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

SENS-401-202

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.

2022-12-30

2024-06-01

2024-08-01

Recruiting

Early phase I

58

Inclusion Criteria: 1. Age ≥ 18 years at the time of signing the ICF. 2. 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: 1. 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. 2. A congenital or hereditary disease known to decrease hearing function. 3. Any medical history affecting the middle ear function such as chronic otitis, cholesteatoma, or tympanic membrane perforation. 4. 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). 5. Having a history of sudden sensory neural hearing loss. 6. Having a fluctuating hearing loss (e.g, due to Meniere's disease, vestibular aqueduct syndrome, or autoimmune inner ear disease). 7. History of head trauma with hearing loss. 8. History of meningitis. 9. 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.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 58, 'type': 'ESTIMATED'}}

2023-03-03