A Phase 2,Double-Blind, Randomized, Placebo-Controlled, Dose Escalating, Multicenter Study of SGX942 For the Attenuation 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
- 2 期
- 状态
- 已完成
- 发起方
- Soligenix
- 入组人数
- 111
- 试验地点
- 1
- 主要终点
- Duration of Severe Oral Mucositis (SOM)
研究概览
简要总结
To evaluate the safety and efficacy of SGX942 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 non-metastatic squamous cell carcinoma of the mouth or oropharynx and is planned to receive a standard course of concomitant CRT.
- •Patients who have received surgery are eligible if surgery is performed within 6 weeks prior to study initiation.
- •Planned to receive standard cisplatin chemotherapy administered either weekly or every third week.
- •Must be able to read and understand informed consent
- •Adequate birth control methods for the duration of the study
排除标准
- •Current mucositis.
- •Prior radiation to the head and neck.
- •Chemotherapy treatment within the previous 12 months.
- •Tumors of the lips, sinuses, salivary glands or nasopharynx.
- •Unknown primary tumor.
- •Stage 4c metastases.
- •Evidence of significant hepatic, hematologic, or immunologic disease.
- •Women who are pregnant or breast-feeding.
研究组 & 干预措施
Placebo
Control
干预措施: Placebo (Drug)
SGX942
Investigational Drug i) 1.5 mg/kg ii) 3.0 mg/kg iii) 6.0 mg/kg
干预措施: SGX942 (Drug)
结局指标
主要结局
Duration of Severe Oral Mucositis (SOM)
时间窗: 4 weeks after end of therapy
Duration of SOM was defined as the number of days from the onset of SOM until resolution of SOM. If the patient did not meet the requirements for resolution of SOM by the 1-month follow up visit, he/she was considered censored at the 1-month follow-up visit (or point of discontinuation of the study, if the patient had discontinued prior to the end of planned treatment). Patients who did not experience SOM were assigned a duration of 0.01. OM was evaluated using the published World Health Organization (WHO) OM grading scale that uses a scale of 0 to 4.
次要结局
- Residual Severe Oral Mucositis (SOM)(4 weeks after end of therapy)
- Incidence of Clinically Reported, Non-fungal Infections(4 weeks after end of therapy)
- Survival(12 months after end of therapy)
- Duration of Severe Oral Mucositis (SOM) in Patients Receiving Every 3rd Week Cisplatin(4 weeks after end of therapy)
- Duration of Severe Oral Mucositis (SOM)(4 weeks after end of therapy)
- Percent of Patients With RECIST 1.1 Classification of "Complete Response"(12 months after end of therapy)
- Incidence of Severe Oral Mucositis (SOM) in Patients Receiving Every 3rd Week Cisplatin(4 weeks after end of therapy)