urothelial carcinoma
Conditions
Interventions
None listed
Sponsors
University of Shizuoka
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Histologically or cytologically confirmed unresectable urothelial carcinoma that has progressed after chemotherapy 2.Patients aged 20 years or older at the time of informed consent 3.Patients with ECOG Performance status of 0 or 1 4.Patients who have given written informed consent of their own free will after fully understanding their participation in this study. 5.Patients who are expected to survive for 3 months or more from the start date of the study.
Exclusion criteria
Exclusion criteria: 1.Patients with a history of drug hypersensitivity that may interfere with this treatment. 2.Patients with uncontrolled serious complications. 3.Patients who are pregnant or may be pregnant. 4.Others deemed inappropriate by the attending physician.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| At days 1, 15, 29, 43, 53, and 71 after the start of administration of enfortumab vedotin, blood and stratum corneum sampling by tape stripping will be performed. And the following items will be evaluated. 1.Dry skin: transepidermal water loss (TEWL), stratum corneum intercellular lipids (ceramides, fatty acids, cholesterol) 2.Peripheral neuropathy: blood monomethyl auristatin E concentration, galectin 3 concentration 3.Hyperglycemia: sugar metabolites | — |
Countries
Japan
Contacts
Public ContactTomonobu Uchino
University of Shizuoka Department of Clinical Pharmaceutics, School of Pharmaceutical Sciences
Outcome results
None listed