A Study of Herceptin (Trastuzumab) in Patients With Metastatic or Advanced Gastric Cancer With Disease Progression
2014年7月23日 更新者：Hoffmann-La Roche
An Open-label Pilot Study of Herceptin Monotherapy on Objective Treatment Response in Patients With Metastatic or Locally Advanced Gastric Cancer Who Had Disease Progression During Platinum-based or 5-fluoropyrimidine-based Chemotherapy
This study will evaluate the efficacy and safety of Herceptin in patients with metastatic or advanced gastric cancer with disease progression during platinum-based or 5-fluoropyrimidine-based chemotherapy.
The anticipated time on study treatment is until disease progression.
研究概览
研究类型
介入性
注册 (实际的)
6
阶段
- 阶段2
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。
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 至 75年 (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:
- adult patients 18-75 years of age;
- metastatic or advanced gastric cancer;
- disease progression under or after 1 prior platinum-based or 5-fluoropyrimidine-based chemotherapy for metastatic disease;
- >=4 weeks from last platinum-based or fluoropyrimidine-based chemotherapy;
- >=1 measurable lesion;
- HER2 overexpression (IHC [2+] or [3+]).
Exclusion Criteria:
- concurrent chemotherapy or immunotherapy;
- brain or meningeal metastases;
- clinically significant cardiac disease, advanced pulmonary disease or severe dyspnoea;
- co-existing malignancies or malignancies diagnosed within last 5 years, except basal cell cancer or cervical cancer in situ;
- women who are pregnant or breastfeeding.
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：非随机化
- 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：Trastuzumab Monotherapy
Initial dose of 4 milligrams (mg) per (/) kilogram (kg) by body weight (BW), followed by 2 mg/kg BW at each subsequent visit
|
4 mg/kg initial dose, followed by 2 mg/kg
其他名称：
|
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 |
|---|---|---|
|
Percentage of Participants With a Response by Response Evaluation Criteria In Solid Tumors (RECIST) Category
大体时间：Weekly throughout study
|
Tumor response assessed according to RECIST.
Complete response (CR): complete disappearance of all target and non-target lesions, with exception of nodal disease.
All nodes, both target and non-target, must decrease to normal (short axis less than [<]10 millimeters [mm]); no new lesions.
Partial response (PR): greater than or equal to (≥)30 percent (%) decrease under baseline of sum of diameters of all target lesions.
Short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions; no unequivocal progression of non-target disease; no new lesions.
Stable disease (SD): not qualifying for CR, PR, or progressive disease (PD).
Participants who could not be classified per RECIST were allocated as follows: early death from malignant disease (death due to cancer), early death because of other cause (death not related to toxicity or cancer disease), and unknown (for not fitting into the above categories).
|
Weekly throughout study
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Percentage of Participants With Clinical Benefit
大体时间：Weekly throughout the study
|
Participants were classified as having a clinical benefit if they had a best overall tumor response of CR, PR, or SD.
Tumor response assessed according to RECIST.
CR: complete disappearance of all target and non-target lesions, with exception of nodal disease.
All nodes, both target and non-target, must decrease to normal (short axis <10 mm); no new lesions.
PR: ≥30% decrease under baseline of sum of diameters of all target lesions.
Short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions; no unequivocal progression of non-target disease; no new lesions.
Stable SD: not qualifying for CR, PR, or PD.
|
Weekly throughout the study
|
|
Percentage of Participants With a Best Overall Response of CR or PR
大体时间：Weekly throughout the study
|
Tumor response assessed according to RECIST.
CR: complete disappearance of all target and non-target lesions, with exception of nodal disease.
All nodes, both target and non-target, must decrease to normal (short axis <10 mm); no new lesions.
PR: ≥30% decrease under baseline of sum of diameters of all target lesions.
Short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions; no unequivocal progression of non-target disease; no new lesions.
|
Weekly throughout the study
|
|
Overall Survival - Number of Participants Who Died
大体时间：Weekly throughout the study
|
OS was defined as the time, in months, from the date of study entry to the date of the death due to any cause.
If a participant's date of death was unknown, or had not occurred, the last date of examination, treatment, and follow-up dates were included in the analysis.
|
Weekly throughout the study
|
|
Overall Survival
大体时间：Weekly throughout the study
|
Overall survival (OS) was defined as the time, in months, from the date of study entry to the date of the death due to any cause.
If a participant's date of death was unknown, or had not occurred, the last date of examination, treatment, and follow-up dates were included in the analysis.
|
Weekly throughout the study
|
|
Time to Progression - Number of Participants With an Event
大体时间：Weekly throughout the study
|
Time to progression was defined as the time, in months, from the date of study entry to the date of disease progression or death due to any cause.
If a participant's date of disease progression or death was unknown, or had not occurred, the last date of examination, treatment, and follow-up dates were included in the analysis.
|
Weekly throughout the study
|
|
Time to Progression
大体时间：Weekly throughout the study
|
Time to progression was defined as the time, in months, from the date of study entry to the date of disease progression or death due to any cause.
If a participant's date of disease progression or death was unknown, or had not occurred, the last date of examination, treatment, and follow-up dates were included in the analysis.
|
Weekly throughout the study
|
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
2004年1月1日
初级完成 (实际的)
2008年2月1日
研究完成 (实际的)
2008年2月1日
研究注册日期
首次提交
2013年12月4日
首先提交符合 QC 标准的
2013年12月4日
首次发布 (估计)
2013年12月9日
研究记录更新
最后更新发布 (估计)
2014年8月11日
上次提交的符合 QC 标准的更新
2014年7月23日
最后验证
2014年7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.