Phase I Study of Dasatinib (BMS-354825) and Capecitabine for Advanced Breast Cancer
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 52
- 试验地点
- 5
- 主要终点
- Number of Participants With Dose Limiting Toxicities Per Dose Level - Safety Population
研究概览
简要总结
The purpose of this study is to learn about the safety and efficacy of Dasatinib in combination with Capecitabine for patients with advanced breast cancer, and who have received treatment with a taxane and an anthracycline
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
- Female
- 接受健康志愿者
- 否
入选标准
- •Female with advanced breast cancer previously treated with a taxane and an anthracycline
- •No pleural or pericardial effusion
- •Not receiving anticoagulants
排除标准
- 未提供
研究组 & 干预措施
50 mg BID dasatinib + 825 mg/m^2 BID capecitabine
Twice a day (BID) for 2 weeks of a 3-week cycle
干预措施: Dasatinib (Drug)
50 mg BID dasatinib + 825 mg/m^2 BID capecitabine
Twice a day (BID) for 2 weeks of a 3-week cycle
干预措施: Capecitabine (Drug)
70 mg BID dasatinib + 825 mg/m^2 BID capecitabine
BID for 2 weeks of a 3-week cycle
干预措施: Dasatinib (Drug)
70 mg BID dasatinib + 825 mg/m^2 BID capecitabine
BID for 2 weeks of a 3-week cycle
干预措施: Capecitabine (Drug)
70 mg BID dasatinib + 1000 mg/m^2 BID capecitabine
BID for 2 weeks of a 3-week cycle
干预措施: Dasatinib (Drug)
70 mg BID dasatinib + 1000 mg/m^2 BID capecitabine
BID for 2 weeks of a 3-week cycle
干预措施: Capecitabine (Drug)
100 mg QD dasatinib + 1000 mg/m^2 BID capecitabine
2 weeks of a 3-week cycle
干预措施: Dasatinib (Drug)
100 mg QD dasatinib + 1000 mg/m^2 BID capecitabine
2 weeks of a 3-week cycle
干预措施: Capecitabine (Drug)
结局指标
主要结局
Number of Participants With Dose Limiting Toxicities Per Dose Level - Safety Population
时间窗: Day 1 to 30 days post last dose
Safety was assessed from first dose of study drug through at least 30 days after the last dose, until resolution of drug-related toxicity or when toxicity was deemed irreversible, whichever was longer. An adverse event (AE) was considered a dose limiting toxicity (DLT) if it occurred in the first 21 days and was at least possibly related to study drugs and were: Clinically-evident toxicity of Grade \>= 3, or of Grade 2 which required interruption of treatment for \>= 7 days (consecutive or non-consecutive); non-hematologic abnormal laboratory value of Grade \>= 3, or hematologic toxicity of Grade 4, which persisted 7 days; any grade toxicity which in the judgment of the investigator required a dose reduction or removal from further study therapy.
次要结局
- Number of Participants With Overall Response to Tumor - Efficacy Evaluable Population(Day 1 to 30 days post last dose)
- Number of Participants With Deaths, Serious Adverse Events, Adverse Events, Adverse Events Leading to Discontinuation and Treatment-related Adverse Events - Safety Population(Day 1 up to 30 days post last dose)
- Number of Participants On-study With Grade 3 - 4 Chemistry Laboratory Values in Those Participants With a Baseline Laboratory Value of Grade 0 - Safety Population(Day 1 to 30 days post last dose)
- Objective Response Rate (ORR) and Disease Control Rate - Efficacy Evaluable Population(Day 1 up to 30 days post last dose)
- Number of Participants On-Study With Grade 3 - 4 Hematology Laboratory Test Values in Those Participants With a Baseline Laboratory Value of Grade 0 - Safety Population(Day 1 up to 30 days post last dose)