Molecular Screening Analysis Used as Decision Tool for Targeted Molecular Treatment
试验速览
- 阶段
- 不适用
- 入组人数
- 2,150
- 试验地点
- 2
- 主要终点
- Progression free survival (PFS) using a targeted treatment selected by molecular profiling compared to the PFS for the most recent regimen
研究概览
简要总结
The primary objective of the study is to use high throughput molecular analysis (CGH Array and sequencing) to treat patients with metastatic cancer with targeted therapeutics in order to improve the progression free survival compared to the previous treatment line.
The secondary objectives are to investigate clinical practical feasibility of such technics, to potentially improve the overall survival of patients and to describe molecular portrait of Phase 1 candidates.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 6 Months 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Solid tumors ; Stade IV ; Local relapse or metastatic ; Uncurable
- •Age > 6 months
- •PS 0/1 or Lansky play scale >= 70%
- •Minimum one treatment line, no limit in the prior number of treatment line
- •Evaluable or measurable disease
排除标准
- •Life expectancy < 3 months
- •Carcinomatous meningitis
- •Symptomatic or progressive radiologic brain metastasis for non-CNS tumors
- •Polynuclear neutrophil < 1 x 10^9/L
- •Platelets < 100 x 10^9/L
- •Hemoglobin < 90 g/L
- •ALT/AST > 2.5 N
- •bilirubin > 1.5 N
- •Creatinine >1.5 N
- •Calcemia > ULN
- •Phosphate > ULN
- •Coagulation anomaly non-indicated for biopsy
结局指标
主要结局
Progression free survival (PFS) using a targeted treatment selected by molecular profiling compared to the PFS for the most recent regimen
时间窗: From date of start of targeted treatment oriented by MOSCATO until the date of first progression or date of death from any cause, whichever came first, assessed up to 1 year
Progression according to RECIST criteria or clinical progression or death of any cause
次要结局
- Number of patient who received a targeted treatment oriented by molecular profiling(From the start to the end of enrollment, up to 3 years)
- Progression free Survival, Overall Survival and Response Rate(Until progression, up to 1 year)