Safety and efficacy of prophylactic topical steroid application for skin reactions associated with enfortumab vedotin.

Kita Yuki0 sites12 target enrollmentOctober 27, 2023

Overview

No summary available.

Registry

who.int

Start Date

October 27, 2023

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Sponsor

Kita Yuki

•1\. Male and female patients receiving EV at the standard dose (1\.25 mg/kg) for the treatment of unresectable urothelial carcinoma that has progressed after chemotherapy.
•2\. Patients must be at least 18 years of age at the time of consent.
•3\. Patients who have given written consent to participate in this study.

•1\. Patients with a history of EV administration.
•2\. Patients participating in other clinical studies or trials involving interventions within 1 month prior to obtaining consent.
•3\. Patients treated with systemic steroid therapy (prednisolone equivalent \>10 mg/day) within 2 weeks prior to the first dose of EV
•4\. Patients with an ECOG Performance Status of 3 or higher.
•5\. Patients with poorly controlled eczema, atopic dermatitis, psoriasis vulgaris, or autoimmune bullous disease.
•6\. Patients who are judged by the investigators or subinvestigators to be unsuitable for the safe conduct of this study.
•Translated with www.DeepL.com/Translator (free version)