Phase I Open Label Trial to Assess Safety of BIBW 2992 in Combination With Herceptin® in Patients With HER2-positive Advanced Breast Cancer.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 5
- 主要终点
- Number of Participants With Dose Limiting Toxicities (DLT)
研究概览
简要总结
Study to determine the Maximum Tolerated dose of BIBW 2992 given in combination with Herceptin®
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
- Female
- 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
BIBW 2992 + Trastuzumab
Find maximum tolerated dose of the non-marketed substance:BIBW 2992 given orally with fixed weekly infusion doses of 2mg/kg Herceptin. Escalating doses of BIBW 2992 starting at 20mg daily.
干预措施: Trastuzumab (Drug)
BIBW 2992 + Trastuzumab
Find maximum tolerated dose of the non-marketed substance:BIBW 2992 given orally with fixed weekly infusion doses of 2mg/kg Herceptin. Escalating doses of BIBW 2992 starting at 20mg daily.
干预措施: BIBW 2992 (Drug)
结局指标
主要结局
Number of Participants With Dose Limiting Toxicities (DLT)
时间窗: 28 days
Number of participants with DLT in the first cycle (28 days) for the determination of the maximum tolerated dose (MTD). Important Limitations and Caveats are provided in the respective section.
Maximum Tolerated Dose (MTD) of Afatinib in Combination With Herceptin(R)
时间窗: 28 days
The MTD was defined as the highest dose at which no more than 1 of 6 patients experienced DLT. It was determined using a standard 3 + 3 dose escalation cohort design. To confirm the MTD, the MTD cohort was to be expanded to 18 patients with no more than 3/18 patients experiencing a DLT. Please refer to CAVEATs and Limitations.
次要结局
- Number of Patients With Objective Response (OR)(Tumor assessment was performed at screening and every 2nd cycle until earliest time of progression, death or end of treatment.)
- Progression Free Survival (PFS)(Baseline until disease progression, death or data cut-off.)
- Summary of Concentration of Herceptin in Plasma(0.05 hours (h) before dosing and 0.5-1h, 2h, 3h, 4h, 5h, 6h, 8h after dosing)
- Number of Patients With Best Overall Response(Tumor assessment was performed at screening and every 2nd cycle until earliest time of progression, death or end of treatment.)
- Summary of Concentration of Afatinib in Plasma(0.05 hours (h) before dosing and 0.5-1h, 2h, 3h, 4h, 5h, 6h, 8h after dosing)
- Time From Dosing to the Maximum Concentration of Afatinib in Plasma at Steady State (Tmax,ss)(0.05 hours (h) before dosing and 0.5-1h, 2h, 3h, 4h, 5h, 6h, 8h after dosing)