NCT05378360已完成2 期
A Multi-center, Randomized, Double-blind, Placebo-controlled, Therapeutic Exploratory, Phase II Clinical Trial for the Efficacy Investigation and Safety Evaluation of DWP708
Daewoong Pharmaceutical Co. LTD.2 个研究点 分布在 2 个国家目标入组 96 人开始时间: 2022年5月2日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 96
- 试验地点
- 2
- 主要终点
- To estimate the response rate of Rash acneiform
研究概览
简要总结
A Multi-center, Randomized, Double-blind, Placebo-controlled, Therapeutic Exploratory, Phase II Clinical Trial for the Efficacy Investigation and Safety Evaluation of DWP708 for Treating Rash Acneiform
详细描述
All the patients had Grade ≥2 ERSEs according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI-CTCAE) v. 5.0
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: older than 19
- •Eastern Cooperative Oncology Group (ECOG) performance status 0 -2
- •Patients who have Rash acneiform Gr≥2 (NCI CTCAE v5.0)
- •Patients who are currently administering EGFR TKI or EGFR mAb
排除标准
- •Known allergies, hypersensitivity, or intolerance to study drugs, chemotherapy drugs using this clinical trial
- •Patients with a history of topical medication
- •Steroids within 3 days prior to baseline visit
- •Antihistamine, Antipruritic agents, Antibiotics agents within 1 week prior to baseline visit
- •Tacrolimus, Pimecrolimus within 2 weeks prior to baseline visit
结局指标
主要结局
To estimate the response rate of Rash acneiform
时间窗: Up to 28 days
The effectiveness of the DWP708 was defined as follows: 1. Downgraded to more than 2 steps 2. Downgraded to ≤Grade 1
次要结局
- To estimate the amount of change papule and/or pustule(Up to 56 days)
- To evaluate the patients' Quality of Life (QoL) by Skin evaluation method(Up to 56 days)
研究者
研究点 (2)
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