A Phase I Study of Intravaginally Administered Artesunate In Women With High Grade Cervical Intraepithelial Neoplasia (CIN2/3)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 3
- 主要终点
- Number of Participants With Serious Adverse Events
研究概览
简要总结
This phase I research protocol is designed to assess immunogenicity and clinical endpoints in patients with human papillomavirus (HPV) 16 cervical intraepithelial neoplasia (CIN)2/3. The protocol tests the use of artesunate in suppository formulation applied intravaginally in patients with cervical dysplasia (CIN2/3).
The primary endpoint is to determine and evaluate the safety, tolerability, and feasibility of intravaginal administration of artesunate in health women with CIN2/3.
详细描述
Phase I open-label dose escalation study of intravaginal artesunate, formulated in suppositories, in adult females with biopsy-confirmed CIN2/3. Thirty (30) subjects will undergo up to a total of three cycles of intravaginal artesunate. The first cycle will be initiated on Day 0, the second at Week 4, and the third and final cycle at week 8.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •≥ 18 years
- •Capable of informed consent
- •HPV-positive by DNA test
- •Histologically confirmed CIN 2, CIN 3, or CIN 2/3
- •Body weight ≥ 50 kg
- •Immune competent
排除标准
- •Pregnant and nursing women
- •HIV seropositive
- •Active autoimmune disease
- •Taking immunosuppressive medication
- •Evidence of concurrent adenocarcinoma in situ
- •Concurrent malignancy except for nonmelanoma skin lesions
研究组 & 干预措施
50 mg Artesunate suppositories, 1 cycle
Subjects enrolled in this cohort will receive 1 five day cycle of Artesunate suppositories prior to therapeutic resection of their lesion (if clinically indicated).
干预措施: Artesunate Suppositories (Drug)
200 mg Artesunate suppositories, 1 cycle
Subjects enrolled in this cohort will receive 1 five day cycle of Artesunate suppositories prior to therapeutic resection of their lesion (if clinically indicated).
干预措施: Artesunate Suppositories (Drug)
200 mg Artesunate suppositories,2 cycles
Subjects enrolled in this cohort will receive 2 five day cycles of Artesunate suppositories prior to therapeutic resection of their lesion (if clinically indicated).
干预措施: Artesunate Suppositories (Drug)
200 mg Artesunate suppositories,3 cycles
Subjects enrolled in this cohort will receive 3 five day cycles of Artesunate suppositories prior to therapeutic resection of their lesion (if clinically indicated).
干预措施: Artesunate Suppositories (Drug)
结局指标
主要结局
Number of Participants With Serious Adverse Events
时间窗: 41 weeks
Number of participants with serious adverse events or dose limiting toxicities related to the study intervention assessed using Common Terminology Criteria for Adverse Events (CTCAE) 4.0 criteria.
次要结局
- Viral Clearance of HPV(41 weeks)
- Histologic Regression of CIN2/3(41 weeks)