NCT01017601终止2 期
A Randomized Double-Blinded Phase II Study of NTX-010, a Replication-Competent Picornavirus, After Standard Platinum-Containing Cytoreductive Induction Chemotherapy in Patients With Extensive Stage Small Cell Lung Cancer
适应症
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 59
- 试验地点
- 392
- 主要终点
- Progression-free Survival
研究概览
简要总结
RATIONALE: A virus called Seneca Valley virus-001 (NTX-010) may be able to kill tumor cells without damaging normal cells. It is not yet known whether NTX-010 is more effective than a placebo in treating small cell lung cancer.
PURPOSE: This randomized phase II trial is studying NTX-010 to see how well it works compared with a placebo when given after chemotherapy in treating patients with extensive-stage small cell lung cancer.
详细描述
OBJECTIVES:
Primary
- To compare the progression-free survival (PFS) of patients with extensive-stage small cell lung cancer treated with Seneca Valley virus-001 (NTX-010) vs placebo.
Secondary
- To compare the overall survival (OS) of patients treated with NTX-010 vs placebo.
- To describe the adverse events profile and safety of NTX-010 in this patient population.
- To determine the antitumor response rate, as assessed by RECIST criteria, and duration of tumor response in this patient population.
- To assess the quality of life of this patient population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Progression-free Survival
时间窗: Time from randomization to the disease progression or death (up to 5 years)
The progression-free survival (PFS) was defined as the time from date of randomization to the documentation of disease progression or death as a result of any cause, whichever comes first.
次要结局
- Number of Participants With at Least One Grade 3 or Above Adverse Events Assessed by NCI CTCAE v4.0(Up to 23 months)
- Clinical Significance Change From Baseline to Day 30-59 in the LASA QOL(Day 1 Cycle 1 prior to treatment (baseline) and day 30-59 (during the active monitoring phase))
- Overall Survival(Time from randomization to death or last follow-up (up to 5 years))
- Response Rate (Complete Response and Partial Response) as Assessed by Response Evaluation Criteria in Solid Tumors (RECIST)(Up to 5 years)
- Duration of Response(Up to 5 years)
- Change From Baseline to Day 20-29 in the LASA QOL(Day 1 Cycle 1 prior to treatment (baseline) and day 20-29 (during the active monitoring phase))
- Change From Baseline to Day 30-59 in the LASA QOL(Day 1 Cycle 1 prior to treatment (baseline) and day 30-59 (during the active monitoring phase))
- Clinical Significance Change From Baseline to Day 20-29 in the LASA QOL(Day 1 Cycle 1 prior to treatment (baseline) and day 20-29 (during the active monitoring phase))
研究者
研究点 (392)
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