NCT00544960已完成2 期
A Phase 2, Randomized, 2-Arm, Double-Blind Study of AT-101 in Combination With Docetaxel Versus Docetaxel Plus Placebo in Patients With Relapsed or Refractory Non-Small Cell Lung Cancer (NSCLC)
Ascenta Therapeutics2 个研究点 分布在 2 个国家目标入组 106 人开始时间: 2007年9月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 106
- 试验地点
- 2
- 主要终点
- duration of disease remission
研究概览
简要总结
This is a double- blind, multicenter, randomized Phase II study to evaluate the efficacy and safety of AT-101 in combination with docetaxel in relapsed/refractory non-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
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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 Stage IIIb with pleural/pericardial effusion or Stage IV non-small cell lung cancer (NSCLC).
- •Progression of disease after one prior systemic chemotherapeutic regimen for locally advanced or metastatic NSCLC. (Systemic therapies given in the adjuvant setting are counted only if the patient relapses within 6 months of the last cycle of therapy.) In addition to the one prior chemotherapeutic regimen, patients may have received erlotinib in any setting.
- •All patients must have measurable disease.
- •No unstable or progressive brain metastases.
- •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
- •Prior chemotherapy regimen containing docetaxel.
- •Active secondary malignancy.
- •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).
研究组 & 干预措施
1
Experimental
AT-101 and docetaxel
干预措施: AT-101 and docetaxel (Drug)
2
Placebo Comparator
placebo and docetaxel
干预措施: placebo and docetaxel (Drug)
结局指标
主要结局
duration of disease remission
时间窗: 12 months
次要结局
- number of participants with adverse events(12 months)
研究者
研究点 (2)
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