Safety and Efficacy Study of SPI-1005 for Prevention of Chemotherapy Induced Hearing Loss
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Number of participants with adverse events
研究概览
简要总结
Chemotherapy treatment with platinum based agents is well noted to cause ototoxicity. It is the objective of this study to determine the safety and efficacy of SPI-1005 at three dose levels when delivered orally twice daily for 3 days, surrounding each cycle of platinum chemotherapy in head and neck or non-small cell lung cancer patients to prevent and treat chemotherapy induced hearing loss and tinnitus.
详细描述
Chemotherapy treatment with the platinum containing chemotherapies (e.g. cisplatin, carboplatin) are well noted and studied for their ability to cause ototoxicity which includes hearing loss, tinnitus, vertigo, or dizziness. It is the objective of this study to determine the safety and efficacy of SPI-1005 at three dose levels when delivered orally twice daily for 3 days, surrounding each cycle of platinum chemotherapy for head and neck or non-small cell lung cancer patients to prevent and treat chemotherapy induced hearing loss and tinnitus.
SPI-1005, a proprietary oral formulation of ebselen is a small molecule mimic and inducer of the enzyme Glutathione Peroxidase. GPx reduces reactive oxygen species (ROS) by reacting with glutathione. SPI-1005 has been shown to reduce cisplatin induced hearing threshold shift in animal studies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult male and female subjects, 19-80 years of age;
- •Confirmed diagnosis of advanced head and neck cancer or advanced lung cancer
- •Voluntarily consent to participate in the study
- •Females of childbearing potential should either be sexually inactive (abstinent) for 14 days prior to screening and throughout the study or be using one of the following acceptable birth control methods:
- •IUD in place for at least 3 months prior to study;
- •Barrier method (condom or diaphragm) with spermicide for at least 14 days prior to screening through study completion;
- •Stable hormonal contraceptive for at least 3 months prior to study through completion of study;
- •Surgical sterilization (vasectomy) of partner at least 6 months prior to study.
- •Females of non-childbearing potential should be surgically sterile (bilateral tubal ligation with surgery at least 6 months prior to study, hysterectomy, or bilateral oophorectomy at least 2 months prior to study).
排除标准
- •Subjects previously treated with chemotherapy, antibiotics, or diuretics known to cause hearing loss in the last 90 days
- •History or presence of significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, otologic, or psychiatric disease
- •Presence of alcoholism or drug abuse
- •Participation in another investigational drug or device clinical trial within 30 days prior to the study
- •Female subjects who are pregnant or lactating
研究组 & 干预措施
Placebo
0 mg SPI-1005, capsule, po, bid, x3d surrounding each cycle of chemotherapy
干预措施: Placebo (Drug)
SPI-1005 Low Dose
200 mg SPI-1005, capsule, po, bid, x3d surrounding each cycle of chemotherapy
干预措施: SPI-1005 Low Dose (Drug)
SPI-1005 Middle Dose
400 mg SPI-1005, capsule, po, bid, x3d surrounding each cycle of chemotherapy
干预措施: SPI-1005 Middle Dose (Drug)
SPI-1005 High Dose
600 mg SPI-1005, capsule, po, bid, x3d surrounding each cycle of chemotherapy
干预措施: SPI-1005 High Dose (Drug)
结局指标
主要结局
Number of participants with adverse events
时间窗: 12 months
次要结局
- Reduction of hearing loss incidence and severity(From baseline through 1 month after last chemotherapy cycle)
- Reduction of tinnitus incidence and severity.(From baseline through 1 month after last chemotherapy cycle)