NCT00969761已完成1 期
A Phase I Dose Escalation Trial of BI 6727 in Combination With Cisplatin or Carboplatin in Patients With Advanced or Metastatic 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
- 61
- 试验地点
- 2
- 主要终点
- Maximum Tolerated Dose
研究概览
简要总结
The primary objective of this trial is to identify the maximum tolerated dose (MTD) of BI 6727 therapy in terms of drug-related adverse events when combined with a platinum therapy (cisplatin or carboplatin).
Secondary objectives are the collection of overall safety and antitumour efficacy data and the determination of the pharmacokinetic profile of BI 6727 combination treatment with cisplatin and carboplatin.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
A. BI 6727-cisplatin
Experimental
patient to receive 3-weekly infusion escalating dose of BI 6727 combined to cisplatin
干预措施: BI 6727 (Drug)
B. BI 6727-carboplatin
Experimental
patient to receive 3-weekly infusion escalating dose of BI 6727 combined to carboplatin
干预措施: BI-6727 (Drug)
结局指标
主要结局
Maximum Tolerated Dose
时间窗: 3 weeks
The maximum tolerated dose (MTD) was defined as the highest dose studied for which the incidence of DLT was less than 33% (i.e. 1/6 patients) during the first cycle, for Volasertib in combination with cisplatin or carboplatin. 0=not maximum tolerated dose, 1=was maximum tolerated dose.
次要结局
- Duration of Objective Response(From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days)
- Best Overall Response(From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days)
- Progression-free Survival(From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days)
- Incidence and Intensity of Adverse Events According to CTCAE Version 3.0(From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days)
- Change From Baseline in Pulse Rate(Baseline and from first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days)
- Change From Baseline in Neutrophils(Baseline and from first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days)
- Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Platelets Based on Last Value on Treatment(From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days)
- Total Plasma Clearance After Intravascular Administration (CL)(1 hour (h) 35 minutes (min) before start of volasertib infusion and 1h, 2h, 8h, 24h, 48h, 168h and 336h after start of volasertib infusion)
- Frequency of Participants (%) With Possible Clinically Significant Abnormalities for Neutrophils(From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days)
- Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Neutrophils Based on Last Value on Treatment(From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days)
- Objective Response Rate(From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days)
- Percentage of Participants With Significant Adverse Events(From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days)
- Change From Baseline in Platelets(Baseline and from first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days)
- Frequency of Participants (%) With Possible Clinically Significant Abnormalities for Platelets(From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days)
- Percentage of Participants With Dose Limiting Toxicities(3 weeks)
- Disease Control Rate(From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days)
- Duration of Disease Control(From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days)
- Percentage of Participants With Serious Adverse Events(From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days)
- Apparent Volume of Distribution at Steady State Following Intravascular Administration (Vss)(1 hour (h) 35 minutes (min) before start of volasertib infusion and 1h, 2h, 8h, 24h, 48h, 168h and 336h after start of volasertib infusion)
- Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Platelets Based on Worst Value on Treatment(From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days)
- Worst CTCAE Grade on Treatment for Platelets(From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days)
- Worst CTCAE Grade on Treatment for Neutrophils(From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days)
- Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Neutrophils Based on Worst Value on Treatment(From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days)
研究者
研究点 (2)
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