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SENS-401 to Prevent the Ototoxicity Induced by Cisplatin in Adult Subjects With a Neoplastic Disease
Sponsor: Sensorion
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.
Official title: A Phase IIa, Multicenter, Randomized, Controlled, Open Label Study to Evaluate the Efficacy of SENS-401 to Prevent the Ototoxicity Induced by Cisplatin in Adult Subjects With a Neoplastic Disease
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
48
Start Date
2022-12-30
Completion Date
2025-06-11
Last Updated
2026-07-02
Healthy Volunteers
No
Conditions
Interventions
SENS-401 (R-Azasetron Besylate)
Patients will receive SENS-401 ((R)-azasetron besylate) B.I.D. up to 23 weeks: 1 week prior to the initiation of the cisplatin treatment, during the whole duration of the chemotherapy treatment (estimated to last up to 18 weeks) and 4 weeks after stopping chemotherapy.
Locations (1)
Hôpital Henri Mondor
Créteil, France