Double Blind Randomized Phase III Study of Maintenance Pazopanib Versus Placebo in NSCLC Patients Non Progressive After First Line Chemotherapy. MAPPING, an EORTC Lung Group Study.
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 102
- 试验地点
- 21
- 主要终点
- Overall survival
研究概览
简要总结
RATIONALE: Pazopanib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. It is not yet known whether pazopanib hydrochloride is more effective than a placebo in treating patients with non-small cell lung cancer that has not progressed after first-line chemotherapy.
PURPOSE: This randomized phase II/III trial is studying how well giving pazopanib hydrochloride works and compares it with giving a placebo in treating patients with non-small cell lung cancer who have received first-line chemotherapy.
详细描述
OBJECTIVES:
Primary
- To compare the therapeutic benefit, in terms of overall survival, of maintenance pazopanib hydrochloride in patients with non-small cell lung cancer who have not progressed after first-line chemotherapy.
Secondary
- To compare progression-free survival (PFS) overall and at specific time points (6 and 12 months).
- To document the toxicity profile of pazopanib hydrochloride according to the CTCAE v 4.
- To assess the use of C-reactive protein (CRP) in the detection of progression of disease in the maintenance phase of therapy.
- To compare quality-of-life of patients on maintenance therapy.
- To compare discontinuation rate/treatment compliance of patients treated with these regimens.
- To collect health economics data on resource utilization as documented by the EQ-5D generic QoL instrument.
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 120 Years（Adult, Older Adult）
- 性别
- All
- 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
Pazopanib
2 weeks at 600mg and then maintenance at 800mg
干预措施: pazopanib hydrochloride (Drug)
Pazopanib
2 weeks at 600mg and then maintenance at 800mg
干预措施: laboratory biomarker analysis (Other)
Pazopanib
2 weeks at 600mg and then maintenance at 800mg
干预措施: pharmacogenomic studies (Other)
Pazopanib
2 weeks at 600mg and then maintenance at 800mg
干预措施: pharmacological study (Other)
Pazopanib
2 weeks at 600mg and then maintenance at 800mg
干预措施: quality-of-life assessment (Procedure)
Placebo
placebo match 2 weeks at 600mg and then maintenance at 800mg
干预措施: laboratory biomarker analysis (Other)
Placebo
placebo match 2 weeks at 600mg and then maintenance at 800mg
干预措施: pharmacogenomic studies (Other)
Placebo
placebo match 2 weeks at 600mg and then maintenance at 800mg
干预措施: pharmacological study (Other)
Placebo
placebo match 2 weeks at 600mg and then maintenance at 800mg
干预措施: quality-of-life assessment (Procedure)
结局指标
主要结局
Overall survival
次要结局
- Progression-free survival (PFS) overall and at 6 and 12 months
- Correlation of C-reactive protein with PFS at weeks 6, 14, and 22
- Toxicity
- Health economics
- Quality of life
- Comparison of discontinuation rate with treatment compliance