2024-516339-28-00招募中2 期
A phase 2a multicentric study of TAR-0520 gel in EGFR inhibitor-induced folliculitis
Tarian Pharma7 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年11月13日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 7
- 主要终点
- Incidence of Adverse Events, Adverse Events of Special Interest and Serious Adverse Events
研究概览
简要总结
To confirm the good local tolerance of TAR-0520 gel applied to the face and chest of colorectal cancer patients treated with anti-EGFR antibodies
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Male or female, who is at least 18 years of age or older at screening visit
- •Clinical diagnosis of metastatic colorectal carcinoma planned to be treated with cetuximab or panitumumab injections as part of the chemotherapy protocol
排除标准
- •Patient with a medical history of EGFRi treatment in the past two years
- •Patient has a history of other skin disorders (eg, atopic dermatitis, psoriasis, recurrent skin infections), or history of illness that, in the opinion of the Investigator, would confound results of the study
结局指标
主要结局
Incidence of Adverse Events, Adverse Events of Special Interest and Serious Adverse Events
Incidence of Adverse Events, Adverse Events of Special Interest and Serious Adverse Events
次要结局
- Modified folliculitis CTCAE
- Facial folliculitis severity score
- Modified FACT-EGFRI-18 questionnaire
研究者
Janusz Czernielewski
Scientific
Tarian Pharma
研究点 (7)
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