NCT00035087已完成2 期
An Open-Label Phase IIa Trial Evaluating the Safety and Efficacy of EPO906 as Therapy in Patients With Advanced Colorectal Cancer
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- Tumor response as assessed by radiologic techniques and/or physical examination based on Response Evaluation Criteria in Solid Tumors (RECIST)
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 colorectal cancer.
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must meet the following criteria to be eligible for the study:
- •Histologically or cytologically documented evidence of colorectal cancer with at least one measurable lesion (if previous radiation treatment, the target lesion must have demonstrated progression since the radiation)
- •The patient should have failed or progressed on no more than two prior chemotherapies for metastatic disease (the prior chemotherapy must have included a fluoropyrimidine and either Irinotecan or oxaliplatin, or any combination of these agents, with the last chemotherapy having contained Irinotecan or oxaliplatin)
- •Patients who have received only adjuvant therapy for their disease are eligible, as long as they have relapsed within six months of completing such therapy and that therapy contained 5-FU and Irinotecan or oxaliplatin administered in combination as part of an investigational protocol
- •Must have a life expectancy of greater than three (3) months.
排除标准
- •The following patients are not eligible for the study:
- •Patients with symptomatic CNS metastases or leptomeningeal involvement
- •Patients with unresolved bowel obstruction
- •Patients with any peripheral neuropathy or unresolved diarrhea greater than Grade 1
- •Patients with severe cardiac insufficiency
- •Patients who have undergone major surgery for any cause less than 4 weeks prior to study entry
- •Patients with radiation therapy or chemotherapy within the last four weeks
- •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
结局指标
主要结局
Tumor response as assessed by radiologic techniques and/or physical examination based on Response Evaluation Criteria in Solid Tumors (RECIST)
次要结局
- Time to progression
- Overall survival
研究者
研究点 (1)
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