NCT02181465已完成2 期
Phase II, Open Label, Single Center, Two Arm Study Study to Assess the Safety, Tolerance and Efficacy of a 2 mg Dose of G17DT Via Intramuscular Injection in Patients With Advanced Metastatic Colorectal Adenocarcinoma.
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- Number of participants with adverse effects
研究概览
简要总结
Pancreatic, gastric, and colorectal cancers have all been shown to overexpress the gastrin gene and to be sensitive to the trophic effects of the gastrin in animal models. The hypothesis of this study is that G17DT will elicit specific and high-affinity antibodies that will bind gastrin-17, thus preventing the trophic activity of cancer cells.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 81 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically verified adenocarcinoma of the colon or rectum
- •Recurrent/ metastatic disease not amenable to curative surgery and/or radiotherapy
- •measurable/ evaluable lesions
- •Life expectancy > 3 months
- •Karnofsky index > 50% or WHO performance rating of 0-2
- •Biochemical markers:
- •renal function < 25% above upper limit of normal range (creatinine, 140 imol/1 unless malignant involvement proven)
- •liver function < 25% above upper limit of normal range (bilirubin ~25 mcmol/1 unless malignant involvement proven)
- •Haematological status:
- •haemoglobin, 11 g/ dl
- •WBC, 4 X 109/1
- •platelets, 100 x 109/l
- •Written consent
排除标准
- •Other concomitant malignant disease except treated basal cell carcinoma of the skin or cancer of the uterine cervix stage 0-1
- •H 2 receptor antagonist or proton pump inhibitor therapy
- •Previous gastric surgery (including vagotomy)
- •Active uncontrolled infection
- •Autoimmune disorders
- •Anticancer treatment within the last three months unless progression of the disease occurred in the interim
- •Women of child-bearing age
- •Patient is a poor medical risk because of non-malignant systemic disease
- •Previous radiotherapy to all measurable or evaluable lesions.
结局指标
主要结局
Number of participants with adverse effects
时间窗: Up to week 16
次要结局
- Measure serum anti gastrin-17 antibodies to determine immunological response to medication(Up to week 16)
研究者
研究点 (1)
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