NCT00050336终止3 期
A Phase 3 Randomized Study of Lonafarnib in Combination With Paclitaxel and Carboplatin vs. Placebo in Combination With Paclitaxel and Carboplatin in Patients With Non-Small Cell Lung Cancer
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 702
研究概览
简要总结
The purpose of this study is to determine the overall survival of patients diagnosed with Stage 3b or 4 non-small cell lung cancer (NSCLC) treated with an oral Farnesyl Protein Transferase Inhibitor (Lonafarnib/SCH 66336) in combination with paclitaxel and carboplatin with that of patients treated with placebo in combination with paclitaxel and 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
- Single
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
- •Male or female
- •Histologically or cytologically 3b or 4 (metastatic) non-small cell lung cancer. Patients must meet any subcriteria as detailed in the protocol.
- •Age greater than or equal to 18 years old
- •ECOG performance status of 0 to 1
- •Prior diagnosis of brain metastases from NSCLC eligible provided that the brain metastases have been adequately treated, patient is neurologically stable and no new or progressive brain metastases identified.
- •Meets protocol requirements for specified laboratory values
- •Written informed consent
- •Appropriate use of effective contraception if of childbearing potential
- •Prior basal cell carcinoma or carcinoma in-situ of the cervix are eligible provided they have been treated with no evidence of disease
排除标准
- •Prior chemotherapy for any stage of NSCLC
- •Prior surgery or radiation therapy within the last 2 weeks or incomplete recovery from prior procedures or therapy
- •Concurrent treatment or treatment within the last 2 years for any other malignancy
- •Grade 2 or greater nausea or Grade 1 or greater vomiting (despite antiemetic medication)
- •Medical conditions that would interfere with taking oral medications
- •Patients with bone metastases as the only site of disease
- •Pregnant or nursing women
- •Known HIV positivity or AIDS-related illness
- •Patients with significant QTc prolongation at baseline
研究者
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Study of Lonafarnib in Combination With Paclitaxel and Carboplatin in Patients With Non-Small Cell Lung Cancer (Study P01901)PER-035-02SCHERING PLOUGH RESEARCH INSTITUTE,
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