NCT00035126已完成2 期
An Open-Label Phase IIa Trial Evaluating the Safety and Efficacy of EPO906 as Therapy in Patients With Advanced Breast 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
- 46
- 试验地点
- 2
- 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 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 breast 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
- Female
- 接受健康志愿者
- 否
入选标准
- •The following patients may be eligible for this study:
- •Histologically or cytologically documented evidence of disease with at least one measurable lesion;
- •Life expectancy of greater than three (3) months;
- •Patients who have had only one prior therapy for metastatic disease;
- •Patients who have received prior treatment with hormonal agents or who have had prior treatment regimens of radiotherapy in addition to one or no previous chemotherapy regimens are eligible;
- •Patients who have had no prior therapy for metastatic disease, but who have received a taxane and an anthracycline (single or combination therapy) as adjuvant treatment, are eligible. For patients who have had previous radiation therapy to the target lesion(s), the lesion(s) must since have demonstrated progression.
排除标准
- •The following patients are not eligible for this study:
- •Bone-only disease;
- •Symptomatic pleural effusions;
- •Symptomatic CNS metastases or leptomeningeal involvement;
- •Any peripheral neuropathy or unresolved diarrhea greater than Grade 1;
- •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 ckin cancer or cervical cancer in situ;
- •Active or suspected acute or chronic uncontrolled infection including abcesses or fistulae;
- •HIV+ patients;
- •Pregnant or lactating females;
- •Patients who have had radiation, chemotherapy, or hormonal therapy within the last four (4) weeks excluding palliative radiotherapy to isolated peripheral bone metastases not being used as markers for efficacy;
- •Patients taking Herceptin less than three (3) weeks prior to study start.
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 as assessed by radiologic techniques and/or physical examination based on Response Evaluation Criteria in Solid Tumors (RECIST)
时间窗: Every 8 weeks
次要结局
- Duration of overall response(every 8 weeks as clinically needed)
- Safety of study drug(weekly for the first 8 weeks, then every other week)
- Time to progression(until disease progression, death or date of last follow-up)
- Overall survival(date of death or last date patient was known to be alive)
- pharmacokinectics of study drug(every 8 weeks)
研究者
研究点 (2)
Loading locations...
相似试验
已完成
2 期
EPO906 Therapy in Patients With Advanced Kidney CancerKidney NeoplasmsNCT00035243Novartis Pharmaceuticals53
已完成
2 期
EPO906 Therapy in Patients With Advanced Colorectal CancerColonic NeoplasmsColorectal NeoplasmsNCT00035087Novartis Pharmaceuticals62
已完成
2 期
EPO906 Therapy in Patients With Advanced Ovarian, Primary Fallopian, or Primary Peritoneal CancerOvarian NeoplasmsPeritoneal NeoplasmsFallopian Tube NeoplasmsNCT00035100Novartis Pharmaceuticals54
已完成
2 期
EPO906 Therapy in Patients With Prostate CancerProstatic NeoplasmsNCT00035113Novartis Pharmaceuticals48
已完成
2 期
EPO906 Therapy in Patients With Advanced MelanomaMelanomaNCT00035165Novartis Pharmaceuticals51