Randomized, Placebo-Controlled, Double-Blind, Phase 2 Study Of AG-013736 In Combination With Docetaxel Versus Docetaxel Alone In Patients With Metastatic Breast Cancer Preceded By A Phase 1 Evaluation Of The Combination
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 174
- 试验地点
- 1
- 主要终点
- Time to Tumor Progression (TTP)
研究概览
简要总结
The primary purpose of the study is to determine the time to progression of the combination of study drug (AG-013736) and docetaxel versus docetaxel alone in patients who have not received prior chemotherapy for metastatic breast cancer. The secondary purpose of the study is to determine the dose of study drug that can be given with docetaxel administered on an every 3 week schedule.
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
- Double (Participant, Investigator)
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 patients with histologically/cytologically proven metastatic breast carcinoma (stage IV, or recurrent with local or regional spread or distant metastatic disease)
- •Adequate bone marrow, liver, and renal function
排除标准
- •Adjuvant chemotherapy given in the past 12 months
- •Uncontrolled brain metastases
研究组 & 干预措施
Docetaxel + Placebo
Docetaxel + Placebo
干预措施: Placebo (Drug)
Docetaxel + Placebo
Docetaxel + Placebo
干预措施: Docetaxel (Drug)
Docetaxel + AG-013736
Docetaxel + AG-013736
干预措施: AG-013736 (axitinib) (Drug)
Docetaxel + AG-013736
Docetaxel + AG-013736
干预措施: Docetaxel (Drug)
结局指标
主要结局
Time to Tumor Progression (TTP)
时间窗: Phase 2 double-blind baseline until tumor progression or death or discontinuation from study treatment, assessed every 9 weeks up to 129 weeks
Time in days from start of study treatment to first documentation of objective tumor progression or death due to cancer, whichever comes first. TTP was calculated as first event date minus the date of first dose of study medication plus 1. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease \[PD\]).
次要结局
- Percentage of Participants With Objective Response (OR) for Phase 2 (Double-blind)(Phase 2 double- blind baseline until the date of first documented progression or discontinuation from the study treatment due to any cause, assessed every 9 weeks up to 129 weeks)
- Percentage of Participants With Objective Response (OR) for Phase 2 (Open-label)(Phase 2 open-label baseline until the date of first documented progression or discontinuation from the study due to any cause, assessed every 8 weeks up to 58 weeks)
- Duration of Response (DR) for Phase 2 (Double-blind)(Phase 2 double-blind baseline until the date of first documented progression or discontinuation from the study due to any cause, assessed every 9 weeks up to 129 weeks)
- Duration of Response (DR) for Phase 2 (Open-label)(Phase 2 open-label baseline until the date of first documented progression or discontinuation from the study due to any cause, assessed every 8 weeks up to 58 weeks)