A Phase 2, Multi-center, Randomized, Double-blind, Placebo-controlled, Dose Ranging Study to Assess the Safety and Efficacy of SC-07 for the Delay to Onset of Severe Oral Mucositis in Subjects Receiving Chemoradiation Therapy for the Treatment of Cancers of the Head and Neck.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 59
- 试验地点
- 19
- 主要终点
- Safety will be assessed by collecting and recording AEs and laboratory assessments. Labs will be collected at screening,weekly throughout the subject's RT treatment and on the last day of radiotherapy.
研究概览
简要总结
Oral Mucositis (OM) is a painful and debilitating side effect of many of the drug or radiation regiments used to treat cancer. This study examines the investigational drug SCV-07 and it's possible application in treating Oral Mucositis. Studies have shown that SCV-07 can possibly increase a broad immune system response, thus lowering the painful side effects experienced when treated for head and neck cancer.
The purpose of this study is to assess the safety and tolerability of SCV-07 and it's ability to delay the onset of Oral Mucositis for patients receiving chemoradiation for head and neck cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject must have a body weight less than 150 kg at screening
- •Have recently-diagnosed, pathologically-confirmed squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx or larynx that will be treated with chemoradiation therapy as first line treatment(postoperative patients are eligible, if surgery is < 6 weeks prior to initiation of radiotherapy.
- •Plan to receive a continuous course of conventional external beam irradiation
- •Plan to receive a standard cisplatin chemotherapy regimen
排除标准
- •Pregnant or breastfeeding
- •Have head and neck tumors of the lips, sinuses, salivary glands or unknown primary tumor
- •Prior radiation to the head and neck
- •Have a plan to receive cetuximab (Erbitux) in conjunction with chemotherapy
- •Had curative surgery more than 6 weeks prior to the initiation of radiotherapy
- •Have current oral mucositis
- •Presence of active infectious disease excluding oral candidiasis
- •Chronic immunosuppression
- •Seropositive for HIV or hepatitis B surface antigen or C antibody
- •Used an investigational agent within 30 days of randomization
- •Have a known sensitivity to any investigational agent
研究组 & 干预措施
1
Placebo
干预措施: Placebo (Drug)
2
SCV-07 at a dose of 0.02 mg/kg
干预措施: SCV-07 (Drug)
3
SCV-07 at a dose of 0.10 mg/kg
干预措施: SCV-07 (Drug)
结局指标
主要结局
Safety will be assessed by collecting and recording AEs and laboratory assessments. Labs will be collected at screening,weekly throughout the subject's RT treatment and on the last day of radiotherapy.
时间窗: 7 Weeks
Efficacy of Oral Mucositis assessment will be completed by trained site personnel. The WHO score will be the primary measure and NCI CTCAE will be a secondary measure for assessing Oral Mucositis.
时间窗: 7 weeks
次要结局
未报告次要终点