EUCTR2015-004860-12-ES进行中（未招募）不适用
Integrated Genomics and Avatar Mouse Models for Personalized Treatment of Pancreatic Cancer
Centro Nacional Investigaciones Oncológicas (CNIO)0 个研究点开始时间: 2016年2月17日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Patients who are 18 years or older;
- •2. Histologically or cytologically confirmed metastatic adenocarcinoma of the pancreas.
- •3. One or more metastatic tumor sites that are amenable for biopsy.
- •4. Measurable or evaluable disease.
- •5. Patients must have received either no previous radiotherapy, surgery, chemotherapy or investigational therapy for the treatment of metastatic disease or be within the first 3 cycles of first line chemotherapy. Palliative radiotherapy for bone metastasis is allowed.
- •6. Adequate blood counts at baseline (obtained <=14 days prior to randomization):
- •- Absolute neutrophil count (ANC) >= 1.5 × 109/L;
- •- Platelet count >= 100,000/mm3 (100 × 109/L);
- •- Hemoglobin (Hgb) >= 9 g/dL.
- •7. Patient has the following blood chemistry levels at baseline:
- •- AST (SGOT), ALT (SGPT) <= 2.5 × upper limit of normal range (ULN), unless liver metastases are clearly present, then <= 5 × ULN is allowed
- •- Total bilirubin <= 1.5 x ULN
- •- Total albumin >= 0.75 ULN
- •- Serum creatinine <= 1.5 x ULN
- •8. Eastern Cooperative Oncology Group (ECOG) performance score of 1 or lower.
- •9. Written informed consent.
- •10. Patient of child-bearing potential (for female patient: study entry after a menstrual period and a negative pregnancy test) must agree to use two medically acceptable methods of contraception during the study and for 4 months after the last study treatment intake for women and 6 months for men.
- •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 100
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 46
排除标准
- •1. Known brain metastases, unless previously treated and well-controlled for at least 3 months.
- •2. Only locally advanced disease.
- •3. History of malignancy in the last 5 years.
- •4. Active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy.
- •5. Contraindication for performing a tumor biopsy.
- •6. Known historical or active infection with HIV, hepatitis B, or hepatitis C.
- •7. High cardiovascular risk, including, but not limited to, recent coronary stenting or myocardial infarction in the past year.
- •8. Serious medical risk factors involving any of the major organ systems, or serious psychiatric disorders, which could compromise the patient's safety or the study data integrity.
- •9. Female patient is pregnant or breast-feeding.
- •10. Unwilling or unable to comply with study procedures. The patients must be agreeable to performing a tumor biopsy if allocated to the interventional arm.
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