Urinary Bladder Neoplasms
Conditions
Interventions
investigational material(s)
Generic name etc : Erdafitinib
INN of investigational material : Erdafitinib
Therapeutic category code : 429 Other antitumor agents
Dosage and Administration for Investigat
Sponsors
Janssen Pharmaceutical K.K.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Histologically confirmed, recurrent, non-muscle-invasive urothelial carcinoma of the bladder. Variant pathology are allowed - Tumor with specified fibroblast growth factor receptor (FGFR) mutations or fusions - Bacillus Calmette- Guerin (BCG)-unresponsive after adequate BCG therapy or BCG experienced participants - Refuses or is not eligible for cystectomy (Cohort 1 and Cohort 2 only) - Eastern Cooperative Oncology Group (ECOG) performance status Grade 0- 1 - Must sign an informed consent form (ICF) (or their legally acceptable representative must sign) indicating that he or she understands the purpose of, and procedures required for, the study and is willing to participate in the study - A woman of childbearing potential must have a negative pregnancy test (beta-hCG [beta-human chorionic gonadotropin]) (urine or serum) within 7 days before randomization (Cohort 1) or the first dose of study drug (Cohort 2 and Cohort 3) - Adequate bone marrow, liver, and renal function as specified in the protocol
Exclusion criteria
Exclusion criteria: - Histologically confirmed, muscle-invasive (T2 or higher stage) urothelial carcinoma of the bladder - Histopathology demonstrating any small cell component, pure adenocarcinoma, pure squamous cell carcinoma, or pure squamous CIS of the bladder - Prior treatment with an FGFR inhibitor - Active malignancies other than the disease being treated under study. The only allowed exceptions are: (a) skin cancer treated within the last 24 months that is considered completely cured (b) adequately treated lobular carcinoma in situ (LCIS) and ductal CIS (c) history of localized breast cancer and receiving antihormonal agents, or history of localized prostate cancer (N0M0) and receiving androgen deprivation therapy - Current central serous retinopathy or retinal pigment epithelial detachment of any grade
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| efficacy Recurrence-Free Survival (RFS) Up to 4 years RFS is defined as the time from the date of randomization until the date of the reappearance of high-risk disease, or death, whichever is reported first. | — |
Secondary
| Measure | Time frame |
|---|---|
| efficacy Time to Progression Up to 4 years Time from the date of randomization until the date of first documented evidence of any of progression or death. Participants who are progression -free and alive or have unknown status will be censored at the date of the last tumor assessment. efficacy Overall Survival Up to 4 years The time from the date of randomization to the date of the participant's death resulting from any cause. Participants who are alive or have unknown vital status will be censored at the date the participant was last known to be alive. efficacy Recurrence-Free Survival Months 6 and 12 RFS is defined as the time from the date of randomization until the date of the reappearance of high-risk disease, or death, whichever is reported first. Participants who are recurrence-free and alive or have unknown status will be censored at the last tumor assessment. pharmacokinetics Plasma Concentration of Erdafitinib Cycle 1 Day 14, Cycle 2 Day 1 (each cycle is of 28 days) Plasma concentration of erdafitinib will be reported. safety Number of Participants with Adverse events Up to 4 years An adverse event 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 | — |
Countries
Asia except Japan, Europe, Japan, North America
Contacts
Public ContactMedical Information Center
Janssen Pharmaceutical K.K.
Outcome results
None listed