Localized Bladder Cancer Non-Muscle-Invasive or Muscle-Invasive Bladder Cancer
Conditions
Interventions
TAR-210 Drug-device combination product Intravesical system.
Sponsors
Janssen-Cilag
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Age 1. >=18 years (or the legal age of consent in the jurisdiction in which the study is taking place) at the time of informed consent. Type of Participant and Disease Characteristics 2. Recurrent, non-muscle-invasive or muscle-invasive urothelial carcinoma of the bladder. a) Mixed histology tumors are allowed if urothelial differentiation is predominant (ie, =2 audiometric hearing loss - NCI-CTCAE v.5.0 Grade >=2 peripheral neuropathy 8. Eastern Cooperative Oncology Group (ECOG) performance status score of <=2 (Cohorts 1 and 3)or <=1 (Cohorts 2 and 4)(see Section 10.9 for ECOG scoring) 9. Adequate bone marrow, liver, and renal function: a. Bone marrow function (without the support of growth factor
Exclusion criteria
Exclusion criteria: Medical Conditions 1. Concurrent extra-vesical (ie, urethra, ureter, renal pelvis) transitional cell carcinoma of the urothelium. 2. Prior treatment with an FGFR inhibitor. 3. Known hypersensitivity to any study component including: - Erdafitinib (or other drug excipients) or chemically related drugs, - TAR-210 device constituent materials, - UPC materials. Refer to the TAR-210 IB for complete information on excipients, device constituent materials, and UPC materials 4. Received pelvic radiotherapy 6 months prior to the start of study treatment, there must be no cystoscopic evidence of radiation cystitis. 5. Presence of any bladder or urethral anatomic feature that in the opinion of the investigator may prevent the safe placement, indwelling use, or removal of TAR-210. 6. Indwelling urinary catheter. Intermittent catheterization is acceptable. 7. Cystoscopic evidence of bladder perforation unless such perforation has resolved prior to dosing. 8. Bladder post-void residual volume (PVR) >350 mL after second voided urine. 9. History of clinically significant polyuria with recorded 24-hour urine volumes >4,000 mL. 10 Subjects with active bladder stones or history of bladder stones <6 months prior to the start of study treatment. 11. Active malignancies (ie, progressing or requiring treatment change in the last 24 months) other than the disease being treated under study. Potential allowed exceptions include the following (others maybe allowed with sponsor approval) a. skin cancer (non-melanoma or melanoma)that is considered completely cured. b. non-invasive cervical cancer that is considered completely cured. c. adequately treated lobular carcino main situ(LCIS)and ductal CIS d. history of localized breastcancer and receiving antihormonal agents e. history of localized prostate cancer (N0M0) and receiving androgen deprivation therapy f. Localized prostate cancer (N0M0) - with a Gleason score of 6, treated within the last 24 months or untreated and under surveillance, - with a Gleason score of3+4 that has been treated more than 6 months prior to full study Screening and considered to have a very low risk of recurrence, - or history of localized prostate cancer and receiving androgen deprivation therapy and considered to have a very low risk of recurrence. 12. Current central serous retinopathy or retinal pigment epithelial detachment of any grade. 13. History of uncontrolled cardiovascular disease including: - Any of the following within 3 months prior to the start of study treatment: unstable angina, myocardial infarction, ventricular arrhythmias or clinically significant atrial arrythmias (eg, atrial fibrillation with uncontrolled rate), cardiac arrest, or known congestive New York Heart Association Class III-IV heart failure (Appendix 10), cerebrovascular accident, or transient ischemic attack. - Pulmonary embolism or other venous thromboembolism within 1 month prior to the planned start of study treatment. 14. Active or chronic hepatitis B or C infection according to the following criteria: - Seropositive for hepatitis B: defined by a positive test for hepatitis B surface antigen [HBsAg]. Participants with resolved infection (ie, participants who are HbsAg negative with antibod
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Endpoints: *Incidence and severity of AEs, including dose-limiting toxicity (DLT) | — |
Secondary
| Measure | Time frame |
|---|---|
| Endpoints: *Plasma and urine concentration-time profiles and PK parameters for erdafitinib Cohorts 1 and 2: * Recurrence-free survival (RFS) Cohort 3: * Complete response (CR) rate * Duration of CR Cohort 4: * Pathological complete response (pCR) rate * pT0 rate * Rate of downstaging to | — |
Countries
Netherlands
Outcome results
None listed