An Open, Single-center Study to Determine the Antibody Repsonse to Gastrimmune and Its Safety and Tolerability in Patients With Advanced Pancreatic Carcinoma (PC1)
2014年3月26日 更新者:Cancer Advances Inc.
Phase II, Open, Single-center Study to Determine the Antibody Response to Gastrimmune and Its Safety and Tolerability in Patients With Advanced Pancreatic Carcinoma
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.
研究概览
研究类型
介入性
注册 (实际的)
34
阶段
- 阶段2
参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:不适用
- 介入模型:单组作业
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
---|---|
实验性的:G17DT
|
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Pharmacodynamic
大体时间: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.
|
Up to week 16
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Patient Survival
大体时间:Up to week 139
|
The vital status was monitored throughout the study and was followed up to the death of the last patient.
|
Up to week 139
|
Number of Participants with Serious and Non-Serious Adverse Events
大体时间:Up to week 60
|
Adverse events, defined as any event involving adverse reactions, illnesses with onset during the study, or exacerbations of pre-exisiting illnesses, were assessed at each visit.
|
Up to week 60
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
1999年4月1日
初级完成 (实际的)
2001年7月1日
研究完成 (实际的)
2002年2月1日
研究注册日期
首次提交
2014年3月12日
首先提交符合 QC 标准的
2014年3月26日
首次发布 (估计)
2014年3月28日
研究记录更新
最后更新发布 (估计)
2014年3月28日
上次提交的符合 QC 标准的更新
2014年3月26日
最后验证
2014年3月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.
G17DT的临床试验
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Cancer Advances Inc.完全的
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Cancer Advances Inc.Clinical Project Services; MPS Research Unit完全的