NCT02997189终止2 期
A Multicenter, Randomized, Phase 2 Study to Assess the Feasibility, Safety and Efficacy of OTO-104 Given by Intratympanic Administration in Subjects at Risk for Ototoxicity From Cisplatin Chemotherapy Regimens in the Treatment of Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Feasibility assessed via a questionnaire
研究概览
简要总结
This is a multicenter, Phase 2 study to assess the feasibility, safety and efficacy of OTO-104 given by intratympanic administration in subjects at risk for ototoxicity from cisplatin chemotherapy regimens in the treatment of cancer.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 6 Months 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject is aged 6 months to 21 years inclusive.
- •Subject is diagnosed with neuroblastoma, hepatoblastoma, osteosarcoma or extracranial germ cell tumors and has not been previously treated with cisplatin or carboplatin.
- •Subject is scheduled to receive a chemotherapy regimen that includes a cumulative cisplatin dose of ≥ 200 mg/m
- •Subject has normal baseline auditory function, defined as ≤ 20 dB from 2000 to 8000 Hz, in both ears and does not have a history of sensorineural hearing loss.
排除标准
- •Subject has middle ear effusion upon clinical examination.
- •Subject has a history of central nervous system radiotherapy that encompasses all or part of the cochlea or will receive such radiation therapy during the course of the study.
- •Subject is receiving sodium-thiosulfate or amifostine therapy with chemotherapy.
- •Subject is currently participating on a separate otoprotection clinical study.
研究组 & 干预措施
OTO-104
Active Comparator
One of the subject's ears will receive up to three administrations of study drug prior to cisplatin-based therapy
干预措施: OTO-104 (Drug)
结局指标
主要结局
Feasibility assessed via a questionnaire
时间窗: Up to 18 weeks
Feasibility to assess incorporating OTO-104 with a cisplatin-based therapy regimen
次要结局
- Local tolerability as assessed by otoscopic examinations(Up to 6 months)
- Hearing function in each ear according to SIOP-Boston Ototoxicity Scale(Up to 6 months)
- Safety as assessed by adverse events(Up to 6 months)
研究者
研究点 (1)
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