NCT00652340已完成2 期
APRiCOT-L (Apricoxib in Combination Oncology Treatment - Lung) A Randomized, Double-Blind, Placebo-Controlled Multicenter Phase 2 Study of the Efficacy and Safety of Apricoxib in Combination With Erlotinib in Non-Small Cell Lung Cancer Patients
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 120
- 主要终点
- Time to Disease Progression (TDP)
研究概览
简要总结
This study will compare the anti-tumor efficacy of apricoxib and erlotinib with placebo and erlotinib as measured by time to disease progression to test the hypothesis that down regulation of COX-2 and EGFR pathways in patients with up-regulated COX-2 expression in tumor will have a clinical benefit compared with erlotinib alone.
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
- All
- 接受健康志愿者
- 否
入选标准
- •Pathologically determined Stage IV NSCLC including Stage IIIb (pleural effusion)
- •Failed at least one prior platinum-based chemotherapy for Stage IIIb or Stage IV NSCLC. Patients receiving platinum-based chemotherapy only given in an adjuvant setting are not eligible.
- •Measurable disease by RECIST
- •Greater than or equal to 18 years of age
- •ECOG PS of 0 or 1
排除标准
- •Radiation therapy within 2 weeks; chemotherapy within 3 weeks; non-cytotoxic investigational agents within 4 weeks of initiating study treatment
- •Evidence of NYHA class III or greater cardiac disease
- •History of MI, stroke, ventricular arrhythmia, or symptomatic conduction abnormality within 12 months
- •Known HIV infection or AIDS
- •Symptomatic CNS metastases
- •Pregnant or nursing women
- •Hypersensitivity or intolerance to erlotinib, sulfonamides, aspirin, or other NSAIDs.
- •History of upper GI bleeding, ulceration, or perforation
- •Prior history of COX-2 inhibitor therapy for the treatment of metastatic NSCLC
- •Previous anti-EGFR kinase therapy
研究组 & 干预措施
A
Experimental
干预措施: apricoxib/erlotinib (Drug)
B
Placebo Comparator
干预措施: erlotinib/placebo (Drug)
结局指标
主要结局
Time to Disease Progression (TDP)
时间窗: Baseline and every other cycle.
次要结局
- Overall Survival(Randomization and every cycle)
研究者
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