NCT02228785终止2 期
Study of the Safety and Tolerance of Three Doses of G17DT in Patients With Metastatic Colorectal Cancer.
适应症
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 5
- 主要终点
- Antibody Levels
研究概览
简要总结
This study was designed to investigate the safety and tolerance of three doses (100µg, 200µg, 500µg) of G17DT for the treatment of patients with colorectal cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Patients aged 18 years or over with histologically verified adenocarcinoma of colon or rectum.
- •Recurrent of metastatic disease not amenable to curative surgery and/or radiotherapy.
- •Life expectancy greater than 3 months.
- •Karnofsky Index Score greater than or equal to 50%.
- •Written informed consent obtained.
排除标准
- •Neoplastic lesions other than colorectal cancer (except treated basal cell carcinoma of the skin or cancer of the uterine cervix, through Stage I.
- •Acute intercurrent illness.
- •Patient considered to be a medical risk because of non-malignant systemic disease or grossly abnormal laboratory results.
- •Patients who had received any other anticancer therapy within 3 months.
- •Factor liable to alter the serum gastrin concentration or affect intra-gastric acidity, for instance concomitant therapy with H2 receptor antagonist drugs, proton pump inhibitors, or previous gastric surgery.
- •Patients immunologically compromised including those on corticosteroid therapy.
- •Women of child-bearing age.
- •Positive immediate hypersensitivity reaction to skin testing with study medication.
- •Patients unable to complete the diary book
- •Haematogical Status Haemoglobin count less than 10g/dL White Blood Cell count less than 4.0 x 10^9/L Platelet count less than 100 x 10^9/L
结局指标
主要结局
Antibody Levels
时间窗: Through Week 12
Gastrin-17 antibodies are produced as a result of treatment with G17DT and the proportion of patients producing gastrin-17 antibodies was considered to be an appropriate measure of the immunogenicity of the dosing schedule under study.
Injection Site Reaction
时间窗: Through Week 12
An examination was performed to assess injection site tolerability at every posttreatment visit.
次要结局
- Intra-gastric pH(Through Week 8)
研究者
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