A First-in Human Phase I, Non-randomised, Open-label, Multi-center Dose Escalation Trial of BI 836880 Administered by Repeated Intravenous Infusions in Patients With Solid Tumors.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 29
- 试验地点
- 3
- 主要终点
- Maximum Tolerated Dose (MTD)
研究概览
简要总结
This is a Phase I, non-randomized, uncontrolled, open-label, dose escalating study of BI 836880 administered intravenously. The eligible patient population will be patients with advanced solid tumours. At any time during the trial, it will not be permitted to escalate to a dose which does not fulfil the escalation with overdose control (EWOC) criterion
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 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
40 mg BI 836880
BI 836880
干预措施: BI 836880 (Drug)
120 mg BI 836880
BI 836880
干预措施: BI 836880 (Drug)
360 mg BI 836880
BI 836880
干预措施: BI 836880 (Drug)
720 mg BI 836880
BI 836880
干预措施: BI 836880 (Drug)
1000 mg BI 836880
BI 836880
干预措施: BI 836880 (Drug)
结局指标
主要结局
Maximum Tolerated Dose (MTD)
时间窗: Up to 3 weeks after the first administration of trial medication.
Maximum tolerated dose (MTD) defined as the highest dose with less than 25% risk of the true dose-limiting toxicity (DLT) rate being above 0.33 during the MTD evaluation period, defined as 3 weeks after first administration of trial medication (i.e. cycle 1). Patients who did not complete the MTD evaluation period for reasons other than DLT were excluded from the analysis of the primary endpoint.
Number of Patients With Dose-limiting Toxicities (DLT) in the Maximum Tolerated Dose (MTD) Period
时间窗: Up to 3 weeks after the first administration of trial medication.
DTLs are defined as followed: * Drug-related Common Terminology Criteria for Adverse Events (CTCAE) grade ≥3 non-haematological toxicity * CTCAE Grade 4 neutropenia lasting \>7 days or complicated by infection (please note that in case of grade 4 neutropenia a more frequent follow up of patient was necessary * Febrile neutropenia of CTCAE Grade ≥3 * CTCAE Grade 4 thrombocytopenia or CTCAE Grade ≥3 thrombocytopenia with bleeding * Treatment delay for \>2 weeks due to unresolved drug-related AEs, which started within 3 weeks after the first treatment * Hypertension: increase of diastolic blood pressure (DBP) by 15 millimetre of mercury (mmHg) confirmed by a second measurement or by ambulatory blood pressure measurement (when indicated, e.g. white coat effect) which could not be controlled by hypertensive medication and required a dose reduction of BI 836880 for further treatment cycle * Proteinuria: urinary protein ≥3.5 gram/day (CTCAE Grade 3)
次要结局
- Number of Patients With Drug-related Adverse Events Leading to Dose Reduction or Discontinuation During Treatment Period(From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days.)
- Area Under the Serum Concentration-time Curve Over the Time Interval From 0 Extrapolated to Infinity (AUC0-tz) After the First Dose(5 minutes before start of BI 836880 infusion and immediately after end of infusion (i.e. 1.5 hours (h) after start of infusion) and 2h, 3h, 5h, 8h, 24h, 72h, 168h, 336h and 504h after start of BI 826880 infusion in cycle 1.)
- Terminal Half-life (t_1/2) of BI 836880(5 minutes before start of BI 836880 infusion and immediately after end of infusion (i.e. 1.5 hours (h) after start of infusion) and 2h, 3h, 5h, 8h, 24h, 72h, 168h, 336h and 504h after start of BI 826880 infusion in cycle 1.)