A Pilot Study Utilizing Molecular Profiling of Patients' Tumors to Find Potential Targets and Select Treatments for Their Refractory Cancers
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 86
- 试验地点
- 18
- 主要终点
- To compare progression-free survival using a treatment regimen selected by molecular profiling with progression-free survival for the most recent regimen the patient has progressed on.
研究概览
简要总结
This is an open-label, multicenter pilot study in patients with advanced solid tumors.
The primary objective of this study is to compare progression-free survival using a treatment regimen selected by molecular profiling with progression-free survival for the most recent regimen the patient has progressed on.
To be eligible, patients must have received at least two lines of prior chemotherapeutic, hormonal or biological regimens for advanced disease, have measurable or evaluable, refractory disease and have clear documentation of the time between treatment start and documented progression on the last treatment prior to study entry. Eligible patients must undergo or have available a tumor biopsy for molecular profiling within 2 months of IHC/FISH and/or DNA microarray analysis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- •Metastatic cancer which has progressed on 2 prior chemotherapeutic, hormonal or biological regimens for advanced disease.
- •Be defined as refractory to the last line of therapy
- •Have documentation of the best clinical response to the treatment regimen immediately prior to entering this study
排除标准
- •Patients with symptomatic CNS metastasis
- •Any previous history of another malignancy within 5 years of study entry
- •Uncontrolled intercurrent illness
- •Known HIV, HBV, HCV infection
- •Pregnant or breast-feeding
结局指标
主要结局
To compare progression-free survival using a treatment regimen selected by molecular profiling with progression-free survival for the most recent regimen the patient has progressed on.
时间窗: Every 8 weeks disease assessments are performed
次要结局
- To determine the frequency with which molecular profiling of a patient's tumor by IHC/FISH and/or microarray analysis yields a target against which there is a commercially available, approved therapeutic regimen.(Time of Profiling- Baseline)
- To determine the response rate (according to RECIST or disease-specific response criteria) and the percent of patients with non-progression at 4 months in patients with solid tumors whose therapy is selected by molecular profiling.(4 months)