Study of Erdafitinib Intravesical Delivery System for Localized Bladder Cancer

Last Updated   August 7, 2024

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CR109115

OVERVIEW

  • Sexes Eligible for Study
    all
  • Age
    18+ years
  • Phase
    phase 1
    1
  • Sites
    21 Sites
  • Status
     Recruiting

SUMMARY

Bladder cancer is one of the most common malignancy worldwide, and non-muscle invasive (NMIBC) requires intensive regimens of frequent monitoring and local resection (transurethral resection of bladder [TURBT]). This study enrolls participants with non-muscle invasive or muscle invasive bladder cancer with activating fibroblast growth factor receptor (FGFR) mutations or fusions. Erdafitinib is a pan-FGFR inhibitor with demonstrated clinical activity when administered orally in patients with solid tumors, including bladder cancer, with FGFR genetic alterations. The Erdafitinib intravesical delivery system is designed to provide release of Erdafitinib in the bladder to treat localized bladder cancer, while reducing systemic toxicities. The study consists of a screening phase, a treatment phase, and a follow-up phase. Total duration of the study is 5 years 3 months.

CONDITIONS

  • Bladder Cancer
  • Receptors, Fibroblast Growth Factor

ELIGIBILITY


Inclusion Criteria:

* Muscle-invasive or recurrent, non-muscle-invasive urothelial carcinoma of the bladder
* For selected Cohorts: Activating tumor pan-fibroblast growth factor receptor (FGFR) mutation or fusion, as determined by local or central testing, approved by the sponsor

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DETAILS

LOCATIONS

Locations in:
United States, Germany, South Korea, Netherlands, Spain
Country (5) City or Province (21) Status
United States Los Angeles University of Southern California
RECRUITING
United States Tampa H Lee Moffitt Cancer Center
RECRUITING
United States Chicago Northwestern University
RECRUITING
United States Charlotte Levine Cancer Institute, Carolinas HealthCare System
RECRUITING
United States Myrtle Beach Carolina Urologic Research Center
RECRUITING
United States Nashville Urology Associates
RECRUITING
United States San Antonio Urology San Antonio Research
RECRUITING
Germany Frankfurt am Main Universitatsklinikum Frankfurt
RECRUITING
Germany Herne Marien hospital Herne
RECRUITING
Germany Münster Universitatsklinikum Munster
RECRUITING
Germany Ulm Universitaetsklinikum Ulm
RECRUITING
South Korea Goyang-Si National Cancer Center
RECRUITING
South Korea Gwangju Chonnam National University Hospital
RECRUITING
South Korea Seoul Seoul National University Hospital
RECRUITING
South Korea Seoul The Catholic University of Korea Seoul St Marys Hospital
RECRUITING
Netherlands Nijmegen Radboud Umcn
COMPLETED
Netherlands Utrecht UMC Utrecht
COMPLETED
Spain Barcelona Fund. Puigvert
COMPLETED
Spain Barcelona Hosp Univ Vall D Hebron
RECRUITING
Spain Barcelona Hosp Clinic de Barcelona
RECRUITING
Spain Madrid Hosp. Univ. 12 de Octubre
RECRUITING
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Geo Locations

34.05223, -118.24368

27.94752, -82.45843

41.85003, -87.65005

35.22709, -80.84313

33.68906, -78.88669

36.16589, -86.78444

29.42412, -98.49363

50.11552, 8.68417

51.5388, 7.22572

51.96236, 7.62571

48.39841, 9.99155

37.65639, 126.835

35.15472, 126.91556

37.566, 126.9784

37.566, 126.9784

51.8425, 5.85278

52.09083, 5.12222

41.38879, 2.15899

41.38879, 2.15899

41.38879, 2.15899

40.4165, -3.70256

x
50

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10

Indicates 10+ sites in this region: click to zoom in.

5

Indicates < 10 sites in this region: click to zoom in.

Corresponds to individual site.

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