BridgeMD
New treatment option for Non-Muscle Invasive Bladder Neoplasms
Official title Study of Erdafitinib Intravesical Delivery System for Localized Bladder Cancer
ClinicalTrials.gov ID: NCT05316155
What this study is testing
What is Erdafitinib Intravesical Delivery System?
Erdafitinib Intravesical Delivery System is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for non-muscle invasive bladder neoplasms.
Also referred to as JNJ-42756493.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The purpose of the study in Part 1 (dose escalation) and in Part 2 (dose expansion) is to determine the recommended Phase 2 dose(s) (RP2D(s)) and evaluate preliminary clinical efficacy. Part 3 (dose expansion) will confirm safety and preliminary clinical activity at the RP2D.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Parts 1-3:
- 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...
- Cohorts 1 and 2: Bacillus Calmette-Guérin (BCG) experienced, or participants with no BCG experience because BCG was not available as a treatment...
- Cohort 1 only: Refuses or is not eligible for radical cystectomy (RC)
You likely can't join if
- Parts 1-3:
- 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 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...
- Indwelling urinary catheter. Intermittent catheterization is acceptable Part 4:
See the full eligibility criteria
- Parts 1-3:
- 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...
- 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...
- Cohort 1 only: Refuses or is not eligible for radical cystectomy (RC)
- Cohorts 2 and 4: Willing and eligible for RC Part 4:
- Have histologically confirmed diagnosis of recurrent Intermediate-risk-non-muscle invasive bladder cancer (IR-NMIBC) Ta LG tumors
- Must not have undergone tumor debulking or selective ablation of visible lesions; partial tumor biopsy to confirm diagnosis and provide tissue for biomarker testing is permitted as long as remaining tumor is at least 5...
- Must submit tissue and urine for FGFR testing
- Can have a prior or concurrent second malignancy which natural history or treatment is unlikely to interfere with any study endpoints of safety or the how well it works of the study treatment
- Parts 1-3:
- 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 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 Part 4:
- Histologically confirmed diagnosis of T1 NMIBC, HR NMIBC (HG/G2 or HG/G3 or CIS) or MIBC, locally advanced, non-resectable, or metastatic urothelial carcinoma at any time prior to enrollment. Previous high grade (HG)...
- Known allergies, hypersensitivity, or intolerance to any study component or its excipients
- Has a current diagnosis of newly diagnosed IR-NMIBC
- Received an investigational treatment for bladder cancer after Transurethral Resection of the Bladder Tumor (TURBT) for the current NMIBC diagnosis or within 4 weeks or the agent/therapy washout period, whichever is...
- Evidence of current bladder perforation by cystoscopy or imaging
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
- Los Angeles, California, United States
- Lone Tree, Colorado, United States
- Hialeah, Florida, United States
- Largo, Florida, United States
- Orlando, Florida, United States
- Oxford, Florida, United States
- Tampa, Florida, United States
- Chicago, Illinois, United States
- Chicago Ridge, Illinois, United States
- Greenwood, Indiana, United States
- Merrillville, Indiana, United States
- Lexington, Kentucky, United States
- Lafayette, Louisiana, United States
- Plymouth, Massachusetts, United States
- St Louis, Missouri, United States
- Hackensack, New Jersey, United States
- Syracuse, New York, United States
- Charlotte, North Carolina, United States
- Gahanna, Ohio, United States
+ 32 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Birmingham, Alabama, United States; Los Angeles, California, United States; Lone Tree, Colorado, United States; Hialeah, Florida, United States; Largo, Florida, United States; Orlando, Florida, United States and 46 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.