Registry Study for Personalized Cancer Therapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Tumor Response
研究概览
简要总结
Objectives:
Primary Objectives:
To evaluate the anti-cancer activity of commercially available, targeted anti-cancer therapies used off-label for treatment in patients with advanced solid cancer with known genomic aberrations.
Secondary Objectives:
To determine outcomes of patients who were treated with matched targeted anti-cancer therapies based on known genomic aberrations.
To obtain treatment related adverse events in patients with advanced solid tumor who were treated with off -label targeted therapies.
To determine co-genomic aberrations that may contribute to treatment response or resistance mechanisms.
To determine feasibility of detecting the genomic alterations in plasma, and the genomic evolution of circulating biomarkers.
详细描述
Study Treatment Assignment:
If you are found to be eligible to take part in this study, the study doctor will review the test results in your medical records that were previously performed as part of your routine care. The results of the testing may be helpful in managing your treatment and may also help the doctor to find effective off-label use of FDA approved therapies for the type of cancer you have.
After reviewing the screening tests and the molecular test results in your medical records, the study staff and your study doctor will work together to find an off-label use for an FDA approved therapy that is best for you. You may receive a single therapy or a combination of therapies. You and the study doctor will discuss this.
The study doctor or study staff will tell you which drug(s) you will be taking, the dose of the study drug(s), and how often you should take them. You will sign a separate consent form that explains in more detail how the study drug(s) are administered and the potential benefits and side effects of taking the study drug(s).
Study Visits:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- •Patients with advanced or metastatic cancer that is refractory to standard therapy or that has relapsed after standard therapy or has no standard therapy that increases survival by at least three months.
- •Patients with a potentially actionable genomic alteration.
- •All prior treatment-related toxicities must be resolved to CTCAE (Version 4.0) < or = Grade 2 (except alopecia) at the time of screening.
- •Patients willing to sign informed consent.
- •Patients under the age of 18 years old are allowed as long as the safety profile of the drug is established in the pediatric population.
排除标准
- •Any serious and/or unstable pre-existing medical disorder, psychiatric disorder, or other conditions that could interfere with subject's safety, obtaining informed consent or compliance to the study procedures, in the opinion of the Investigator.
- •Have a known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to planned treatment drug.
- •Rapidly progressing leptomeningeal or brain metastases or spinal cord compression.
- •Clinical trial (including targeted and/or non-targeted) other than registry study is available; patient is willing and eligible to enroll in such trial.
结局指标
主要结局
Tumor Response
时间窗: 8 weeks
Evaluation of tumor: the same imaging technique used during the initial evaluation or more sophisticated studies performed once after 2 cycles. Patients with measurable disease assessed by standard RECIST (Version 1.1).
次要结局
未报告次要终点