Urothelial Cancer
Conditions
Interventions
investigational material(s)
Generic name etc : Erdafitinib
INN of investigational material : -
Therapeutic category code : 429 Other antitumor agents
Dosage and Administration for Investigational mate
Sponsors
Janssen Pharmaceutical K.K.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Histologic demonstration of transitional cell carcinoma of the urothelium. Minor components ( less than [<] 50 percent [%] overall) of variant histology such as glandular or squamous differentiation, or evolution to more aggressive phenotypes such as sarcomatoid or micropapillary change are acceptable - Metastatic or surgically unresectable urothelial cancer - Documented progression of disease, defined as any progression that requires a change in treatment, prior to randomization - Cohort 1: Prior treatment with an anti-PD-(L) 1 agent as monotherapy or as combination therapy; no more than 2 prior lines of systemic treatment. Cohort 2: No prior treatment with an anti-PD-(L) 1 agent; only 1 line of prior systemic treatment for metastatic urothelial cancer. Subjects who received neoadjuvant or adjuvant chemotherapy and showed disease progression (as defined above), within 12 months of the last dose are considered to have received systemic therapy chemotherapy in the metastatic setting. - A woman of childbearing potential who is sexually active must have a negative pregnancy test (beta human chorionic gonadotropin [beta hCG]) at Screening (urine or serum) - Participants must meet appropriate molecular eligibility criteria - Eastern Cooperative Oncology Group (ECOG) performance status Grade 0, 1, or 2 - Adequate bone marrow, liver, and renal function
Exclusion criteria
Exclusion criteria: - Treatment with any other investigational agent or participation in another clinical study with therapeutic intent within 30 days prior to randomization - Active malignancies (that is, requiring treatment change in the last 24 months). The only allowed exceptions are: urothelial cancer, skin cancer treated within the last 24 months that is considered completely cured, localized prostate cancer with a gleason score of 6 (treated within the last 24 months or untreated and under surveillance) and localized prostate cancer with a gleason score of 3+4 that has been treated more than 6 months prior to full study screening and considered have a very low risk of recurrence. - Symptomatic central nervous system metastases - Received prior fibroblast growth factor receptor (FGFR) inhibitor treatment - Known allergies, hypersensitivity, or intolerance to erdafitinib or its excipients - Current central serous retinopathy (CSR) or retinal pigment epithelial detachment of any grade. - History of uncontrolled cardiovascular disease including - Impaired wound healing capacity defined as skin/decubitus ulcers, chronic leg ulcers, known gastric ulcers, or unhealed incisions
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall Survival (OS) -Date of first randomization to the date of participant's death (approximately up to 3 years) -Overall survival is measured from the date of randomization to the date of the participant's death. If the participant is alive or the vital status is unknown, the participant will be censored at the date the participant was last known to be alive. | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free Survival (PFS) -Date of randomization to the date of disease progression or relapse from complete response (CR) or death, whichever is reported first (approximately up to 3 years) -PFS is defined as duration in days from date of randomization to disease progression date (assessed per Response Evaluation Criteria in Solid Tumors Version 1.1 [RECIST v1.1] by investigator) or relapse from CR or death, whichever is reported first. RECIST 1.1, progressive disease is defined as a 20 percent (%) increase in the sum of diameters of all target lesions and a minimum absolute increase of 5 millimeter (mm) in the sum. CR is defined as disappearance of all target lesions, non-target lesions and normalization of tumor marker level. Overall Response Rate (ORR) -Approximately up to 3 years -ORR is defined as the proportion of participants who achieve CR (CR; disappearance of all target lesions and disappearance of all non-target lesions and normalization of tumor marker level) or partial response (PR; at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters), as assessed per RECIST v1.1 by the investigator. Change from Baseline in Participant-Reported Health Status and Physical Functioning Scales of the Functional Assessment of Cancer Therapy (FACT-Bl) -Baseline up to end of treatment (approximately 3 years) -The FACT-Bl consists of 36 core items, with 5-point Likert response scales, covering 5 primary domains: Physical well-being, social/family well-being, emotional well-being, functional well-being, and bladder symptom subscale. The answer scales range from "Not at all (score=0)" to "very much (score=4)" to assess the meaningful significant symptom deterioration. Time Until Symptom Deterioration (Subset of FACT-BI Items) -Baseline up to end of treatment (approximately 3 years) -The FACT-Bl consists of 36 core items, with 5-point Likert response scales, covering 5 primary domains: Physical well-being, soc | — |
Countries
Argentina, Australia, Austria, Brazil, Bulgaria, Canada, China, France, Germany, Greece, Hungary, Israel, Italy, Mexico, Netherlands Kingdom Of The, Poland, Portugal, Russian Federation, Spain, Taiwan Province Of China, Turkiye, Ukraine, United Kingdom Of Great Britain
Contacts
Public ContactMedical Information Center
Janssen Pharmaceutical K.K., Japan
Outcome results
None listed