A study to select rational therapeutics based on the analysis of matched tumor and normal biopsies in subjects with advanced malignancies

Fundació Hospital Universitari Vall d'Hebron - Institut de Recerca (VHIR)0 个研究点目标入组 200 人开始时间: 2013年4月9日最近更新: 2018年11月19日

适应症

试验速览

暂无简介。

•- Informed consent
•- Any histologic type of metastatic cancer, in which histologic normal counterpart can be obtained.
•- At least one prior regimen for advanced disease
•- Ability to undergo a biopsy or surgical procedure to obtain fresh tumor biopsy paired with its normal counterpart
•- Age from 18 years
•- Life expectancy of at least 3 months
•- Performance status of 0 to 1
•- Measurable or evaluable disease according to RECIST
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 150
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 50

•Alteration of organ function or hematopoietic function as defined by the following criteria:
•- Serum aspartate transaminase (AST) and serum alanine transaminase (ALT) >2.5 x upper limit of normal (ULN)
•- Bilirubin > 1.5 x ULN
•- Polynuclear neutrophil < 1.5 x 109/L
•- Platelets < 100 x 10 9/L
•- Hemoglobin < 90 g/L
•- Creatinine > 1.5 ULN
•- Calcemia > ULN
•- Phosphatemia > ULN
•Coagulation abnormality prohibiting a biopsy
•Symptomatic or progressive brain metastases detected by radio imaging, or meningeal
•Patient who received a personalized therapeutic treatment based on molecular anomaly during the last treatment (defining the PFS1)

发起方

Fundació Hospital Universitari Vall d'Hebron - Institut de Recerca (VHIR)