NCT00657137终止2 期
A Phase 2 Study of the Efficacy and Safety of Apricoxib in Combination With Lapatinib and Capecitabine in the Treatment of Patients With HER2/Neu+ Breast Cancer Who Have Failed Trastuzumab and Chemotherapy Including a Taxane
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 12
- 试验地点
- 44
- 主要终点
- To determine the anti-tumor activity of the combination of apricoxib/lapatinib-capecitabine compared with placebo/lapatinib-capecitabine as measured by time to disease progression.
研究概览
简要总结
This study will compare the anti-tumor efficacy of apricoxib and lapatinib/capecitabine with placebo and lapatinib/capecitabine as measured by time to disease progression and evaluate urinary PGE-M measurements or baseline COX-2 expression in tumor tissue by IHC as a surrogate selection criterion for patients who will benefit from future treatment with apricoxib.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Females with pathologically determined locally advanced or metastatic human epidermal growth factor receptor 2 positive (HER2/neu+) breast cancer
- •Have progressed after treatment with chemotherapy including a taxane and trastuzumab
- •Must have measurable disease by RECIST
- •ECOG PS of 0,1, or 2
- •MUGA scan or echocardiogram results show left ventricular ejection fraction greater than or equal to 50%
排除标准
- •Radiation therapy within 2 weeks, chemotherapy within 3 weeks, or noncytoxic investigational agents within 4 weeks of initiating study treatment
- •Evidence of New York Heart Association class III or greater cardiac disease
- •History of MI, stroke, ventricular arrhythmia, or symptomatic conduction abnormality
- •History of congenital QT prolongation
- •Concurrent severe or uncontrolled medical disease
- •Symptomatic central nervous system metastases
- •Pregnant or nursing women
- •Hypersensitivity or intolerance to apricoxib, lapatinib, capecitabine, 5-FU, sulfonamides, aspirin, or NSAIDs
- •Severe renal insufficiency
- •History of upper GI bleeding, ulceration, or perforation- Concurrent use of potent CYP3A4 inhibitors and CYP3A4 inducers
- •Prior treatment with capecitabine
- •Patients on anti-arrhythmic treatment
- •Prior lapatinib therapy
研究组 & 干预措施
A
Experimental
apricoxib + lapatinib + capecitabine
干预措施: apricoxib + lapatinib + capecitabine (Drug)
B
Placebo Comparator
placebo + lapatinib + capecitabine
干预措施: placebo + lapatinib + capecitabine (Drug)
结局指标
主要结局
To determine the anti-tumor activity of the combination of apricoxib/lapatinib-capecitabine compared with placebo/lapatinib-capecitabine as measured by time to disease progression.
时间窗: Time to disease progression
次要结局
- Progression-free survival and safety/tolerability(Time to disease progression)
研究者
研究点 (44)
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