A Study to Select Rational Therapeutics Based on the Analysis of Matched Tumor and Normal Biopsies in Subjects With Advanced Malignancies
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 3
- 试验地点
- 4
- 主要终点
- Progression-Free Survival (PFS)
研究概览
简要总结
The goal of this laboratory research study is to learn if using molecular information (matched therapy) or not using molecular information and having the study doctor choose the therapy based on your past experience are more effective ways to choose the best cancer treatment for you.
This is an investigational study.
Up to 200 participants will take part in this study. Up to 50 will be enrolled at MD Anderson.
详细描述
If you agree to take part in this study, your tumor tissue and blood samples will be tested for molecular profiling. Molecular profiling is the classification of tissue based on the expression of certain genes within a tumor compared to normal tissue. This may be used to predict how the tumor responds to therapy. Your doctor may use the results of the molecular profiling to help decide which treatment might be the most beneficial for the disease.
Study Procedures:
Blood (about 2 teaspoons) will be drawn and you will have a tumor biopsy and a biopsy of normal tissue when you enroll in this study. Blood (about 2 teaspoons) will be drawn again about 2-3 weeks after you begin treatment. The type of biopsy you have will depend on the type of disease you have. The risks of this procedure will be discussed in more detail with you.
If there is not enough tissue with which the study doctor can perform the study tests (described below), you may need to have a second biopsy. The study staff will discuss this with you if it is needed.
Treatment Arms:
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
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
- •Informed consent
- •Any histologic type of metastatic cancer, (except for lung and brain at US sites), in which histologic normal counterpart can be obtained. See list of cancer types included in the trial in Appendix
- •Progression by RECIST (Response Evaluation Criteria In Solid Tumors) or other criteria on 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
- •ECOG Performance status of 0 to 1
- •Measurable or evaluable disease according to RECIST 1.1 criteria
- •For US sites only: advanced cancer patients that have exhausted all effective therapy for their disease and have progressed after previous line of therapy (documented disease progression under last treatment received) and conventional methods of assigning new therapy would not be expected to increase survival by more than 3 months.
排除标准
- •For US sites only: Any patient that might require a lung or brain biopsy are excluded
- •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), except for patients with liver metastases, for which AST and ALT > 5.0 ULN is the exclusion criteria.
- •Bilirubin > 2.0 ULN to allow for Gilberts
- •Polynuclear neutrophil < 1.5 x 109/L
- •Platelets < 100 x 10 9/L
- •Hemoglobin < 90 g/L
- •Creatinine > 1.5 ULN
- •i. Calcemia > 1.5 ULN g. Phosphatemia > 1.5 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 treatment period immediately prior to the WINTHER directed treatment (defining the PFS1). Hormonal therapy may be continued during WINTHER suggested therapy. The exclusion of prior matched targeted therapy includes but is not limited to all targeted therapeutics that are EMA approved and genomically matched to patients. If there are questions about whether or not a prior therapy is a matched targeted treatment it will be agreed on by discussion between PIs who are also Clinical Management Committee members; the resolution should take place prior to starting Winther directed treatment.
结局指标
主要结局
Progression-Free Survival (PFS)
时间窗: 2 - 3 weeks after treatment begins
Progression-free survival (PFS) of the last therapeutic line (PFS1) before entering into study, with the PFS2 under study treatment. A clinical meaningful improvement is defined as demonstrating a PFS ratio (PFS2/PFS1) of being 1.5 or better.
次要结局
未报告次要终点