NCT00531401已完成2 期
Salirasib for Treatment of Advanced Non-Small Cell Lung Cancer: a Phase II Study
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 71
- 试验地点
- 1
- 主要终点
- Rate of non-progression (as reflected in the tumor control rate of percent patients with CR+PR+SD) defined as the number of patients whose tumor did not progress (<20% tumor increase to total disappearance of tumor according to RECIST)
研究概览
简要总结
The purpose of this study is to determine whether Salirasib is effective to shrink or prevent the growth of the tumors associated with non-small cell lung cancer in both patients who are newly diagnosed or have recurrent disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
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
- •Age 18 or older
- •Non-Small Cell Lung Cancer not amenable to curative therapy with surgery or radiation
- •Measurable disease
- •Adenocarinoma of the lung, have not received prior chemotherapy for the malignancy and has a ≥ 15 pack year history of smoking; OR previously treated with recurrent disease and documented KRAS mutation
- •Last dose of radiotherapy > 3 weeks prior to study entry and recovered from all acute toxicities associated with the prior therapy
- •No history of another malignancy in the past 5 years except treated non-melanomatous skin cancer or superficial bladder cancer or carcinoma-in-situ of the cervix
- •Karnofsky Performance status of 70 or greater
- •Body Weight > 50 kg
- •Life expectancy ≥ 3 months
- •Serum Creatinine ≤2.0 mg/dL, total bilirubin ≤ 2.0 mg/dL, ALT and AST ≤ 3x ULN, alkaline phosphatase ≤ 5x ULN, WBC > 3000/mm³, ANC ≥ 1500/mm³, platelets ≥ 100,000/mm³, hemoglobin ≥ 10g/dL.
- •No coexisting cardiac or medical problems that would limit compliance in the study
- •Willing to undergo blood sampling for pharmacokinetic analysis
- •Negative pregnancy test, if applicable
排除标准
- •Evidence of active heart disease including myocardial infarction within previous 3 months
- •Active infectious process
- •Active central nervous system metastases (requiring increasing doses of corticosteroids over the prior month, known progressing lesions)
- •Pregnant or lactating
- •Major surgery without full recovery or major surgery within 3 weeks prior to treatment start
- •QTc Interval > 470 msec
- •Gastrointestinal tract disease resulting in inability to take or absorb oral medications
结局指标
主要结局
Rate of non-progression (as reflected in the tumor control rate of percent patients with CR+PR+SD) defined as the number of patients whose tumor did not progress (<20% tumor increase to total disappearance of tumor according to RECIST)
时间窗: 10 weeks
次要结局
未报告次要终点
研究者
研究点 (1)
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