Urinary Bladder Neoplasms Clinical Trial
Official title:
Phase 1 Study of Erdafitinib Intravesical Delivery System (TAR-210) in Participants With Non- Muscle-Invasive or Muscle-Invasive Bladder Cancer and Selected FGFR Mutations or Fusions
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.
Status | Recruiting |
Enrollment | 112 |
Est. completion date | March 31, 2028 |
Est. primary completion date | March 30, 2028 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
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 |
Country | Name | City | State |
---|---|---|---|
Germany | Universitatsklinikum Frankfurt | Frankfurt am Main | |
Germany | Marien hospital Herne | Herne | |
Germany | Universitatsklinikum Munster | Münster | |
Germany | Universitaetsklinikum Ulm | Ulm | |
Korea, Republic of | National Cancer Center | Goyang-Si | |
Korea, Republic of | Chonnam National University Hospital | Gwangju | |
Korea, Republic of | Seoul National University Hospital | Seoul | |
Korea, Republic of | The Catholic University of Korea Seoul St. Mary's Hospital | Seoul | |
Netherlands | Radboud Umcn | Nijmegen | |
Netherlands | UMC Utrecht | Utrecht | |
Spain | Fund. Puigvert | Barcelona | |
Spain | Hosp Clinic de Barcelona | Barcelona | |
Spain | Hosp. Univ. Vall D Hebron | Barcelona | |
Spain | Hosp. Univ. 12 de Octubre | Madrid | |
United States | Levine Cancer Institute, Carolinas HealthCare System | Charlotte | North Carolina |
United States | Northwestern University | Chicago | Illinois |
United States | University of Southern California | Los Angeles | California |
United States | Carolina Urologic Research Center | Myrtle Beach | South Carolina |
United States | Urology Associates | Nashville | Tennessee |
United States | Urology San Antonio Research | San Antonio | Texas |
United States | H Lee Moffitt Cancer Center | Tampa | Florida |
Lead Sponsor | Collaborator |
---|---|
Janssen Research & Development, LLC |
United States, Germany, Korea, Republic of, Netherlands, Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of Participants with Adverse Events (AEs) | An adverse event (AE) is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. | Up to 5 years 3 months | |
Primary | Number of Participants with AEs by Severity | Severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0. Severity scale ranges from Grade 1 (Mild) to Grade 5 (Death). Grade 1= Mild, Grade 2= Moderate, Grade 3= Severe, Grade 4= Life-threatening and Grade 5= Death related to adverse event. | Up to 5 years 3 months | |
Primary | Number of Participants with Dose-limiting Toxicity (DLT) | Number of participants with DLT will be assessed. The DLTs are specific adverse events and are defined as any of the following: high grade non-hematologic toxicity, or hematologic toxicity. | Up to 28 days | |
Secondary | Plasma Concentration of Erdafitinib | Plasma concentration of Erdafitinib will be reported. | Cohorts 1, 3 and 5: up to 6 months; Cohort 2 and 4: up to 8 weeks | |
Secondary | Urine Concentration of Erdafitinib | Urine concentration of Erdafitinib will be reported. | Cohorts 1, 3 and 5: up to 6 months; Cohort 2 and 4: up to 8 weeks | |
Secondary | Cohorts 1 and 2: Recurrence-Free Survival (RFS) | RFS is defined as the time from start of treatment to the first detection of any new high-grade bladder cancer or upper tract urothelial carcinoma or positive urine cytology. | Up to 5 years 3 months | |
Secondary | Cohort 3 and 5: Complete Response (CR) Rate | CR is defined as the absence of urothelial carcinoma by cystoscopy, confirmed pathologically at first assessment, and negative urine cytology. | At 3 months | |
Secondary | Cohort 3 and 5: Duration of CR | Duration of CR is defined as the time from first documentation of CR until the date of documented recurrence or progression, or death, whichever comes first. | Up to 5 years 3 months | |
Secondary | Cohort 4: Pathological Complete Response (pCR) Rate | pCR rate is defined as percentage of participants with no pathologic evidence of intravesical disease (pT0) and no pathologic evidence of nodal involvement (pN0). | Up to 8 weeks | |
Secondary | Cohort 4: No Pathologic Evidence of Intravesical Disease (pT0) | pT0 rate is defined as percentage of participants with no Pathologic Evidence of Intravesical Disease. | Up to 8 weeks | |
Secondary | Cohort 4: Rate of downstaging to Less than (<) pT2 | Rate of downstaging to Up to 8 weeks |
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