A Phase I Study of Ixabepilone in Combination With Capecitabine in Japanese Patients With Metastatic Breast Cancer Previously Treated With an Anthracycline and a Taxane
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Participants Experiencing Dose Limiting Toxicity (DLT)
研究概览
简要总结
The purpose of this study is to determine the dose-limiting toxicity (DLT), maximum tolerated dose (MTD) and recommended Phase II dose of ixabepilone in combination with capecitabine in Japanese participants with metastatic breast cancer.
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
- •Women ≥ 20 years
- •Histologically or cytologically confirmed diagnosis of adenocarcinoma originating in the breast
排除标准
- •Number of prior chemotherapy lines of treatment in the metastatic setting ≥3
研究组 & 干预措施
Ixabepilone + Capecitabine
干预措施: Ixabepilone (Drug)
Ixabepilone + Capecitabine
干预措施: Capecitabine (Drug)
结局指标
主要结局
Participants Experiencing Dose Limiting Toxicity (DLT)
时间窗: From initiation of drug through last day of Cycle 2 (Day 42)
DLT was defined as any ixabepilone and/or capecitabine related events requiring study discontinuation during the first two treatment cycles.
Participants Achieving the Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D)
时间窗: At the end of Cycle 2 (Day 42)
The MTD was defined as the highest dose evaluated for which less than 1/3 of the participants experienced DLT during the first two treatment cycles. If toxicities (e.g. hand-foot syndrome, existing peripheral neuropathy, etc.) occurred or became more severe in later cycles, the recommended Phase II dose was to be determined after due consideration of their severity.
次要结局
- Adverse Events (AEs) and Serious Adverse Events (SAEs)(Baseline to Day 42, continuously)
- Participant Tumor Response at Study Endpoint(At baseline and after every 42 days (every 2 21-day cycles) after baseline)
- Mean Ixabepilone Maximum Plasma Concentration (Cmax) in One Dosing Interval(During Cycle 1 at specified timepoints (Day 1 to Day 8).)
- Mean Ixabepilone Area Under the Concentration Curve (AUC INF) in One Dosing Interval(During Cycle 1 at specified timepoints (Day 1 to Day 8).)
- Mean Ixabepilone Terminal Elimination Half Life (T 1/2) in One Dosing Interval(During Cycle 1 at specified timepoints (Day 1 to Day 8).)
- Mean Ixabepilone Volume of Distribution at Steady State (Vss) in One Dosing Interval(During Cycle 1 at specified timepoints (Day 1 to Day 8).)
- Mean Ixabepilone Total Body Clearance (CLT) in One Dosing Interval(During Cycle 1 at specified timepoints (Day 1 to Day 8).)