Clinical Evaluation of Lapatinib Administered With Capecitabine in Japanese Patients With ErbB2 Overexpressing Advanced or Metastatic Breast Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 51
- 试验地点
- 1
- 主要终点
- Clinical Benefit Response (Independent Reviewer-assessed)
研究概览
简要总结
This study is to evaluate the safety and efficacy of lapatinib taken together with capecitabine in Japanese patients. The study will proceed in two phases; the first phase(Part1) will lead to an evaluation of the mainly tolerability as well as PK parameters. If there are no major safety concerns in Part 1, the study will move into the second phase (Part 2) to further evaluate the safety and clinical activity.
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
- 20 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
Lapatinib+capecitabine
Lapatinib 1250mg once daily +capecitabine 2000mg/m^2 twice daily (14 days out of 21 days)
干预措施: Lapatinib (Drug)
Lapatinib+capecitabine
Lapatinib 1250mg once daily +capecitabine 2000mg/m^2 twice daily (14 days out of 21 days)
干预措施: capecitabine (Drug)
结局指标
主要结局
Clinical Benefit Response (Independent Reviewer-assessed)
时间窗: Baseline, every 6 weeks until Week 24 and then every 12 weeks until disease progression (up to Week 119)
CBR is defined as the percentage of participants receiving at least one dose of study medication who achieved a best overall response classified as a complete or partial (confirmed) tumor response or stable disease for at least 6 months (24 weeks). A "complete response" is defined as the disappearance of all target or non-target lesions, "partial response" and "disease progression" as at least a 30% decrease and at least a 20% increase, respectively, in the sum of the longest diameter of target lesions, and "stable disease" as neither "partial response" nor "disease progression."
次要结局
- Progression-free Survival (PFS) (Independent Reviewer-assessed)(Baseline, every 6 weeks until Week 24 and then every 12 weeks until disease progression or death (up to Week 119))
- Area Under the Plasma Concentration-time Curve From Zero to 24 Hours AUC0-24 of Lapatinib(Week 2)
- Overall Survival (Independent Reviewer-assessed)(Baseline and then followed every 4 weeks until death (up to Week 157.9) while on treatment. After treatment termination, followed every 12 weeks until death (up to Week 157.9))
- Maximum Plasma Concentration (Cmax) of Lapatinib(Week 2)
- Time to Response (Independent Reviewer-assessed)(Baseline, every 6 weeks until Week 24 and then every 12 weeks until disease progression or death (up to Week 119))
- Trough Concentration of Lapatinib(Week 2)
- Terminal Elimination Half-life (t1/2) of Lapatinib(Week 2)
- AUC0-tau of Capecitabine, 5'-Fluorouracil (5-FU), and Alpha-fluoro-beta-alanine (FBAL)(Week 2)
- Area Under the Plasma Concentration-time Curve From Zero to 12 Hours (AUC0-12) of Capecitabine, 5'-Fluorouracil (5-FU), and Alpha-fluoro-beta-alanine (FBAL)(Week 2)
- Time to Progression (Independent Reviewer-assessed)(Baseline, every 6 weeks until Week 24 and then every 12 weeks until disease progression or death due to breast cancer (up to Week 119))
- 6-Month Progression-free Survival (Independent Reviewer-assessed)(Baseline and then every 6 weeks until Month 6 (Week 24))
- Objective Response (Independent Reviewer-assessed)(Baseline every 6 weeks until Week 24 and then every 12 weeks until disease progression or death (up to Week 119))
- Duration of Response (Independent Reviewer-assessed)(Baseline, every 6 weeks until Week 24 and then every 12 weeks until disease progression or death (up to Week 119))
- Tmax of Capecitabine, 5'-Fluorouracil (5-FU), and Alpha-fluoro-beta-alanine (FBAL)(Week 2)
- Time to Maximum Plasma Concentration (Tmax) of Lapatinib(Week 2)
- Area Under the Plasma Concentration-time Curve Within the Dosing Interval AUC0-tau of Lapatinib(Week 2)
- Cmax of Capecitabine, 5'-Fluorouracil (5-FU), and Alpha-fluoro-beta-alanine (FBAL)(Week 2)
- Trough Concentration of Capecitabine, 5-FU, and FBAL(Week 2)
- t1/2 of Capecitabine, 5'-Fluorouracil (5-FU), and Alpha-fluoro-beta-alanine (FBAL)(Week 2)