The study of Preventive Approach for Skin Trouble caused by Enfortumab vedotin treatment for urothelial cancer

JRCT ID: jRCTs031220257

Registered date:08/08/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Urothelial carcinoma
• Date of first enrollment: 11/04/2023
• Target sample size: 30
• Study type: Interventional
• Intervention(s): To realize whether prophylactic skin care intervention prior to treatment with enfolzumab vedotin can reduce the occurrence of skin disorders, patients will be applied with heparinoid from animal organs 2 weeks prior to administration of enfolzumab vedotin.

Outcome(s)

• Primary Outcome: Incidence of Grade 2 or higher adverse skin events
• Secondary Outcome: Incidence of skin adverse events for all CTCAE grades, median time to onset of skin disorders, response rate according to RECIST ver. 1.1, Relative Dose Intensity for padceb, dropout rate (number of patients who discontinued padceb treatment due to skin disorders/number of patients enrolled), identification of biomarkers for skin disorders

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1) Patients who have agreed to be treated with enfoltumab vedotin for metastatic urothelial carcinoma
2) Patients who are at least 18 years of age at the time of consent
3) Patients with an Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 to 2
4) Patients who are estimated by the attending physician to be expected to survive at least 3 months
(5) Patients who have been fully informed about the study and who have written consent based on their full understanding of the study.

Exclude criteria

1) Patients with hypersensitivity to heparinoid from animal organs
2) Patients already using hydrate foam animal organs
3) Patients who are applying steroid agent to the entire body
4) Patients with Grade 2 or higher skin disorder according to the CTCAE 5th edition at the time of enrollment.
5) Patients with any disease requiring oral or intravenous corticosteroid (prednisone equivalent >10 mg/day) or other immunosuppressive drugs within 14 days prior to enrollment.
6) Other patients deemed inappropriate as subjects by the Principal Investigators.

Related Information

• Primary Sponsor: Nitta Satoshi
• Source(s) of Monetary Support: University of Tsukuba Hospital