SENS-401 to Prevent the Ototoxicity Induced by Cisplatin in Adult Subjects With a Neoplastic Disease

Summary

This study is intended to evaluate the ability of SENS-401 to prevent the ototoxicity induced by cisplatin in subjects with a neoplastic disease. It is a multicenter, randomized, controlled, two-arm, open-label efficacy and safety study in adults with neoplastic disease requiring treatment with cisplatin as part of the chemotherapy protocol plan.

Timeline

Start

2022-12-30

Primary completion

2025-04-16

Completion

2025-06-11

Outcome

Missed primary endpoint

registry analysis (superiority test); Arm A (Control Arm) vs Arm B (Treatment Arm); p = 0.3141; Mean Difference (Net) 3.6 (95% CI -3.7 to 11.0); ANCOVA NCT05628233 ↗

Drugs

Indications