Study of Erdafitinib Intravesical Delivery System for Localized Bladder Cancer

Last Updated   July 17, 2024 - 21:06

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OVERVIEW

  • Gender
    all
  • Age
    18+ years
  • Phase
    phase 1
    Researchers test a new drug or treatment in a small group of people for the first time to gather information on its safety, dosing, and side effects.
  • 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 prior to the start of study treatment. Local tissue-based results (if already existing) from next-generation sequencing (NGS) or polymerase chain reaction (PCR) tests performed in Clinical Laboratory Improvement Amendments (CLIA) -certified or equivalent laboratories, or results from commercially available PCR or NGS tests

* Cohorts 1 and 2: Bacillus Calmette-Guérin (BCG) experienced, or participants with no BCG experience because BCG was not available as a treatment option in the participant's location within the previous 2 years and is currently unavailable. Participants who received an abbreviated course of BCG due to toxicity are still eligible

* Cohort 1 only: Refuses or is not eligible for radical cystectomy (RC)

* Cohorts 2 and 4: Willing and eligible for RC

Exclusion Criteria:

* Concurrent extra-vesical (that is, urethra, ureter, renal pelvis) transitional cell carcinoma of the urothelium

* Prior treatment with an pan-fibroblast growth factor receptor (FGFR) inhibitor

* Received pelvic radiotherapy <=6 months prior to the planned start of study treatment. If received pelvic radiotherapy greater than (>)6 months prior to the start of study treatment, there must be no cystoscopic evidence of radiation cystitis

* Presence of any bladder or urethral anatomic feature that in the opinion of the investigator may prevent the safe use of Erdafitinib intravesical delivery system

* Indwelling urinary catheter. Intermittent catheterization is acceptable

DETAILS

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.

LOCATIONS

Locations in:
United States, Spain, South Korea, Netherlands, Germany
Country (5) City or Province (21) Status
United States Charlotte, NC Levine Cancer Institute, Carolinas HealthCare System
RECRUITING
United States Chicago, IL Northwestern University
RECRUITING
United States Los Angeles, CA University of Southern California
RECRUITING
United States Myrtle Beach, SC Carolina Urologic Research Center
RECRUITING
United States Nashville, TN Urology Associates
RECRUITING
United States San Antonio, TX Urology San Antonio Research
RECRUITING
United States Tampa, FL H Lee Moffitt Cancer Center
RECRUITING
Spain Barcelona, BA Fund. Puigvert
COMPLETED
Spain Barcelona, BA Hosp Clinic de Barcelona
RECRUITING
Spain Barcelona, BA Hosp Univ Vall D Hebron
RECRUITING
Spain Madrid, MD Hosp. Univ. 12 de Octubre
RECRUITING
South Korea Goyang-Si, 41 National Cancer Center
RECRUITING
South Korea Gwangju, 46 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, GE Radboud Umcn
COMPLETED
Netherlands Utrecht, UT UMC Utrecht
COMPLETED
Germany Frankfurt am Main, HE Universitatsklinikum Frankfurt
RECRUITING
Germany Herne Marien hospital Herne
RECRUITING
Germany Münster Universitatsklinikum Munster
RECRUITING
Germany Ulm, BW Universitaetsklinikum Ulm
RECRUITING
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50

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10

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5

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

Corresponds to individual site.

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