NCT00426582已完成1 期
A Phase Ib, Multicenter, Open-label, Dose-finding Study of Patupilone Administered Intravenously Every 3 Weeks in Combination With Carboplatin AUC 6 in Adult Patients With Advanced Solid Tumors
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
- 48
- 试验地点
- 5
- 主要终点
- Maximum tolerated dose (MTD) and dose-limiting toxicity (DLT) of patupilone in combination with carboplatin (AUC 6)
研究概览
简要总结
This study will evaluate the maximum tolerated dose (MTD) and dose-limiting toxicity (DLT) of patupilone combined with carboplatin in adult patients with advanced solid tumors who progressed despite standard therapy or for whom no standard therapy exists or who might benefit from treatment with carboplatin
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
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Patupilone only
Experimental
Cycle 1 patupilone alone Cycle 2 and onward patupilone and carboplatin
干预措施: Patupilone (Drug)
Carboplatin alone
Active Comparator
Cycle 1 Carboplatin alone Cycle 2 and onward patuilone and carboplatin
干预措施: Patupilone (Drug)
结局指标
主要结局
Maximum tolerated dose (MTD) and dose-limiting toxicity (DLT) of patupilone in combination with carboplatin (AUC 6)
时间窗: Every 3 weeks
次要结局
- Overall response rate (complete and partial response; CR + PR) according to RECIST (response evaluation criteria in solid tumors)(Every 6 weeks)
- Time to progression (TTP), duration of overall response, duration of stable disease and time to overall response(Every 6 weeks)
- Safety of patupilone combined with carboplatin assessed by adverse events, serious adverse events, laboratory values and physical examinations(Every 6 weeks)
- Pharmacokinetic profile of patupilone combined with carboplatin(First 6 weeks (cycle 1 & 2 only))
- Relationship between pharmacokinetics and clinical outcome(Every 6 weeks during cycle 1 & cycle 2)
研究者
研究点 (5)
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