Urothelial carcinoma
Conditions
Interventions
The study drug (Delmovate ointment or Vaseline ointment, double-blind) is applied to the right and left axilla/groin/medial upper arm/medial thigh/flexor wrist/waist twice daily in the morning and eve
Sponsors
Kita Yuki
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Male and female patients receiving EV at the standard initial dose (1.25 mg/kg) for the treatment of unresectable urothelial carcinoma.
Exclusion criteria
Exclusion criteria: 1. Patients with a history of EV administration. 2. Patients treated with systemic steroid therapy (prednisolone equivalent >10 mg/day) within 2 weeks prior to the first dose of EV. 3. Patients with an ECOG Performance Status of 3 or higher, with an assessment of ECOG Performance Status within 7 days prior to the first dose of EV 4. Patients with poorly controlled eczema, atopic dermatitis, psoriasis vulgaris, or autoimmune bullous disease.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Frequency of grade 2 or higher skin disorders based on CTCAE v5.0 or SDRIFE up to 4 weeks of EV administration | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety, frequency of skin disorders of all grades or SDRIFE up to 12 weeks of EV, frequency of EV withdrawal, dose reduction, or discontinuation due to skin disorders, site-specific IGA score at visit date and at discontinuation up to 12 weeks of EV, pain and pruritus scale up to 12 weeks of EV, objective response rate at 12 weeks, progression-free survival, overall survival, blood cortisol and adrenocorticotropic hormone (ACTH) levels, and EQ-5D-5L score up to 12 weeks of EV | — |
Contacts
Public ContactYuki Kita
Kyoto University Hospital
Outcome results
None listed