Bladder Cancer Clinical Trial

Study of Erdafitinib Intravesical Delivery System for Localized Bladder Cancer

Summary

The purpose of the study in Part 1 (dose escalation) is to determine the recommended Phase 2 dose(s) (RP2D[s]) and in Part 2 (dose expansion) is to determine the safety of Erdafitinib Intravesical Delivery System administered at the RP2D(s).

View Full Description

Full Description

Bladder cancer is the most common malignancy worldwide where non-muscle invasive (NMIBC), requiring intensive regimens of frequent monitoring, 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.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Recurrent, non-muscle-invasive or muscle-invasive urothelial carcinoma of the Bladder
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

Study is for people with:

Bladder Cancer

Phase:

Phase 1

Estimated Enrollment:

92

Study ID:

NCT05316155

Recruitment Status:

Recruiting

Sponsor:

Janssen Research & Development, LLC

Check Your Eligibility

Let’s see if you might be eligible for this study.

What is your age and gender ?

Submit

There are 25 Locations for this study

See Locations Near You

University of Southern California
Los Angeles California, 90033, United States
Cedars-Sinai Medical Center
Los Angeles California, 90048, United States
The Urology Center of Colorado
Denver Colorado, 80211, United States
Northwestern University
Chicago Illinois, 60611, United States
Levine Cancer Institute, Carolinas HealthCare System
Charlotte North Carolina, 28204, United States
Carolina Urologic Research Center
Myrtle Beach South Carolina, 29572, United States
Urology Associates
Nashville Tennessee, 37209, United States
Urology San Antonio Research
San Antonio Texas, 78229, United States
Chu Rennes - Hopital Pontchaillou
Rennes Cedex , 35033, France
Institut Claudius Regaud
Toulouse , 31059, France
Gustave Roussy
Villejuif Cedex , 94800, France
Universitatsklinikum Frankfurt
Frankfurt am Main , 60590, Germany
Marien hospital Herne
Herne , 44625, Germany
Universitätsklinikum Münster
Münster , 48149, Germany
Universitaetsklinikum Ulm
Ulm , 89081, Germany
National Cancer Center
Goyang-Si , 10408, Korea, Republic of
Chonnam National University Hospital
Gwangju , 61469, Korea, Republic of
Seoul National University Hospital
Seoul , 03080, Korea, Republic of
The Catholic University of Korea Seoul St. Mary's Hospital
Seoul , 06591, Korea, Republic of
Radboud Umcn
Nijmegen , 6525 , Netherlands
UMC Utrecht
Utrecht , 3584 , Netherlands
Fundacion Puigvert
Barcelona , 08025, Spain
Hosp. Univ. Vall D Hebron
Barcelona , 08035, Spain
Hosp. Clinic I Provincial De Barcelona
Barcelona , 08036, Spain
Hosp. Univ. 12 de Octubre
Madrid , 28041, Spain

How clear is this clinincal trial information?

Study is for people with:

Bladder Cancer

Phase:

Phase 1

Estimated Enrollment:

92

Study ID:

NCT05316155

Recruitment Status:

Recruiting

Sponsor:


Janssen Research & Development, LLC

How clear is this clinincal trial information?

×

Introducing, the Journey Bar

Use this bar to access information about the steps in your cancer journey.