Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 2:45 AM
Ignite Modification Date:
2025-12-25 @ 2:45 AM
NCT ID:
NCT05628233
Brief 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.
Detailed Description:
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. Cisplatin treatment per chemotherapy protocol must be given at a cumulative dose high enough to significantly increase the iatrogenic likelihood of ototoxicity (unit cisplatin dose of at least 70 mg/m2 and cumulative cisplatin dose of at least 210 mg/m²). If all the eligibility criteria are met, subjects will be randomized to one of two study arms as follows:
* Study Arm A (control 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.
* Study Arm B: Subjects receiving 43.5 mg of oral SENS-401 b.i.d for 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. This arm will provide data on the potential protective effects of SENS-401 on cisplatin induced ototoxicity.
All subjects will be followed up to 12 weeks after the completion of the cisplatin therapy.
Study:
NCT05628233
Study Brief:
Protocol Section:
NCT05628233