NCT02098291已完成2 期
Phase II, Open, Single-center Study to Determine the Antibody Response to Gastrimmune and Its Safety and Tolerability in Patients With Advanced Pancreatic Carcinoma
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 34
- 主要终点
- Pharmacodynamic
研究概览
简要总结
This study was designed to determine the effect of jaundice on the ability of G17DT to generate antibodies before and after treatment of biliary obstruction due to advanced pancreatic cancer.
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 histological or cytological confirmation of pancreatic carcinoma who were not suitable for pancreatic tumour resection with curative intent
- •Patients who had not received chemotherapy in the previous month and who would either not receive chemotherapy in the period of study or who would commence gemcitabine treatment in week 4 of the study
- •Male or female patients over 18 years of age
- •Patients with a life expectancy of at least 2 months
- •Patients must have given written informed consent
- •Patients with a Karnofsky Performance Status score of ≥ 50%
- •Patients who would not receive chemotherapy in the period of the Extension Survival Study, except for concomitant gemcitabine ongoing at visit (for extension study)
排除标准
- •History of other malignant disease except non-melanomatous skin carcinoma or in situ carcinoma of the uterine cervix
- •Concomitant use or anticipated use in the period of the study of radiotherapy
- •Chemotherapy in the previous month preceding screening, anticipated concomitant use of chemotherapy between screening and week 4 of the study or anticipated useof chemotherapeutic agents other than gemcitabine from week 4 for the period of the study
- •Use in the past month or 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 enrolment or during the study
- •Haematological indicators:
- •Haemoglobin <9.5g/dl White blood cell count <3.5 x 109/l Platelets <100 x 109/l
研究组 & 干预措施
G17DT
Experimental
干预措施: G17DT (Drug)
结局指标
主要结局
Pharmacodynamic
时间窗: Up to week 16
Anti-Gastrin 17 antibodies were determined at baseline (week0) and measured at subsequent visits during the first 16 weeks after the first G17DT injection to determine the effect of jaundice on the ability of patients to generate antibodies.
次要结局
- Patient Survival(Up to week 139)
- Number of Participants with Serious and Non-Serious Adverse Events(Up to week 60)
研究者
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