NCT00397293已完成1 期
An Open-label, Multicenter, Phase I/II Study of AT-101 in Combination With Topotecan in Patients With Relapsed or Refractory Small Cell Lung Cancer After Prior Platinum Containing First Line Chemotherapy
Ascenta Therapeutics20 个研究点 分布在 4 个国家目标入组 36 人开始时间: 2006年11月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 36
- 试验地点
- 20
- 主要终点
- Number of participants with adverse events.
研究概览
简要总结
This is an open label, multicenter Phase I/II study to evaluate the safety and efficacy of AT-101 in combination with topotecan in relapsed/refractory small cell lung cancer
详细描述
Further Study Details provided by Ascenta:
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 confirmed small cell lung cancer (SCLC). Mixed histology will not be eligible.
- •Progression of disease after only one prior platinum containing chemotherapy regimen. Prior Regimen must not have contained irinotecan
- •All patients must have measurable disease.
- •Patients may have received prior radiation therapy but they must have recovered from all treatment-related toxicities.
- •ECOG performance status 0-1
- •Adequate hematologic function
- •Adequate liver and renal function
- •Ability to swallow oral medication
排除标准
- •Patients with more than one prior regimen of chemotherapy or prior regimen that did not contain a platinum agent. Note: Patient who stopped prior therapy due to toxicity or had less than 2 cycles of platinum based therapy would not be eligible for the phase II portion of this study.
- •Prior chemotherapy regimen containing irinotecan.
- •Active secondary malignancy.
- •Unstable or progressive brain metastases.
- •Prior history of radiation therapy to > 25% of the bone marrow.
- •Uncontrolled concurrent illness including, but not limited to: serious uncontrolled infection, symptomatic congestive heart failure (CHF), unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with the study requirements.
- •Failure to recover from toxicities related to prior therapy (e.g., surgery, radiation, chemotherapy).
结局指标
主要结局
Number of participants with adverse events.
时间窗: 13 months
次要结局
- complete or partial remission of disease(16 months)
研究者
研究点 (20)
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