BIBW 2992 Phase I Combination With Pemetrexed in Advanced Solid Tumours
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 53
- 试验地点
- 2
- 主要终点
- Investigator Defined Dose Limiting Toxicity (DLT) During First Course of Treatment, Treated Set
研究概览
简要总结
This Phase I study will investigate the safety of BIBW 2992 in combination with standard dose pemetrexed (500mg/m2) given on a 21 day cycle in patients with advanced solid cancers. BIBW 2992 will be given on two different dose schedules; dosing on days 1-21 and dosing on days 1 to 6 of a 21 day cycle.
The use of epidermal growth factor receptor tyrosine kinase inhibitors (EGFR TKIs), including BIBW 2992 have demonstrated efficacy in solid tumors including non-small cell lung cancer (NSCLC). In addition, pemetrexed has demonstrated efficacy and has been approved as single agent chemotherapy in second-line NSCLC patients with adenocarcinoma. The data obtained from this trial shall allow for a conclusion as to whether BIBW 2992 may be safely administered in advanced cancer patients in combination therapy with pemetrexed.
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
BIBW 2992 high dose 6 day
patient receives high dose BIBW 2992 po daily on days 1-6 plus pemetrexed 500mg/m^2 on day 1 of 21 day cycle
干预措施: BIBW 2992 high dose 6 day (Drug)
BIBW 2992 low dose
patient receives low dose tablet BIBW 2992 po daily plus pemetrexed 500mg/m^2 on day 1 of 21 day cycle
干预措施: BIBW 2992 low dose (Drug)
BIBW 2992 low dose
patient receives low dose tablet BIBW 2992 po daily plus pemetrexed 500mg/m^2 on day 1 of 21 day cycle
干预措施: pemetrexed (Drug)
BIBW 2992 medium dose
patient receives medium dose BIBW 2992 po daily plus pemetrexed 500mg/m^2 on day 1 of 21 day cycle
干预措施: pemetrexed (Drug)
BIBW 2992 medium dose
patient receives medium dose BIBW 2992 po daily plus pemetrexed 500mg/m^2 on day 1 of 21 day cycle
干预措施: BIBW 2992 medium dose (Drug)
BIBW 2992 high dose
patient receives high dose BIBW 2992 po daily plus pemetrexed 500mg/m^2 on day 1 of 21 day cycle
干预措施: BIBW 2992 high dose (Drug)
BIBW 2992 high dose
patient receives high dose BIBW 2992 po daily plus pemetrexed 500mg/m^2 on day 1 of 21 day cycle
干预措施: pemetrexed (Drug)
BIBW 2992 low dose 6 day
patient receives low dose BIBW 2992 po daily on days 1-6 plus pemetrexed 500mg/m^2 on day 1 of 21 day cycle
干预措施: pemetrexed (Drug)
BIBW 2992 low dose 6 day
patient receives low dose BIBW 2992 po daily on days 1-6 plus pemetrexed 500mg/m^2 on day 1 of 21 day cycle
干预措施: BIBW 2992 low dose 6 day (Drug)
BIBW 2992 medium dose 6 day
patient receives medium BIBW 2992 po daily on days 1-6 plus pemetrexed 500mg/m^2 on day 1 of 21 day cycle
干预措施: pemetrexed (Drug)
BIBW 2992 medium dose 6 day
patient receives medium BIBW 2992 po daily on days 1-6 plus pemetrexed 500mg/m^2 on day 1 of 21 day cycle
干预措施: BIBW 2992 medium dose 6 day (Drug)
BIBW 2992 high dose 6 day
patient receives high dose BIBW 2992 po daily on days 1-6 plus pemetrexed 500mg/m^2 on day 1 of 21 day cycle
干预措施: pemetrexed (Drug)
结局指标
主要结局
Investigator Defined Dose Limiting Toxicity (DLT) During First Course of Treatment, Treated Set
时间窗: DLT were assessed during the first cycle (days 1-21)
Occurence of DLT during the first course of treatment to determine the maximum tolerated dose (MTD) of Afatinib at two different dose schedules in combination with the standard established dose of pemetrexed (500 mg/m2).
次要结局
- Investigator Defined Dose Limiting Toxicity (DLT) During All Courses of Treatment, Treated Set(DLT were assessed during all cycles of treatment)
- Objective Response (OR)(Every 6 weeks before week 48 and every 12 weeks after week 48 until progression)
- Disease Control(Every 6 weeks before week 48 and every 12 weeks after week 48 until progression)
- Progression Free Survival (PFS)(Every 6 weeks before week 48 and every 12 weeks after week 48 until progression)
- Tumour Shrinkage(Every 6 weeks before week 48 and every 12 weeks after week 48 until progression)