An Open Label Phase I Dose Escalation Trial of Intravenous BI 6727 in Combination With Oral BIBF 1120 in Patients With Advanced Solid Tumours 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
- 30
- 试验地点
- 2
- 主要终点
- Number of Participants With Dose Limiting Toxicities (DLTs) in the First Cycle for the Determination of the Maximum Tolerated Dose (MTD).
研究概览
简要总结
The primary objective of the current study is to investigate the Maximum Tolerated Dose (MTD) in terms of safety and tolerability of BI 6727 in combination with fixed dose BIBF 1120, in patients with advanced or metastatic solid tumours.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
BIBF 1120 and BI 6727
Finding Maximum Tolerated Dose of BI 6727 in combination with BIBF 1120
干预措施: BI 6727 (Drug)
BIBF 1120 and BI 6727
Finding Maximum Tolerated Dose of BI 6727 in combination with BIBF 1120
干预措施: BIBF 1120 (Drug)
结局指标
主要结局
Number of Participants With Dose Limiting Toxicities (DLTs) in the First Cycle for the Determination of the Maximum Tolerated Dose (MTD).
时间窗: 28 days
DLT was defined as: 1. Drug-related CTCAE (Common Terminology Criteria for Adverse Events) grade 3 or 4 non-haematological toxicity (except untreated vomiting, untreated nausea, or untreated diarrhoea) or 2. Drug-related CTCAE grade 4 neutropenia for 7 or more days and/or complicated by infection or 3. CTCAE grade 4 thrombocytopenia
Maximum Tolerated Dose (MTD) of Volasertib in Combination With Nintedanib
时间窗: 28 days
The MTD was determined using a 3+3 design with de-escalation. The MTD was defined as the highest dose level at which maximal 1 out of 6 patients experienced DLT in the first course of the escalation nd de-escalation phase. However, all DLT's occurring in the trial were considered for selection of the recommended dose for further development.
次要结局
- Number of Participants With Drug Related Adverse Events(From first study drug administration until 28 days after the last administration of any study medication, up to 485 days)
- Number of Participants With Dose Limiting Toxicities(From first study drug administration until 28 days after the last administration of any study medication, up to 485 days)
- Cmax of Volasertib(0:05 h before start of Volasertib infusion and 1:00, 2:00, 3:00, 4:00, 8:00 and 24 h after start of Volasertib infusion)
- CL of Volasertib(0:05 h before start of Volasertib infusion and 1:00, 2:00, 3:00, 4:00, 8:00 and 24 h after start of Volasertib infusion)
- Vss of Volasertib(0:05 h before start of Volasertib infusion and 1:00, 2:00, 3:00, 4:00, 8:00 and 24 h after start of Volasertib infusion)
- Cmax of Nintedanib(5 min before Nintedanib administration in the morning and 1:00, 2:00, 3:00, 4:00, 6:00 h after administration on Day 9)
- AUC(0-6h) of Nintedanib(5 min before Nintedanib administration in the morning and 1:00, 2:00, 3:00, 4:00, 6:00 h after administration on Day 9)
- Tmax of Nintedanib(5 min before Nintedanib administration in the morning and 1:00, 2:00, 3:00, 4:00, 6:00 h after administration on Day 9)
- Number of Patients With Best Overall Response(Tumor assessment was performed at screening and every 2nd course until earliest time of progression, death or end of treatment.)
- Number of Patients With Objective Response (OR)(Tumor assessment was performed at screening and every 2nd course until earliest time of progression, death or end of treatment.)
- Number of Patients With Disease Control(Tumor assessment was performed at screening and every 2nd course until earliest time of progression, death or end of treatment.)
- Duration of Disease Control(Tumor assessment was performed at screening and every 2nd course until earliest time of progression, death or end of treatment.)
- Progression Free Survival (PFS)(Tumor assessment was performed at screening and every 2nd course until earliest time of progression, death or end of treatment.)