SENS-401 to Prevent the Ototoxicity Induced by Cisplatin in Adult Subjects With a Neoplastic Disease
About the study
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.
Who can take part
You may be eligible to participate in the study if you meet the following criteria:
INCLUSION 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
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.
Study Locations
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How to Apply
Contact the study center to learn if this study is a good match for you.
Study Details
Contition
Hearing Loss Ototoxic
Age
18+
Phase
PHASE2
Participants Needed
58
Est. Completion Date
Aug 31, 2024
Treatment Type
INTERVENTIONAL
Sponsor
Sensorion
ClinicalTrials.gov NCT Identifier
NCT05628233
Study Number
SENS-401-202
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