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
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Sensorion
- 入组人数
- 48
- 试验地点
- 7
- 主要终点
- SENS-401 Efficacy Assessment With Change From Baseline of the Average of the Hearing Threshold 4 Weeks After the Completion of Cisplatin Treatment in Each Eligible Ear of Each Subject
研究概览
简要总结
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.
详细描述
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:
- 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.
- 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65+ years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
- •Previous treatment with a platinum treatment should be considered as an exclusion criterion.
结局指标
主要结局
SENS-401 Efficacy Assessment With Change From Baseline of the Average of the Hearing Threshold 4 Weeks After the Completion of Cisplatin Treatment in Each Eligible Ear of Each Subject
时间窗: 4 weeks after the completion of cisplatin treatment
Pure tone audiometry (PTA) is a behavioral, subjective hearing test used to assess an individual's hearing threshold levels measured in decibels (dB) and determine the degree of hearing loss. A decrease of hearing threshold is considered as an improvement and an increase as a deterioration of the audition. PTA assessments were conducted at Baseline (prior to the first dose of cisplatin), 4 weeks and 12 weeks after the completion of cisplatin treatment for all participants (Arms A and B). The change in hearing threshold from baseline was evaluated at the average across three contiguous hearing frequencies (8-10-12.5 kHz) using PTA.
Change from baseline of the average of the hearing threshold of 3 contiguous hearing frequencies assessed with a 0.5-12.5 kHz audiogram 4 weeks after the completion of the last cisplatin treatment in each eligible ear of each subject.
Change from baseline of the average of the hearing threshold of 3 contiguous hearing frequencies assessed with a 0.5-12.5 kHz audiogram 4 weeks after the completion of the last cisplatin treatment in each eligible ear of each subject.
次要结局
- SENS-401 Efficacy Assessment With Change From Baseline of the Average of the Hearing Threshold 12 Weeks After the Completion of Cisplatin Treatment in Each Eligible Ear of Each Subject.(12 weeks after the completion of cisplatin treatment)
- Please cf Protocol (there is too many caracters to be put here)