SENS-401 to Prevent the Ototoxicity Induced by Cisplatin in Adult Subjects With a Neoplastic Disease (NOTOXIS)
Hearing Loss Ototoxic
About this trial
This is an interventional prevention trial for Hearing Loss Ototoxic
Eligibility Criteria
Inclusion Criteria: Age ≥ 18 years at the time of signing the ICF. Neoplastic subject that regardless of participation in this study is planned to be treated with a chemotherapy that includes a dose of cisplatin of at least 70 mg/m² per cycle and a cumulative dose of cisplatin of at least 210 mg/m². Exclusion Criteria: Any condition or past medical history that, in the opinion of the Investigator, may compromise the safety or compliance of the subject or would preclude the subject from successful completion of the study. A congenital or hereditary disease known to decrease hearing function. Any medical history affecting the middle ear function such as chronic otitis, cholesteatoma, or tympanic membrane perforation. Any inner ear disease that is likely to decrease hearing function according to the Investigator's judgment (e.g, herpes zoster oticus; Meniere's disease; purulent labyrinthitis; vestibular schwannoma). Having a history of sudden sensory neural hearing loss. Having a fluctuating hearing loss (e.g, due to Meniere's disease, vestibular aqueduct syndrome, or autoimmune inner ear disease). History of head trauma with hearing loss. History of meningitis. Having received concomitant treatment known or suspected to induce an ototoxicity within 6 months prior to Screening (i.e, aminoglycosides, loop diuretics, quinine) and any other treatments listed in Appendix 5. Previous treatment with a platinum treatment should be considered as an exclusion criterion.
Sites / Locations
- Hôpital Henri MondorRecruiting
Arms of the Study
Arm 1
Arm 2
No Intervention
Experimental
Study Arm A (control arm)
Study Arm B (treatment arm)
Subjects receiving cisplatin-based chemotherapy without receiving SENS-401. This control arm will provide natural history data, particularly the incidence and the time to onset of hearing impairment due to ototoxicity.
Subjects receiving 43.5 mg of oral SENS-401 b.i.d for up to 23 weeks. This arm will provide data on the potential protective effects of SENS-401 on cisplatin induced ototoxicity.