Randomised Double-Blind Placebo-Controlled Study of Orally Administered ATL-104 to Assess Safety, Tolerance and Effect on Oral Mucositis in Patients Following Treatment With Chemotherapy and Peripheral Blood Stem Cell Transplant (PBSCT)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 63
- 试验地点
- 1
- 主要终点
- Safety: Adverse events
研究概览
简要总结
This purpose of this study is to investigate whether ATL-104 is safe and well tolerated, and whether it shows evidence of efficacy in mucositis in patients undergoing PBSCT
详细描述
Mucositis is a serious side effect of cancer therapy and Peripheral Blood Stem Cell Transplant (PBSCT) which requires appropriate and effective management. Mucositis is a condition in which there is inflammation and ulceration of the mouth, throat and gut caused by damage to the mucosal barrier induced by chemo- and radiotherapy. Symptoms include pain, nausea, abdominal cramping, and vomiting. This study will investigate whether ATL-104, when administered as a swallowable mouthwash, is safe and well tolerated in patients undergoing PBSCT and to investigate its potential to reduce the level of severity of mucositis associated with PBSCT.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with haematological malignancies undergoing chemotherapy in association with PBSCT
排除标准
- •Clinically significant conditions that would exclude the patient receiving chemotherapy in association with PBSCT
- •Visible oral disease
- •Significantly reduced platelet and neutrophil count
研究组 & 干预措施
1
ATL-104 50mg
干预措施: ATL-104 (Drug)
2
ATL-104 100mg
干预措施: ATL-104 (Drug)
3
ATL-104 150mg
干预措施: ATL-104 (Drug)
4
Placebo
干预措施: ATL-104 (Drug)
结局指标
主要结局
Safety: Adverse events
时间窗: 28 days post-treatment
Efficacy: Oral mucositis scale
时间窗: 28 days post-treatment
次要结局
- Pharmacokinetics of ATL-104
- Safety: Laboratory monitoring, vital signs, ECG(28 days post-treatment)
