NCT02417753终止2 期
A Pilot Study of AZD9150, a STAT3 Antisense Oligonucleotide in Malignant Ascites
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- Changes in Immune Parameters in the Malignant Ascites of Patients With Advanced Cancer Following Therapy With AZD9150
研究概览
简要总结
Background:
- Some people with gastrointestinal or ovarian cancer also have ascites. That is free fluid built up in the abdomen. Researchers want to see if a new drug can affect some of the immune cells in the ascites. This may also treat the cancer.
Objective:
- To look at the immune markers the ascites of people with gastrointestinal or ovarian cancer.
Eligibility:
- Adults age 18 and older with a malignancy of the gastrointestinal tract (GI) tract or metastatic ovarian cancer. As a result, they have ascites in the abdomen.
Design:
- Participants will be screened with:
- Medical history, physical exam, and blood tests.
- Echocardiogram: sound waves make images of the heart.
- Electrocardiogram: measures electrical activity of the heart.
- Paracentesis: a needle will be inserted in the abdomen and will remove some of the ascites fluid.
- They may have a tumor biopsy.
- Participants will get AZD9150 through a vein for 3 hours. They will get this 6 times in cycle 1 and 4 times all other cycles. Each cycle is 28 days.
- Each cycle, participants will:
- Have a physical exam.
- Have blood tests weekly.
- Be asked about how they feel and any medicines they are taking.
- After every 2 cycles (about every 2 months), participants will have scans and x-rays of their tumor.
- Participants will have paracentesis 2 more times during the study. They will have another echocardiogram.
- At the end of therapy, participants will have a physical exam and blood tests. They will be asked about how they feel and any medicines they are taking.
详细描述
Background:
- Signal transducer and activator of transcription 3 (STAT)3 is considered to be a promising cancer drug target because of its pleiotropic involvement in tumorigenesis. STAT3 not only regulates the expression of many genes which are directly important for the survival of tumor cells, but it is also an important factor in non-tumor cells in the tumor microenvironment involved in immune evasion of tumor cells, angiogenesis, and metastasis.
- AZD9150 is an antisense oligonucleotide designed to target and down-regulate expression of human STAT3 mRNA.
- By focusing on patients with malignant ascites it will be more feasible for us to sample the tumor environment and to do it more frequently than, for example, conventional tumor tissue biopsies. Malignant ascites is a relatively common occurrence in ovarian and gastrointestinal malignancies, impacting greatly on quality of life.
Objectives:
-To measure changes in immune parameters in the malignant ascites of patients with advanced cancer following therapy with AZD9150.
Select Eligibility:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
AZD9150 in People with Malignant Ascites
Experimental
AZD9150 over a 28 day cycle
干预措施: AZD9150 (Drug)
结局指标
主要结局
Changes in Immune Parameters in the Malignant Ascites of Patients With Advanced Cancer Following Therapy With AZD9150
时间窗: 1.5 years
Participants were to undergo research paracentesis. Ascitic fluid was to be obtained and processed for changes in the percentages of memory cluster of differentiation 8 (CD8) + cells, regulatory T cells, plasmacytoid dendritic cell (pDC), B cells and natural killer (NK) cells will be analyzed by flow cytometry.
次要结局
- Effect on Signal Transducer and Activator of Transcription 3(STAT3)-Dependent & Associated Signaling Both in Tumor Cells, Peripheral Blood and the Microenvironment, Including Modulations in Chemokine and Cytokine Response Following Treatment With AZD9150(1.5 years)
- Reduction in Tyrosine-phosphorylated Signal Transducer and Activator of Transcription 3 (STAT3) Phospho- Signal Transducer and Activator of Transcription 3 (p- STAT3) Expression, Comparing Before and After Therapy, in Ascites and Peripheral Blood(1.5 years)
- Response Rate (RR) in Patients With Malignant Ascites Treated With AZD9150(1.5 years)
- Count of Participants With Serious and Non Serious Adverse Events(4 months and 15 days)
- Progression Free Survival (PFS) in Patients With Malignant Ascites Treated With AZD9150(1.5 years)
- Overall Survival (PFS) in Patients With Malignant Ascites Treated With AZD9150(1.5 years)
研究者
Tim Greten, M.D.
National Cancer Institute
National Institutes of Health Clinical Center (CC)
研究点 (1)
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