A Pivotal, Double-Blind, Randomized, Placebo-Controlled, Multinational Study of SGX942 (Dusquetide) for the Treatment of Oral Mucositis in Patients Being Treated With Concomitant Chemoradiation for the Treatment of Squamous Cell Carcinoma of the Head and Neck
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Soligenix
- 入组人数
- 266
- 试验地点
- 53
- 主要终点
- Duration of Severe Oral Mucositis (SOM)
研究概览
简要总结
To assess the efficacy of SGX942 compared to placebo in decreasing the duration of severe oral mucositis in patients receiving chemoradiation treatment for the treatment of head and neck cancer
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Biopsy-proven squamous cell carcinoma of the oral cavity or oropharynx without distant organ metastases
- •Scheduled to receive cisplatin chemotherapy of 80-100 mg/m²
- •Scheduled to receive a continuous course of fractionated, conventional external beam with a cumulative radiation dose between 55 and 72 Gy at each site
排除标准
- •Current mucositis
- •Current, clinically significant, active infection that in the opinion of the Investigator would make them an unfit participant in the trial
- •Planned to receive Erbitux™ (Cetuximab) or similar targeted therapy between Baseline and 6 weeks post-RT
- •Prior radiation to the head and neck
- •Chemotherapy treatment within the previous 12 months
- •Tumors of the lips, sinuses, salivary glands, nasopharynx, hypopharynx, or larynx
- •Evidence of significant renal, hepatic, hematologic, or immunologic disease determined by any one of the following: Estimated creatinine clearance <30 mL/min; ALT or AST level greater than 10-fold the upper limit of normal or total bilirubin greater than 3-fold the upper limit of normal; Manifestations of end-stage liver disease, such as ascites or hepatic encephalopathy; Thrombocytopenia; or CD4+ T cell count below 200 cells per μL
- •Evidence of immediate life-threatening disease or a life expectancy of less than 3 months
- •Women who are pregnant or breast-feeding
- •Participation in any study involving administration of an investigational agent within 30 days of randomization into this study
研究组 & 干预措施
SGX942
Patients are randomized 1:1 active/placebo.
干预措施: SGX942 (Drug)
Placebo
Patients are randomized 1:1 active/placebo.
干预措施: Placebo (Drug)
结局指标
主要结局
Duration of Severe Oral Mucositis (SOM)
时间窗: approx. 13 weeks
To assess the efficacy of SGX942 compared to placebo in decreasing the duration of severe oral mucositis (SOM; defined as World Health Organization \[WHO\] Grade ≥3). Duration of SOM is defined as the number of days from the onset of SOM until resolution of SOM. OM is evaluated using the published WHO OM grading scale that uses a scale of 0 to 4, with SOM defined as a score ≥3.
次要结局
未报告次要终点