Phase II Clinical Trial Repurposing Atovaquone for the Treatment of Platinum-Resistant Ovarian Cancer
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Progression free survival (PFS)
研究概览
简要总结
This phase II trial test tests how well repurposing atovaquone works in treating patients with platinum-resistant ovarian cancer. Atovaquone is used for the treatment or prevention of certain infections. Atovaquone is in a class of medications called antiprotozoal agents. It works by stopping the growth of certain types of protozoa that can cause pneumonia. Giving atovaquone may be effective in treating platinum-resistant ovarian cancer and result in improved outcomes compared to standard chemotherapy regimens.
详细描述
PRIMARY OBJECTIVE:
I. To determine progression free survival of twenty-eight patients with platinum-resistant ovarian cancer treated with atovaquone.
SECONDARY OBJECTIVES:
I. To determine clinical benefit rate (complete response, partial response or stable disease) at six months.
II. To determine overall survival. III. To quantitate the on-target STAT3 inhibitory effect of atovaquone on STAT3-dependent gene transcription.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Patients with platinum-resistant, high-grade serous ovarian cancer, defined as disease progression within six months of completion of their last platinum-based chemotherapy
- •Patients must maintain Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- •There will be no limitations on number of prior lines of therapy
- •Trial is open to non-English speaking patients
- •Trial is open to patients referred from community practice
排除标准
- •Patients who are < 18 years old
- •Patients who are pregnant or breastfeeding (due to cancer of their reproductive organs, patients enrolled in the trial are unable to conceive)
- •Patients who are incarcerated
- •Patients who are unable to provide consent / lack decision-making capacity
研究组 & 干预措施
Treatment (atovaquone)
Patients receive atovaquone PO on study. Patients also undergo CT and biopsy or paracentesis throughout the study.
干预措施: Paracentesis (Procedure)
Treatment (atovaquone)
Patients receive atovaquone PO on study. Patients also undergo CT and biopsy or paracentesis throughout the study.
干预措施: Atovaquone (Drug)
Treatment (atovaquone)
Patients receive atovaquone PO on study. Patients also undergo CT and biopsy or paracentesis throughout the study.
干预措施: Biopsy (Procedure)
Treatment (atovaquone)
Patients receive atovaquone PO on study. Patients also undergo CT and biopsy or paracentesis throughout the study.
干预措施: Computed Tomography (Procedure)
结局指标
主要结局
Progression free survival (PFS)
时间窗: From initiation of atovaquone to progression or death, assessed up to 1 year
Will be estimated using the Kaplan-Meier method, and a 95% confidence interval for median PFS will be estimated using the Brookmeyer-Crowley approach.
次要结局
- Clinical benefit rate(At 6 months)
- Overall survival (OS)(From diagnosis to death from any cause, where patients who are alive will be censored at last follow-up date, assessed up to 1 year)
- Incidence of adverse events(Up to 30 days)
研究者
Namita Khanna
Principal Investigator
Emory University