Gastric Cancer RAD001 Study
2019年3月31日 更新者:CCTU、Chinese University of Hong Kong
Phase I/II Study of Paclitaxel / Carboplatin / RAD001 as First Line Therapy for Advanced Adenocarcinoma of the Stomach
The purpose of this study is to determine dose limiting toxicities (DLT) and maximum tolerated dose (MTD) of RAD001, as well as to assess tumor response and overall survival.
研究概览
研究类型
介入性
注册 (实际的)
35
阶段
- 阶段2
- 阶段1
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习地点
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Hong Kong、香港
- Department of Clinical Oncology, Prince of Wales Hospital
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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:
- Histologically or cytologically proven adenocarcinoma of the stomach. Patients who have adenocarcinoma of the gastroesophageal junction will be eligible if the majority of the tumor bulk is below the junction.
- Metastatic or Loco-regionally advanced disease
- Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as >= 20 mm with conventional techniques or as >= 10 mm with spiral CT /MRI scan. See section 11.2 for the evaluation of measurable disease.
- Age >= 18 years.
- Life expectancy of greater than 12 weeks.
- ECOG performance status <= 2 (Karnofsky >= 60%).
Exclusion Criteria:
- Patients who have received more than one line of palliative chemotherapy are allowed, provided that (i) the prior chemotherapy does not contain taxane, cisplatin or carboplatin; (ii) 4 weeks have elapsed prior to the start of the current study treatment, and that (iii) they have recovered from adverse events due to previous treatment [except alopecia].
- Patients who have had radiotherapy or major surgery within 4 weeks prior to entering the study or those who have not recovered from adverse events due to treatment administered more than 4 weeks earlier.
- Patients who are on CYP3A4 modifiers are excluded from the study
- Patients with known brain metastases.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to RAD001.
Significant cardiovascular disease including unstable angina pectoris, uncontrolled hypertension, congestive heart failure related to primary cardiac disease, a condition requiring anti-arrhythmic therapy, ischemic or severe valvular heart disease, or a myocardial infarction within 6 months prior to the trial entry.
- Patients with severe concurrent medical illness such as severe impairment of lung function should be excluded from studies of RAD001.
- Uncontrolled intercurrent such as, but not limited to, ongoing or active infection, or psychiatric illness/social situations that would limit compliance with study requirements.
- Poorly controlled diabetes mellitus
- High LDL cholesterol or triglyceride level
- Pre-existing neuropathy of >= grade 2
- Patients with a history of second malignancies are eligible they have been disease free for at least 5 years and are deemed by the investigator to be at low risk of recurrence. Par8entswith the following cancers are eligible if diagnosed and treated within the past 5 years: cervical carcinoma in situ, melanoma in situ, and basal cell or squamous cell carcinoma of the skin
- Pregnancy or lactation.
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 |
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实验性的:RAD001
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Pharmacology of RAD001 as a combination partner for conventional agents.
其他名称:
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研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
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to determine the Maximum tolerated dose and dose limiting toxicity of RAD001 in combination with paclitaxel and carboplatin
大体时间:2 years
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2 years
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次要结果测量
结果测量 |
大体时间 |
---|---|
Toxicity of combination Paclitaxel/carboplatin/RAD001 in advanced adenocarcinoma of the stomach and gastroesophageal junction
大体时间:2 Years
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2 Years
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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。
调查人员
- 首席研究员:Winnie Yeo, MD, FRCP、Department of Clinical Oncology, The Chinese University of Hong Kong
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 (实际的)
2008年1月23日
初级完成 (实际的)
2019年3月6日
研究完成 (实际的)
2019年3月6日
研究注册日期
首次提交
2011年11月22日
首先提交符合 QC 标准的
2012年1月17日
首次发布 (估计)
2012年1月20日
研究记录更新
最后更新发布 (实际的)
2019年4月2日
上次提交的符合 QC 标准的更新
2019年3月31日
最后验证
2019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.
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