A Phase I Single Dose Escalation Study of Two Dosing Schedules of BI 6727 Administered Intravenously in Asian Patients With Various Solid Cancers With Repeated Administration in Patients With Clinical Benefit
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 59
- 试验地点
- 2
- 主要终点
- Percentage of Participants With Dose Limiting Toxicities (DLT) in Cycle 1 for the Determination of the Maximum Tolerated Dose (MTD) of Volasertib
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 in Asian cancer patients, and to provide safety data in terms of drug-related adverse events.
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
BI 6727
Schedule A
干预措施: BI 6727 (Drug)
结局指标
主要结局
Percentage of Participants With Dose Limiting Toxicities (DLT) in Cycle 1 for the Determination of the Maximum Tolerated Dose (MTD) of Volasertib
时间窗: From first administration of study drug up to 3 weeks
Primary objective for this trial was to identify the MTD of volasertib for 2 dosing schedules. The MTD was defined as the highest volasertib dose studied for which the incidence of DLT was less than 2/6 patients. The MTD was defined on the basis of DLTs observed during the first treatment course only. In this outcome measure the percentage of participants with DLTs in cycle 1 is presented.
MTD of Volasertib
时间窗: From the first administration of study drug up to 3 weeks
Primary objective for this trial was to identify the MTD of volasertib for 2 dosing schedules. The MTD was defined as the highest volasertib dose studied for which the incidence of DLT was less than 2/6 patients. This outcome measure shows the MTD.
次要结局
- Percentage of Participants With Incidence and Intensity of Drug-related AEs According to CTCAE v.3.0(From first administration of volasertib to 21 days after the last dose, up to 548 days)
- Change From Baseline to Last Value on Treatment in Platelets(Baseline (Visit 1, prior to first administration of volasertib) and up to 21 days after last observation on treatment (up to 548 days))
- Change From Baseline to Last Value on Treatment in Neutrophils(Baseline (Visit 1, prior to first administration of volasertib) and up to 21 days after last observation on treatment (up to 548 days))
- Patient Performance(From first administration of volasertib to the last dose, up to 527 days)
- Vital Signs (Blood Pressure)(Baseline (Visit 1, prior to the first administration of volasertib), up to 21 days after last observation on treatment (up to 548 days))
- Vital Signs (Pulse Rate)(Baseline (Visit 1, prior to the first administration of volasertib), up to 21 days after last observation on treatment (up to 548 days))
- ECG(Baseline, 2 hours (before the end of infusion of volasertib) and 24 hours after first infusion in Cycle 1)
- Objective Response(At screening and at the end of every other treatment course up to 527 days (= longest treatment exposure))
- Progression-free Survival(At screening and at the end of every other treatment course up to 527 days (= longest treatment exposure))
- Response Duration(From first drug administration up to at 3 month interval after final End of treatment visit until disease progression, death, or lost to follow-up, up to 548 days)
- Disease Control(At screening and at the end of every other treatment course up to 527 days (= longest treatment exposure))
- Sum of the Largest Diameters of Target Lesions(At screening and at the end of every other treatment course up to 527 days (= longest treatment exposure))
- Pharmacokinetics (PK) AUC0-∞ of Volasertib(Both schedules: 10 minutes prior to first drug administration and 1 hour (h), 2, 2:30, 3, 4, 8, 24, 336h thereafter; additional planned times in schedule D1+D8: 167:50, 169, 170, 170:30, 171, 172, 176, 192h; additional planned time in D1 schedule: 168h)
- Pharmacokinetics (PK) AUC0-168 of Volasertib(Both schedules: 10 minutes prior to first drug administration and 1 hour (h), 2, 2:30, 3, 4, 8, 24, 336h thereafter; additional planned times in schedule D1+D8: 167:50, 169, 170, 170:30, 171, 172, 176, 192h; additional planned time in D1 schedule: 168h)
- Pharmacokinetics (PK) Cmax of Volasertib(Both schedules: 10 minutes prior to first drug administration and 1 hour (h), 2, 2:30, 3, 4, 8, 24, 336h thereafter; additional planned times in schedule D1+D8: 167:50, 169, 170, 170:30, 171, 172, 176, 192h; additional planned time in D1 schedule: 168h)