A Study of Ridaforolimus in Non-Small Cell Lung Cancer (NSCLC) Patients With Kirsten Rat Sarcoma Viral Oncogene Homolog (KRAS) Mutations (MK-8669-021 AM1)
2015年1月19日 更新者：Merck Sharp & Dohme LLC
A Randomized Discontinuation Phase II Trial of Ridaforolimus in Non-Small Cell Lung Cancer (NSCLC) Patients With KRAS Mutations
This is a randomized discontinuation study of ridaforolimus in patients with advanced NSCLC who have failed at least 1 but no more than 3 prior treatment regimens and who have KRAS mutant lung cancer.
Following 8 weeks of open-label ridaforolimus lead-in there will be an assessment of disease status.
Patients assessed by the investigator to have stable disease after 8 weeks will be randomized to double-blind treatment with ridaforolimus or placebo.
Patients assessed to have partial or complete response will continue on open-label ridaforolimus.
Patients assessed to have disease progression will be discontinued from study.
研究概览
地位
终止
条件
详细说明
Allocation and Arms Additional Information: All Patients will receive an 8-week
open-label lead-in treatment of ridaforolimus. After this 8 week period patients will be re-assessed for disease status. Patients who are stable after 8 weeks are randomized in a double-blind fashion to continue treatment with ridaforolimus or to a placebo until disease progression. (Those patients who have stable disease but are randomized to placebo may cross-over to open-label ridaforolimus at the time of disease progression.)
Those patients with tumor shrinkage during the open-label lead-in treatment will continue on open-label ridaforolimus, while those patients who have disease progression at 8-weeks are taken off-study.
研究类型
介入性
注册 (实际的)
80
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:
- Patient has histologically confirmed stage IIIB/IV non-small cell lung cancer
- Patient has a documented mutation of the KRAS gene
- Patient has evidence of disease progression following 1 but no more than 3 prior chemotherapy regimens
- A minimum of 4 weeks has passed since the most recent anti-cancer treatment
- Women of childbearing potential must have a negative pregnancy test prior to start of therapy and must use an approved contraceptive method for the duration of the study
- Patient has adequate organ function
- Patient has performance status of <=2 on Eastern Cooperative Oncology Group (ECOG) performance scale
- Patient is >=18 years of age
Exclusion Criteria:
- Patient has received more than 2 prior chemotherapy regimens for the treatment lung cancer
- Patient is known to have active brain metastases
- Patient is currently participating or has participated in an investigational drug study within 30 days
- Patient is known to be Human Immunodeficiency Virus (HIV) positive or has a known history of Hepatitis B or C
- Patient has an active infection requiring prescribed intervention
- Patient has newly diagnosed or un-controlled Type 1 or 2 diabetes
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：随机化
- 介入模型：并行分配
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
安慰剂比较：安慰剂
|
Four 10mg tablets of ridaforolimus once daily for five consecutive days each week followed by 2 days days of treatment holiday, during the 8 week lead in treatment period.
其他名称：
Four tablets of blinded placebo (to match ridaforolimus) administered daily for 5 consecutive days each week followed by 2 days of treatment holiday
|
|
实验性的：Ridaforolimus
|
Four 10mg tablets of ridaforolimus once daily for five consecutive days each week followed by 2 days days of treatment holiday, during the 8 week lead in treatment period.
其他名称：
Four tablets of blinded ridaforolimus administered daily for 5 consecutive days each week followed by 2 days days of treatment holiday
其他名称：
|
研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
Progression-free survival (PFS) in the randomized population
大体时间：Randomization (Week 8) and every 8 weeks until progressive disease or death
|
Randomization (Week 8) and every 8 weeks until progressive disease or death
|
次要结果测量
结果测量 |
大体时间 |
|---|---|
|
Overall response rate (ORR) in the full analysis population
大体时间：Study entry (Visit 1) and every 8 weeks until progressive disease or death
|
Study entry (Visit 1) and every 8 weeks until progressive disease or death
|
|
Overall survival (OS) in the full analysis population
大体时间：From study entry (Visit 1) to death due to any cause
|
From study entry (Visit 1) to death due to any cause
|
|
OS in the randomized population
大体时间：From study entry (Visit 1) to death due to any cause
|
From study entry (Visit 1) to death due to any cause
|
|
PFS in the full analysis population
大体时间：Study entry (Visit 1) and every 8 weeks until progressive disease or death
|
Study entry (Visit 1) and every 8 weeks until progressive disease or death
|
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
2009年3月1日
初级完成 (实际的)
2012年8月1日
研究完成 (实际的)
2012年8月1日
研究注册日期
首次提交
2009年1月7日
首先提交符合 QC 标准的
2009年1月7日
首次发布 (估计)
2009年1月8日
研究记录更新
最后更新发布 (估计)
2015年1月21日
上次提交的符合 QC 标准的更新
2015年1月19日
最后验证
2015年1月1日
更多信息
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