NCT00035100已完成2 期
An Open-Label Phase IIa Trial Evaluating the Safety and Efficacy of EPO906 as Therapy in Patients With Advanced Ovarian, Primary Fallopian, or Primary Peritoneal Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- Tumor response rate
研究概览
简要总结
This study will examine whether the new investigational drug EPO906, given by intravenous infusion (IV directly into the vein), is effective in shrinking tumors and preventing the growth of cells that cause ovarian, fallopian, or peritoneal cancers. Recruitment in the United States is complete but the study is still enrolling in other countries.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •The following patients may be eligible for the study:
- •Histologically or cytologically documented evidence of ovarian, primary Fallopian or primary peritoneal cancer with at least one measurable lesion (if previous radiation treatment, the target lesion must have demonstrated progression since the radiation)
- •Must have a life expectancy of greater than three (3) months
- •Prior failure to respond following front-line treatment with a taxane and platinum (or a combination therapy) may be eligible.
排除标准
- •The following patients are not eligible for the study:
- •Patients with radiation therapy or chemotherapy within the last four weeks
- •Patients who have had any chemotherapy not containing a taxane and platinum for their disease
- •Patients with borderline ovarian and macropapillary tumors
- •Patients with unresolved bowel obstruction
- •Patients with symptomatic CNS metastases or leptomeningeal involvement
- •Patients with any peripheral neuropathy or unresolved diarrhea greater than Grade 1
- •Patients with severe cardiac insufficiency
- •Patients taking Coumadin or other warfarin-containing agents with the exception of low dose Coumadin (1 mg or less) for the maintenance of in-dwelling lines or ports
- •History of another malignancy within 5 years prior to study entry except curatively treated non-melanoma skin cancer or cervical cancer in situ
- •Patients with active or suspected acute or chronic uncontrolled infection including abcesses or fistulae
- •HIV+ patients
- •Pregnant or lactating females.
研究组 & 干预措施
EPO906
Experimental
干预措施: epothilone b (Drug)
结局指标
主要结局
Tumor response rate
时间窗: Every 2 cycles
tumor response was defined by the Response Evaluation Criteria in Solid Tumors (RECIST).
次要结局
- Time to disease progression(from start of treatment to documented disease progression, death from study indication, or the date of last follow-up)
- Overall survival(measured from the start of treatment to the date of death or the last date the patient was known to be alive.)
- Duration of response(Every 3 months)
- recording all adverse events (AEs) and serious adverse events (SAEs)(Every 3 months)
- pharmacogenetic analyses with blood and tumor samples from these patients(Every 3 months)
研究者
研究点 (1)
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