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临床试验/PER-035-02
PER-035-02已完成未知

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

SCHERING PLOUGH RESEARCH INSTITUTE,0 个研究点目标入组 0 人开始时间: 2002年5月9日最近更新:

试验速览

阶段
未知
状态
已完成

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

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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