A Phase 1 Trial of Amplimexon® (Imexon, Inj.) Plus Taxotere® (Docetaxel) in Previously Treated Inoperable Stage III and Stage IV Non-Small Cell Lung Cancer (NSCLC), Locally Advanced or Metastatic Previously Treated Breast Cancer or Hormone Refractory Prostate Cancer
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Determine the tolerability
研究概览
简要总结
Protocol AMP-010 is a Phase 1b study of imexon plus docetaxel for patients with previously treated breast cancer, previously treated lung cancer or hormone refractory prostate cancer. Docetaxel is approved by the Food and Drug Administration (FDA) as a second line therapy for these cancers. The imexon is administered on days 1-5 and the docetaxel on day 1 of every 3 week cycle. The objective of the protocol is to determine the highest dose of imexon which can be given with a full dose of docetaxel, and to provide information to enable the design of a future study focused on one or more specific cancer types.
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
- •Be diagnosed with previously treated breast, lung, or prostate cancer where docetaxel is indicated.
- •Prior treatment; at least one prior regimen required.
- •Able to perform the activities of daily living.
- •Off prior cancer therapy for at least 4 weeks.
- •If female neither pregnant nor nursing.
- •Willing to use contraceptives to prevent pregnancy.
- •No other serious illnesses.
- •No other active malignancy.
- •No serious infections.
- •No other current drug therapy for the cancer.
- •Blood counts and blood chemistries in or near normal range.
- •Prior radiation is permitted.
排除标准
- •Active brain metastases.
研究组 & 干预措施
A
Docetaxel plus imexon
干预措施: imexon (Drug)
A
Docetaxel plus imexon
干预措施: docetaxel (Drug)
结局指标
主要结局
Determine the tolerability
时间窗: duration of study
determine the maximally tolerated dose (MTD)
时间窗: duration of study
determine the dose limiting toxicities (DLT) of increasing doses of imexon in combination with standard doses of docetaxel
时间窗: duration of study
correlate changes in plasma glutathione (GSH) levels with imexon dose levels
时间窗: cycle 1
次要结局
- Record any objective tumor responses which may occur(duration of study)