An Open, Multi-center Study to Determine the Antibody Response to 500µg G17DT Given at Weeks 0, 2, and 6 in the Treatment of Patients With Gastric Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Antibody Levels
研究概览
简要总结
This study was designed to investigate the antibody response generated by a 500µg dose of G17DT in patients with gastric cancer.
详细描述
Another study, GC2, initiated prior to the start of this study investigated the appropriate dose and dosing schedule for G17DT in patients with Stage I-III gastric cancer. The highest dose tested in the GC2 study was 250µg. This dose was well tolerated but was not considered sufficiently immunogenic. Since tolerability had not constrained dosing up to 250µg, the GC5 study was designed to investigate a 500µg dose administered as a regimen of 0, 2, and 6 weeks.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with histologically confirmed UICC Stage I, II or III gastric adenocarcinoma.
- •Patients must have had a macroscopically curative resection for gastric cancer with absence of metastatic disease at the time of entry to the trial.
- •Male or Female patients aged 18 years or older.
- •Life expectancy of at least 3 months.
- •WHO Performance Status of 0 to
- •Written informed consent
排除标准
- •Gastric surgery within four weeks of baseline (Week 0, visit 2) or gastric surgery anticipated during the period of the study.
- •History of other malignant disease within the previous five years, except nonmelanomatous skin cancer or in situ carcinoma of the uterine cervix.
- •Previous use within the last four weeks, concomitant use of anticipated use in the period of study, of any anti-cancer therapies.
- •Concomitant use of immunosuppressants, including systemic (i.e. oral or injected) corticosteroids.
- •Females who were pregnant, planning to become pregnant or lactating.
- •Patients taking part in another study involving an investigational or licensed drug or device in the three months preceding enrollment or during this study.
- •Previous G17DT treatment.
- •Haematologicial indicators:
- •Haemoglobin (Hb) < 10g/dL White blood cell count (WBC) < 4.0 x 10^9/L Platelets < 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: Up to Week 12
A physical examination for the presence of an abscess at the injection site was performed on each patient to assess tolerability to treatment at every posttreatment visit from Week 0 to Week 12.
Change in Subject's World Health Organization Performance Status
时间窗: Through Week 12
The subject's WHO performance status was evaluated at each visit up to Week 12 to assess changes in subject's ability complete normal daily activities.
次要结局
- Overall Survival(From date of randomization up to Week 24 or until death)
- Adverse Events(Through week 12)