NCT00969046已完成1 期
EPO906 Phase I 6-arm Trial to Optimize Administration Exploring Single Dose Bolus and Continuous Infusion Over 1 or 5 Days Every 3 or 4 Weeks in Patients With Pretreated Advanced Colon Cancer With Nutritional Support Treatment and Intensive Management of Diarrhea
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- To identifymaximum tolerated dose (MTD)
研究概览
简要总结
This study is exploring different administration schedules (short versus prolonged infusion) to optimize the safety and efficacy profile of EPO906A (patupilone) in patients with pretreated advanced colon cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed, locally advanced, progressive or metastatic colon cancer, up to 4 prior lines of prior chemotherapy, at least one measurable lesion according to RECIST
- •Age ≥ 18 years
- •Life expectancy ≥ 12 weeks
- •WHO performance status of 0-1
- •Negative serum pregnancy test
- •Adequate hepatic or renal function and hematological parameters
排除标准
- •Brain metastases
- •Ileostomy or colonostomy
- •History of pelvic radiotherapy
- •Grade > 1 diarrhea at baseline
- •Other protocol-defined inclusion/exclusion criteria may apply
研究组 & 干预措施
Bolus
Experimental
20 min bolus infusion
干预措施: EPO906 (patupilone) (Drug)
CIV-1d
Experimental
1 day continuous infusion
干预措施: EPO906 (patupilone) (Drug)
CIV-5d
Experimental
5 day continuous infusion
干预措施: EPO906 (patupilone) (Drug)
结局指标
主要结局
To identifymaximum tolerated dose (MTD)
时间窗: During cycle 1 and 2 (approx 6 to 8 wks)
次要结局
- To characterize the safety and tolerability of patupilone by assessing adverse events (AEs) and serious adverse events (SAEs), hematology and biochemistry labs, vital signs, performance status, and by physical/neurological exams(at base line, every 3 weeks prior to start of the next dose, at end of treatment)
- To evaluate preliminary anti-tumor activity of patupilone using standard imaging technologies (e.g. best overall response rate and time to progression according to Response Evaluation Criteria in Solid Tumors [RECIST])(at baseline and every 8 wks)
- To evaluate the blood concentrations profile (pharmacokinetics [PK]) of patupilone by multiple blood sampling before, during and after drug administration(Cycle 1 and 4)
研究者
研究点 (1)
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