A Presurgical Study To Evaluate Molecular Changes That Occur In Human Non-Small Cell Lung Cancer Tissue After Short Term Exposure To PF-00299804
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- Pfizer
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- To identify the molecular changes which occur in human non-small cell lung cancer tissue after short-term exposure to PF-00299804 administered at 45 mg daily after a loading dose
研究概览
简要总结
This study will enroll patients who are planned to undergo surgical removal of their tumor. The goal of the study is to evaluate the changes that occur in the tumor after brief (about 8 days) exposure to the study drug.
详细描述
The A7471031 study was terminated on May 2, 2012. The decision for unplanned study termination was triggered by feasibility of further conduct of this trial as only 22 of the protocol-specified 75 patients were enrolled since the study initiated in February 2010. Based on this low accrual rate it was determined that the study was highly unlikely to complete accrual and provide meaningful data. The discontinuation of the study is not due to any safety issue.
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
- Basic Science
- 盲法
- None
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
- •Radiographs consistent with lung cancer for which resection is indicated upon histologic confirmation of non-small cell lung cancer.
- •Patient willing to take PF-00299804 for 5 to 11 days and provide blood and tissue specimens as required in the study.
排除标准
- •Prior or concurrent systemic anticancer therapy for cancer (immunotherapy, hormonotherapy, biological therapy, or chemotherapy) less than one year from time of consent.
- •Prior or concurrent radiation therapy to tumor at site of planned resection.
- •Congestive heart failure (LVEF < 50%), uncontrolled hypertension, significant ventricular arrythmia.
- •Drugs that are highly dependent on CYP2D6 for metabolism, or are generally accepted to have a risk of causing Torsades de Pointes.
- •Prior or concurrent radiation therapy to tumor at site of planned resection.
研究组 & 干预措施
treatment
Patients treated with brief exposure to PF-00299804 prior to surgical resection
干预措施: PF-00299804 (Drug)
结局指标
主要结局
To identify the molecular changes which occur in human non-small cell lung cancer tissue after short-term exposure to PF-00299804 administered at 45 mg daily after a loading dose
时间窗: 30 months
次要结局
- To correlate molecular changes with specific gene and protein changes (eg, mutations, amplifications, over expression) in members of the EGFR and HER2 signal transduction pathways (eg, KRAS, EGFR, HER2)(30 months)
- To assess the effect of short term treatment of PF-00299804 on serum levels of the extracellular domain of EGFR and other serum markers of HER signaling (eg, serum HER2/neu and serum E-cadherin)(30 months)
- To assess the relationship between the pharmacokinetic parameters with molecular changes detected in non-small cell lung cancer(30 months)
- To assess the safety and tolerability of PF-00299804 in this setting(30 months)