth-Hitchcock Medical Center | Lebanon | New Hampshire | 03766 | — |
| John Theurer Cancer Center at Hackensack University Medical Center | Hackensack | New Jersey | 07601 | — |
| New Jersey Urology - Saddle Brook | Saddle Brook | New Jersey | 07663 | — |
| New Jersey Urology | Voorhees Township | New Jersey | 08043 | — |
| Albany Medical Center - Division of Urology | Albany | New York | 12208 | — |
| Associated Medical Professionals - Syracuse | Syracuse | New York | 13210 | — |
| Duke University Cancer Center | Durham | North Carolina | 27710 | — |
| Accellacare-DuPage Medical Group | Raleigh | North Carolina | 27609 | — |
| Wake Forest Baptist Health | Winston-Salem | North Carolina | 27157 | — |
| University of Toledo | Arlington | Ohio | 43606 | — |
| Oncology Hematology Care | Cincinnati | Ohio | 45242 | — |
| Cleveland Clinic | Cleveland | Ohio | 44195 | — |
| The Ohio State University College of Medicine | Columbus | Ohio | 43210 | — |
| The University of Toledo Medical Center | Toledo | Ohio | 43614 | — |
| Stephenson Cancer Center | Oklahoma City | Oklahoma | 73104 | — |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | — |
| Urology Associates | Nashville | Tennessee | 37209 | — |
| Harold C. Simmons Comprehensive Cancer Center | Dallas | Texas | 75390 | — |
| Bayor College of Medicine | Houston | Texas | 77030 | — |
| Houston Methodist Hospital- Department of Urology | Houston | Texas | 77030 | — |
| The University of Texas MD Anderson Cancer Center | Houston | Texas | 77030 | — |
| UT Southwestern | Richardson | Texas | 75080 | — |
| Urology San Antonio | San Antonio | Texas | 78229 | — |
| Huntsman Cancer Institute and Hospital | Salt Lake City | Utah | 84112 | — |
| Seattle Cancer Care Alliance | Seattle | Washington | 98109 | — |
| West Virginia University | Morgantown | West Virginia | 26506 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 96 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04197986, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Mar 13, 2024 · Synced Oct 21, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04197986 live on ClinicalTrials.gov.