NCT00073450终止2 期
An Open-Label Phase 2 Study of Lonafarnib in Patients With Recurrent Squamous Cell Carcinoma of the Head and Neck
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 15
研究概览
简要总结
The purpose of this study is to determine the safety and efficacy of an oral Farnesyl Protein Transferase Inhibitor (Lonafarnib/SCH 6636) as a single agent in Adult Patients With Squamous Cell Carcinoma of the Head & Neck and will help determine if further development is justified.
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
- Treatment
- 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
- •Histologically or cytologically proven squamous cell carcinoma of the head & neck.
- •Age greater than or equal to
- •ECOG performance status of 0 to 1
- •Measurable malignant disease.
- •Patients that have failed at least one platinum-containing regimen and have received no more than three prior regimens and do not have other curative treatment options.
- •Patients must be at least 2 wks post surgery or radiation therapy
- •Patients must be at least 4 weeks post chemotherapy
- •Meets protocol requirements for specified laboratory values.
- •Written informed consent and cooperation of patient.
- •Appropriate use of effective contraception if of childbearing potential.
- •No investigational drugs of any type within 30 days prior to administration.
排除标准
- •Prior exposure to farnesyl transferase inhibitors
- •Medical conditions that would interfere with taking oral medications.
- •Patients with significant QTc prolongation at baseline (>500 msec.)
- •Pregnant or nursing women
- •Known HIV positivity or AIDS-related illness.
- •Concomitant chemotherapy, hormonal therapy, radiotherapy or immunotherapy
- •Patients with any signs of involvement of the dura, meninges, or brain.
- •Patients with squamous cell carcinoma of the nasopharynx
- •Patients who currently have other cancers or have been treated in the last 5 years for any other malignancy.
研究者
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