An Open-label, Dose-finding, Schedule-changing, Multi-center Study to Determine the Antibody Response to G17DT Treatment of Patients With Gastric Cancer.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 33
- 主要终点
- Antibody Levels
研究概览
简要总结
An open label, dose-finding, schedule-changing, sequential, multiple dose, multi-center study in patients with Stage I-III gastric cancer. The first group of patients received a starting dose of 250 µg at weeks 0, 1, and 3. Thereafter, allocation to treatment with 100 µg or 500 µg was based on antibody response and dose tolerability.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed UICC Stage I, II or III gastric adenocarcinoma. 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 and over 18 years of age
- •Must have a life expectancy of at least three months
- •World Health Organization Performance Status of 0 to 1
- •Given written conformed consent
排除标准
- •Gastric surgery within four weeks of baseline (week 0) or gastric surgery anticipated in the period of the study
- •History of other malignant disease within the previous five years, except non-melanomatous skin cancer or in situ carcinoma of the uterine cervix
- •Previous use within the last four weeks, concomitant use or anticipated use in the period of the study, of any anti-cancer therapies
- •Concomitant use of immunosuppressants, including systemic (i.e. oral or injected) corticosteroids
- •Females who pregnant, planning to become pregnant or lactating
- •Taking part in another study involving an investigational or licensed drug or device in the three months preceding enrollment or during this study
- •Previously received G17DT treatment
- •Haemoglobin (Hb) < 10.0 g/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: Up to Week 24
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
An examination was performed to assess injection site tolerability at every posttreatment visit from Week 1 to Week 12 (end of core phase).
World Health Organization (WHO) Performance Status
时间窗: Up to Week 12
WHO performance status was monitored up to Week 12 to compare final status with baseline status.
Diptheria Toxoid Antibody Levels
时间窗: Up to Week 12
Diptheria toxoid antibody levels were measured at screening and at Week 12 to assess toxicity from Diptheria toxoid.
次要结局
- Adverse Events(Up to Week 24)