An Open, Multiple Dose, Single Centre Study to Determine the Antibody Response to G17DT in Patients With Advanced Pancreatic Cancer.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 41
- 主要终点
- Patient Survival
研究概览
简要总结
The study was designed to assess the effect of jaundice on the ability of G17DT to generate antibodies before and after treatment of biliary obstruction due to advances pancreatic cancer.
详细描述
Jaundiced patients with advanced pancreatic cancer (either locally, advanced or metastatic) were treated with G17DT either immediately (Group A), or following biliary stenting when jaundice had resolved (Group B). Patients not jaundiced at time of presentation were to enter Group B. Patients received 3 Intramuscular injections of G17DT at weeks 0, 1, and 3. A booster injection was offered to patients who had measurable anit-G17Dt antibodies but had anti-G17DT antibodies that fell below a pre-specified threshold after week 23. Patients were evaluated until study closure ort until patient death.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with a pancreatic adenocarcinoma (cytologically or histologically proven), not suitable for a potentially curative resection.
- •If patients were jaundiced, bilirubin had to be >80 μmol/L.
- •Male or female patients over 18 years of age.
- •World Health Organization (WHO) performance status of 0 to
- •Patients with a life expectancy of at least 8 weeks.
- •Patients must have given written informed consent.
排除标准
- •Patients undergoing a potentially curative resection.
- •Jaundiced patients with a bilirubin value <80 μmol/L.
- •Patients not considered fit for endoscopic or percutaneous biliary stenting.
- •Patients receiving any other anti-cancer therapy.
- •History of other malignant disease except non-melanomatous skin cancer or in situ carcinoma of the cervix.
- •Females who were pregnant, planning to become pregnant, or who were lactating.
- •Patients taking part in another study involving an investigational or licensed drug or device in the three months preceding enrolment or during this study.
- •Previous G17DT treatment.
- •Haematological indicators:
- •Haemoglobin (Hb) <10.0 g/dL. White cell count (WCC) <4.0×109/L. Platelets <100×109/L.
研究组 & 干预措施
Group A
Jaundiced patients with bilirubin value >80 μmol/L. Received G17DT immediately prior to biliary stenting.
干预措施: G17DT (Drug)
Group B
Patients to be treated following biliary decompression or for immediate treatment if non-jaundiced. Received G17DT 2 weeks after biliary stenting when bilirubin was <40 μmol/L.
干预措施: G17DT (Drug)
结局指标
主要结局
Patient Survival
时间窗: Up to week 139
The vital status of patients was monitored throughout the study and was followed until death or the end of the study.
Pharmacodynamic
时间窗: Weeks 0, 1,3,4,6,8,12, 16+
Gastrin-17 antibodies were measured at baseline (Week 0) and measured at each post-treatment visit.
次要结局
- Injection Tolerability(Up to Week 16)