NCT00148902已完成1 期
A Phase I, Open-Label Study of the Safety, Tolerability and Pharmacokinetics of GW572016 in Combination With Docetaxel (Taxotere)
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Number of subjects with adverse events (AEs) or serious AEs (SAEs)
研究概览
简要总结
This is a safety and tolerability study of GW572016 given with docetaxel (TAXOTERE).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Advanced solid tumors.
- •Able to swallow oral medication.
排除标准
- 未提供
研究组 & 干预措施
All treated subjects
Experimental
All subjects received Lapatinib in Combination with Docetaxel (Taxotere)
干预措施: lapatinib (Drug)
All treated subjects
Experimental
All subjects received Lapatinib in Combination with Docetaxel (Taxotere)
干预措施: docetaxel (Drug)
结局指标
主要结局
Number of subjects with adverse events (AEs) or serious AEs (SAEs)
时间窗: Up to 7 weeks in each cycle
An AE is any untoward medical occurrence in a subject or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, any other situation according to medical or scientific judgment that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the subject or may require medical or surgical intervention will be categorized as SAE.
Number of subjects with abnormal change from Baseline in laboratory parameters
时间窗: Baseline and up to 7 weeks in each cycle
Blood sample will be collected to evaluate laboratory parameters.
Number of subjects with Optimally Tolerated regimen
时间窗: Up to 7 weeks in each cycle
Optimally Tolerated regimen is a dose regimen where 1 out of 6 subjects experiences a dose-limiting toxicity (DLT).
次要结局
- Tmax of GW572016 when given in combination with docetaxel (PK cohort 2)(Sequence 1, Day 23 and Sequence 2, Day 1: Prior to the GW572016 oral dose and docetaxel infusion, at 20 and 40 minutes after the start of the infusion, at 1, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, and 24 hours after the start of the docetaxel infusion)
- Cmax of GW572016 alone (PK cohort 2)(Sequence 1, Day 1 and Sequence 2, Day 21: Prior to GW572016 dose and at 20 and 40 minutes; 1, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, and 24 hours after the dose.)
- Cmax of GW572016 when given in combination with docetaxel (PK cohort 1)(Sequence 1, Day 22 and Sequence 2, Day 1: Prior to the GW572016 oral dose and docetaxel infusion, at 20 and 40 minutes after the start of the infusion, at 1, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, and 24 hours after the start of the docetaxel infusion.)
- Cmax of GW572016 when given in combination with docetaxel (PK cohort 2)(Sequence 1, Day 23 and Sequence 2, Day 1: Prior to the GW572016 oral dose and docetaxel infusion, at 20 and 40 minutes after the start of the infusion, at 1, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, and 24 hours after the start of the docetaxel infusion)
- Time to maximum observed plasma drug concentration (Tmax) of docetaxel alone (PK cohort 1)(Sequence 1, Day 1 and Sequence 2, Day 22: Prior to the docetaxel infusion, at 20 and 40 minutes after the start of the infusion, at 1, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, and 24 hours after start of the infusion.)
- Tmax of GW572016 alone (PK cohort 2)(Sequence 1, Day 1 and Sequence 2, Day 21: Prior to GW572016 dose and at 20 and 40 minutes; 1, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, and 24 hours after the dose.)
- Tmax of GW572016 when given in combination with docetaxel (PK cohort 1)(Sequence 1, Day 22 and Sequence 2, Day 1: Prior to the GW572016 oral dose and docetaxel infusion, at 20 and 40 minutes after the start of the infusion, at 1, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, and 24 hours after the start of the docetaxel infusion.)
- Concentration at the last measurable time point (Ctau) for GW572016 along (PK cohort 2)(Sequence 1, Day 1 and Sequence 2, Day 21: Prior to GW572016 dose and at 20 and 40 minutes; 1, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, and 24 hours after the dose.)
- Time to first measurable plasma drug concentration (Tlag) for GW572016 along (PK cohort 2)(Sequence 1, Day 1 and Sequence 2, Day 21: Prior to GW572016 dose and at 20 and 40 minutes; 1, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, and 24 hours after the dose.)
- AUC from time zero to time of last measurable concentration (AUClast) for docetaxel alone (PK cohort 1)(Sequence 1, Day 1 and Sequence 2, Day 22: Prior to the docetaxel infusion, at 20 and 40 minutes after the start of the infusion, at 1, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, and 24 hours after start of the infusion.)
- Clearance (CL) for docetaxel alone (PK cohort 1)(Sequence 1, Day 1 and Sequence 2, Day 22: Prior to the docetaxel infusion, at 20 and 40 minutes after the start of the infusion, at 1, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, and 24 hours after start of the infusion.)
- Area under the plasma drug concentration curve (AUC) from 0 to infinity (AUC[0-inf]) of docetaxel alone (Pharmacokinetic [PK] cohort 1)(Sequence 1, Day 1 and Sequence 2, Day 22: Prior to the docetaxel infusion, at 20 and 40 minutes after the start of the infusion, at 1, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, and 24 hours after start of the infusion.)
- AUC within the dosing interval (AUC[0-tau]) of GW572016 alone (PK cohort 2)(Sequence 1, Day 1 and Sequence 2, Day 21: Prior to GW572016 dose and at 20 and 40 minutes; 1, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, and 24 hours after the dose.)
- AUC (0-tau) of GW572016 when given in combination with docetaxel (PK cohort 1)(Sequence 1, Day 22 and Sequence 2, Day 1: Prior to the GW572016 oral dose and docetaxel infusion, at 20 and 40 minutes after the start of the infusion, at 1, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, and 24 hours after the start of the docetaxel infusion.)
- AUC (0-tau) of GW572016 when given in combination with docetaxel (PK cohort 2)(Sequence 1, Day 23 and Sequence 2, Day 1: Prior to the GW572016 oral dose and docetaxel infusion, at 20 and 40 minutes after the start of the infusion, at 1, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, and 24 hours after the start of the docetaxel infusion)
- Maximum observed plasma drug concentration (Cmax) of docetaxel alone (PK cohort 1)(Sequence 1, Day 1 and Sequence 2, Day 22: Prior to the docetaxel infusion, at 20 and 40 minutes after the start of the infusion, at 1, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, and 24 hours after start of the infusion.)
- Volume of distribution at steady state (Vss) for docetaxel alone (PK cohort 1)(Sequence 1, Day 1 and Sequence 2, Day 22: Prior to the docetaxel infusion, at 20 and 40 minutes after the start of the infusion, at 1, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, and 24 hours after start of the infusion.)
- Elimination half-life (Thalf) for docetaxel alone (PK cohort 1)(Sequence 1, Day 1 and Sequence 2, Day 22: Prior to the docetaxel infusion, at 20 and 40 minutes after the start of the infusion, at 1, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, and 24 hours after start of the infusion.)
- Number of subjects with complete response(Week 3 of every third cycle)
- Number of subjects with partial response(Week 3 of every third cycle)
- Number of subjects with stable disease(Week 3 of every third cycle)
- Number of subjects with progressive disease(Week 3 of every third cycle)
研究者
研究点 (1)
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