NCT00473889终止2 期
A Phase II/III Randomized, Double-Blind Study of Paclitaxel Plus Carboplatin in Combination With Vorinostat or Placebo in Patients With Stage IIIB (With Pleural Effusion) or Stage IV Non-Small-Cell Lung Cancer (NSCLC)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 253
- 主要终点
- Overall Survival
研究概览
简要总结
This Phase III clinical trial which incorporates an initial Phase II component will determine the survival of advanced Non-small cell lung cancer patients when treated with MK0683 and paclitaxel plus carboplatin
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
- •Males and females at least 18 years of age who have confirmed diagnosis of Non-small Cell Lung Cancer
- •Patients with no systemic prior systemic treatment for lung cancer except patients at least 12 months from prior adjuvant therapy
- •Adequate bone marrow,kidney and liver function
- •Must be recovered and at least 4 weeks from major surgery or radiation
- •ECOG (Eastern Cooperative Oncology Group) performance status of 0 or 1
- •Men and women must agree to use birth control during the study
- •Women able to have children must have a negative pregnancy test 14 days before study enrollment
排除标准
- •Patients with prior treatment with other investigational agents less than 4 weeks before study enrollment
- •Pregnant or nursing female patients
- •Patients who are HIV positive
- •Patients who have Hepatitis A, B, or C
- •Patients unable to take study medication by mouth
- •Patients with untreated brain cancer
- •Patient eligible for treatment with bevacizumab and for whom bevacizumab is available
研究组 & 干预措施
1
Experimental
vorinostat; IV paclitaxel; IV carboplatin
干预措施: vorinostat (Drug)
结局指标
主要结局
Overall Survival
时间窗: Start of treatment to death
Defined as the time from date of randomization to death due to any cause. Patients without documented death at the time of the final analysis will be censored at the date of the last follow-up.
次要结局
- Progression Free Survival(Start of treatment to disease progression or death)
- Number of Participants Who Had a Disease Response to Treatment(Every 42 days from start of treatment until disease response)
研究者
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