A Phase I Study of Intra-Anally Administered Artesunate in Patients With High-Grade Anal Intraepithelial Neoplasia (AIN 2/3)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 2
- 主要终点
- Incidence of treatment-emergent adverse events (Safety and tolerability) of Artesunate suppositories for the treatment of anal intraepithelial neoplasia (AIN2/3)
研究概览
简要总结
This open label study investigates a novel non-surgical approach to the treatment of HPV-associated anal intraepithelial neoplasia, using Artesunate suppositories.
详细描述
Patients diagnosed with AIN 2/3 will be enrolled sequentially in treatment cohorts receiving different doses of Artesunate suppositories administered trans-anally. Doses of escalation will be 200 mg, 400 mg, and 600 mg. Treatment cohorts will consist of 2 or 3 cycles at each dose level. Suppositories will be administered daily for 5 days. Five days constitutes 1 cycle. Up to 3 cycles will be administered at Weeks 0, 2, and 4.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years
- •Biopsy-confirmed high-grade anal dysplasia (AIN 2, AIN 3, HSIL) by high resolution anoscopy (HRA)
- •Female of childbearing potential: negative urine pregnancy test
- •Able to provide informed consent
- •Patients who have the ability to collaborate with planned follow-up (transportation, compliance history, etc.).
- •Weight ≥50 kg.
排除标准
- •Diagnosis of low-grade anal dysplasia (AIN 1, LSIL) by high resolution anoscopy
- •Known anal, vulvar, cervical, or penile cancer
- •CD4 count < 200 at the time of consideration for entry into this study
- •Unable to provide informed consent
- •Currently receiving systemic chemotherapy or radiation therapy for another cancer.
- •Patients who are on medical treatment with systemic immunosuppressants or steroids (e.g., active autoimmune disease)
- •Extensive anal condyloma precludes the ability for the clinician to visualize HSIL during HRA
研究组 & 干预措施
ART 200 mg, 2 cycles
Two five-day cycles of Artesunate suppositories, 200 mg/day
干预措施: Artesunate Suppositories (Drug)
ART 200 mg, 3 cycles
Three five-day cycles of Artesunate suppositories, 200 mg/day
干预措施: Artesunate Suppositories (Drug)
ART 400 mg, 2 cycles
Two five-day cycles of Artesunate suppositories, 400 mg/day
干预措施: Artesunate Suppositories (Drug)
ART 400 mg, 3 cycles
Three five-day cycles of Artesunate suppositories, 400 mg/day
干预措施: Artesunate Suppositories (Drug)
ART 600 mg, 2 cycles
Two five-day cycles of Artesunate suppositories, 600 mg/day
干预措施: Artesunate Suppositories (Drug)
ART 600 mg, 3 cycles
Three five-day cycles of Artesunate suppositories, 600 mg/day
干预措施: Artesunate Suppositories (Drug)
结局指标
主要结局
Incidence of treatment-emergent adverse events (Safety and tolerability) of Artesunate suppositories for the treatment of anal intraepithelial neoplasia (AIN2/3)
时间窗: 6 weeks from the date of the first dosing
Number of patients with serious adverse events or dose limiting toxicities related to the study medication, according to CTCAE4.0
次要结局
- Number of patients with viral clearance of human papillomavirus (HPV) virus measured by HPV genotyping(40 weeks)
- Number of patients with histologic regression of anal intraepithelial neoplasia (AIN2/3) to AIN1 or less(28 weeks)