A Phase II Open-label Randomized Study of a Fixed-dose Combination of Capecitabine and Cyclophosphamide Administered at Different Doses/Regimens With Metronomic Schedule in Patients With Metastatic Breast Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 2
- 试验地点
- 5
- 主要终点
- Assessment of PK parameter: time to reach Cmax (Tmax)
研究概览
简要总结
Primary Objectives:
- To assess the safety for each cohort of patients on a fixed-dose combination pill of capecitabine and cyclophosphamide administered at flat dose and with metronomic schedule (defined as continuous daily treatment without interruption) in patients with metastatic breast cancer.
- To assess the pharmacokinetics (PKs) and bioavailability of the fixed-dose combination pill of capecitabine and cyclophosphamide administered at different doses/regimens by metronomic schedule in patients with metastatic breast cancer.
Secondary Objectives:
- To assess antitumor activity of the fixed-dose combination pill of capecitabine and cyclophosphamide administered at different doses/regimens by metronomic schedule in patients with metastatic breast cancer given at 3 different doses and schedules (regimen 1=standard dose twice daily [BID], regimen 2=full dose once daily [OD], regimen 3=low dose [OD])
- Disease Control Rate (DCR)
- Overall Response Rate (ORR)
- Time to Progression (TTP) using the Response Evaluation Criteria in Solid Tumors (RECIST) criteria (version 1.1).
- To evaluate the compliance under treatment.
- To describe evolution of toxicities.
- To assess safety all along patient's treatment.
详细描述
Primary objective will be evaluated at 12 weeks. Patients who show evidence of efficacy will be treated and followed-up until progression of the disease.
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 65 Years（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
SAR439281(Cohort 1)
Regimen 1: one full-dose tablet containing capecitabine and cyclophosphamide, given BID without interruption
干预措施: Fixed-dose combination of capecitabine and cyclophosphamide SAR439281 (Drug)
SAR439281(Cohort 2)
Regimen 2: two tablets containing capecitabine and cyclophosphamide, given OD without interruption
干预措施: Fixed-dose combination of capecitabine and cyclophosphamide SAR439281 (Drug)
SAR439281(Cohort 3)
Regimen 3: one tablet containing capecitabine and cyclophosphamide, given OD without interruption
干预措施: Fixed-dose combination of capecitabine and cyclophosphamide SAR439281 (Drug)
结局指标
主要结局
Assessment of PK parameter: time to reach Cmax (Tmax)
时间窗: Daily 12 weeks
Proportion of patients with adverse events
时间窗: 12 weeks
Assessment of PK parameter: maximum concentration (Cmax)
时间窗: Daily 12 weeks
次要结局
- Time to Progression (TTP)(12 weeks)
- Disease Control Rate (DCR)(12 weeks)
- Objective Response Rate (ORR)(12 weeks)
- Proportion of patients compliant with treatment(12 weeks)