The purpose of the study is to determine the tolerability of erdafitinib intravesical delivery system (TAR-210) in Japanese participants.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
5
Erdafitinib intravesical delivery system will be administered.
St Marianna University Hospital
Kanagawa, Japan
Osaka International Cancer Institute
Osaka, Japan
Toyama University Hospital
Toyama, Japan
University of Tsukuba Hospital
Tsukuba, Japan
Number of Participants with Dose-limiting Toxicity (DLT)
Number of participants with DLT will be assessed. The DLTs are specific adverse events related to erdafitinib intravesical delivery system and are defined as any of the following: high grade non-hematologic toxicity or hematologic toxicity.
Time frame: Up to 28 days
Plasma Concentration of Erdafitinib
Plasma concentration of erdafitinib will be reported.
Time frame: Up to 180 days
Urine Concentration of Erdafitinib
Urine concentration of erdafitinib will be reported.
Time frame: Up to 180 days
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.
Time frame: Up to 3 years 10 months
Number of Participants with AEs by Severity
Severity of AEs 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.
Time frame: Up to 3 years 10 months
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