A Phase II Open-Label Multicenter Study to Evaluate the Safety and Efficacy of Pazopanib (GW786034) as Neoadjuvant Therapy in Treatment-Naïve Subjects With Stage IA, IB, IIA or IIB (to T2) Resectable Non-Small Cell Lung Cancer (NSCLC)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Number of Participants Achieving Tumor Shrinkage Based on Change in Tumor Volume
研究概览
简要总结
This is a phase 2 open-label, multicenter, non-randomized study to evaluate the safety and efficacy of oral pazopanib as neoadjuvant treatment for patients with stage 1A, 1B, IIA or IIB (to T2) resectable Non-Small Cell Lung Cancer (NSCLC).
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
- 21 Years 至 —（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
Single Arm
800 mg pazopanib oral daily
干预措施: Pazopanib (Drug)
结局指标
主要结局
Number of Participants Achieving Tumor Shrinkage Based on Change in Tumor Volume
时间窗: Baseline to at least two weeks or at most six weeks
Tumor shrinkage was assessed as the change in tumor volume using high-resolution computed tomography scans of the thorax following treatment with pazopanib. Response is defined as the number of participants achieving at least 50% tumor volume reduction following pazopanib treatment. "Responder" is a participant whose tumor volume reduced at least 50% following pazopanib treatment. "Non-responder" is a participant whose tumor volume did not reduce at least 50% following treatment. Tumor assessments were conducted by a central reviewer.
次要结局
- Number of Participants Achieving a Clinical Response Based on RECIST(Baseline to at least two weeks or at most six weeks)
- Number of Participants Achieving a >=60% Reduction in Tumor Metabolic Activity Determined as Standard Uptake Value (SUV)(Baseline to at least two weeks or at most six weeks)
- Number of Participants With Shifts From Baseline to Grade 2 or Greater in Hematology Values(Baseline to at least three weeks and at most 8 weeks)
- Number of Participants With Shifts From Baseline to Grade 2 or Greater in Chemistry Values(Baseline to at least three weeks and at most 8 weeks)
- Number of Participants With the Indicated Change From Baseline in Systolic and Diastolic Blood Pressure(Baseline to at least three weeks and at most 8 weeks)
- Number of Cells Exhibiting Apoptosis in Participant Samples(Baseline to at least three weeks and at most 8 weeks (surgery date))
- Ratio of Post- to Pretreatment Expression Levels for Each of the Indicated Pazopanib Target Genes(Baseline to at least three weeks and at most 8 weeks (surgery date))
- Gene Mutations in Pre- or Post-treatment Tumor Biopsies(Baseline to at least three weeks and at most 8 weeks (surgery date))
- Intratumoral Levels of Specific Biomarkers(Baseline tumor biopsy)
- Plasma Levels of Lactate Dehydrogenase-5 (LDH5)(Baseline to at least three weeks and at most 8 weeks)
- Genetic Variations in Germline DNA(Baseline)
- Semiquantitative Levels of Staining in Pre-treatment Tumor Biopsies (e.g. VEGF, VEGFR-1,VEGFR-2).(Entire study interval)
- Ratio of Post- to Pretreatment Expression Levels for Each of the Indicated Pazopanib Target Proteins(Baseline to at least two weeks and at most 6 weeks)